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Archive for March, 2009

President of M.D. Anderson Outlines 10 Steps To Achieve Progress Against Cancer.

Posted by Paul Cacciatore on March 31, 2009

“The Houston Chronicle recently published a commentary by John Mendelsohn, M.D., president of M. D. Anderson, outlining actions the nation should take to achieve great progress against cancer. … Here are 10 steps we can take to ensure that deaths decrease more rapidly, the ranks of survivors swell, and an even greater number of cancers are prevented in the first place. …”

“Ten Pieces Help Solve Cancer Puzzle

John Mendelsohn, M.D., President, The University of Texas M.D. Anderson Cancer Center

John Mendelsohn, M.D., President, The University of Texas M.D. Anderson Cancer Center

The Houston Chronicle recently published a commentary by John Mendelsohn, M.D., president of M. D. Anderson, outlining actions the nation should take to achieve great progress against cancer.

An American diagnosed with cancer today is very likely to join the growing ranks of survivors, who are estimated to total 12 million and will reach 18 million by 2020. The five-year survival rate for all forms of cancer combined has risen to 66%, more than double what it was 50 years ago.

Along with the improving five-year survival rates, the cancer death rate has been falling by 1% to 2% annually since 1990.

According to the World Health Organization, cancer will be the leading worldwide cause of death in 2010. Over 40% of Americans will develop cancer during their lifetime.

While survival rates improve and death rates fall, cancer still accounts for one in every five deaths in the U.S., and cost this nation $89.0 billion in direct medical costs and another $18.2 billion in lost productivity during the illness in 2007, according to the National Institutes of Health.

Here are 10 steps we can take to ensure that deaths decrease more rapidly, the ranks of survivors swell, and an even greater number of cancers are prevented in the first place.

#1.  Therapeutic cancer research should focus on human genetics and the regulation of gene expression.

Cancer is a disease of cells that have either inherited or acquired abnormalities in the activities of critical genes and the proteins for which they code. Most cancers involve several abnormally functioning genes – not just one – which makes understanding and treating cancer terribly complex. The good news is that screening for genes and their products can be done with new techniques that accomplish in days what once took years.

Knowledge of the human genome and mechanisms regulating gene expression, advances in technology, experience from clinical trials, and a greater understanding of the impact of environmental factors have led to exciting new research approaches to cancer treatment, all of which are being pursued at M. D. Anderson:

  • Targeted therapies.  These therapies are designed to counteract the growth and survival of cancer cells by modifying, replacing or correcting abnormally functioning genes or their RNA and protein products, and by attacking abnormal biochemical pathways within these cells.
  • Molecular markers.  Identifying the presence of particular abnormal genes and proteins in a patient’s cancer cells, or in the blood, will enable physicians to select the treatments most likely to be effective for that individual patient.
  • Molecular imaging.  New diagnostic imaging technologies that detect genetic and molecular abnormalities in cancers in individual patients can help select optimal therapy and determine the effectiveness of treatment within hours.
  • Angiogenesis.  Anti-angiogenesis agents and inhibitors of other normal tissues that surround cancers can starve the cancer cells of their blood supply and deprive them of essential growth-promoting factors which must come from the tumor’s environment.
  • Immunotherapy. Discovering ways to elicit or boost immune responses in cancer patients may target destruction of cancer cells and lead to the development of cancer vaccines.

#2.  Better tests to predict cancer risk and enable earlier detection must be developed.

New predictive tests, based on abnormalities in blood, other body fluids or tissue samples, will be able to detect abnormalities in the structure or expression of cancer-related genes and proteins. Such tests may predict the risk of cancer in individuals and could detect early cancer years before any symptoms are present.

The prostate-specific antigen test for prostate cancer currently is the best known marker test to detect the possible presence of early cancer before it has spread. Abnormalities in the BRCA 1 and BRCA 2 genes predict a high risk for breast cancer, which can guide the decisions of physicians and patients on preventive measures. Many more gene-based predictors are needed to further our progress in risk assessment and early detection.

#3.  More cancers can and must be prevented.

In an ideal world, cancer “care” would begin with risk assessment and counseling of a person when no malignant disease is present. Risk factors include both inherited or acquired genetic abnormalities and those related to lifestyle and the environment.

The largest risk factor for cancer is tobacco smoking, which accounts for nearly one-third of all cancer deaths. Tobacco use should be discouraged with cost disincentives, and medical management of discontinuing tobacco use must be reimbursed by government and private sector payors.

Cancer risk assessment should be followed by appropriate interventions (either behavioral or medical) at a pre-malignant stage, before a cancer develops. Diagnosis and treatment of a confirmed cancer would occur only when these preventive measures fail.

A full understanding of cancer requires research to identify more completely the genetic, environmental, lifestyle and social factors that contribute to the varying types and rates of cancer in different groups in this country and around the world. A common cancer in Japan or India, for example, often is not a common cancer in the U.S. When prostate cancer occurs in African-Americans it is more severe than in Caucasians. A better understanding of the factors that influence differences in cancer incidence and deaths will provide important clues to preventing cancer in diverse populations worldwide.

#4.  The needs of cancer survivors must become a priority.

Surviving cancer means many things: reducing pain, disability and stress related to the cancer or the side effects of therapy; helping patients and their loved ones lead a full life from diagnosis forward; preventing a second primary cancer or recurrence of the original cancer; treating a difficult cancer optimally to ensure achieving the most healthy years possible, and more.  Since many more patients are surviving their cancers – or living much longer with cancer – helping them manage all the consequences of their disease and its treatment is critically important.  It is an area ripe for innovative research and for improvement in delivery of care.

#5.  We must train future researchers and providers of cancer care.

Shortages are predicted in the supply of physicians, nurses and technically trained support staff needed to provide expert care for patients with cancer.  On top of this, patient numbers are projected to increase.  We are heading toward a “perfect storm” unless we ramp up our training programs for cancer professionals at all levels.   The pipeline for academic researchers in cancer also is threatened due to the increasing difficulty in obtaining peer-reviewed research funding. We must designate more funding from the NIH and other sources specifically for promising young investigators, to enable them to initiate their careers.

#6.  Federal funding for research should be increased.

After growing by nearly 100% from 1998-2002, the National Cancer Institute budget has been in decline for the past four years. Through budget cuts and the effects of inflation, the NCI budget has lost approximately 12% of its purchasing power.  Important programs in tobacco control, cancer survivorship and support for interdisciplinary research have had significant cuts.  The average age at which a biomedical researcher receives his or her first R01 grant (the gold standard) now stands at 42, hardly an inducement to pursue this field. This shrinks the pipeline of talented young Americans who are interested in careers in science, but can find easier paths to more promising careers elsewhere.  Lack of adequate funding also discourages seasoned scientists with outstanding track records of contributions from undertaking innovative, but risky research projects.  The U.S. leadership in biomedical research could be lost.

Biomedical research in academic institutions needs steady funding that at least keeps up with inflation and enables continued growth.

#7.  The pace of clinical research must accelerate.

As research ideas move from the laboratory to patients, they must be assessed in clinical trials to test their safety and efficacy. Clinical trials are complicated, lengthy and expensive, and they often require large numbers of patients.  Further steps must be taken to ensure that efficient and cost-effective clinical trials are designed to measure, in addition to outcomes, the effects of new agents on the intended molecular targets. Innovative therapies should move forward more rapidly from the laboratory into clinical trials.

The public needs to be better educated about clinical trials, which in many cases may provide them with access to the best care available.  Greater participation in trials will speed up drug development, in addition to providing patients with the best options if standard treatments fail.  The potential risks and benefits of clinical trials must continue to be fully disclosed to the patients involved, and the trials must continue to be carefully monitored.

The issue of how to pay for clinical trials must be addressed. The non-experimental portion of the costs of care in clinical trials currently are borne in part by Medicare, and should be covered fully by all payors. The experimental portion of costs of care should be covered by the owner of the new drug, who stands to benefit from a new indication for therapeutic use.

#8.  New partnerships will encourage drug and device development.

One way to shorten the time for drug and device development is to encourage and reward collaboration among research institutions, and collaboration between academia and industry.  Increasingly, partnerships are required to bring together sufficient expertise and resources needed to confront the complex challenges of treating cancer. There is enormous opportunity here, but many challenges, as well.

Academic institutions already do collaborate, but we need new ways to stimulate increased participation in cooperative enterprises.

Traditionally, academic institutions have worked with biotech and pharmaceutical companies by conducting sponsored research and participating in clinical trials.  By forming more collaborative alliances during the preclinical and translational phases prior to entering the clinic, industry and academia can build on each other’s strengths to safely speed drug development to the bedside. The challenge is that this must be done with agreements that involve sharing, but also protect the property rights and independence of both parties.

The results of all clinical trials must be reported completely and accurately, without any influence from conflicts of interest and with full disclosure of potential conflicts of interest.

#9. We must provide access to cancer care for everyone who lives in the U.S.

More than 47 million Americans are uninsured, and many others are underinsured for major illnesses like cancer. Others are uninsurable because of a prior illness such as cancer.  And many are indigent, so that payment for care is totally impossible.

Depending on where they live and what they can afford, Americans have unequal access to quality cancer care. Treatment options vary significantly nationwide. We must find better ways to disseminate the best standards of high-quality care from leading medical centers to widespread community practice throughout the country.

Cancer incidence and deaths vary tremendously among ethnic and economic groups in this country. We need to address the causes of disparities in health outcomes and move to eliminate them.

We are unique among Western countries in not providing direct access to medical care for all who live here. There is consensus today among most Americans and both political parties that this is unacceptable.  Especially for catastrophic illnesses like cancer, we must create an insurance system that guarantees access to care.

A number of proposals involving income tax rebates, vouchers, insurance mandates and expanded government insurance programs address this issue. Whatever system is selected should ensure access and include mechanisms for caring for underserved Americans.  The solution will require give-and-take among major stakeholders, many of which benefit from the status quo.  However, the social and economic costs have risen to the point that we have no choice.

#10.  Greater attention must be paid to enhancing the quality of cancer care and reducing costs.

New therapies and medical instruments are expensive to develop and are a major contributor to the rising cost of medical care in the U.S.  The current payment system rewards procedures, tests and treatments rather than outcomes.  At the same time, cancer prevention measures and services are not widely covered.  A new system of payment must be designed to reward outcomes, as well as the use of prevention services.

Quality of care can be improved and costs can be reduced by increasing our efforts to reduce medical errors and to prescribe diagnostic tests and treatments only on the basis of objective evidence of efficacy.

A standardized electronic medical record, accessible nationwide, is essential to ensuring quality care for patients who see multiple providers at multiple sites, and we are far behind many other nations.  Beyond that, a national electronic medical record could provide enormous opportunities for reducing overhead costs, identifying factors contributing to many illnesses (including cancer), determining optimal treatment and detecting uncommon side effects of treatment.

What the future holds in store.

I am optimistic. I see a future in which more cancers are prevented, more are cured and, when not curable, more are managed as effectively as other chronic, life-long diseases. I see a future in which deaths due to cancer continue to decrease.

Achieving that vision will require greater collaboration among academic institutions, government, industry and the public.  Barriers to quality care must be removed.  Tobacco use must be eradicated.  Research must have increased funding.  Mindful that our priority focus is on the patient, we must continue to speed the pace of bringing scientific breakthroughs from the laboratory to the bedside.

M. D. Anderson resources:

John Mendelsohn, M.D.”

Primary SourceTen Pieces Help Solve Cancer Puzzle, by John Mendelsohn, M.D., Feature Article, The University of Texas M.D. Anderson Cancer Center Cancer News, Mar. 2009.

Posted in Advocacy, Biological Therapies, Clinical Trials, Diagnosis & Treatment, Early Detection, Inspirational, Molecular Diagnostics, Novel Therapies, Prevention, Survivorship | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a Comment »

Senators Kennedy & Hutchison Renew War On Cancer

Posted by Paul Cacciatore on March 30, 2009

On March 26, 2009, Senators Edward M. Kennedy (D-Massachusetts) and Kay Bailey Hutchison (R-Texas) introduced the 21st Century Cancer Access to Life-Saving Early detection, Research and Treatment (ALERT) Act, a bill to comprehensively address the challenges our nation faces in battling cancer. This is the first sweeping cancer legislation introduced since the National Cancer Act in 1971, authored by Senator Kennedy. The 21st Century Cancer ALERT Act is a comprehensive approach to cancer prevention and detection, research and treatment. It invests in cancer research infrastructure and improves collaboration among existing efforts. Prevention and early detection for those most at risk are emphasized through support for innovative initiatives and new technologies such as biomarkers.  The legislation addresses the need to increase enrollment in clinical research by increasing access and removing barriers to patients’ participation in clinical trials. The bill also includes a plan designed to improve care for cancer survivors. Additional provisions regarding prevention and screening initiatives will increase access to care for underserved populations and reduce the burden of disease and cost of healthcare to the nation.

kennedy1

Edward M. Kennedy, U.S. Senator For The Commonwealth of Massachusetts

On March 26, 2009, Senators Edward M. Kennedy (D-Massachusetts) and Kay Bailey Hutchison (R-Texas) introduced the 21st Century Cancer Access to Life-Saving Early detection, Research and Treatment (ALERT) Act, a bill to comprehensively address the challenges our nation faces in battling cancer. This is the first sweeping cancer legislation introduced since the National Cancer Act in 1971, authored by Senator Kennedy. The 21st Century Cancer ALERT Act is a comprehensive approach to cancer prevention and detection, research and treatment. It invests in cancer research infrastructure and improves collaboration among existing efforts. Prevention and early detection for those most at risk are emphasized through support for innovative initiatives and new technologies such as biomarkers.  The legislation addresses the need to increase enrollment in clinical research by increasing access and removing barriers to patients’ participation in clinical trials. The bill also includes a plan designed to improve care for cancer survivors. Additional provisions regarding prevention and screening initiatives will increase access to care for underserved populations and reduce the burden of disease and cost of healthcare to the nation.

We provide below the full text of the following documents:

_____________________________________________________

KENNEDY ON THE INTRODUCTION OF THE 21st Century ALERT Act

As Entered into the [Congressional] Record

March 26, 2009

FOR IMMEDIATE RELEASE

Thirty seven years ago, a Republican President and Democratic Congress came together in a new commitment to find a cure for cancer. At the time, a cancer diagnosis meant almost certain death. In 1971, we took action against this deadly disease and passed the National Cancer Act with broad bipartisan support, and it marked the beginning of the War on Cancer.

Since then, significant progress has been made. Amazing scientific research has led to methods to prevent cancer, and treatments that give us more beneficial and humane ways to deal with the illness. The discoveries of basic research, the use of large scale clinical trials, the development of new drugs, and the special focus on prevention and early detection have led to breakthroughs unimaginable only a generation ago.

As a result, cancer today is no longer the automatic death sentence that it was when the war began. But despite the advances we have made against cancer, other changes such as aging of the population, emerging environmental issues, and unhealthy behavior, have allowed cancer to persist. The lives of vast numbers of Americans have been touched by the disease. In 2008, over 1.4 million Americans were diagnosed with some form of cancer, and more than half a million lost their lives to the disease.

The solution isn’t easy but there are steps we can and must take now, if we hope to see the diagnosis rate decline substantially and the survival rate increase in the years ahead. The immediate challenge we face is to reduce the barriers that obstruct progress in cancer research and treatment by integrating our current fragmented and piecemeal system of addressing the disease.

Last year, my colleague Senator Hutchison and I agreed that to build on what the nation has accomplished, we must launch a new and more urgent war on cancer. The 21st Century Cancer ALERT Act we are introducing today will accelerate our progress by using a better approach to fighting this relentless disease. Our goal is to break down the many barriers that impede cancer research and prevent patients from obtaining the treatment that can save their lives.

We must do more to prevent cancer, by emphasizing scientifically proven methods such as tobacco cessation, healthy eating, and exercise. Healthy families and communities that have access to nutritious foods and high quality preventive health care will be our best defense against the disease. I’m confident that swift action on national health reform will make our vision of a healthier nation a reality. Obviously, we cannot prevent all cancers, so it is also essential that the cancers that do arise be diagnosed at an initial, curable stage, with all Americans receiving the best possible care to achieve that goal.

We cannot overemphasize the value of the rigorous scientific efforts that have produced the progress we have made so far. To enhance these efforts, our bill invests in two key aspects of cancer research– infrastructure and collaboration of the researchers. We include programs that will bring resources to the types of cancer we least understand. We invest in scientists who are committed to translating basic research into clinical practice, so that new knowledge will be brought to the patients who will most benefit from it.

One of the most promising new breakthroughs is in identifying and monitoring the biomarkers that leave enough evidence in the body to alert clinicians to subtle signs that cancer may be developing. Biomarkers are the new frontier for improving the lives of cancer patients because they can lead to the earliest possible detection of cancer, and the Cancer ALERT Act will support the development of this revolutionary biomarker technology.

In addition, we give new focus to clinical trials, which have been the cornerstones of our progress in treating cancer in recent decades. Only through clinical trials are we able to discover which treatments truly work. Today, however, less than 5% of cancer patients currently are enrolled in clinical trials, because of the many barriers exist that prevent both providers and patients from participating in these trials. A primary goal of our bill is to begin removing these barriers and expanding access to clinical trials for many more patients.

Further, since many cancer survivors are now living longer lives, our health systems must be able to accommodate these men and women who are successfully fighting against this deadly disease. It’s imperative for health professionals to have the support they need to care for these survivors. To bring good lifelong care to cancer survivors, we must invest more in research to understand the later effects of cancer and how treatments affect survivors’ health and the quality of their lives.

We stand today on the threshold of unprecedented new advances in this era of extraordinary discoveries in the life sciences, especially in personalized medicine, early diagnosis of cancer at the molecular level, and astonishing new treatments based on a patient’s own DNA. To make the remarkable promise of this new era a reality, we must make sure that patients can take DNA tests, free of the fear that their genetic information will somehow be used to discriminate against them. We took a major step toward unlocking the potential of this new era by approving strong protections against genetic discrimination in health insurance and employment when the Genetic Nondiscrimination Act was signed into law last year.

In sum, we need a new model for research, prevention and treatment of cancer, and we are here today to start that debate in Congress. We must move from a magic bullet approach to a broad mosaic of care, in which survivorship is also a key part of our approach to cancer. By doing so, we can take a giant step toward reducing or even eliminating the burden of cancer in our nation and the world. It’s no longer an impossible dream, but a real possibility for the future.

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Press Contact

Anthony Coley/ Melissa Wagoner (202) 224-2633

___________________________________________

Kennedy Renews the War Against Cancer

March 26, 2009

FOR IMMEDIATE RELEASE

Bill will Renew America’s Commitment to Fighting Cancer and Finding Cures

WASHINGTON, DC— Senators Edward M. Kennedy and Kay Bailey Hutchison today introduced the 21st Century Cancer Access to Life-Saving Early detection, Research and Treatment (ALERT) Act, a bill to comprehensively address the challenges our nation faces in battling this disease. This is the first sweeping cancer legislation introduced since the National Cancer Act in 1971, authored by Kennedy.

The 21st Century Cancer ALERT Act will provide critical funding for promising research in early detection, and supply grants for screening and referrals for treatment. These measures will also ensure patient access to prevention and early detection, which is supplemented by increased access to clinical trials and information.

The bill places an emphasis on strengthening cancer research and the urgent need for resources to both prevent and detect cancers at an early stage. The bill strives to give scientists the tools they need to fight cancer and to understand more thoroughly how the disease works. Through fostering new treatments, increased preventative measures and funding for research, the ALERT Act begins a new chapter in how Americans will live with and fight cancer.

Senators Kennedy and Hutchison first proposed the idea for comprehensive cancer legislation last May, when the Health, Education, Labor and Pensions Committee held a hearing to discuss the need for a renewed focus on the deadly disease. Elizabeth Edwards, Lance Armstrong and Hala Moddelmog from Susan G. Komen for the Cure testified at the hearing.

Senator Kennedy, Chairman of the Health, Education, Labor, and Pensions Committee, said, “We’ve come a long way in fighting cancer since we passed the National Cancer Act thirty-eight years ago, but not far enough. Americans still live in fear that they or someone they love will be affected. Today, we’re better equipped for the fight— learning each and every day a little bit more about the disease and what we can do to fight it. Cancer is a complex disease and it requires comprehensive strategies to fight it— strategies that integrate research, prevention and treatment. This bill will renew our efforts to make progress in the battle against cancer, and to give patients and their families a renewed sense of hope.”

“Our nation declared the War on Cancer in 1971, yet, nearly 38 years later, cancer is expected to become the leading killer of Americans. We must bring renewed focus and vigor to this fight.” said Senator Hutchison. “The prescription isn’t simple, but there are steps we must take if we are going to see the cancer diagnosis rate decline, while raising the prognosis for survival among those who do have the disease. Our legislation will enact those necessary steps so we may see more progress and coordination in cancer research and treatment.”

“We know how to lengthen and improve the lives of people with cancer, but we’ve chosen as a nation to turn our backs on some of us who have the disease,” said Elizabeth Edwards. “I urge the United States Senate to embrace the ALERT Act and get it to the President’s desk as soon as possible.”

“In 2010, cancer is expected to be the leading cause of death worldwide. Every American is touched by this disease,” said Lance Armstrong, chairman and founder of the Lance Armstrong Foundation. “The 21st Century Cancer ALERT Act and its authors’ leadership in reforming our nation’s approach to the war on cancer are a very welcome step forward to every member of the LIVESTRONG movement.”

“It’s been 38 years since our nation first declared war on cancer, and yet we are still facing a significant cancer crisis.  The Kennedy-Hutchison Cancer ALERT Act will reignite the war on cancer,” said Nancy G. Brinker, founder of Susan G. Komen for the Cure.  “We must all work together and let nothing stand in the way of discovering and delivering the cures to cancer.”

Senate action on this bill is expected this Congressional session.

A section-by-section summary of the legislation is below as well as an op-ed authored by Senators Hutchison and Kennedy that appeared this morning in the Houston Chronicle and on the Boston Globe’s website.

_____________________________________________

21st Century Cancer ALERT Act

Senators Kennedy and Hutchison

Section by Section Summary

The 21st Century Cancer ALERT Act is a comprehensive approach to cancer prevention and detection, research and treatment. It invests in cancer research infrastructure and improves collaboration among existing efforts. Prevention and early detection for those most at risk are emphasized through support for innovative initiatives and new technologies such as biomarkers.  The legislation addresses the need to increase enrollment in clinical research by increasing access and removing barriers to patients’ participation in clinical trials. The bill also includes a plan designed to improve care for cancer survivors. Additional provisions regarding prevention and screening initiatives will increase access to care for underserved populations and reduce the burden of disease and cost of healthcare to the nation.

Section 1 and 2 – Findings and Declaration of Purpose

Section 3- Advancement of the National Cancer Program (NCP)

Modernize the role of the National Cancer Institute (NCI) in coordinating the NCP

  • Identifies relevant federal agencies to coordinate with NCI
  • Improves the annual budget estimate for the NCP by including the needs of the entire NCP and submitting the budget annually to House and Senate Budget and Appropriations Committees
  • Increases participation of other federal agencies in the National Cancer Advisory Board
  • Encourages early detection and translational research opportunities

Biological Resource Coordination and Advancement of Technologies for Cancer Research

Section 4 – Comprehensive and Responsible Access to Research, Data, and Outcomes

  • Calls for guidance from the Office of Human Research Protection on the use of a centralized Institutional Review Board
  • Improves privacy standards in clinical research by clarifying when de-identified patient information may be disclosed
  • Calls for HHS to study the advantages and disadvantages of the synchronization of the standards for research under the Common Rule and the Privacy Rule
  • Clarifies the application of the Privacy Rule to external researchers

Section 5- Enhanced Focus and Reporting on Cancer Research

  • Calls for NCI to report annually on plans and progress regarding research on cancers with low incidence and low survival rates
  • Establishes grants program to conduct research on cancers with low incidence and low survival rates

Section 6 – Continuing Access to Care for Prevention and Early Detection

Screening and Early Detection

Cancer Prevention

  • Authorizes grants for a medical mobile van program to conduct cancer screening and prevention education activities in communities that are underserved and suffer from barriers to preventative cancer care

Access to Prevention and Early Detection for Certain Cancers

Section 7– Early Recognition and Treatment of Cancer Through the Use of Biomarkers

Promote the Discovery and Development of Biomarkers

  • Establishes and coordinates federal agencies to establish a highly directed, contract based program that will support the development of innovative biomarker discovery technologies
  • Calls for FDA and CMS to work together to create guidelines for clinical study designs that will enable sponsors to generate clinical data that will be adequate for review by both agencies
  • Conducts a demonstration project to provide limited regional coverage for biomarker tests and establish procedures for independent research entities to conduct high quality assessments of the efficacy and cost effectiveness of biomarker tests

Section 8: National Cancer Coverage Guidelines

Ensure Patient Access to Clinical Trials

  • Facilitates expanded access to clinical trials by requiring ERISA governed health plans to continue to provide coverage of routine care regardless of whether a patient enrolls in a clinical trial

Section 9: Health Professions Workforce

Ensure a Stable Workforce for the Future

Section 10: Patient Navigator Program

Improve Upon Existing Patient Navigator Programs

  • Ensures that patient navigators meet minimum core proficiencies
  • Reauthorizes the Patient Navigator program through 2015

Section 11: Cancer Care and Coverage Under Medicaid and Medicare

Improvements in Coverage of Cancer Services

  • Codifies current Medicare policy to reimburse for routine care while patients are enrolled in clinical trials
  • Conducts a demonstration project to evaluate the cost, effectiveness, and potential savings to Medicare of reimbursing providers for comprehensive cancer care planning services to the Medicare population
  • Directs states to offer tobacco cessation medications and counseling to pregnant women enrolled in Medicaid

Section 12: Cancer Survivorship and Complete Recovery Initiatives

Childhood Cancers

  • Establishes priority areas for NIH activities related to childhood cancer survivorship
  • Authorizes grants for research on the causes of health disparities in childhood cancer survivorship and to evaluate follow up care for childhood cancer survivors

Complete Recovery Care

  • Defines “complete recovery care” which includes care to address secondary effects of cancer and its treatment, including late and psychosocial effects
  • Coordinates complete recovery care activities across federal agencies
  • Establishes a Collaborative that will develop a plan for workforce development for complete recovery care

Section 13: Activities of the Food and Drug Administration

Sense of the Senate

  • Encourages the FDA to harmonize policies to facilitate the development of drugs; explore clinical trial endpoints; and, modernize the Office of Oncology Drug Products

____________________________________________

Renewing the War on Cancer

By Edward M. Kennedy and Kay Bailey Hutchison

Kay Bailey Hutchinson, U.S. Senator For Texas

Kay Bailey Hutchison, U.S. Senator For State of Texas

Cancer is a relentless disease. It doesn’t discriminate between men and women, wealthy or poor, the elderly or the young. In 2008, over 1.4 million Americans were diagnosed with some form of the disease. If it wasn’t you, it may have been a spouse or sibling, a parent or a child, a friend or a coworker. We, too, have known the challenges of cancer diagnoses for ourselves or our family members or friends. And while there are many stories of survival, this disease still takes far too many lives. More than half a million Americans lost their battle with cancer last year.

Since the War on Cancer was declared in 1971, we have amassed a wealth of knowledge about the disease. Advances in basic and clinical research have improved treatments significantly. Some of the most important progress has been made in prevention and early detection, particularly screening, including mammography and colonoscopy. Behavior modifications, such as smoking cessation, better eating habits, regular exercise, and sunscreen have been found to prevent many cancers. Continued focus must be placed on prevention, which will always be the best cure.

Though heightened awareness and prevention should be emphasized, alone they don’t translate into adequate progress for those with cancer. Since 1971, the cancer mortality rate has decreased by only 6 percent. In the same period, by contrast, mortality rates have dramatically declined for heart disease (by 56 percent) and stroke (by 66 percent). Today, cancer is the second leading cause of death in the United States, exceeded only by heart disease. If the current trend continues, the National Cancer Institute predicts that one in every two men and one in every three women will be diagnosed with cancer in their lifetimes, and that cancer will become the leading killer of Americans.

The solution isn’t easy, but there are steps we should take now if we hope to see the diagnosis rate decline substantially and the survival rate increase.  To do so, we must identify and remove the numerous barriers that obstruct our progress in cancer research and treatment.

First, it is essential that cancer be diagnosed at an initial, curable stage. One of the most promising breakthroughs is the monitoring of biomarkers, which leave evidence within the body that alerts clinicians to hidden activity indicating that cancer may be developing. Identification of such biomarkers can lead to the earliest possible detection of cancer in patients.

Second, even if we significantly improve early detection, lack of health insurance and other impediments to care will preclude many Americans from undergoing routine screening. With early screening, the disease may be detected at a treatable stage and dramatically increase the rate of survival. Greater outreach is clearly needed to make screening more available to all, and especially to underserved populations.

Third, we must adopt a more coordinated approach to cancer research. Establishing an interconnected network of biorepositories with broadly accessible sources of tissue collection and storage will enable investigators to share information and samples much more effectively. Integrated research will help accelerate the progress of lifesaving research. The search for cures should also be a cooperative goal. The current culture of isolated career research must yield to more cooperative arrangements to expedite breakthroughs. Our national policy should encourage all stakeholders in the War on Cancer to become allies and work in concert toward cures.

Fourth, as our nation’s best and brightest researchers seek new ways to eradicate cancer, we must improve treatment for those who have it today. Raising awareness of clinical trials would result in more patients and their doctors knowing what promising trials are available. Doing so will expand treatment options for patients, and enable researchers to develop better methods for prevention, diagnosis, and therapy.  Today, less than five percent of the 10 million adults with cancer in the United States participate in clinical trials. Disincentives by the health insurance market, preventing patients from enrolling in clinical trials, must be eliminated.

Finally, as our knowledge of cancer advances and patients live longer, we need a process that will improve patient survivorship through comprehensive care planning services. There is great value in equipping patients with a treatment plan and summary of their care when they first enter remission, in order to achieve continuity of therapy and preventing costly, duplicative, or unnecessary services.

We have introduced bipartisan legislation to bring about these necessary changes, and we hope to see the bill enacted in the coming weeks and months. These policy initiatives cannot be fully implemented without broad support and sufficient resources, and we are committed to leading this effort to completion.

It’s time to reinvigorate the War on Cancer, and more effective coordination of policy and science is indispensible for rapid progress.

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The Rock Band “N.E.D.”: Their Medical Skills Save Many; Their Music Could Save Thousands

Posted by Paul Cacciatore on March 29, 2009

When spoken by a doctor, the medical term “N.E.D.” – No Evidence of Disease – is music to the ears of an ovarian cancer survivor.   A band of doctors, called “N.E.D.,” wants to be music to the ears of the general public when it comes to raising awareness about women’s cancers. …During the day, this eclectic group of highly skilled physicians perform under the bright lights of the operating room while caring for women who are battling gynecological cancers.  By night, these physicians turn into artists who play a mix of rock and alternative rock music to give a voice to the needs, struggles, and triumphs of their cancer patients. … Victor Hugo, the French author of the classic novels Les Misérables and Notre-Dame de Paris (The Hunchback of Notre Dame), once said, “music expresses that which cannot be said and on which it is impossible to be silent.”  The band N.E.D. believes in the same principle when it comes to the promotion of gynecologic cancer awareness and education through music.  The N.E.D. band members will save many women’s lives throughout their medical careers; however, they could very well save thousands of lives through the educational cancer awareness message brought to light through their music.

Explanation of LOGO:Pink for breast cancer, yellow is the symbolic color for hope, teal for gyn cancer, the other three colors are just complimentary, but there are six colors total, one for each band member.

Explanation of the N.E.D. Logo: Pink for Breast Cancer, Yellow is the Symbolic Color for Hope, Teal for Gynecologic Cancer; the Remaining Three Colors are Just Complimentary, But There Are Six Colors Total, One for Each Band Member. (Photo Source: Motema Music)

When spoken by a doctor, the medical term “N.E.D.” – No Evidence of Disease – is music to the ears of an ovarian cancer survivor.   A band of doctors, called “N.E.D.,” wants to be music to the ears of the general public when it comes to raising awareness about women’s cancers.  Yes, you read that correctly, six gynecologic oncologists want to raise awareness about ovarian cancer and other women’s cancers through their music. During the day, this eclectic group of highly skilled physicians perform under the bright lights of the operating room while caring for women who are battling gynecological cancers.  By night, these physicians turn into artists who play a mix of rock and alternative rock music to give a voice to the needs, struggles, and triumphs of their cancer patients.

The members of N.E.D. are set forth below.

On drums and percussion as well as guitar is Nimesh P. Nagarsheth, Assistant Professor, Division of Gynecologic Oncology, Mount Sinai Medical Center, New York, New York & Englewood Hospital and Medical Center, Englewood, New Jersey.

On lead guitar is William E. Winter, III, M.D., Northwest Cancer Specialists, Portland, Oregon.

On bass guitar, harmonica and vocals, William R. (Rusty) Robinson, M.D. FACS, FACOG. , Professor, Director of Clinical Research, Harrington Cancer Center, Texas Tech University Health Science Center, Amarillo, Texas.

On guitar and lead vocals, John F. Boggess, M.D., Associate Professor, Fellowship Program Director, Gynecology Oncology, Director, Robotic Assisted Medicine Center, University of North Carolina at Chapel Hill.

On lead vocals and guitar, Joanie Hope, M.D., Fellow, Gynecologic Oncology, New York University Langone Medical Center, New York, New York.

On guitar, John T. Soper, M.D., The Hendricks Professor of Obstetrics and Gynecology, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill.

The Backstory

Most of the N.E.D. band members played in musical groups during their youth. Nimesh Nagarsheth’s interest in music relates back to his college days. As a student at the University of Wisconsin, Nagarsheth focused on musical percussion study, but later, due to pragmatism, he refocused his concentration on medicine. “I saw many really talented peers who worked really hard and were not getting jobs as musicians.” “Music has always been a passion of mine, ever since I was a child,” said Nagarsheth,. “But to be honest with you, I didn’t really develop an interest in medicine until I went to college.”

While in medical school in Oregon, John Boggess played in a band with other medical students in the 1980s to earn rent money, and he developed a small following.  But, Boggess gave up musical pursuits to practice medicine.  Joanie Hope said that she has been musical since she was a child: “When I was in medical school, I wrote lots of songs with medical themes, because medicine is, after all, about people and their troubles. When I was in residency, I didn’t have time to do much with music, but now that I’ve found this band, I’m able to tap into my creative energy again.”  John Soper played in high school and college bands, and as an adult was a member of a local bluegrass group called Piney Mountain Boys, which split up in 1989.

Oddly enough, the creation of N.E.D. arose from an immediate need for entertainment at the 2008 annual meeting of the Society of Gynecologic Oncologists (SGO).  In short order, the six gynecologic oncologists met and rehearsed in preparation for the gig.  Notably, with the exception of John Soper and John Boggess, the band members never met, much less played together. They rehearsed one night, and performed the next. William Winter,  a band member, said he and his colleagues were game to play for their peers, but noted that “[n]one of us are known for our music.” As stated in the vernacular by John Soper, the goal “was to not suck.” Despite the band’s hasty creation and short preparation time, the doctors who attended the SGO meeting loved the band’s music and rocked out on Led Zeppelin and Allman Brothers Band songs. The band played the 30 or so classic covers that they rehearsed, and when the large crowd of doctors asked for more, the band performed the same songs again. “People were sticking around,” Winter said. “We didn’t get booed off the stage. We actually got asked to do some encores. We played everything we know. We had to replay songs.” Marsha Wilson, communications director for the Gynecologic Cancer Foundation (GCF), said ” “Everybody went crazy. They were really good.”

After receiving positive feedback for its performance at the 2008 SGO Annual Meeting, N.E.D. went on to perform at the First National Gynecologic Cancer Symposium and played at Arlington National Cemetery in front of the memorial to military women who died in the line of duty. After several more successful gigs, the seeds were planted for a band that would be devoted entirely to raising gynecologic cancer awareness and funding for disease screening, clinical trials, and patient education.

The Band’s Mission of Gynecologic Cancer Awareness & Education

“Do you ever see the words gynecologic oncology in print?” asked John Boggess.  Boggess’ comment carries the underlying message that gynecological cancers are often overlooked, and reveals the overarching charitable mission of N.E.D. In a world where “me first” mentality is commonplace, and rock stars drive ultra-luxury sports cars, run with entourages, and make a habit of attending rehab, these multifaceted doctors simply want to raise the general public’s awareness about women’s cancers.  “We think that people need to understand about these diseases and the women who have them,” said John Boggess. “So anything that we can do outside of the surgery we do every day in the operating room and in the clinic, we find to be an incredible privilege.”

In 2008, several band members were asked about the future potential of N.E.D. as a vehicle for cancer awareness.  At that time, Joanie Hope stated that she wanted a future for the band that would “speak to people” through music. “I want people to listen to us at home so that our music and lyrics reflect what they are feeling if they have cancer, or someone they love does,” said Hope. Nimesh Nagarsheth responded, “I’d like us to make a CD.  We could sell them at concerts as a fundraising tool, and we could put educational inserts about women’s cancer inside the case.  Joanie [Hope] and I, as the ‘New York division of N.E.D.,’ have already written ten original songs, some with lyrics about cancer …”

Each original song written by the band was inspired by the doctors’ work with women’s cancers.  Joanie Hope wrote a song entitled, “Rhythm Heals,” which is intended to inspire her patients.  “It encompasses what we’re all about,” said Hope. “There are many ways to heal beyond what we do as doctors. My patients teach me that all the time.” Nimesh Nagarsheth wrote the song “Third-Person Reality” to address a doctor’s struggle to help patients dealing with cancer diagnoses.  “It’s tempting to remove yourself from the situation and be like a third person,” said Nagarsheth, “but we have to overcome that because our patients need us.”  The hard-rocking track “False Pretenses,” written by William Winter and sung by John Boggess, urges genuine communication when time is short due to a patient’s dire diagnosis.

Motéma Music & The Gynecologic Cancer Foundation Take Interest

NED Group Picture

Meet The Band: (Bottom Row) John Boggess; (Center Row, left to right) Nimesh Nagarsheth, Joanie Hope, William Winter, William (Rusty) Robinson; (Top Row) John Soper. (Photo Source: N.E.D. Facebook Page)

The 2008 comments made by Joanie Hope and Nimesh Nagarsheth in regard to N.E.D.’s future were indeed prophetic. Shortly thereafter, the band landed a record deal with Motéma Music, a New York record label that features world music and jazz musicians.  Motéma artist K.J. Denhert is currently working with the band as a performance and songwriting coach. Mario McNulty, who has worked with David Bowie, Linkin’ Park and other classic rock bands, will produce the band’s first album.

N.E.D.’s first album is set for release in November 2009 during Gynecologic Cancer Month. Although the band wants to appeal to cancer patients and their families, William Winter said that they also want to reach others who may not be aware of the other types of cancers that afflict women. Winter’s hope is to “market it to anyone and everyone . . . and have them understand what goes on with women’s cancers, and the pain behind these things and what women feel and what cancer patients feel and go through.”

N.E.D. also receives support from the GCF.  GCF believes that N.E.D.’s efforts are consistent with its charitable and educational mission. In fact, the band will be featured as part of a GCF national campaign, the Gynecologic Cancer Awareness Movement, which is scheduled to kick off in November 2009 in Washington D.C.  Although the band has received support from GCF, additional monies are needed to fund the band’s CD recording and post-production costs. GCF is accepting donations and soliciting funds to support the production of the band’s first CD. Any future proceeds from the sale of the CD and live performances will be donated to the Gynecologic Cancer Foundation (GCF) whose mission is to educate the public about gynecologic cancers and support promising research.  You can help by making a donation to the GCF (marked with a designation for “N.E.D.”) through one of the methods provided below.

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Online Contribution (Through the Network for Good):

CLICK HERE to donate now.

By Mail:

Mail your tax deductible contribution to:
The Gynecologic Cancer Foundation
230 W. Monroe, Suite 2528
Chicago, Il. 60606-4703
CLICK HERE for a donation form (Microsoft Word Document) to mail in with your contribution.

By Telephone:

Call GCF at 312-578-1439 and donate with a credit card

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In addition to landing the Motéma record contract, N.E.D. has been invited to appear on “The Bonnie Hunt Show,” and is in discussions with CBS and ABC with respect to potential appearances on “The Early Show” and “Good Morning America,” respectively.  Also, the band hopes to obtain an audience with Oprah Winfrey.

Their Medical Skills Save Many; Their Music Could Save Thousands

The importance of N.E.D. and its mission to raise women’s cancer awareness is best understood through the eyes of a gynecologic cancer patient.  Samantha Hill, one of Nimesh Nagarsheth’s patients, was diagnosed with ovarian cancer at a young age.  Samantha says that when she learned that her doctor played in a rock band, she was not surprised. Hill emphasized that it is her greatest hope that N.E.D.’s message gets across to the general public.  “You’re 35 years old and you hear that you have cancer, and you’re in shock,” she recalls. “I felt that he [Nagarsheth] could relate and I think music is a very important tool.  And I think that specifically, ovarian cancer, there’s not much awareness and it’s really a silent killer.”

Victor Hugo, the French author of the classic novels Les Misérables and Notre-Dame de Paris (The Hunchback of Notre Dame), once said, “music expresses that which cannot be said and on which it is impossible to be silent.”  The band N.E.D. believes in the same principle when it comes to promotion of gynecologic cancer awareness and education through music.  The N.E.D. band members will save many women’s lives throughout their medical careers; however, they could very well save thousands of lives through the educational cancer awareness message brought to light through their music.

N.E.D. Band Rehearsal 1, December 7, 2008  (Motema artist KJ Denhert working with the band)


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About Gynecologic Cancers & Gynecologic Oncologists

Gynecologic cancers originate in the female reproductive organs, including the cervix, ovaries, uterus, fallopian tubes, vagina and vulva.  Every woman is at risk for developing a gynecologic cancer. It is estimated that there were approximately 78,000 new cases diagnosed, and approximately 28,000 deaths, from gynecologic cancers in the United States during 2008.

Gynecologic oncologists are physicians committed to the comprehensive treatment of women with cancer. After completing four years of medical school and four years of residency in obstetrics and gynecology, these physicians pursue an additional three to four years of training in gynecologic oncology through a rigorous fellowship program overseen by the American Board of Obstetrics and Gynecology. Gynecologic oncologists are not only trained to be skilled surgeons capable of performing wide-ranging cancer operations, but they are also trained in prescribing the appropriate chemotherapy for those conditions and/or radiation therapy when indicated. Frequently, gynecologic oncologists are involved in research studies and clinical trials that are aimed at finding more effective and less toxic treatments to further advance the field and improve cure rates.  Studies on outcomes from gynecologic cancers, especially ovarian cancer, demonstrate that women treated by a gynecologic oncologist have a better likelihood of prolonged  survival compared to care rendered by non-specialists. Due to their extensive training and expertise, gynecologic oncologists often serve as the “team captain” who coordinates all aspects of a woman’s cancer care and recovery. Gynecologic oncologists understand the impact of cancer and its treatments on all aspects of women’s lives, including future childbearing, sexuality, physical and emotional well-being, and the impact cancer can have on the patient’s whole family.  But, there are only about 1,000 board-certified gynecologic oncologists in the United States.  Women may need to ask their primary care provider for referral to a gynecologic oncologist if a gynecologic cancer is suspected because not all physicians are aware of the practice scope of modern gynecologic oncologists. Women can find a gynecologic oncologist by going online to www.wcn.org and clicking on the find a doctor button. This simple step may be the first stride forward to long-term survivorship and cure.  It’s important to start gynecologic cancer care with the right team and a winning game plan.

About the Gynecologic Cancer Foundation

The Gynecologic Cancer Foundation (GCF) is a 501(c)(3) not-for-profit organization whose mission is to ensure public awareness of gynecologic cancer prevention, early diagnosis and proper treatment. In addition, GCF supports research and training related to gynecologic cancers. GCF advances this mission by increasing public and private funds that aid in the development and implementation of programs to meet these goals. For more information about GCF, its educational materials or research grants, please visit www.thegcf.org or contact GCF Headquarters by phone at 312-578-1439 or by e-mail at info@thegcf.org.  For additional information on gynecologic cancers or a referral to a gynecologic oncologist or a related specialist, please call the toll-free GCF Information Hotline at 800-444-4441.  For more information about women’s cancers, visit GCF’s Women’s Cancer Network Web site:  www.wcn.org. Log on for a confidential risk assessment to learn about your risk for developing gynecologic and breast cancers. Comprehensive information about each gynecologic cancer and breast cancer is available on the site. The site also provides the opportunity to locate a nearby gynecologic oncologist, a step women are urged to take if they suspect or have been diagnosed with a gynecologic cancer.

Primary Sources:

N.E.D. Band Bio, Artist Profile, Motéma Music.

N.E.D. on Facebook.

Doctor (and former Danbury resident) fights cancer with rock ‘n’ roll, by Brian Koonz, The News-Times, Mar. 16, 2009.

UNC doctor-rockers score record deal, by Allen Mask, M.D., News Video Story, WRAL.com, Feb. 5, 2009 (CLICK HERE to watch video)

Medicine Meets Music: Surgeons Form Unusual Rock Band, by Gillian Granoff, Education Update Online, Feb. 2009.

Album will benefit gynecological cancer causes, by Sarah Avery – Staff Writer, The News & Observer, Jan. 30, 2009.

Band of Doctors, English, Music, Videos, Franz Strasser Blog, Dec. 17, 2008 (video news story).

Cancer doc rocks out, lands contract, tour next?, By Noelle Crombie, The Oregonian, KATU.com, Dec. 12, 2008.

Cancer docs form rock ‘n’ roll band and land a record deal, by Noelle Crombie, The Oregonian, Dec. 9, 2008 (story includes free MP3 clip of the N.E.D. song “False Pretenses”)

Doctors Double As Rock Stars To Help Raise Cancer Awareness, by Kafi Drexel, NY1 News, Dec. 9, 2008 (including video news story).

All hail the rock docs!, by Bill Egbert, Health Section, Daily News, December 8, 2008.

GynOncs Rock at Society Meetings, Band Looks Forward to Bigger & Better Gigs, While Raising Awareness of Women’s Cancers, by Margot J. Fromer, Oncology Times, Aug. 14, 2008. [PDF Document].

2008 State of the State of Gynecologic Cancers, Sixth Annual Report to the Women of America, Gynecologic Cancer Foundation. [PDF Document]

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To Screen or Not To Screen? Ultrasound + CA125 Blood Test Fail to Detect Early Stage Ovarian Cancer

Posted by Paul Cacciatore on March 25, 2009

On March 10, 2009, Libby’s H*O*P*E*™ reported on the preliminary findings of a large British study that suggest that the combination of transvaginal ultrasound and CA125 blood test (a blood serum marker for ovarian cancer) can detect early ovarian cancer.  A recent U.S. study, published in the April 2009 issue of Obstetrics & Gynecology, found that the same combination screening regime did not detect early stage ovarian cancer and often resulted in unnecessary surgery. The U.S. and British studies, taken together, highlight the need to find an effective screening method to detect ovarian cancer.

On March 10, 2009, Libby’s H*O*P*E*™ reported on the preliminary findings of a large British study that suggest that the combination of transvaginal ultrasound and CA125 blood test (a blood serum marker for ovarian cancer) can detect early ovarian cancer.  A recent U.S. study, published in the April 2009 issue of Obstetrics & Gynecology, found that the same combination screening regime did not detect early stage ovarian cancer and often resulted in unnecessary surgery. The U.S. and British studies, taken together, highlight the need to find an effective screening method to detect ovarian cancer.

partridge-edward

Dr. Edward E. Partridge is the Director of the University of Alabama Birmingham Comprehensive Cancer Center, Birmingham, Alabama.

In a recent interview with U.S. News & World Report, the lead researcher of the U.S. study, Dr. Edward Partridge, Director of the University of Alabama Birmingham Comprehensive Cancer Center, said, “The jury is still out on the efficacy of screening with CA125 and transvaginal ultrasound in terms of reducing the mortality rate of ovarian cancer.  In this study, we do not have mortality data on the screening versus the non-screening group, so no conclusions can be made of the impact of screening with CA125 and transvaginal ultrasound.”

Partridge noted that this study only reports data on women who were screened. “We learned that the positive predictive value for the combination of tests is pretty low — in the 1 to 1.3 percent range,” he said. “A substantial number of the tests are false positives.”  In addition, screening with transvaginal ultrasound lead to a higher rate of surgery for positive findings than positive CA125, Partridge said. “Transvaginal ultrasound leads to more ‘unnecessary’ surgeries,” he said.  Partridge also noted that a high percentage of the cancers detected through screening were late-stage malignancies.  “If you detect them at a late stage, it is unlikely that you are going to impact mortality,” he said. “In order to affect mortality, one has to detect them at an earlier stage.”

As part of the study, the U.S. researchers collected data on 34,261 women who underwent annual screening for CA125 and also had transvaginal ultrasound.  A CA 125 value at or above 35 units/mL or an abnormality on transvaginal ultrasound was considered a “positive” screen.  The researchers found that  transvaginal ultrasound produced more positive findings for cancer than CA125 screening over the four years of screening, while the CA125 positive tests decreased from 60 percent in the first year to 34 percent in the third year.  Of the 89 invasive ovarian cancers diagnosed, 60 were detected through screening. In addition, 72 percent of the screen-detected cancer were late-stage cancers, the U.S. researchers reported.

Partridge told U.S. News & World Report that even detecting cancer early may not have an impact on mortality. “In any screening trial, the ultimate test of its usefulness is does it impact mortality,” he said.  Patridge added that based upon the findings of this study and The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) study published by Menon et. al. in the March 10 online edition of  The Lancet Oncology, the CA125 blood test & ultrasound screening method will not have any effect on mortality. “What we need is a more sensitive and specific screening test,” Partridge said.

In the UKCTOCS study, a British research team found that screening was able to identify most women with gynecologic cancer. The combination of the CA125 blood test and ultrasound found 90 percent of the cancers, while ultrasound alone found 75 percent of the cancers.  The researchers also found that almost 50 percent of all the cancers found were in an early stage (stage I or II).  And, 48 percent of the more invasive ovarian cancers detected were designated as being stage I tumors. By way of comparison, the British researchers pointed out that only 28 percent of ovarian cancers are identified in this early stage.

Dr. David G. Mutch, the Ira C. and Judith Gall Professor of Obstetrics and Gynecology at Washington University, St. Louis, and author of an accompanying journal editorial, agreed there is no worthwhile screening test for ovarian cancer as yet.  “Patients who were screened presented at the same stage as they would have if they were unscreened,” Mutch said. “There is no good screening test at this point.”  Mutch added that there is no reason to screen for ovarian cancer in the general population at this point. “The prevalence of the diseases is so low, one in 2,500, and the specificity of the tests are so low, that we are going to operate on a lot of patients unnecessarily,” he said.

Primary Sources:

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Ovarian Cancers Detected Early May Be Less Aggressive

Posted by Paul Cacciatore on March 24, 2009

“The biology of ovarian cancers discovered at an early stage may render them slower growing and less likely to spread than more aggressive cancers, which typically are discovered in an advanced stage, according to a study led by investigators in the Duke Comprehensive Cancer Center.  This finding has implications for the question of whether screening for ovarian cancer could save lives. …”

“The biology of ovarian cancers discovered at an early stage may render them slower growing and less likely to spread than more aggressive cancers, which typically are discovered in an advanced stage, according to a study led by investigators in the Duke Comprehensive Cancer Center.  This finding has implications for the question of whether screening for ovarian cancer could save lives.

berchuck-andrew

Dr. Andrew Berchuck is Director of the Duke Division of Gynecologic Oncology, Duke Comprehensive Cancer Center, Durham, North Carolina

‘Our study showed that the ovarian cancers currently detected at an early stage have gene expression profiles that correlate with favorable outcome, rather than being representative of the entire spectrum of disease aggressiveness,’ said Andrew Berchuck, MD, a gynecologic oncologist at Duke and lead investigator on this study.  ‘This highlights the potential challenges of developing a screening test for this disease, because earlier detection of aggressive cases is essential if screening is to reduce ovarian cancer deaths.’

The results of this study and the implications for screening as an approach to decreasing mortality parallel the challenges seen in lung cancer and prostate cancer.  In those cancers, while screening approaches based on radiological imaging and/or blood markers detect cancers, it remains unclear whether cancer-related deaths are prevented because screening preferentially detects more benign cancers that are much less likely to be fatal, Berchuck said.

‘While these results could be seen as discouraging, it must be remembered that this information is an important piece of the ovarian cancer puzzle, and data like these that increase our understanding of the disease hopefully will eventually lead to breakthroughs in prevention, early detection and treatment of this deadly disease,’ Berchuck said.  Although there is currently no approved ovarian cancer screening test for the general population, the CA125 blood test and transvaginal ultrasound imaging currently are being evaluated in clinical trials.

The researchers looked at gene expression patterns in 166 ovarian cancer tissue samples taken from patients who were treated at Duke, H. Lee Moffitt Cancer Center, and Memorial Sloan-Kettering Cancer Center and from the Gynecologic Oncology Group Tumor Bank.  For this study, researchers examined samples of advanced ovarian cancers from patients who had experienced long-term survival — over seven years — and patients who had done extremely poorly, and died within three years of diagnosis.  The researchers used microarrays – a method for examining thousands of snippets of DNA — with about 22,000 probe sets to examine patterns of gene expression among the samples, and identified genes that were most predictive of survival.

‘We found that certain patterns predicted long-term survival and others predicted a poorer prognosis in advanced stage cases,’ Berchuck said. ‘Cancers that were detected at an early stage almost always shared gene expression characteristics with advanced stage cases that were long-term survivors, suggesting a shared favorable biology.’

The researchers published their results in the March 24, 2009, issue of the journal Clinical Cancer Research. The study was funded by the Gail Parkins Ovarian Cancer Research Fund and the National Institutes of Health.

Other researchers involved in this study include Edwin Iversen, Jingqin Luo, Jennifer Clarke, Hisani Horne, Angeles Secord, Jason Barnett, Susan Murphy, Holly Dressman, Jeffrey Marks of Duke; Douglas Levine and Jeff Boyd of Memorial Sloan-Kettering Cancer Center in New York City, NY; Miguel Alonso of the Universidad Autonoma de Madrid; and Johnathan Lancaster of H. Lee Moffitt Cancer Center and Research Institute.”

Primary SourceSpotlight:  Ovarian Cancers Detected Early May Be Less Aggressive, News Article, Duke Comprehensive Cancer Center, March 23, 2009.

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Routine Screening for Hereditary Breast and Ovarian Cancer Recommended By ACOG & SGO

Posted by Paul Cacciatore on March 24, 2009

Evaluating a patient’s risk of hereditary breast and ovarian cancer syndrome is an important first step in cancer prevention and early detection and should be a routine part of ob-gyn practice. Those who are likely to have the syndrome should be referred for further assessment to a clinician with expertise in genetics, according to a new Practice Bulletin jointly released today by The American College of Obstetricians and Gynecologists [ACOG] and the Society of Gynecologic Oncologists [SGO]. The new document also provides information on how to counsel patients with hereditary risk in cancer prevention and how to perform surgical removal of the ovaries and fallopian tubes in this population

“Routine Screening for Hereditary Breast and Ovarian Cancer Recommended

Washington, DC — Evaluating a patient’s risk of hereditary breast and ovarian cancer syndrome is an important first step in cancer prevention and early detection and should be a routine part of ob-gyn practice. Those who are likely to have the syndrome should be referred for further assessment to a clinician with expertise in genetics, according to a new Practice Bulletin jointly released today by The American College of Obstetricians and Gynecologists [ACOG] and the Society of Gynecologic Oncologists [SGO]. The new document also provides information on how to counsel patients with hereditary risk in cancer prevention and how to perform surgical removal of the ovaries and fallopian tubes in this population.

Hereditary breast and ovarian cancer syndrome is an inherited cancer-susceptibility syndrome marked by multiple family members with breast cancer, ovarian cancer or both; the presence of both breast and ovarian cancer in a single individual; and early age of breast cancer onset.

lu-karen-pic

Karen Lu, M.D., Professor of Gynecologic Oncology at the University of Texas MD Anderson Cancer Center

‘The vast majority of families who have hereditary breast and ovarian cancer syndrome carry an inherited mutation of the BRCA1 or BRCA2 tumor suppressor genes. Women in these families may have a higher risk of breast, ovarian, peritoneal, and fallopian tube cancers,’ said Karen Lu, MD, professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, who helped develop the ACOG Practice Bulletin. ‘Though having a BRCA gene mutation does not mean an individual will undoubtedly develop cancer, it is better to know sooner rather than later who may be at risk.’

Women with either BRCA mutation have a 65%-74% chance of developing breast cancer in their lifetime. Ovarian cancer risk is increased by 39%-46% in women with a BRCA1 mutation and by 12-20% in women with a BRCA2 mutation. Approximately 1 in 300 to 1 in 800 individuals in the US are BRCA carriers. BRCA mutations may occur more frequently in some populations founded by small ancestral groups, such as Ashkenazi (Eastern European) Jews, French Canadians, and Icelanders. An estimated 1 in 40 Ashkenazi Jews has a BRCA1 or BRCA2 mutation.

The new document addresses the ob-gyn’s role in identifying, managing, and counseling patients with an inherited cancer risk. The initial screening evaluation should include specific questions about personal and family history of breast cancer and ovarian cancer. Because BRCA mutations can be passed down from both the father’s and mother’s side of the family, both sides of a woman’s family should be carefully examined. Obtaining a full family history may be impeded in women who were adopted, those from families that have multiple women who had a hysterectomy and oophorectomy at a young age, or those from families with few female relatives. The results of a general evaluation will help determine whether the patient would benefit from a more in-depth hereditary cancer risk assessment, which should be conducted by a health care provider with expertise in cancer genetics.

Further genetic risk assessment is recommended for women who have more than a 20%-25% chance of having an inherited predisposition to breast or ovarian cancer. These women include:

  • Women with a personal history of both breast cancer and ovarian cancer
  • Women with ovarian cancer and a close relative—defined as mother, sister, daughter, grandmother, granddaughter, aunt—with ovarian cancer, premenopausal breast cancer, or both
  • Women of Ashkenazi Jewish decent with breast cancer who were diagnosed at age 40 or younger or who have ovarian cancer
  • Women with breast cancer at 50 or younger and who have a close relative with ovarian cancer or male breast cancer at any age
  • Women with a close relative with a known BRCA mutation

Genetic risk assessment may also be appropriate for women with a 5%-10% chance of having hereditary risk, including:

  • Women with breast cancer by age 40
  • Women with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer or high grade, serous histology at any age
  • Women with cancer in both breasts (particularly if the first cancer was diagnosed by age 50)
  • Women with breast cancer by age 50 and a close relative with breast cancer by age 50
  • Women with breast cancer at any age and two or more close relatives with breast cancer at any age (particularly if at least one case of breast cancer was diagnosed by age 50)
  • Unaffected women with a close relative that meets one of the previous criteria

Before testing, a genetic counselor can discuss the possible outcomes of testing; options for surveillance, chemoprevention, and risk-reducing surgery; cost and legal and insurance matters surrounding genetic tests and test results; and the psychologic and familial implications that may follow. The counselor can also provide written materials that women can share with family members who may also have an inherited risk.

Screening, Prevention, and Surgical Intervention

Those with hereditary breast and ovarian cancer syndrome can begin a screening and prevention plan based on individual risk factors and family history. Ovarian cancer screening approaches are currently limited. For women with a BRCA mutation, ACOG recommends periodic screening with CA 125 and transvaginal ultrasonography beginning between the ages of 30 and 35 years or 5-10 years earlier than the earliest age of first diagnosis of ovarian cancer in the family.

Risk-reducing salpingo-oophorectomy surgery—which removes both of the ovaries and fallopian tubes—can reduce the risk of ovarian and fallopian tube cancer by about 85% to 90% among BRCA carriers. Women who have BRCA1 or BRCA2 mutations should be offered risk-reducing salpingo-oophorectomy by age 40 or when childbearing is complete. The ideal time for this surgery depends on the type of gene mutation.

‘In this population, risk-reducing salpingo-oophorectomy and pathology review must be extremely comprehensive to check for microscopic cancers in the ovaries, fallopian tubes, and abdominal cavity,’ Dr. Lu said. According to the Practice Bulletin, all tissue from the ovaries and fallopian tubes should be removed, and a complete, serial sectioning that includes microscopic examination for occult cancer should be conducted. A thorough visualization of the peritoneal surfaces with pelvic washings should be performed. Any abnormal areas should undergo biopsy.

Strategies recommended to reduce breast cancer risk in women with a BRCA mutation include semiannual clinical breast examination; an annual mammogram and annual breast magnetic resonance imaging screening beginning at age 25 or sooner based on the earliest age onset in the family; chemoprevention therapy with tamoxifen; and bilateral mastectomy to remove both breasts, which reduces the risk of breast cancer by greater than 90%-95%.

Practice Bulletin #103 “Hereditary Breast and Ovarian Cancer Syndrome” is published in the April 2009 edition of Obstetrics & Gynecology.”

_______________________________________________________

About the American College of Obstetricians & Gynecologists

The American College of Obstetricians and Gynecologists is the national medical organization representing over 53,000 members who provide health care for women.

About the Society of Gynecologic Oncologists

The Society of Gynecologic Oncologists is a national medical specialty organization of physician-surgeons who are trained in the comprehensive management of women with malignancies of the reproductive tract.  The purpose of the SGO is to improve the care of women with gynecologic cancers by encouraging research and disseminating knowledge to raise the standards of practice in the prevention and treatment of gynecologic malignancies, in cooperation with other organizations interested in women’s health care, oncology and related fields. This is reflected in the Society’s Mission statement to “promote and ensure the highest quality
of comprehensive clinical care through excellence in education and research in gynecologic cancers.”

Primary Source:  Routine Screening for Hereditary Breast and Ovarian Cancer Recommended, News Release, American College of Obstetricians & Gynecologists, March 20, 2009.

Posted in Genetics, Prevention | Tagged: , , , , , , , , , , , , , , , , , | 1 Comment »

Meet Laurey Masterton, 20-Year Ovarian Cancer Survivor Extraordinaire

Posted by Paul Cacciatore on March 20, 2009

To call Laurey Masterton an “overachiever” is akin to calling Lance Armstrong a “decent” bike rider. …On March 6, 2009, Laurey dipped her rear bicycle tire into the Pacific Ocean (San Diego, CA), and started a 58-day, 3100-mile trek that will culminate in the dipping of her front bicycle tire into the Atlantic Ocean (St. Augustine, FL) on or about April 30th. … The purpose of her bike trip is to raise awareness about ovarian cancer. …

To call Laurey Masterton an “overachiever” is akin to calling Lance Armstrong a “decent” bike rider.   A few of Laurey’s amazing talents and achievements (past & present) include the following:

Laurey Masterton, 20-Year Ovarian Cancer Survivor, Bikes Across America to Raise Awareness About the Early Warning Signs & Symptoms of Ovarian Cancer (Photo Source: Ovarian Cancer National Alliance)

Laurey Masterton, 20-Year Ovarian Cancer Survivor, Bikes Across America to Raise Awareness About the Early Warning Signs & Symptoms of Ovarian Cancer (Photo Source: Ovarian Cancer National Alliance)

  • Graduate from the University of New Hampshire;
  • Outward Bound Instructor who co-created and instructed the first Outward Bound courses for cancer survivors at The North Carolina Outward Bound School;
  • Intern for Nora Pouillion, the creator of the first 100 percent certified organic restaurant in the U.S.;
  • Founder of Laurey’s Catering & Gourmet to Go, a very successful catering business and shop for “gourmet comfort food;”
  • Author of Elsie’s Biscuits:Simple Stories of Me, My Mother, and Food, a “culinary memoir-with recipesin which she tells about growing up in the golden light of a small inn, losing her parents as a child, and then finding her way back to them through food and stories;
  • In 1999, Laurey was awarded the Small Business Leader of the Year for both Asheville, North Carolina and the state of North Carolina;
  • In 2001, Laurey was the recipient of  The Athena Award, which promotes women’s leadership and honors outstanding leaders;
  • Board Chair of  the Asheville Area Chamber of Commerce;
  • Board Member of the Appalachian Sustainable Agriculture Project;
  • Participant in local farm-to-table initiatives, with a particular interest in helping children experience gardening, cooking and the eating of “real food;”
  • Glassblowing student, who collects sea urchins, antique chafing dishes, and old Clementine boxes;
  • Italian speaking leader of guided culinary tours to the Tuscany region of Italy and the Provence region of France;
  • Active long-distance bike rider and beekeeper;
  • Resident of Asheville, North Carolina, where she lives with her partner Chris and her dog Tye;
  • Follower of the motto “don’t postpone joy;” and
  • 20-year survivor of ovarian cancer, one of the deadliest cancers affecting women today.

Yup, I “buried the lead” as they say in journalism.  Laurey is a 20-year ovarian cancer survivor who fully recognizes and appreciates her good fortune.  As you probably guessed by now, the appreciation of good fortune is simply not enough for Laurey.   On March 6, 2009, Laurey dipped her rear bicycle tire into the Pacific Ocean (San Diego, CA), and started a 58-day, 3100-mile trek that will culminate in the dipping of her front bicycle tire into the Atlantic Ocean (St. Augustine, FL) on or about April 30th. The purpose of her bike trip is to raise awareness about the warning signs and symptoms of ovarian cancer and the dire need for early detection.  In an interview with the Ovarian Cancer National Alliance (OCNA), Laurey said, “Being a 20-year ovarian cancer survivor is a special victory because sadly most of its victims don’t reach this milestone. I’m one of the lucky ones because I was able to feel symptoms early on and was diagnosed in Stage I. I was in touch with my body, I knew something was wrong, I was persistent with the doctors and it saved my life. Early detection and awareness of ovarian cancer is the message that I want my bike ride to convey.”

Historically ovarian cancer was called the “silent killer” because symptoms were not thought to develop until the chance of cure was poor. However, recent studies have shown this term is untrue and that the following symptoms are much more likely to occur in women with ovarian cancer than women in the general population. These symptoms include:

  • Bloating
  • Pelvic or abdominal pain
  • Difficulty eating or feeling full quickly
  • Urinary symptoms (urgency or frequency)

As in Laurey’s case, women with ovarian cancer report that symptoms are persistent and represent a change from normal for their bodies. The frequency and/or number of such symptoms are key factors in the diagnosis of ovarian cancer. Several studies show that early stage ovarian cancer can produce these symptoms. Women who have these symptoms daily for more than a few weeks should see their doctor, preferably a gynecologist. Prompt medical evaluation can lead to detection at the earliest possible stage of the disease which is associated with an improved prognosis.  Additional symptoms can include fatigue, indigestion, back pain, pain with intercourse, constipation and menstrual irregularities.

The ovarian cancer facts and figures published by the American Cancer Society in 2008 note the following:

  • Ovarian cancer can afflict adolescent, young adult, and mature women, although the risk of disease increases with age and peaks in the late 70s. Pregnancy and the long-term use of oral contraceptives reduce the risk of developing ovarian cancer.
  • There is no reliable screening test for the detection of early stage ovarian cancer. Pelvic examination only occasionally detects ovarian cancer, generally when the disease is advanced.  However, the combination of a thorough pelvic exam, transvaginal ultrasound, and a blood test for the tumor marker CA125 can be offered to women who are at high risk of ovarian cancer and to women who have persistent, unexplained symptoms like those listed above.
  • If diagnosed at the localized stage, the 5-year ovarian cancer survival rate is 92%; however, only about 19% of all cases are detected at this stage, usually fortuitously during another medical procedure.
  • Ovarian cancer incidence rates are highest in Western industrialized countries.
  • Ovarian cancer accounts for about 3% of all cancers among women and ranks #2 among gynecologic cancers.
  • An estimated 21,650 new ovarian cancer cases were diagnosed in the U.S.
  • An estimated 15,520 ovarian cancer deaths occurred.
  • Ovarian cancer causes more deaths than any other cancer of the female reproductive system.

Prior to starting her trip, Laurey Masterton raised a portion of her $50,000 goal amount that will be donated to (i) OCNA, in support of its work on research, education, and awareness essential to the fight against ovarian cancer, and (ii) the Women Chefs and Restaurateurs (WCR), an organization that promotes and enhances the education, advancement and connection of women in the culinary industry. In turn, the OCNA and WCR are partnering with Laurey in her efforts to raise ovarian cancer awareness.  “Laurey is an inspiration to women everywhere to never give up and always to have hope no matter how big the obstacle,” says Karen Orloff Kaplan, CEO of OCNA. “We are delighted to support Laurey throughout her bike ride and help her reach her goals in bringing more attention to ovarian cancer.”

Laurey is journaling online in “real time” about various aspects of her ongoing bike trip at www.laureybikes.blogspot.com. On Saturday, March 14th, Laurey stopped at Apache Junction, Arizona to chat with several ovarian cancer survivors. In one of Laurey’s most touching journal entries to date, entitled A morning to chat, Laurey writes:

mastertonphoenixstop1

(Photo Source: Laurey Bikes at http://www.laureybikes.blogspot.com)

*     *     *

These sweet lovelies came to see me off this morning. FIRST thing! Ovarian cancer survivors (the woman on my left is a 38 year survivor!) and supporters, they arrived, armed with teal feather boas and a video camera and good questions. The sun rose over those fragrant eucalyptus trees and we talked about riding and surviving and persisting in the face of chemotherapy or miles and miles of uphill, bumpy roads.

Before I left Asheville I had a Reiki session with a friend and told her that I was not sure I was doing the right thing by leaving my business and my home and my friends and my life to go gallivanting around on my red Trek. She said I would find signs to tell me I WAS doing the right thing. She said, “Your spirit guides will tell you. They especially like to show themselves in the form of pennies and feathers.”

Ha!

Here they are.

*     *     *


I encourage everyone to check out Laurey’s Google Map below, which sets forth her anticipated travel route and stops.  As of this writing, Laurey was leaving Lordsburg, New Mexico, so please visit Laurey’s blog to learn how you can support her during her cross-country bike ride.

If I were a betting man, I would say that there is no doubt that Laurey will complete her cross country trek, while educating thousands of women about the warning signs and symptoms of ovarian cancer, and the need for early detection. Throughout her entire life, Laurey did not allow difficult life circumstances and past achievements to define her. Nothing has changed. She always moves forward, living by the motto “don’t postpone joy.”  Laurey not only represents a strong role model for ovarian cancer survivors, she is an inspiring and passionate role model for anyone with a heartbeat.

Babe Ruth, the legendary baseball player, once said, “It’s hard to beat a person who refuses to give up.”  A word to the wise:  Never bet against Laurey because the word “quit” is not in her vocabulary!

In the video below, TV Personality and Chef Sara Moulton conducts an intimate interview with Laurey Masterton regarding her cross country bike ride to raise awareness about the early warnings signs and symptoms of ovarian cancer.

TV Personality & Chef Sara Moulton Interviews Laurey Masterton

About the Ovarian Cancer National Alliance

The Ovarian Cancer National Alliance (OCNA) is the nation’s vision and voice for ovarian cancer issues. The OCNA, a 501(c)(3) nonprofit organization, leads the national initiative to conquer ovarian cancer by uniting individuals and local, state and national organizations in a consolidated movement to advance ovarian cancer research, improve health care practice and find an effective screening test and a cure for the disease. To learn more about the OCNA, visit its website at www.ovariancancer.org.

About the Women Chefs and Restaurateurs

The mission of  Women Chefs & Restaurateurs is to promote and enhance the education, advancement and connection of women in the culinary industry. Formed in 1993 by eight of the nation’s top women chefs and restaurateurs, WCR has grown to a membership of over 2,000 members, offering a variety of networking, professional and support services. To learn about WCR, visit its website at www.womenchefs.org.
____________________________________

Primary Source20-Year Ovarian Cancer Survivor Celebrates Golden Birthday – Chef Laurey Masterton Bikes 3,098 Miles Across US to Raise Awareness About Ovarian Cancer, Press Release, Ovarian Cancer National Alliance, March 4, 2009.  Libby’s H*O*P*E*™ would like to extend a special thank you to Laurey Masterton and the Ovarian Cancer National Alliance for allowing us to feature Laurey’s story along with her photographs and google map.

Posted in Healthy Living, Inspirational, Ovarian Cancer Survivor | Tagged: , , , , , , , , , , , , , , , , , , , | 4 Comments »

Libby’s H*O*P*E* Wishes All Of Our Readers A Happy St. Patrick’s Day

Posted by Paul Cacciatore on March 17, 2009

I know what you’re thinking.  With a last name like Cacciatore, he can’t be Irish. But alas, you would be mistaken, as I am one-half Irish and proud of it.  My old college roommate (who is a 1st generation Irish American) considers St. Patrick’s Day the holiest of holy days … along with the entire college campus of the University of Notre Dame.

In honor of the day, I provide you with an Irish toast & song as both go hand-in-hand (usually with a pint of Guinness reserved for one hand).

The Toast: “May you live to be 100 years old with an extra year to repent! Sláinte!”

The Song: “The Galway Girl“* by the Irish artist Mundy. Mundy’s live performance of this song is provided below.

*”The Galway Girl” is a song originally written by Steve Earle and recorded with the Irish fiddler Sharon Shannon on Earle’s 2000 album Transcendental Blues.  The video below features a cover version of the song made famous in 2007-2008 by the Irish artist Mundy.  Mundy’s cover version of the Irish song reached even higher profile in the U.S. after being featured by director Richard LaGravenese in the movie P.S. I Love You (click here to view a video that features the Galway Girl song and excerpts from P.S. I Love You).

The Galway Girl Performed by Mundy

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Early Detection Remains Key in Updated National Comprehensive Cancer Network (NCCN) Guidelines for Ovarian Cancer

Posted by Paul Cacciatore on March 16, 2009

New updates to the NCCN Clinical Practice Guidelines in Oncology™ for Ovarian Cancer were presented at the NCCN 14th Annual Conference on March 14. Notable additions to the NCCN Guidelines are a section on managing allergic reactions to chemotherapy agents and new agents for recurrence therapy. Robert J. Morgan Jr., M.D., F.A.C.P. of  the City of Hope Comprehensive Cancer Center presented the updated NCCN Guidelines that continue to stress early detection of ovarian cancer and the enrollment of patients in clinical trials.

“Early Detection Remains Key in Updated NCCN Guidelines for Ovarian Cancer


New updates to the NCCN Clinical Practice Guidelines in Oncology™ for Ovarian Cancer were presented at the NCCN 14th Annual Conference on March 14. Notable additions to the NCCN Guidelines are a section on managing allergic reactions to chemotherapy agents and new agents for recurrence therapy. Robert J. Morgan, MD, of City of Hope Comprehensive Cancer Center presented the updated NCCN Guidelines that continue to stress early detection of ovarian cancer and the enrollment of patients in clinical trials.


March 16, 2009

morganrobert

Robert J. Morgan Jr., M.D., F.A.C.P., Professor of Medical Oncology, Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte, CA & Chair of the NCCN Guidelines Panel for Ovarian Cancer

HOLLYWOOD, FL — Improvements in screening and early detection remains the key for women with ovarian cancer according to Robert J. Morgan, MD, of City of Hope Comprehensive Cancer Center and chair of the NCCN Guidelines Panel for Ovarian Cancer. Dr. Morgan discussed the future of ovarian cancer and notable changes to the recently updated NCCN Ovarian Cancer Guidelines at the NCCN Annual Conference on Saturday, March 14.

Dr. Morgan began by explaining that the major challenge in treating ovarian cancer is that by the time the majority of patients (70 percent) are diagnosed with the disease, it has already progressed to stage III or IV. ‘We have not yet found a good way to screen the general population or even the high-risk population of women for ovarian cancer,’ he said.

New to the NCCN Guidelines is a section on the management of allergic reactions in patients receiving chemotherapy for ovarian cancer. Dr. Morgan explained the need for this section as ovarian cancer tends to respond to the same treatment repeatedly. Combined with the fact that recurrence rates of ovarian cancer are high, this can result in patients often being retreated with the same chemotherapeutic agent. Given that virtually all chemotherapy drugs have the potential to cause infusion reactions, including agents commonly used in ovarian cancer, the NCCN Guidelines Panel felt it was important to provide information on allergic reactions and recommendations on desensitization regimens.

‘Most patients experiencing allergic reactions are able to be desensitized allowing for continued chemotherapeutic treatment, which is vital to the management of ovarian cancer,’ said Dr. Morgan.

Also new to the updated NCCN Guidelines is the addition of new agents for recurrence therapy, most notably pemetrexed (Alimta®, Eli Lilly and Company) as well as recommendations for therapies based on the timing of recurrence.

‘Seventy-five to 80 percent of patients with stage III or IV ovarian cancer will experience recurrence and this recurrence can occur at any time – during treatment, within 6 months of completing treatment, or more than a year after completing treatment,’ Dr. Morgan noted. ‘In the updated NCCN Guidelines, we differentiated appropriate therapy for recurrence based upon the time frame on which it occurs.’

Additionally, Dr. Morgan referred to a clinical trial suggesting that pemetrexed is active in recurrent ovarian cancer, to support the new recommendation in the updated NCCN Guidelines.

Dr. Morgan described new updates to the Principles of Primary Surgery section in the updated NCCN Guidelines that included the recommendation to consider completion surgery for patients responsive to chemotherapy with initially unresectable residual disease, as well as recommendations relating to special circumstances including minimally-invasive procedures, and fertility sparing procedures.

Dr. Morgan also discussed recent clinical studies conducted abroad that studied the effect of chemotherapy as an up-front therapy in patients with ovarian cancer, and concluded that ‘in the United States, up-front debulking surgery remains the recommendation for the best overall survival.’

Another addition to the updated NCCN Guidelines is a section on the Principles of Chemotherapy. This section emphasizes the encouragement of patients participating in clinical trials during all aspects of their treatment course as well as noting that patients with newly diagnosed tumors should be informed about the different options available, particularly IV [intravenous] vs. IV/IP chemotherapy and the risks and benefits of each regimen.

‘The future of ovarian cancer lies in early detection and improvements in screening,’ Dr. Morgan noted as he discussed potential biomarkers for the detection, prediction and prognostication of ovarian cancer.

He concluded that steady progress is being made in the treatment of ovarian cancer, but further trials are necessary to investigate the role of targeted agents alone and in combination in newly diagnosed and recurrent ovarian cancer. Finally, he again stressed the need for physicians to encourage their patients to participate in clinical trials.

For questions about NCCN or for interview information, please contact Megan Martin 215.690.0576.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 21 of the world’s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers. The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives. For more information, visit www.nccn.org.

The NCCN Member Institutions are

Cited SourceEarly Detection Remains Key in Updated NCCN Guidelines for Ovarian Cancer, News, National Comprehensive Cancer Network (NCCN), March 16, 2009.

Posted in Chemotherapy, Early Detection, Fertility, Meeting Highlights, Treatment Overview | Tagged: , , , , , , , , , , , , , , , , , , | Leave a Comment »

Can FDA-Approved HIV Drugs Treat Chemoresistant Ovarian Cancer?

Posted by Paul Cacciatore on March 15, 2009

Two recent in vitro studies conducted in the U.S. and Europe raise a provocative question:  Can FDA-approved human immunodeficiency virus (HIV) drugs be used to treat chemoresistant ovarian cancer?  Both studies were based upon the fact that HIV patients taking antiretroviral inhibitors have a lower incidence of infection-associated malignancies.  Based upon that fact, the researchers conducting both studies hypothesized that such drugs could produce anti-cancer activity.

Two recent in vitro studies conducted in the U.S. and Europe raise a provocative question:  Can FDA-approved human immunodeficiency virus (HIV) drugs be used to treat chemoresistant ovarian cancer?  Both studies were based upon the fact that HIV patients taking antiretroviral inhibitors have a lower incidence of infection-associated malignancies.  Based upon that fact, the researchers conducting both studies hypothesized that such drugs could produce anti-cancer activity.

The first in vitro study was conducted by University of Munich Hospital researchers.  The stated purpose of the German in vitro study was to determine whether nelfinavir could (i) sensitize drug resistant ovarian cancer cells to chemotherapeutic agent, or (ii) act as a monotherapy against drug resistant ovarian cancer cells.  Upon conclusion of the study, the German researchers discovered that nelfinavir induced cell death in carboplatin- sensitive and carboplatin-resistant ovarian cancer cell lines, as well as in cancer biopsies and ascites samples from patients with recurrent ovarian cancer.  The researchers noted that nelfinavir significantly changed the morphology of the ovarian cancer cells by creating the so-called “unfolded protein response” (UPR). UPR, in turn, caused ovarian cancer cell cycle arrest and death. The German researchers also observed a downregulation of cell cycle regulatory proteins after nelfinavir treatment, and hypothesized that it contributed to ovarian cancer cell death. Because nelfinavir represents a FDA-approved drug for use in humans with HIV infection, the researchers concluded that it could be tested rapidly in clinical studies as a potential treatment strategy against drug-resistant ovarian cancer.

The second in vitro study was conducted by University of Michigan researchers.  The stated purpose of the University of Michigan study was to (i) determine whether the protease inhibitor saquinavir could produce anticancer activity in ovarian cancer cell lines, and (ii) understand the mechanism through which such anti-cancer activity occurs.  Upon conclusion of the study, the University of Michigan researchers discovered that saquinavir induced cell death in chemosensitive and chemoresistant ovarian cancer cells in a time- and dose-dependent manner. Specifically, cellular morphology assessed by transmission electron microscopy (TEM) revealed apoptotic, autophagic, and necrotic cell death. The University of Michigan researchers concluded that saquinavir, as an FDA-approved drug for the treatment of HIV, could have clinical application in the treatment of chemoresistant ovarian cancer.

Comment:

There is no guarantee that the in vitro study results discussed above could be replicated in human beings.  The in vitro study results are nevertheless provocative because they were performed with drugs that are already FDA-approved, abeit for HIV, and therefore, such drugs were previously determined to be relatively safe. In addition, the findings of both in vitro studies are nearly identical despite the fact that two different FDA-approved HIV drugs were tested by two separate medical facilities. Given the chemoresistant nature of ovarian cancer, it seems that nelfinavir and saquinavir should be tested in future clinical trials.

Primary Sources:

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Small Phase II Study Tests the Use of Fulvestrant in the Treatment of Recurrent Epithelial Ovarian Cancer

Posted by Paul Cacciatore on March 15, 2009

… University of Minnesota researchers evaluated the use of fulvestrant [Faslodex®] in women with recurrent ovarian or primary peritoneal cancer. …Using modified-RECIST criteria 13 patients (50%) achieved SD …[T]he University of Minnesota researchers concluded that fulvestrant is well-tolerated and efficacious. The researchers also noted that objective response rates are low, but disease stabilization was common.

It is well-known that the goal of treating recurrent ovarian cancer is disease control while minimizing toxicity. Previously, Fulvestrant (Faslodex®), a novel estrogen receptor (ER) antagonist, was proven clinically beneficial and well-tolerated in treating recurrent breast cancer. If a pathologist determines that a women’s ovarian cancer biopsy is estrogen receptor positive (ER+), there is a possibility that she may respond to anti-estrogen therapy.

On this basis, University of Minnesota researchers evaluated the use of fulvestrant in women with recurrent ovarian or primary peritoneal cancer. Patients with ER+, multiply recurrent ovarian or primary peritoneal carcinoma were eligible for trial enrollment if (i) they had measurable disease according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria, or (ii) an abnormal and rising CA-125 blood test measurement. Treatment consisted of single agent fulvestrant, 500 mg IM (intramuscular) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until the patient experienced intolerance or disease progression. Disease response was assessed by monthly physical exams and CA-125 levels as well as bimonthly CT scans. The clinical trial primary endpoint was “clinical benefit” (CB) (i.e., CB=complete response (CR) + partial response (PR) + stable disease (SD)) at 90 days).

Pursuant to the phase II fulvestrant clinical trial, the study researchers reported the following:

  • Thirty-one women were enrolled and 26 women (median age of 61) met inclusion criteria and received at least one dose;
  • Patients received a median of 5 prior chemotherapeutic regimens (range: 2-13) prior to enrollment;
  • One patient experienced CR (4%), one patient experienced PR (4%), and 9 patients experienced SD (35%) using modified-Rustin criteria (CA-125 level);
  • Using modified-RECIST criteria 13 patients (50%) achieved SD;
  • The median time to disease progression was 62 days (mean 86 days); and
  • Grade 1 toxicity included headache (1 patient) and bromidrosis (2 patients).

Based upon the foregoing results, the University of Minnesota researchers concluded that fulvestrant is well-tolerated and efficacious. The researchers also noted that objective response rates are low, but disease stabilization was common.

Primary SourceA phase II study of fulvestrant in the treatment of multiply-recurrent epithelial ovarian cancer; Argenta PA, Thomas SG, Judson PL et. al., Gynecol Oncol. 2009 Feb 22. [Epub ahead of print]

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Massachusetts General Hospital Cancer Center To Genetically Profile All Patient Tumors

Posted by Paul Cacciatore on March 14, 2009

“The Massachusetts General Hospital Cancer Center has recently opened a new Translational Research Laboratory that will uncover the genetic codes and gene mutations from almost all of its cancer patients. … By embarking on such an ambitious approach, Cancer Center pathologists and oncologists hope to gather specific information about tumor properties that will lead to targeted therapies and better personalized treatments. Mass General will be the first and only cancer center to conduct molecular profiling of positive biopsies and tumors from all patients as part of basic patient care. …”

Genetic profiling

09/Mar/2009

massgenlab

Massachusetts General Hospital Cancer Center Opens Molecular Pathology Lab to Genetically Profile All Patient Tumors

The Massachusetts General Hospital Cancer Center has recently opened a new Translational Research Laboratory that will uncover the genetic codes and gene mutations from almost all of its cancer patients. Previously only a sampling of patients had their tumors analyzed in such a comprehensive fashion.

By embarking on such an ambitious approach, Cancer Center pathologists and oncologists hope to gather specific information about tumor properties that will lead to targeted therapies and better personalized treatments. Mass General will be the first and only cancer center to conduct molecular profiling of positive biopsies and tumors from all patients as part of basic patient care.

Scientists and researchers have already identified over 110 genetic mutations responsible for causing tumor growth, many of which are involved in several different types of cancers. Codirectors of the Transplational Research Laboratory, Leif Ellisen, MD, PhD, and A. John Iafrate, MD, PhD, have equipped the lab with state-of-the-art robotic technology, which will make it possible to quickly genotype tumor specimens within a short period of time.

‘This new and improved classification of cancers that we are doing is intended to give our oncologists more information about a individual patient’s cancer, so they can treat it in a very specific way, thereby significantly increasing the odds of success,’ says Iafrate.

Several new cancer drugs that are currently available or in development are able to block some of the mutations and pathways that cause tumor cells to proliferate. By targeting tumor gene mutations with these smart drugs, doctors may be able to eradicate malignant cells without using traditional treatments like chemotherapy and radiation, which have significant side effects.

The lab’s new tumor genotyping initiative should also expedite the time it takes to find the right drug for the right patient. According to Ellisen, ‘If we are able to identify a mutation in, say, a case of lung cancer, and we know that a particular drug has been successful in treating colon cancer patients with the same mutation, then we have good reason to believe that drug will work turning off the cancer-causing mutation in the lung cancer patient as well.’

The lab will start with the genotyping of Mass General’s lung cancer patients and phase in different disease groups over the next few weeks. It is anticipated that the profiling of all possible patient tumors will occur gradually over the coming months.

Learn more about research at the Cancer Center

Cited SourceMassachusetts General Hospital Cancer Center opens molecular pathology lab to genetically profile all patient tumors, News, Massachusetts General Hospital, Mar. 9, 2009.

Update:

  • Making Personalized Cancer Care Routine, In Depth, NCI Cancer Bulletin, Volume 6 / Number 11, National Cancer Institute, June 2, 2009 (noting that Massachusetts General Hospital & Memorial Sloan-Kettering Cancer Center are performing genetic profiling of all lung cancer tumors).

Posted in Diagnosis & Treatment, Genetics | Tagged: , , , , , , , , , | 14 Comments »

Preliminary Findings of a Large British Study Indicate That CA-125 Blood Test & Transvaginal Ultrasound Test Can Detect Early Ovarian Cancer

Posted by Paul Cacciatore on March 10, 2009

“Ovarian cancer has a high case—fatality ratio, with most women not diagnosed until the disease is in its advanced stages. The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) is a randomised controlled trial designed to assess the effect of screening on mortality. This report summarises the outcome of the prevalence (initial) screen in UKCTOCS. …”

“Background

Ovarian cancer has a high case—fatality ratio, with most women not diagnosed until the disease is in its advanced stages. The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) is a randomised controlled trial designed to assess the effect of screening on mortality. This report summarises the outcome of the prevalence (initial) screen in UKCTOCS.

earlydetecttrialdesign1

The United Kingdom Collaborative Trial of Ovarian Cancer Screening - Overall Trial Design

Methods

Between 2001 and 2005, a total of 202,638 post-menopausal women aged 50—74 years were randomly assigned to [1] no treatment (control; n=101,359); [2] annual CA125 screening (interpreted using a risk of ovarian cancer algorithm) with transvaginal ultrasound scan as a second-line test (multimodal screening [MMS]; n=50,640); or [3] annual screening with transvaginal ultrasound (USS; n=50,639) alone in a 2:1:1 ratio using a computer-generated random number algorithm. All women provided a blood sample at recruitment. Women randomised to the MMS group had their blood tested for CA125 and those randomised to the USS group were sent an appointment to attend for a transvaginal scan. Women with abnormal screens had repeat tests. Women with persistent abnormality on repeat screens underwent clinical evaluation and, where appropriate, surgery. This trial is registered as ISRCTN22488978 and with ClinicalTrials.gov, number NCT00058032.

Findings

In the prevalence screen, 50,078 (98.9%) women underwent MMS, and 48,230 (95.2%) underwent USS. The main reasons for withdrawal were death (two MMS, 28 USS), non-ovarian cancer or other disease (none MMS, 66 USS), removal of ovaries (five MMS, 29 USS), relocation (none MMS, 39 USS), failure to attend three appointments for the screen (72 MMS, 757 USS), and participant changing their mind (483 MMS, 1,490 USS). Overall, 4,355 of 50,078 (8.7%) women in the MMS group and 5,779 of 48,230 (12.0%) women in the USS group required a repeat test, and 167 (0.3%) women in the MMS group and 1,894 (3.9%) women in the USS group required clinical evaluation. 97 of 50,078 (0.2%) women from the MMS group and 845 of 48,230 (1.8%) from the USS group underwent surgery. 42 (MMS) and 45 (USS) primary ovarian and tubal cancers were detected, including 28 borderline tumours (eight MMS, 20 USS). 28 (16 MMS, 12 USS) of 58 (48.3%; 95% CI 35.0—61.8) of the invasive cancers were stage I/II, with no difference (p=0.396) in stage distribution between the groups. A further 13 (five MMS, eight USS) women developed primary ovarian cancer during the year after the screen. The sensitivity, specificity, and positive-predictive values for all primary ovarian and tubal cancers were 89.4%, 99.8%, and 43.3% for MMS, and 84.9%, 98.2%, and 5.3% for USS, respectively. For primary invasive epithelial ovarian and tubal cancers, the sensitivity, specificity, and positive-predictive values were 89.5%, 99.8%, and 35.1% for MMS, and 75.0%, 98.2%, and 2.8% for USS, respectively. There was a significant difference in specificity (p<0.0001) but not sensitivity between the two screening groups for both primary ovarian and tubal cancers as well as primary epithelial invasive ovarian and tubal cancers.

Interpretation

The sensitivity of the MMS and USS screening strategies is encouraging. Specificity was higher in the MMS than in the USS group, resulting in lower rates of repeat testing and surgery. This in part reflects the high prevalence of benign adnexal abnormalities and the more frequent detection of borderline tumours in the USS group. The prevalence screen has established that the screening strategies are feasible. The results of ongoing screening are awaited so that the effect of screening on mortality can be determined.

Funding

Medical Research Council, Cancer Research UK and the Department of Health, UK; with additional support from the Eve Appeal, Special Trustees of Bart’s and the London, and Special Trustees of University College London Hospital.”

Primary Source

Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS); Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: results of the prevalence screen of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS); Usha Menon MD, Aleksandra Gentry-Maharaj Ph.D., Rachel Hallett Ph.D. et. al, The Lancet Oncology, Early Online Publication, 11 March 2009 doi:10.1016/S1470-2045(09)70026-9.

Comment

During an interview with the New York Times, Dr. Ian Jacobs, director of the Institute for Women’s Health at University College London, and director of the trial, discussed the optimism and the caveats associated with the preliminary clinical study results as follows:

We have now demonstrated we can pick up the vast majority of women with ovarian cancer earlier than they would have otherwise been detected and before they have symptoms, .. and that a good proportion of those women have earlier stage disease than we would normally expect them to have. … [W]omen thinking of having this must understand and realize that there’s a possibility it will do more harm than good. We have reason to think it will save lives, … and then the question is, will it save enough lives to balance out the harm it does? [Emphasis added].

Robert Smith, director of cancer screening for the American Cancer Society informed the New York Times that “[w]e’re not even remotely close to knowing how to screen women of average risk with these tests, or even if we should.” Mr Smith added that it is important to run large clinical trials, but that the preliminary results of this study must be interpreted with caution.

Secondary Sources

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High-Dose Stereotactic Body Radiation Therapy Effective Treatment For Patients With Low Volume Lung or Liver Metastases

Posted by Paul Cacciatore on March 10, 2009

Libby’s H*O*P*E*™ previously reported on potential treatments for “oligometastasis,” which is defined as cancer that spreads to a few distant body sites, on June 23, 2008 and August 17, 2008.  Two related U.S. multi-institutional, phase I/II clinical studies and one Canadian Phase I clinical study reported recently results from an evaluation of the efficacy and tolerability of high-dose stereotactic body radiation therapy (SBRT) for the treatment of patients with liver or lung metastases.  A description of each study and its findings is provided below.  In addition, we have provided an excerpt from an editorial published in the Journal of Clinical Oncologythat comments upon the lessons learned from the three SBRT clinical studies described below, as well as other related studies.

Libby’s H*O*P*E*™ previously reported on potential treatments for “oligometastasis,” which is defined as cancer that spreads to a few distant body sites, on June 23, 2008 and August 17, 2008.  Two related U.S. multi-institutional, phase I/II clinical studies and one Canadian Phase I clinical study reported recently results from an evaluation of the efficacy and tolerability of high-dose stereotactic body radiation therapy (SBRT) for the treatment of patients with liver or lung metastases.  A description of each study and its findings are provided below.  In addition, we have provided an excerpt from an editorial published in the Journal of Clinical Oncology that comments upon the lessons learned from the three SBRT clinical studies described below, as well as other related studies.

sbrtU.S. SBRT Liver Metastases Study

In the first U.S. clinical study, patients with one to three hepatic lesions (with maximum individual tumor diameters less than 6 cm) were enrolled and treated on a multi-institutional, phase I/II clinical trial in which they received SBRT delivered in three fractions. During the phase I clinical study, the total radiation dose was safely escalated from 36 Gy to 60 Gy. During the phase II portion of the clinical study, the dose was 60 Gy. The study primary end point was local control of the hepatic metastases. Hepatic metastatic lesions with at least 6 months of radiographic follow-up were considered assessable for local control. The study secondary end points were toxicity and survival.

As part of this clinical study, 47 patients with 63 lesions were treated with SBRT. Among those patients, 69% had received at least one prior systemic therapy regimen for metastatic disease (range, 0 to 5 regimens), and 45% had extra-hepatic disease at study entry. Forty-nine discrete lesions were assessable for local control. Median follow-up for assessable lesions was 16 months (range, 6 to 54 months). The median maximal tumor diameter was 2.7 cm (range, 0.4 to 5.8 cm). Based upon this criteria, the researchers reported the following findings:

  • Only one patient experienced grade 3 or higher toxicity (2%);
  • Local progression occurred in only three lesions at a median of 7.5 months (range, 7 to 13 months) after SBRT;
  • Actuarial in-field local control rates at one and two years after SBRT were 95% and 92%, respectively;
  • Among lesions with maximal diameter of 3 cm or less, 2-year local control was 100%; and
  • Median survival was 20.5 months.

Based upon the foregoing, the U.S. researchers concluded that the multi-institutional, phase I/II clinical study demonstrates that high-dose liver SBRT is safe and effective for the treatment of patients with one to three liver metastases.

Canadian SBRT Liver Metastases Study

In the phase I Canadian clinical study, patients with liver metastases who were inoperable or medically unsuitable for resection, and were not candidates for standard therapies, were eligible for this individualized SBRT study. Individualized radiation doses were chosen to maintain the same nominal risk of radiation-induced liver disease (RILD) for three estimated risk levels (5%, 10%, and 20%).  Additional patients were treated at the maximal study dose (MSD) in an expanded cohort.  Median SBRT dose was 41.8 Gy (range, 27.7 to 60 Gy) in six fractions over 2 weeks.  Based upon this criteria, the Canadian researchers reported the following findings:

  • Sixty-eight patients with inoperable colorectal (n = 40), breast (n = 12), or other (n = 16) liver metastases were treated;
  • Median tumor volume was 75.2 mL (range, 1.19 to 3,090 mL);
  • The highest RILD risk level investigated was safe, with no dose-limiting toxicity;
  • Two patients experienced grade 3 liver enzyme changes, but no RILD or other grade 3 to 5 liver toxicity was seen, resulting in a low estimated risk of serious liver toxicity;
  • Six patients (9%) experienced acute grade 3 toxicities (two gastritis, two nausea, lethargy, and thrombocytopenia) and one (1%) patient experienced grade 4 toxicity (thrombocytopenia);
  • The 1-year local control rate was 71%; and
  • The median overall survival was 17.6 months.

Based upon the foregoing, the Canadian researchers concluded that individualized six-fraction liver metastases SBRT is safe, with sustained local control observed in the majority of patients.

U.S. SBRT Lung Metastases Study

In the third study, patients with one to three lung metastases (with cumulative maximum tumor diameter smaller than 7 cm) were enrolled and treated as part of a U.S. multi-institutional phase I/II clinical study in which they received SBRT delivered in 3 fractions.  During the phase I clinical study, the total dose was safely escalated from 48 to 60 Gy. During the phase II portion of the clinical study, the phase II dose was 60 Gy.  The study primary end point was local control.  Metastatic lung lesions with at least 6 months of radiographic follow-up were considered assessable for local control.  The study secondary end points included toxicity and survival.

As part of this study, 38 patients with 63 lesions were enrolled and treated at three U.S. participating institutions. Among those patients, 71% received at least one prior systemic regimen for metastatic disease and 34% had received at least two prior regimens (range, 0 to 5 regimens). Two patients had local recurrence after prior surgical resection. Fifty lesions were assessable for local control.  Median follow-up for assessable lesions was 15.4 months (range, 6 to 48 months). The median gross tumor volume was 4.2 mL (range, 0.2 to 52.3 mL). Based upon this criteria, the researchers reported the following findings:

  • There was no grade 4 toxicity;
  • The incidence of any grade 3 toxicity was 8% (3 of 38 patients);
  • Symptomatic pneumonitis occurred in one patient (2.6%);
  • Actuarial local control at one and two years after SBRT was 100% and 96%, respectively;
  • Local progression occurred in one patient, 13 months after SBRT; and
  • Median survival was 19 months.

Based upon the foregoing, the U.S. researchers concluded that the multi-institutional phase I/II clinical study demonstrates that high-dose SBRT is safe and effective for the treatment of patients with one to three lung metastases.

Using a Bigger Hammer: The Role of Stereotactic Body Radiotherapy in the Management of Oligometastases - Journal of Clinical Oncology Editorial

“… What can we learn from these three trials [described above]?

First, we have learned once again that it is possible to conduct prospective trials of new technological approaches. This is an important lesson. This is how future technologies, such as proton therapy, should be tested.

Second, although the poor overall survival of patients in these trials competes with the risk of local relapse, possibly leading to overestimation of the probability of local control at 2 years, it seems likely that SBRT is a good treatment for such patients. It would seem that a standardized dose/fractionation scheme, such as 60Gyin three fractions, works well for tumors smaller than 3 cm; larger ones may benefit from an individualized approach, such as described by Lee et al. [Canadian study decribed above, ftnote omitted]. However, we must continue to remember past experiences with hypofractionation of large volumes, which can produce severe late normal-tissue effects, especially fibrosis. Even if small volumes are irradiated, catastrophic complications can occur.  In the case of lung cancer, severe unacceptable complications (bronchial fibrosis or hemorrhage) have been associated with treatment of lesions within 2 cm of major airways.  A more protracted (five-fraction) regimen is about to be tested in a Radiation Therapy Oncology Group (RTOG) trial that will open in the coming months that will determine if these toxicities can be avoided.  Lesions close to the chest wall may also benefit from a more protracted fractionation to avoid rib fractures.  In the case of medial or central liver lesions, hypofractionation can cause intestinal obstruction or biliary fibrosis.

Finally, we should recognize that the methodology used in these trials applies to patients with relatively normal liver and lung functions.  At this time, it is not clear how to account for organ dysfunction in patients with lung cancer or primary liver tumors.  Certainly, differences in tolerance to radiation between patients with liver metastases and those with primary liver tumors have been observed before [ftnote omitted].  Therefore, although SBRT seems to have given us a bigger hammer, we still have much to learn about how and when to strike the nails.”

Primary Sources:

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M.D. Anderson Researchers Find GM-CSF and rIFN-gamma1b Plus Carboplatin Effective For the Treatment of Recurrent, Platinum-Sensitive Ovarian Cancer

Posted by Paul Cacciatore on March 9, 2009

Researchers working in the Gynecologic Oncology Department of The University of Texas M.D. Anderson Cancer Center, reported Phase II clinical study results from their evaluation of the use of carboplatin, granulocyte-macrophage colony-stimulating factor (GM-CSF) and recombinant interferon gamma 1b (rIFN-gamma1b) in women with recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer. …

Researchers working in the Gynecologic Oncology Department of The University of Texas M.D. Anderson Cancer Center, reported Phase II clinical study results from their evaluation of the use of carboplatin, granulocyte-macrophage colony-stimulating factor (GM-CSF) and recombinant interferon gamma 1b (rIFN-gamma1b) in women with recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer.

As part of this Phase II clinical study, patients with recurrent, platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer were treated with subcutaneous GM-CSF and rIFN-gamma1b before and after intravenous carboplatin until their disease progressed or unacceptable toxicity occurred. All patients had measurable disease and a chemotherapy-free interval >6 months. Response was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria and CA 125 blood serum levels. Between 2003 and 2007, 59 patients received a median of 6 cycles of therapy (range, 1 to 13 cycles). The median patient age at enrollment was 61 years (range, 35 to 79 years). The median patient time to disease progression prior to clinical study enrollment was 11 months (range, 6 to 58 months).

The M.D. Anderson researchers reported the following results:

Based upon the foregoing results, the researchers concluded that the pre- and post-carboplatin cytokine regimen resulted in a reasonable response and a hematologic profile that could invite further evaluation of its components in the treatment of patients with ovarian cancer.

Primary SourceA phase II study of GM-CSF and rIFN-gamma1b plus carboplatin for the treatment of recurrent, platinum-sensitive ovarian, fallopian tube and primary peritoneal cancer; Schmeler KM, Vadhan-Raj S, Ramirez PT et. al., Gynecol Oncol. 2009 Mar 3. [Epub ahead of print].

Posted in Biological Therapies, Clinical Trial Results | Tagged: , , , , , , , , , , , , , , | Leave a Comment »

 
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