OVA1 Blood Test Detects Ovarian Cancer In Women With A Known Ovarian Mass More Accurately Than CA-125

A study published online in Obstetrics & Gynecology reports that the OVA1 blood test detects ovarian cancer in women with a previously discovered ovarian mass more accurately than the CA-125 blood test. The study also considers OVA1’s place in future surgical referral guidelines.

A study published online ahead of print in the June 2011 edition of Obstetrics & Gynecology demonstrated that American College of Obstetrics and Gynecology (ACOG) guidelines for determining the likelihood that an ovarian mass is cancerous prior to surgery would accurately identify more women with ovarian cancer if the OVA1 blood test were used in place of the currently recommended CA-125 (cancer antigen 125) blood test. The study builds on prior research that shows accurate assessment of an ovarian mass for cancer prior to surgery can affect both treatment decisions and health outcomes for women with ovarian cancer.

… When OVA1 was used in place of CA 125 as recommend in the [ACOG] guidelines, 94% of malignancies in women of all ages in the study were accurately detected compared to 77% with CA-125. In addition, OVA1 improved sensitivity in premenopausal women, accurately detecting 91% of women with ovarian cancer in fewer than 58% with CA125. … The study also showed that the OVA1 test was about two times more likely to incorrectly identify women as high risk for ovarian cancer when they were not (a “false positive“) as compared to the CA-125 test overall. … 

OVA1 is the first test cleared by the U.S. Food and Drug Administration (FDA) for aiding in the pre-surgical evaluation of a woman’s ovarian mass for cancer. Vermillion, Inc., a molecular diagnostics company, developed OVA1, and Quest Diagnostics Incorporated, the world’s leading diagnostic testing company, offers OVA1 testing services in the United States and India. Quest Diagnostics and Vermillion both participated in the study and Vermillion also helped fund the study. Neither company had any involvement in the development of the manuscript.

Clinical practice guidelines recommend that women with ovarian cancer be under the care of a gynecologic oncologist, although only an estimated one-third of initial surgeries for ovarian cancer are performed by these specialists. ACOG guidelines for the management of ovarian masses recommend that physicians evaluate several factors, including menopausal status, imaging findings, family history, and CA 125 blood test levels, to divide women into low- and high-risk categories on which treatment plans, including surgical referral, are based.

The study evaluated the performance of the ACOG guidelines using the CA-125 test versus the OVA1 test in 516 women scheduled for surgery for an ovarian mass across a diverse group of primary and specialty care centers. When OVA1 was used in place of CA-125 as recommend in the guidelines, 94% of malignancies in women of all ages in the study were accurately detected compared to 77% with CA 125. In addition, OVA1 improved sensitivity in premenopausal women, accurately detecting 91% of women with ovarian cancer in fewer than 58% with CA-125.

Rachel Ware Miller, M.D., Assistant Professor, Gynecologic Oncology, Markey Cancer Center, University of Kentucky

“The high sensitivity in premenopausal women and early stage cancers is where CA-125 and the College guidelines have underperformed,” wrote investigator Rachel Ware Miller, M.D., assistant professor gynecologic oncology at the University of Kentucky’s Markey Cancer Center, in the study. ” Identifying these patients for referral is valuable because many are not receiving appropriate surgical staging and treatment. An effective preoperative test, particularly for younger women and early-stage cancers, can have a favorable effect on women’s health as survival is better in these populations.”

OVA1 when used with the College guidelines was also effective at detecting advanced disease, when surgery and chemotherapy can “improve overall survival,” wrote Dr. Miller.

The study also showed that the OVA1 test was about two times more likely to incorrectly identify women as high risk for ovarian cancer when they were not (a “false positive“), as compared to the CA-125 test overall. However, as OVA1 is only indicated for women for whom surgery is already planned, a higher rate of false positives would increase the possibility that a woman’s surgery is performed by a gynecologic oncologist rather than a gynecologist or other non-specialist.

The study follows the March 2011 publication in Obstetrics & Gynecology, the official publication of ACOG, of an updated committee opinion, The Role Of The Obstetrician-Gynecologist In The Early Detection Of Epithelial Ovarian Cancer, by ACOG and Society of Gynecologic Oncologists (SGO) that cited the FDA clearance of OVA1 (in 2009) and indicated that OVA1 “appears to improve the predictability of ovarian cancer in women with pelvic masses” and “may be useful for evaluating women with a pelvic mass.”

“Prior to OVA1’s clearance by the FDA, the only lab test physicians could use to assess the likelihood that an ovarian mass was malignant prior to surgery was CA-125, even though CA-125 is not indicated for this use and its performance is variable,” said Dr. Eric T. Fung, chief science officer, Vermillion, Inc. “These data should give physicians more confidence to refer women whose OVA1 test result indicates a high likelihood of cancer to a gynecologic oncologist for surgery.”

Ovarian cancer is the leading cause of death from gynecologic cancers in the United States and the fifth-leading cause of cancer deaths in women. Ovarian masses affect an estimated one million women and lead to as many 300,000 ovarian mass surgeries in the United States each year, according to an analysis by third parties on behalf of Quest Diagnostics.

About OVA1®

OVA1 is the first test cleared by FDA for aiding in the pre-surgical evaluation of a woman’s ovarian mass for cancer, and also is the first protein-based In Vitro Diagnostic Multi-Variate Index Assays (IVDMIA), a new class of state of the art software-based diagnostics. The test utilizes five well-established biomarkers — transthyretin (TT or prealbumin), apoolipoprotein A-1 (Apo A-1), beta 2-microglobulin (beta 2M), transferrin (Tfr) and cancer antigen 125 (CA-125 II) — and proprietary software to determine the likelihood of malignancy in women with ovarian mass for whom surgery is planned.

OVA1 is indicated for women who meet the following criteria: (i) over age 18, (ii) ovarian adnexal mass present for which surgery is planned, and (iii) not yet referred to an oncologist. It is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

About Quest Diagnostics

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at http://www.questdiagnostics.com/.

About Vermillion, Inc.

Vermillion, Inc. is dedicated to the development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in oncology, cardiology and women’s health. Additional information about Vermillion can be found on the Web at http://www.vermillion.com/.

Sources:

U.K. NICE Issues New Clinical Guidelines Re Recognition & Initial Management of Ovarian Cancer

On April 27, 2011, the U.K. National Institute For Health and Clinical Excellence issued new clinical guidelines regarding the recognition and initial management of ovarian cancer.

On April 27, 2011, the U.K. National Institute For Health and Clinical Excellence (NICE) issued new clinical guidelines regarding the recognition and initial management of ovarian cancer.

In the first ever clinical guideline for ovarian cancer, NICE is calling for more initial investigations to take place in primary care settings, such as general practice (GP) surgeries, so that women can be referred to hospital specialists sooner and begin treatment. This guidance updates and replaces recommendation 1.7.4 in Referral guidelines for suspected cancer (NICE clinical guideline 27; published 2005).

NICE also produced a series of tools to help U.K. healthcare professionals put this new guidance into practice, including guidance documents for doctors and patients, podcasts, clinical case scenarios and a slide set. To view a complete list of all NICE-produced guidance materials available to doctors and patients, visit http://guidance.nice.org.uk/CG122.

The full text NICE ovarian cancer clinical guidelines are classified under the following six chapter headings:

  • Epidemiology
  • Detection in Primary Care
  • Establishing the Diagnosis in Primary Care
  • Management of Suspected Early (stage I) Ovarian Cancer
  • Management of Advanced (stage II-IV) Ovarian Cancer
  • Support Needs of Women With Newly Diagnosed Ovarian Cancer

The key priorities identified by NICE for successful implementation of the new ovarian cancer clinical guidelines by primary and secondary healthcare professionals include the topics addressed below.

Awareness of Symptoms & Signs

— Carry out tests in primary care if a woman (especially if 50 or over) reports having any of the following symptoms on a persistent or frequent basis – particularly more than 12 times per month:

  • persistent abdominal distension (women often refer to this as “bloating”);
  • feeling full (early satiety) and/or loss of appetite;
  • pelvic or abdominal pain; and/or
  • increased urinary urgency and/or frequency.

— Carry out appropriate tests for ovarian cancer in any woman of 50 or over who has experienced symptoms within the last 12 months that suggest irritable bowel syndrome (IBS), because IBS rarely presents for the first time in women of this age.

Asking the Right Question – First Tests

— Measure serum CA125 in primary care in women with symptoms that suggest ovarian cancer.

— If serum CA125 is 35 IU/ml or greater, arrange an ultrasound scan of the abdomen and pelvis.

— For any woman who has normal serum CA125 (less than 35 IU/ml), or CA125 of 35 IU/ml or greater but a normal ultrasound:

  • assess her carefully for other clinical causes of her symptoms and investigate if appropriate; and
  • if no other clinical cause is apparent, advise her to return to her general practitioner (GP) if her symptoms become more frequent and/or persistent.

Malignancy Indices

— Calculate a risk of malignancy index I (RMI I) score (after performing an ultrasound) and refer all women with an RMI I score of 250 or greater to a specialist multidisciplinary team.

— Risk of malignancy index I (RMI I): RMI I is a product of the ultrasound scan score (U), menopausal status (M) and serum CA125 level.

— RMI I = U x M x  CA125

  • The ultrasound result is scored 1 point for each of the following characteristics: multilocular cysts, solid areas, metastases, ascites, and bilateral lesions. U = 0 for an ultrasound score of 0 points, U = 1 for an ultrasound score of 1 point, U = 3 for an ultrasound score of 2–5 points.
  • Menopausal status is scored as 1 = pre-menopausal and 3 = post-menopausal. The classification of “post-menopausal” is a woman who has had no period for more than 1 year or a woman over 50 who has had a hysterectomy.
  • Serum CA125 is measured in IU/ml.

Tissue Diagnosis

— If offering cytotoxic chemotherapy to women with suspected advanced ovarian cancer, first obtain a confirmed tissue diagnosis by histology (or by cytology if histology is not appropriate) in all but exceptional cases.

The Role of Systematic Retroperitoneal Lymphadenectomy

— Do not include systematic retroperitoneal lymphadenectomy (block dissection of lymph nodes from the pelvic side walls to the level of the renal veins) as part of standard surgical treatment in women with suspected ovarian cancer whose disease appears to be confined to the ovaries (that is, who appear to have stage I disease).

Adjuvant Systemic Chemotherapy For Stage I Disease

— Do not offer adjuvant chemotherapy to women who have had optimal surgical staging and have low-risk stage I disease ([tumor] grade 1 or 2, stage Ia or Ib).

Support Needs of Women with Newly Diagnosed Ovarian Cancer

— Offer all women with newly diagnosed ovarian cancer information about their disease, including psychosocial and psychosexual issues, that:

  • is available at the time they want it;
  • includes the amount of detail that they want and are able to deal with; and
  • is in a suitable format, including written information.

Source:  Ovarian cancer: the recognition and initial management of ovarian cancer (CG122), Full Guideline, National Institute For Health & Clinical Excellence (NICE), U.K. National Health Service (NHS), April 2011.

Additional Information:

2011 NCCN Conference: New Treatment Options Lead to Steady Progress Against Ovarian Cancer

Recommendations stemming from recent clinical trials highlight notable updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) for Ovarian Cancer at the National Comprehensive Cancer Network® (NCCN®) 16th Annual Conference.

Robert J. Morgan, Jr., M.D., Professor of Medical Oncology, City of Hope Comprehensive Cancer Center; Chair, NCCN Guidelines Panel for Ovarian Cancer

Although finding effective screening tools remains a priority, new treatment options for women with ovarian cancer, such as the ones outlined in the updated NCCN Guidelines for Ovarian Cancer,[1] are vital to making steady progress against the disease according to Robert J. Morgan, Jr., M.D., of City of Hope Comprehensive Cancer Center and chair of the NCCN Guidelines Panel for Ovarian Cancer. Dr. Morgan outlined significant updates to the NCCN Guidelines during a recent presentation at the NCCN 16th Annual Conference.

The NCCN Guidelines address epithelial ovarian cancer (including borderline or low malignant potential) and less common histopathologies, including malignant germ neoplasms, carcinosarcomas, and sex cord-stromal tumors. They also discuss fallopian tube cancer and primary peritoneal cancer, which are less common neoplasms that are managed in a similar manner to epithelial ovarian cancer.

“Regardless of the type of cancer, the NCCN Guidelines for Ovarian Cancer reflect the importance of stage and grade of disease on prognosis and treatment recommendations,” said Dr. Morgan.

The NCCN Guidelines continue to recommend that women with borderline epithelial ovarian cancer of low malignant potential be primarily surgically managed. In contrast to patients with frankly invasive ovarian carcinoma, women with borderline disease tend to be younger and are often diagnosed with stage I disease.

“The benefits of postoperative chemotherapy has not been demonstrated for patients who have no microscopically demonstrable invasive implants, said Dr. Morgan. “Even patients with advanced stage disease at presentation have an excellent prognosis and chemotherapy should be avoided.”

The NCCN Guidelines recommend surgery limited to a unilateral salpingo-oophorectomy (USO) (preserving the uterus and contralateral ovary) for women who wish to maintain their fertility, and standard ovarian cancer debulking surgery is recommended for those not concerned about fertility preservation.

On the contrary, in women diagnosed with stage II, III, or IV epithelial ovarian cancer, the NCCN Guidelines recommend intraperitoneal chemotherapy for first-line therapy and have been updated to include dose-dense paclitaxel (Taxol®:, Bristol-Myers Squibb) as a possible treatment option.

Dr. Morgan noted that in a recent clinical trial, dose-dense weekly paclitaxel with carboplatin (Paraplatin®:, Bristol-Myers Squibb) showed an increase in both progression-free survival and overall survival when compared with conventional intraperitoneal chemotherapy of weekly carboplatin/paclitaxel.[2]

“However, the dose-dense regimen is more toxic, and patients discontinued dose-dense paclitaxel therapy more often than those receiving standard therapy,” stated Dr. Morgan. “As with all treatment decisions, the patient needs to weigh the potential benefits and risks and discuss them thoroughly with their physician.”

Dr. Morgan discussed two additional phase 3 trials assessing bevacizumab (Avastin®:, Genentech/Roche) combined with carboplatin/paclitaxel in the upfront setting compared to carboplatin/paclitaxel alone.[3-4] Although data regarding overall survival and quality of life have not been reported yet, the studies did indicate that the median progression-free survival increased in patients receiving bevacizumab as a first line and maintenance therapy.

“Only modest improvements in progression-free survival were observed in both of these trials. The NCCN Guidelines Panel prefers to await mature results of these trials prior to recommending the routine addition of bevacizumab to carboplatin/paclitaxel,” said Dr. Morgan.

As such, the updated NCCN Guidelines includes new language detailing the Panel’s view on bevacizumab encouraging participation in ongoing clinical trials that are further investigating the role of anti-angiogenesis agents in the treatment of ovarian cancer, both in the upfront and recurrence settings.

Biomarkers continue to emerge as an area of interest in predicting future patterns of the disease. In patients with ovarian cancer, Dr. Morgan discussed the value of monitoring CA-125 levels in regards to a recent study[5] comparing early versus delayed treatment of relapsed ovarian cancer.

“Often, levels of CA-125 have been shown to rise prior to a clinical or symptomatic relapse in women with ovarian cancer. This trial looked at whether there was a benefit of early treatment on the basis of increased CA-125 concentrations compared with delayed treatment on the basis of clinical recurrence,” said Dr. Morgan.

The study, which was published in The Lancet, found that there was no survival benefit to early institution of treatment based on increased CA-125 levels and that the quality of life was superior in patients in the late treatment arm.

“The results of the trial suggest that the utility of the routine monitoring of CA-125 levels in limited,” said Dr. Morgan. “The NCCN Guidelines Panel encourages patients and their physicians to actively discuss the pros and cons of CA-125 monitoring based upon these findings and have updated the NCCN Guidelines to include language supporting this recommendation.”

Virtually all drugs used in oncology have the potential to cause adverse drug reactions while being infused, which can be classified as either infusion or allergic reactions. Recently, hypersensitivity to platinum compounds has been recognized as a potential issue for patients being administered these compounds.

“Platinum compounds remain very important in the treatment of ovarian cancer in both the upfront and recurrence settings, so it was important to design strategies to allow for the safe desensitization of these agents in patients who develop allergies,” said Dr. Morgan.

Standard desensitization regimens include slowly increasing infusion concentrations over several hours. However, Dr. Morgan noted that these procedures must be done in a specific manner in order to be safely administered and pointed to the recommendations within the updated NCCN Guidelines discussing the management of drug reactions.

In conclusion, Dr. Morgan emphasized that although steady progress is being made in the treatment of ovarian cancer, further trials are necessary to investigate the role of targeted agents alone and in combination in newly diagnosed and recurrent ovarian cancer. In addition, enrollment of patients with ovarian cancer must be encouraged.

The NCCN Guidelines are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of expert physicians from NCCN Member Institutions. The most recent version of this and all NCCN Guidelines are available free of charge at NCCN.org. The NCCN Guidelines for Patients™: Ovarian Cancer is available at NCCN.com.

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 NCCN.org.

The NCCN Member Institutions are:

  • City of Hope Comprehensive Cancer Center
  • Dana-Farber/Brigham and Women’s Cancer Center
  • Massachusetts General Hospital Cancer Center
  • Duke Cancer Institute
  • Fox Chase Cancer Center
  • Huntsman Cancer Institute at the University of Utah
  • Fred Hutchinson Cancer Research Center / Seattle Cancer Care Alliance
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
  • Memorial Sloan-Kettering Cancer Center
  • H. Lee Moffitt Cancer Center & Research Institute
  • The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute
  • Roswell Park Cancer Institute
  • Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
  • St. Jude Children’s Research Hospital / University of Tennessee Cancer Institute
  • Stanford Comprehensive Cancer Center
  • University of Alabama at Birmingham Comprehensive Cancer Center
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • University of Michigan Comprehensive Cancer Center
  • UNMC Eppley Cancer Center at The Nebraska Medical Center
  • The University of Texas MD Anderson Cancer Center
  • Vanderbilt-Ingram Cancer Center

References:

1/ Ovarian Cancer Including Fallopian Tube Cancer & Primary Peritoneal Cancer, Version 2.2011, NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™), National Comprehensive Cancer Network. [PDF Adobe Reader Document – requires free registration and log-in at NCCN.org]

2/ Katsumata N, Yasuda M, Takahashi F, et. alJapanese Gynecologic Oncology Group. Dose-dense paclitaxel once a week in combination with carboplatin every 3 weeks for advanced ovarian cancer: a phase 3, open-label, randomised controlled trialLancet. 2009 Oct 17;374(9698):1331-8. Epub 2009 Sep 18. PubMed PMID: 19767092.

3/ Burger RA, Brady MF, Bookman MA, et. al.  Phase III trial of bevacizumab in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC):  a Gynecologic Oncology Group study.  J Clin Oncol 28:18s, 2010 (suppl; abstr LBA1).

4/ Perren T, Swart AM, Pfisterer J, et. alICON7: A phase III randomized gynecologic cancer intergroup trial of concurrent bevacizumab and chemotherapy followed by maintenance bevacizumab, versus chemotherapy alone in women with newly diagnosed epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC).Ann Oncol 21;viii2, 2010 (suppl 8; abstr LBA4).

5/Rustin G, van der Burg M, Griffin C, et. al. Early versus delayed treatment of relapsed ovarian cancer. Lancet. 2011 Jan 29;377(9763):380-1. PubMed PMID: 21277438.

Source:

Additional 2011 NCCN Annual Meeting Information

Risk of Death Doubles For Early Stage Ovarian Cancer Patients Who Are Not Checked For Lymph Node Metastases

University of California Davis Cancer Center and California Cancer Registry researchers determined that the risk of death doubles for those women with apparent early stage ovarian cancer who are not checked for lymph node metastases.

Dr. Gary Leiserowitz, Chief of Gynecologic Oncology at the UC Davis Cancer Center & Rosemary Cress, Research Program Director at the California Cancer Registry, reported that early-stage ovarian cancer patients had nearly twice the risk of death if they were not tested for lymph node metastases.

A team of University of California (UC) Davis Cancer Center and California Cancer Registry researchers determined that more than a quarter of women with apparent early ovarian cancer do not receive lymph node biopsies, which have been shown to improve patient survival.

For the study, the researchers identified patients diagnosed with apparent early-stage epithelial ovarian cancer between 1998 and 2000 from cancer registries in New York and California, then collected detailed information from patient medical records on the types of surgical staging procedures performed on 721 of the patients.

The study set forth the critical findings below.

  • Approximately 90 percent of patients had removal of the omentum and evaluation of the bowel serosa and mesentery.  In contrast, only 72 percent of patients with presumed early-stage disease had lymph nodes from the pelvis and abdomen tested for signs of cancer spread, despite the existence of published, professional guidelines for proper staging of the disease.
  • Only lymph node assessment (as well as node assessment combined with washings and omentectomy) had a statistically significant association with improved survival.
  • The five-year survival for women with early-stage disease who had the node biopsies was 84 percent, compared with 69 percent of those who did not have the tests.
  • Patients who did not have lymph node assessment had nearly twice the risk of death as those who did.
  • Stratification of patients based upon receipt of chemotherapy revealed that lack of lymph node sampling had an effect only on patients who also received no chemotherapy.  Thus, only when patients did not have the lymph nodes tested did chemotherapy improve survival, a finding the researchers attribute to the role chemotherapy likely plays in killing cancer cells that have spread beyond the ovaries.
  • Gynecologic oncologists were nearly six-and-a-half times more likely to perform lymph node biopsies than other surgical specialists, and nearly four times more likely to perform all recommended staging biopsies. (See “Additional Information” below for prior medical study findings, regarding the importance of gynecologic oncologists in the evaluation and treatment of ovarian cancer.)

The study results were published online last week in the journal Gynecology Oncology and will be published in the journal’s April print edition.

“Early-stage patients had nearly twice the risk of death if they didn’t have the lymph nodes tested,” said Rosemary Cress, who is an epidemiologist and research program director at the California Cancer Registry, associate adjunct professor in the Department of Public Health Sciences at UC Davis, and the study’s lead author. “Hopefully, this should raise the awareness among physicians that it’s really important to do lymph node biopsies in these patients.”

Why some surgeons don’t remove lymph nodes during ovary surgery for early-stage cancer patients is a matter of speculation, said Gary Leiserowitz, M.D., chief of Gynecologic Oncology at the UC Davis Cancer Center, who is the senior author of the study. But the tests are important, he said, because patients with positive lymph nodes are given a more advanced stage diagnosis and prescribed follow-up chemotherapy treatment.

“Depending on the knowledge and expertise of the surgeon doing the operation, they may not know they need to do all the biopsies,” said Dr. Leiserowitz. “The literature is pretty consistent in showing that the people who have specialized knowledge in this – gynecological oncologists – are much more likely to follow the guidelines.”

Another reason some surgeons may not perform the lymph node biopsies, he said, is that they don’t believe the patient would benefit, either because of advanced age or because they have other serious illnesses, or both.

“If we have a patient who is medically unsuitable because of their age or medical conditions and is not a candidate for chemotherapy, you wouldn’t do all the staging biopsies,” said Dr. Leiserowitz. “But for a woman, say in her 40’s who is otherwise healthy, it turns out to be critical, because chemotherapy could be lifesaving.”

Leiserowitz said he hopes the results of the study will help educate the medical community and patients about the value of appropriate cancer treatment.

“If you are going to treat someone with a cancer, you really have an obligation to understand what the published practice guidelines are, and adhere to them as well as you can, or refer the patient to someone else who will,” he said.

The study was paid for with a grant from the U.S. Centers for Disease Control and Prevention.

About University of California Davis Cancer Center

University of California (UC) Davis Cancer Center is the only National Cancer Institute- designated center serving the Central Valley and inland Northern California, a region of more than 6 million people. Its top specialists provide compassionate, comprehensive care for more than 9,000 adults and children every year, and offer patients access to more than 150 clinical trials at any given time. Its innovative research program includes more than 280 scientists at UC Davis and Lawrence Livermore National Laboratory. The unique partnership, the first between a major cancer center and national laboratory, has resulted in the discovery of new tools to diagnose and treat cancer. Through the Cancer Care Network, UC Davis is collaborating with a number of hospitals and clinical centers throughout the Central Valley and Northern California regions to offer the latest cancer-care services. For more information, visit cancer.ucdavis.edu.

About the California Cancer Registry

The California Cancer Registry (CCR) is a program of the California Department of Public Health’s Cancer Surveillance and Research Branch (CSRB), and works in collaboration with the Public Health Institute, regional cancer registries, health care providers, cancer registrars, and cancer researchers throughout California and the nation. CSRB collects, analyzes, and disseminates information on cancer incidence and mortality. The statewide population-based cancer surveillance system monitors the incidence and mortality of specific cancers over time and analyzes differential cancer risks cancer by geographic region, age, race/ethnicity, sex, and other social characteristics of the population. It gathers cancer incidence data through CCR, and conducts and collaborates with other researchers on special cancer research projects concerning the etiology, treatment, risk factors, and prevention of specific cancers. In addition, the system is designed to monitor patient survival with respect to the type of cancer, extent of disease, therapy, demographics, and other parameters of prognostic importance. In general, data generated from CCR are utilized as set forth below.

  • Monitor the amount of cancer and cancer incidence trends by geographic area and time in order to detect potential cancer problems of public health significance in occupational settings and the environment, and to assist in their investigation.
  • Provide information to stimulate the development and targeting of resources to benefit local communities, cancer patients, and their families.
  • Promote high-quality epidemiologic and clinical research by enabling population-based studies to be performed that can provide better information for cancer control.
  • Inform health professionals and educate citizens regarding specific health risks, early detection, and treatment for cancers known to be elevated in their communities.
  • Respond to public concerns and questions about cancer.

For more information, visit http://www.ccrcal.org/.

Sources:

Additional Information — The Role of Gynecologic Oncologists and Their Impact on Survival:

National Comprehensive Cancer Network® Posts New Guidelines for Treatment of Ovarian Cancer Patients

National Comprehensive Cancer Network® Posts New “Patient Friendly” Guidelines for Treatment of Ovarian Cancer.

Women with ovarian cancer now have a new resource that provides them with the same credible information their physicians use when determining treatment options. The National Comprehensive Cancer Network® (NCCN®) announces three new additions to the library of NCCN Guidelines for Patients™, patient-friendly translations of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™). NCCN Guidelines for Patients™: Melanoma, Ovarian Cancer, and Prostate Cancer are now available free of charge at NCCN.com.

The NCCN Guidelines for Patients™ are designed to provide people with cancer and their caregivers with state-of-the-art treatment information in easy-to-understand language. Given the prevalence of melanoma and prostate cancer – both among the most frequently diagnosed cancers in men – and the challenges in detecting ovarian cancer in women, it is critical that patients have resources to empower them to take a more active role in their treatment.

The NCCN Guidelines™ are developed by multidisciplinary panels of experts from NCCN Member Institutions and feature algorithms or “decision trees” that address every appropriate treatment option from initial work up throughout the course of the disease. The NCCN Guidelines for Patients™ translate these professional guidelines in a clear, step-by-step manner that patients can use as the basis for making decisions and discussing options with their physicians.

The NCCN Guidelines for Patients™ are available free of charge at NCCN.com, which also features additional informative articles for patients and caregivers.

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.

The NCCN Member Institutions are:

City of Hope Comprehensive Cancer Center, Los Angeles, CA;

Dana-Farber/Brigham and Women’s Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA;

Duke Comprehensive Cancer Center, Durham, NC;

Fox Chase Cancer Center, Philadelphia, PA;

Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT;

Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA;

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD;

Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL;

Memorial Sloan-Kettering Cancer Center, New York, NY;

H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL;

The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, Columbus, OH;

Roswell Park Cancer Institute, Buffalo, NY;

Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO;

St. Jude Children’s Research Hospital/University of Tennessee Cancer Institute, Memphis, TN;

Stanford Comprehensive Cancer Center, Stanford, CA;

University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, AL;

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA;

University of Michigan Comprehensive Cancer Center, Ann Arbor, MI;

UNMC Eppley Cancer Center at The Nebraska Medical Center, Omaha, NE;

The University of Texas MD Anderson Cancer Center, Houston, TX; and

Vanderbilt-Ingram Cancer Center, Nashville, TN.

Sources:

ESMO Clinical Practice Guidelines Regarding BRCA Gene Mutations, Ovarian Cancer & Supportive Cancer Care

The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology, and promoting a multidisciplinary approach to cancer treatment and care. …  The ESMO Clinical Practice Guidelines include coverage of  (i) BRCA gene mutations in breast and ovarian cancer, (ii) gynecologic tumors, and (iii) supportive cancer care …

The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology, and promoting a multidisciplinary approach to cancer treatment and care.  Since its founding in 1975 as a non-profit organization, ESMO’s mission is to support oncology professionals in providing people with cancer the most effective treatments available at the highest quality of care.

Formerly known as the ESMO Clinical Recommendations, the ESMO Clinical Practice Guidelines (CPG) are intended to provide users with a set of requirements for the highest standard of care for cancer patients. The ESMO CPG represent vital, evidence-based information including the incidence of the malignancy, diagnostic criteria, staging of disease and risk assessment, treatment plans and follow-up.

A growing number of the new guidelines were developed using large, multidisciplinary writing groups, ensuring optimal input from the oncology profession and better geographic representation.

For example, two revised guidelines address the prevention of chemotherapy- and radiotherapy–induced nausea and vomiting, developed as a result of the 3rd Perugia Consensus Conference organized by the Multinational Association of Supportive Care in Cancer (MASCC) and ESMO.

The new guidelines published this month and available online represent the first stage of a process that will include recommendations for more than 55 different clinical situations, covering almost all tumor types as well as various other topics including the therapeutic use of growth factors.

The ESMO Clinical Practice Guidelines include coverage of  (i) BRCA gene mutations in breast and ovarian cancer, (ii) gynecologic tumors, and (iii) supportive cancer care, as provided below.

Breast Cancer

Gynecologic Tumors

Supportive Care

Sources:

Two Combination Treatment Regimens Added to Updated NCCN Guidelines for Ovarian Cancer

The National Comprehensive Cancer Network (NCCN) recently updated the NCCN Guidelines for Ovarian Cancer to include two additional combination treatment regimens for women with select types of recurring ovarian cancer.

The National Comprehensive Cancer Network (NCCN) recently updated the NCCN Clinical Practice Guidelines for Oncology™ for Ovarian Cancer to reflect the addition of two preferred combination regimens for a specific cohort of patients based on data from recent clinical research studies.

Key updates to the NCCN Guidelines include the addition of carboplatin (Paraplatin®, Bristol-Myers Squibb)/weekly paclitaxel (Taxol®, Bristol-Myers Squibb) and carboplatin/liposomal doxorubicin (Doxil®, Centocor Ortho Biotech) for cytotoxic therapy for patients with platinum-sensitive epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer that has recurred.

These modifications made to the NCCN Guidelines for ovarian cancer are based on results from recent studies in The Lancet and The Journal of Clinical Oncology demonstrating that both combination regimens improved median progression-free survival in women with specific types of recurring ovarian cancer as compared to conventional regimens. In addition, the carboplatin/weekly paclitaxel regimen improved overall survival.

Robert J. Morgan, Jr., M.D., F.A.C.P., Professor, Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center

“Ovarian cancer is a challenge to treat because by the time the majority of the women are diagnosed with the disease, it has already progressed to stage III or IV,” says Robert J. Morgan, MD, of City of Hope Comprehensive Cancer Center and the chair of the NCCN Guidelines Panel for Ovarian Cancer. “Although finding effective screening tools remains a priority, new treatment options for women with ovarian cancer such as the ones outlined in the updated NCCN Guidelines, remains imperative to making steady progress against the disease.”

Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States and the country’s fifth most common cause of cancer mortality in women. In the year 2009, there were more than 21,000 new diagnoses and nearly 15,000 deaths from this neoplasm in the United States.

The NCCN Clinical Practice Guidelines in Oncology™ are developed and updated through an evidence-based process with explicit review of the scientific evidence integrated with expert judgment by multidisciplinary panels of physicians from NCCN Member Institutions. The most recent version of this and all the NCCN Guidelines are available free of charge at NCCN.org.

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.

Sources: