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Abbott Labs Seeks FDA 510(k) Clearance For New Automated Ovarian Cancer Detection Test

Posted by Paul Cacciatore on February 9, 2010

A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States.

Abbott Laboratories’ ARCHITECT HE4 assay uses a simple blood test to help in monitoring for the recurrence or progression of epithelial ovarian cancer. If approved by the FDA, this important immunoassay would be the first automated HE4 test available in the United States.

A new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States.  Abbott Laboratories’ (Abbott’s) ARCHITECT [Human Epididymal Protein 4] HE4 assay uses a simple blood test to help in monitoring for the recurrence or progression of epithelial ovarian cancer. If approved by the U.S. Food & Drug Administration (FDA), this important immunoassay would be the first automated HE4 test available in the United States.

The 2003 Hellstrom et al. study of known ovarian cancer biomarkers found that HE4, which has been detected in high levels in the blood of some ovarian cancer patients, shows the highest sensitivity and specificity of any other marker and is considered the best single marker for stage 1 of the disease.

According to the American Cancer Society, the five-year survival rate of ovarian cancer patients is 46 percent. However, when the disease is diagnosed and treated earlier, the survival rate increases to 93 percent. Less than 20 percent of all ovarian cancer is found in the early stage.

“The ability to monitor the recurrence or progression of ovarian cancer is a critical part of patient care. The ARCHITECT HE4 assay has the potential to be a powerful tool for both physicians and patients in the management of the disease,” said Michael Warmuth, Senior Vice President, Diagnostics, Abbott.

Abbott partnered with Fujirebio Diagnostics, Inc. in the development of the assay. The ARCHITECT HE4 assay is approved for use in Europe, as well as in other countries in Asia Pacific and Latin America. It is currently an investigational device in the United States.

About ARCHITECT HE4 Assay

The ARCHITECT HE4 assay is designed to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer, and must be used in conjunction with other clinical data. The ARCHITECT HE4 assay should not be used as a cancer screening test. In addition, certain types of cancer (e.g., mucinous or germ cell tumors) rarely express HE4, and the use of the ARCHITECT HE4 assay is not recommended for monitoring patients with those types of cancer.

About Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecological cancers and the fifth-leading cause of cancer death in women. An estimated one in 71 women will develop ovarian cancer in their lifetimes. Women who are postmenopausal are at the greatest risk for ovarian cancer.

About Abbott Diagnostics

Abbott Diagnostics is a global leader in in vitro diagnostics (IVD) and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices and clinics. With more than 69,000 institutional customers in more than 100 countries, Abbott’s diagnostic products offer customers automation, convenience, cost effectiveness and flexibility. The history of Abbott Diagnostics is filled with examples of first-of-a-kind products and significant technological advancements, including the development of the very first diagnostic test to detect HIV.

About Abbott’s Diagnostics Businesses

Abbott is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. With more than 69,000 customers in more than 100 countries, Abbott’s diagnostic products offer customers automation, convenience, bedside testing, cost effectiveness and flexibility. Abbott has helped transform the practice of medical diagnosis from an art to a science through the company’s commitment to improving patient care and lowering costs.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

References:

  • FDA 510(k) Clearances – Overview, Device Approvals & Clearances, Products & Medical Procedures, Medical Devices, U.S. Food & Drug Administration, U.S. Department of Health & Human Services.

Additional Information:

Anderson GL, McIntosh M, Wu L, et. al. Assessing lead time of selected ovarian cancer biomarkers: a nested case-control study. J Natl Cancer Inst. 2010 Jan 6;102(1):26-38. Epub 2009 Dec 30. PubMed PMID: 20042715;PubMed Central PMCID: PMC2802285.

Andersen MR, Goff BA, Lowe KA, et. al. Use of a Symptom Index, CA125, and HE4 to predict ovarian cancer. Gynecol Oncol. 2009 Nov 27. [Epub ahead of print] PubMed PMID: 19945742.

Moore RG, McMeekin DS, Brown AK, et. al.  A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecol Oncol. 2009 Jan;112(1):40-6. Epub 2008 Oct 12. PubMed PMID: 18851871.

Hellstrom I, Hellstrom KE. SMRP and HE4 as biomarkers for ovarian carcinoma when used alone and in combination with CA125 and/or each other. Adv Exp Med Biol. 2008;622:15-21. Review. PubMed PMID: 18546615.

Havrilesky LJ, Whitehead CM, Rubatt JM, et. al. Evaluation of biomarker panels for early stage ovarian cancer detection and monitoring for disease recurrence. Gynecol Oncol. 2008 Sep;110(3):374-82. Epub 2008 Jun 27. PubMed PMID: 18584856.

Moore RG, Brown AK, Miller MC, et. al. The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol. 2008 Feb;108(2):402-8. Epub 2007 Dec 3. PubMed PMID:  18061248.

Rosen DG, Wang L, Atkinson JN, et. al. Potential markers that complement expression of CA125 in epithelial ovarian cancer. Gynecol Oncol. 2005 Nov;99(2):267-77. Epub 2005 Aug 2.  PubMed PMID: 16061277.

Drapkin R, von Horsten HH, Lin Y, et. al. Human epididymis protein 4 (HE4) is a secreted glycoprotein that is overexpressed by serous and endometrioid ovarian carcinomas. Cancer Res. 2005 Mar 15;65(6):2162-9. PubMed PMID: 15781627.

Posted in Biomarker, Discoveries, Early Detection, Molecular Diagnostics, Proteomics | Tagged: , , , , , , , , , , | Leave a Comment »

Identifying & Overcoming Taxane Drug Resistance

Posted by Paul Cacciatore on February 8, 2010

Proteomics study reveals a protein that, when suppressed, makes cancers more susceptible to chemotherapy involving taxane drugs.

Taxanes, a group of cancer drugs that includes paclitaxel (Taxol®) and docetaxel (Taxotere®), have become front-line therapy for a variety of metastatic cancers. But as with many chemotherapy agents, resistance can develop, a frequent problem in breast, ovarian, prostate and other cancers. Now, cancer researchers at Children’s Hospital Boston report a protein previously unknown to be involved in taxane resistance and could potentially be targeted with drugs, making a cancer more susceptible to chemotherapy.

The researchers believe that this protein, prohibitin1, could also serve as a biomarker, allowing doctors to predict a patient’s response to chemotherapy with a simple blood test. The study was published online by the Proceedings of the National Academy of Sciences in its online early edition during the week of January 25.

Bruce Zetter, Ph.D., Charles Nowiszewski Professor of Cancer Biology, Vascular Biology Program, Department of General Surgery, Children's Hospital Boston

The study, led by Bruce Zetter, PhD, of Children’s Vascular Biology Program, used proteomics techniques to compare the proteins present in Taxol-susceptible versus Taxol-resistant human tumor cell lines. The researchers found that the resistant cell lines, but not the susceptible cell lines, had prohibitin1 on their surface. When they suppressed prohibitin1 with RNA interference techniques, the tumor cells became more susceptible to Taxol, both in cell culture and in live mice with implanted Taxol-resistant tumors.

Zetter’s lab is still investigating why having prohibitin1 on the cell surface makes a tumor cell resistant to taxanes. But in the meantime, he believes that not only could prohibitin1 be suppressed to overcome taxane resistance, but that it could also be exploited as a means of targeting chemotherapy selectively to resistant cancer cells.

“We are working to target various cancer drugs to taxane-resistant cells by attaching them to compounds that bind to prohibitin,” Zetter explains. One such compound is already known, and works well in animals to target other prohibitin-rich cells, but has yet to be tested in humans.

Suppressing prohibitin1 alone probably isn’t enough to make a cancer fully Taxol-susceptible, but could be combined with other strategies aimed at increasing taxane susceptibility, such as targeting another protein called GST Pi, the researchers say. Other mechanisms of resistance are known, but they so far haven’t been shown to present effective targets for therapy.

Zetter’s lab is also trying to develop prohibitin1 as a biomarker for taxane resistance that physicians could use in the clinic. Since it’s on the surface of the cell, Zetter believes prohibitin1 may circulate in the blood where it could easily be detected. His lab is in talks with several cancer centers to obtain serum samples from patients who did and didn’t respond to Taxol, so that prohibitin1 levels could be measured and compared.

Zetter notes that prohibitin1 could easily have been overlooked, and was found only because the team happened to look specifically at proteins in the cell membrane, rather than simply doing a whole-cell proteomic analysis.

“The interesting finding was that prohibitin was not just another over-expressed protein,” Zetter says. “It was up-regulated primarily on the cell surface. When we looked at the whole cell, the absolute amount of prohibitin wasn’t changed. Instead, prohibitin was moving from the inside of the cell to the cell surface. It had shifted from one location to another, and when it did, the tumor cells became resistant to taxanes. The fact that it moves to the cell surface also makes it easier to direct drugs to it.”

Children’s Hospital Boston has pending and issued international patents on this technology.  Nish Patel, PhD, was the study’s first author. The study was funded by a grant from the National Institutes of Health.

About Children’s Hospital Boston

Founded in 1869 as a 20-bed hospital for children, Children’s Hospital Boston today is one of the nation’s leading pediatric medical centers, the primary pediatric teaching hospital of Harvard Medical School, and the largest provider of health care to Massachusetts children. In addition to 396 pediatric and adolescent inpatient beds and more than 100 outpatient programs, Children’s houses the world’s largest research enterprise based at a pediatric medical center, where its discoveries benefit both children and adults. More than 500 scientists, including eight members of the National Academy of Sciences, 11 members of the Institute of Medicine and 13 members of the Howard Hughes Medical Institute comprise Children’s research community. For more information about the hospital visit: www.childrenshospital.org/newsroom.

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Disarming Specialized Stem Cells Might Combat Ovarian Cancer

Posted by Paul Cacciatore on February 2, 2010

Eliminating cancer stem cells (CSCs) within a tumor could hold the key to successful treatments for ovarian cancer, which has been notoriously difficult to detect and treat, according to new findings published this week in the journal Oncogene by Yale School of Medicine researchers.

Eliminating cancer stem cells (CSCs) within a tumor could hold the key to successful treatments for ovarian cancer, which has been notoriously difficult to detect and treat, according to new findings published this week in the journal Oncogene by Yale School of Medicine researchers.

“We found that stopping the expression of two genes—Lin28 and Oct4—reduces ovarian cancer cell growth and survival,” said Yingqun Huang, M.D., Ph.D., assistant professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale School of Medicine.

Ovarian cancer is challenging to treat because it tends to recur frequently and develop resistance to treatment. The poor outcome for women with ovarian cancer is associated with subtle and nonspecific symptoms—earning it the moniker the “disease that whispers.”

“This recurrence and drug resistance may be due to the presence of CSCs within the tumors that have the capacity to reproduce and to differentiate into non-CSC tumor cells that repopulate the tumor mass,” said Huang, who is a member of Yale Stem Cell Center and Yale Cancer Center. “Eliminating these CSCs may be key to successful treatments.”

While in the process of studying the functions of stem cell proteins in human embryonic stem cells, Huang and her colleagues unexpectedly discovered that a sub-population of ovarian cancer cells express stem cell proteins Lin28 and Oct4. They also found that the two proteins appear to act together in ovarian cancer tissue cells to produce more advanced tumors. Inhibiting their combined expression led to a significant decrease in the growth and survival of cancer cells. A larger-scale ovarian cancer study is currently underway to confirm the significance of the findings.

Genetic researchers prevent genes from functioning — a process commonly referred to as “knocking down” the gene — by inserting small interfering RNA (siRNA) molecules into the cells. Next, the research team will examine the effect of siRNA in ovarian cancer cells in the lab, and test the technique on mice. If successful, human clinical trials would follow. Treatment on cancer patients could occur within 10 years, Huang said.

“We hope we will soon be able to apply this new information to improve outcomes, perhaps by developing better diagnostic markers and treatment strategies that may be useful in customizing treatment for ovarian cancer patients,” said Huang.

The study was supported by Connecticut Innovations, the Fannie E. Rippel Foundation and the National Cancer Institute.

Other Yale authors on the study included Nita Maihle, Ph.D., and Shuping Peng.

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Removal of Ovarian Cancer Cells From Human Ascites Fluid Using Magnetic Nanoparticles

Posted by Paul Cacciatore on February 1, 2010

Scientists at Georgia Tech and the Ovarian Cancer Institute have further developed a potential new treatment against cancer that uses magnetic nanoparticles to attach to ovarian cancer cells, removing them from the body. The treatment, tested in mice in 2008, has now been tested using samples from human ovarian cancer patients. The results appear online in the journal Nanomedicine.

Nanoparticles, in brown, attach themselves to ovarian cancer cells, in violet, from the human abdominal cavity. (Credit: Ken Scarberry/Georgia Tech)

Scientists at Georgia Institute of Technology (Georgia Tech) and the Ovarian Cancer Institute have further developed a potential new treatment against cancer that uses magnetic nanoparticles to attach to ovarian cancer cells, removing them from the body. The treatment, tested in mice in 2008, has now been tested using samples from human ovarian cancer patients. The results appear online in the journal Nanomedicine.

John McDonald Ph.D., Professor & Associate Dean for Biology Program Development, Georgia Institute of Technology; Chief Research Scientist, Ovarian Cancer Institute (Credit: Georgia Tech)

“We are primarily interested in developing an effective method to reduce the spread of ovarian cancer cells to other organs ,” said John McDonald, professor at the the School of Biology at the Georgia Institute of Technology and chief research scientist at the Ovarian Cancer Institute.

The idea came to the research team from the work of Ken Scarberry, then a Ph.D. student at Georgia Tech. Scarberry originally conceived of the idea as a means of extracting viruses and virally infected cells. At his advisor’s suggestion Scarberry began looking at how the system could work with cancer cells.

He published his first paper on the subject in the Journal of the American Chemical Society in July 2008. In that paper he and McDonald showed that by giving the cancer cells of the mice a fluorescent green tag and staining the magnetic nanoparticles red, they were able to apply a magnet and move the green cancer cells to the abdominal region.

Recently, McDonald and Scarberry (currently a postdoctoral fellow in McDonald’s lab) have shown that the magnetic technique works with human ovarian cancer cells.

Ken Scarberry Ph.D., Postdoctoral Fellow, McDonald Laboratory, Georgia Institute of Technology (Credit: Robert Felt, Georgia Tech.)

“Often, the lethality of cancers is not attributed to the original tumor but to the establishment of distant tumors by cancer cells that exfoliate from the primary tumor,” said Scarberry. “Circulating tumor cells can implant at distant sites and give rise to secondary tumors. Our technique is designed to filter the peritoneal fluid or blood and remove these free floating cancer cells, which should increase longevity by preventing the continued metastatic spread of the cancer.”

In tests, they showed that their technique worked as well with capturing ovarian cancer cells from human patient samples as it did previously in mice. The next step is to test how well the technique can increase survivorship in live animal models. If that goes well, they will then test it with humans.

Sources:

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

Posted by Paul Cacciatore on January 26, 2010

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.

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Vox Populi:* How Do Your Define “Tragedy?”

Posted by Paul Cacciatore on January 22, 2010

How do you define tragedy? … The loss of Archibald “Moonlight” Graham and Sue-Louise Newmann is certainly tragic, however, their lives exemplify hope and inspiration.

Alabama Crimson Tide 37 — Texas Longhorns 21.  That was the final score of the Citi BCS National Championship football game, which was played in the Rose Bowl on January 7, 2010.  The Texas team experienced a major setback in that game when quarterback Colt McCoy, a 2008 Heisman Trophy Finalist, was injured during the first quarter of the game. More specifically, the Texas quarterback was injured on the fifth play of the game. At that moment, all football fans understood the significance of the injury in light of the following records held by Colt McCoy at game’s start: highest NCAA single season passing completion percentage (77.6%); highest NCAA career passing completion percentage (70.9%); and most NCAA football game wins by a starting quarterback (44).

I watched that BCS National Championship game with a friend.  Immediately after Marcell Dareus –an Alabama defensive lineman — hit McCoy, and it was clear that the Texas starting quarterback would not return to the game due to a shoulder injury, my friend exclaimed: “That’s a tragedy!” He elaborated upon his initial comment by describing how important McCoy was to the Texas football team and how Texas’ chance for victory walked off the field along with its injured quarterback. In total dismay, my friend went on to described how important this game was to Colt McCoy and his future National Football League career and related compensation package.

Shortly after football game ended in a Texas defeat, I began to think about my friend’s comment.  It seemed fair in the heat of a sporting moment.  A few hours later, it seems outright ridiculous.  I began to think about what most people consider “a tragedy” in life, and what, if any, example(s) could be used to appropriately define this term in the context of an individual’s life. Two individuals came to mind as a way to place a human face on the proper meaning of the term:  Dr. Archibald “Moonlight” Graham and Sue-Louise Newmann.

Dr. Archibald “Moonlight” Graham

Archibald “Moonlight” Graham was an American professional baseball player who appeared as a right fielder in a single major league game for the New York Giants on June 29, 1905. His story was popularized by Shoeless Joe, a novel by W. P. Kinsella, and the subsequent 1989 Oscar-Nominated “Best Picture” Field of Dreams, starring Kevin Costner, and featuring Burt Lancaster and Frank Whaley as older and younger incarnations of “Moonlight” Graham. On June 29, 1905, the Giants were the visiting team against the Brooklyn Superbas. In the bottom of the eighth inning of that baseball game, Graham was sent in to play right field, replacing George Browne. In the top of the ninth inning, Graham was on deck to bat next when his teammate Claude Elliott flied out resulting in the third and final out. Graham played the bottom of the ninth inning in right field but never came to bat, and that game turned out to be his only appearance in the major leagues.

After playing in the minor baseball leagues through the 1908 season, Graham completed his medical degree from the University of Maryland in 1908.  He obtained his medical license the following year and began his practice in Chisholm, Minnesota. According to Veda Ponikvar, founder of The Chisholm Free Press and Tribune, Graham jumped on a train to Minnesota after reading a small ad listing a doctor’s position. Once in Chisholm, Graham never left. He lived in Chisholm until his death 54 years later in 1965.  “Doc” Graham, as he became known after his career as a ballplayer, served the people of Chisholm for fifty years. From 1915 to 1959, Graham was the doctor for the Chisholm public schools.

In the movie Field of Dreams, Iowa farmer Ray Kinsella (Kevin Costner) hears a disembodied voice in his cornfield, telling him “If you build it, he will come.” This mysterious occurrence leads Ray into the past, on an unexpected cross-country journey, and in search of an elusive connection with his long deceased father. This is a magical film about the transformative power of baseball, the love of a son for his father, and believing in something that you can’t quite define in words. In the later part of the movie, a mystical clue leads Ray to Chisholm, Minnesota.  Once in Chisholm, Ray meets the reincarnated spirit of elderly “Doc” Graham.” Graham tells Ray the story of his life including his single appearance in a major league baseball game — a game in which he never batted. The movie dialogue below provides one example of the proper definition of  “tragedy” in the context of an individual’s life:

Dr. Archibald "Moonlight" Graham as portrayed by Burt Lancaster in the 1989 "Best Picture" Oscar-Nominated movie "Field of Dreams."

Dr. Archibald “Moonlight” Graham: Well, you know I… I never got to bat in the major leagues. I would have liked to have had that chance. Just once. To stare down a big league pitcher. To stare him down, and just as he goes into his windup, wink. Make him think you know something he doesn’t. That’s what I wish for. Chance to squint at a sky so blue that it hurts your eyes just to look at it. To feel the tingling in your arm as you connect with the ball. To run the bases – stretch a double into a triple, and flop face-first into third, wrap your arms around the bag. That’s my wish, Ray Kinsella. That’s my wish. And is there enough magic out there in the moonlight to make this dream come true?

Ray Kinsella: Fifty years ago, for five minutes you came within… y-you came this close. It would KILL some men to get so close to their dream and not touch it. God, they’d consider it a tragedy.

Dr. Archibald “Moonlight” Graham: Son, if I’d only gotten to be a doctor for five minutes… now that would have been a tragedy.

Ray, like my friend, defined “tragedy” in the context of a kid’s game that turned professional. “Moonlight” Graham would have been one of fiction’s (and Hollywood’s) great characters, except for the fact that “Moonlight” Graham was a real person.  He really did become the beloved town doctor of Chisholm, Minnesota. And, he really did play in just one major league baseball game. That one game was played over 100 years ago, and was the subject of a msnbc feature narrated by Keith Olbermann, entitled Moonlight Graham Remembered.

Shortly after his death in 1965, Veda Ponikvar wrote the following obituary for Dr. Archibald Graham in the local Chisholm newspaper:

As the community grew, Doc became an integral part of the population. There were good years and lean ones. There were times when children could not afford eyeglasses, or milk, or clothing because of the economic upheavals, strikes, and depressions. Yet no child was ever denied these essentials, because in the background, there was a benevolent, understanding Doctor Graham. Without a word, without any fanfare or publicity, the glasses or the milk, or the ticket to the ball game found their way into the child’s pocket.

A person would be fortunate to possess the qualities embodied by “Moonlight Graham;” humility, grace, kindness, hope and inspiration. Dr. Graham is a genuine example of a life well-spent.  Archibald “Moonlight” Graham, in life, and as portrayed in the movie, understands the true meaning of the word “tragedy.”

Sue-Louise Newmann

Did you ever sense the inner character an individual without ever meeting that person? I did, and her name is Sue-Louise Newmann. About a week ago, I was updating the Libby’s H*O*P*E* ovarian cancer video library when I came across three YouTube videos posted by Sue-Louise Newmann’s husband. Each video consists of a picture montage set to music. The picture montages reveal the couple’s special life moments such as getting married, having children, celebrating birthdays and anniversaries, and traveling overseas.  The background music playing in each video was composed and sung by Sue-Louise.

In terms of “internet presence,” I only discovered a limited amount of information about Sue-Louise Newmann.  Sue-Louise was married and a mother to two young daughters. She lived in Australia. Newmann was also the head of human resources for an Australian utility company. As a gifted songwriter and muscian, she played many of the instruments that were used to record her songs.

Sue-Louise was diagnosed with ovarian cancer in 2006, and she died in February 2009 at the age of 46. The three songs that accompany the video picture montages were recorded by Sue-Louise after her doctor informed her that she would likely live for only nine more months. The video titles (and the song titles) are Time of My Life, Waiting For a Miracle, and Don’t You Forget About Me. I extend my highest gratitude to Sue-Louise’s husband for creating and publicly sharing these videos.

Time of My Life

Despite the fact that I never met Sue-Louise, the video picture montages leave no doubt that her life was filled with love, family, and music. Sue-Louise’s inner character shines bright in each picture. I believe that Sue-Louise possessed “ordinary grace,” a term coined by the author Kathleen Brehony in her book bearing the same title.  In that book, Brehony explains that ordinary grace does not only live in great cathedrals and holy ashrams, it lives in ordinary people who have found a place in their lives for love, generosity and simple kindness. Sue-Louise’s ordinary grace manifests itself in her pictures, as well as the notes and lyrics of her songs. In proper context, the death of Sue-Louise Newmann, as a wife, a mother, a friend and a talented songwriter, is clearly a tragedy. The loss of any women from ovarian cancer is a tragedy.

From Tragedy Comes Hope & Inspiration

The loss of Archibald “Moonlight” Graham and Sue-Louise Newmann is certainly tragic, however, their lives exemplify hope and inspiration. Dr. Graham turned the loss of a professional baseball career into a life of helping others through medicine and random acts of kindness. Sue-Louise Newmann also lived a full life. When confronted with imminent death from ovarian cancer, Newmann chose to write and sing beautiful songs that will forever touch and inspire us.  Each individual, when faced with difficulty or life-threatening circumstances, chose to inspire hope in others. In the end, such inspiration creates an everlasting legacy that transcends death.

So, the next time you experience a bad day, a career disappointment, an angry driver, or a curt salesperson, take a moment to realize that these events do not rise to the level of a tragedy.  And, at the end of each day, ask yourself the following question: “How will I be remembered in my eulogy or tribute video?”

______________________________

*”Vox Populi,” a Latin phrase that means “voice of the people,” is a term often used in broadcast journalism to describe an interview of the “man on the street.”

In the spirit of Vox Populi, Libby’s H*O*P*E*™ searches online for original pieces of writing or visual media created by ovarian cancer survivors, survivors’ family members, cancer advocates, journalists, and health care professionals, which address one or more aspects of ovarian cancer within the context of daily life. The written and visual media features that we discover run the gamut; sometimes poignant, sometimes educational, sometimes touching, sometimes comedic, but always honest. The Vox Populi feature may take the form of an essay, editorial, poem, letter, story, song or picture montage.

It is our hope that the Vox Populi feature will allow our readers to obtain, in some small way, a better understanding of how ovarian cancer impacts the life of a woman diagnosed with the disease and her family. We invite all readers to submit, or bring to our attention, original written or visual media pieces suitable for publication as Vox Populi features.

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Elevated Proteins May Warn of Ovarian Cancer, But Sufficient Lead Time & Predictive Value Still Lacking

Posted by Paul Cacciatore on January 7, 2010

Fred Hutchinson Cancer Center researchers discovered that concentrations of the serum biomarkers CA125, human epididymis protein 4 (HE4), and mesothelin began to rise 3 years before clinical diagnosis of ovarian cancer, according to a new study published online December 30 in the Journal of the National Cancer Institute. However, the biomarkers became substantially elevated only in the last year prior to diagnosis. … In an accompanying editorial to the study results reported by Anderson et. al., Patricia Hartge, ScD, of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute, applauds the researchers for taking the field one step closer to successful screening study designs by showing that the levels of certain biomarkers do not increase early enough to be used for screening.

Fred Hutchinson Cancer Center researchers discovered that concentrations of the serum biomarkers CA125, human epididymis protein 4 (HE4), and mesothelin began to rise 3 years before clinical diagnosis of ovarian cancer, according to a new study published online December 30 in the Journal of the National Cancer Institute (JNCI). [1] However, the biomarkers became substantially elevated only in the last year prior to diagnosis.

Garnet L. Anderson, Ph.D., Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.

CA125, HE4, mesothelin, B7-H4, decoy receptor 3, and spondin-2 have been identified as potential ovarian cancer serum biomarkers, but their behavior in the prediagnostic period, with the exception of CA125, has not been evaluated.  In the JNCI study, Garnet L. Anderson, Ph.D., of the Division of Public Health Sciences at the Fred Hutchinson Cancer Research Center in Seattle, and colleagues analyzed prediagnostic serum samples and patient data from the Carotene and Retinol Efficacy Trial (CARET), a randomized, double-blind, placebo-controlled chemoprevention trial testing the effects of beta-carotene and retinol on lung cancer incidence among individuals at high risk for lung cancer. Prediagnostic serum samples (taken up to 18 years prior to diagnosis) were obtained for 34 CARET patients with ovarian cancer and 70 matched control CARET subjects. Changes in the levels of these biomarkers prior to ovarian cancer diagnosis were analyzed.

Anderson et. al. discovered that concentrations of CA125, HE4, and mesothelin (but not B7-H4, decoy receptor 3, and spondin-2) began to increase slightly in cancer patients relative to control subjects approximately 3 years before diagnosis, but became substantially elevated within one year prior to diagnosis. Thus, the diagnostic value of these biomarkers is limited because accuracy only increased shortly before diagnosis. “Although these markers are not accurate enough to prompt early intervention in existing screening protocols, the multivariable regression analyses identified modest but statistically significant increases in risk associated with CA125, HE4, and mesothelin, which are consistent with many of the established epidemiological risk factors for ovarian cancer,” say the authors of the study.

“I still think biomarkers may play a role in a cost-effective screening program, although none of these seem accurate enough either alone or together to justify their use in average-risk women,” Anderson told Medscape Oncology. “I do not know of any other currently identified biomarkers that hold more promise than these, but there has been a massive effort over the last few years to identify candidates and not all have been thoroughly vetted,” said Dr. Anderson.

One problem, cites Dr. Anderson, may lie in the approach used in identifying potential ovarian cancer biomarkers. “Most of the discovery work done so far has been conducted in women with advanced-stage disease and compared them to healthy women,” she explained. “If discovery work were done in samples like the ones we used here, representing specimens collected months to years prior to the advanced stage diagnosis, we might have a better chance of finding earlier signals of aggressive disease.”

Another opportunity for improving screening and early diagnosis lies in imaging, she adds. “Currently the most common and only affordable imaging option that could be considered for routine screening is transvaginal ultrasound, but it performs poorly in terms of accurately determining those women [who] have ovarian cancer from those who do not,” said Dr. Anderson. “A substantial improvement in this area would be very exciting.”

Study Limitations Cited By JNCI Editors

The JNCI editors state three limitations that they believe are associated with the study by Anderson et. al. First, the study sample size was small.  Second, all women who participated in CARET had a history of heavy smoking, and therefore, the JNCI editors believe that the blood serum testing results obtained by Anderson et. al. may not apply to other non-smoking groups. Third, the blood collected from women participating in CARET was collected at different times, but only a few samples were collected during the last 2–3 years before ovarian cancer diagnosis.

Designing Ovarian Cancer Early Detection Programs — Accompanying JNCI Editorial

Patricia Hartge, Sc.D. Deputy Director, Epidemiology and Biostatistics Program, Division of Cancer Epidemiology & Genetic, National Cancer Institute

In an accompanying editorial to the study results reported by Anderson et. al., Patricia Hartge, ScD, of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute, applauds the researchers for taking the field one step closer to successful screening study designs by showing that the levels of certain biomarkers do not increase early enough to be used for screening. [2]

Dr. Hartge notes that despite the discovery that CA125 and other serum markers increase before the clinical onset of ovarian cancer, it has been exceedingly difficult to devise a successful ovarian cancer early screening program for asymptomatic women. Nevertheless, Hartge believes that Anderson et al. take a valuable step toward the design of such a successful screening program by demonstrating why screening regimens that are based on markers, or panels of markers, can fail. Specifically, the researchers discovered that blood levels of CA125, HE4, mesothelin, and three other promising markers did not increase early enough in the course of the disease to allow detection in early stages. Dr. Hartge emphasizes that the markers typically rose within one year of the disease symptoms that led to an accurate diagnosis, and therefore, many of the ovarian cancer patients were diagnosed with advanced stage disease.

Hartge further states “[t]hat the results of Anderson et al. are not the last word in serum markers or in combinations of markers.” “Serum markers likely will form a key element in any screening regimen, with the lead time and other parameters of each marker or combination of markers being taken into account. The careful evaluation technique applied in the current study fits into a staged approach necessary for testing performance of early markers of disease.” Hartge adds that “[o]nly the time-consuming, expensive, and demanding randomized clinical trial can reveal whether an early detection program that includes the biomarkers can save lives.”

In support of her position, Dr. Hartge observes that current randomized trials are testing the value of different screening programs that are built on combinations of CA125, ultrasound, and risk factor data (e.g., family history and age). After four rounds of screening 34,261 postmenopausal women for ovarian cancer with both CA125 and ultrasound, University of Alabama at Birmingham School of Medicine investigators of the large U.S. screening trial observed that the predictive value of a positive screen was quite low — approximately 1%. Of the 60 screen-detected cancers, 72% had already advanced to at least stage III. [3] In addition, of every 20 women who underwent surgery after a positive screen, only one women was diagnosed with cancer. Furthermore, in a recent UK trial with a slightly different design, positive predictive values from the first round of screening were higher; 35% in the 50,078 women whose risk was assessed with CA125 and risk factor data, followed by ultrasound only if indicated, and 3% in the 50,639 women screened first with ultrasound. [4] The effects on mortality in both trials remain to be determined.

Confronting The “Daunting Arithmetic” Required To Detect Early Stage Ovarian Cancer

Based upon the foregoing, Dr. Hartge highlights the “daunting arithmetic” required to detect early stage ovarian cancer. In the U.S., Surveillance, Epidemiology and End Results (SEER) data indicates that incidence amounts to 13 cases of ovarian cancer per 100,000 woman per year, referred to by Dr. Hartge as the “proverbial needles in the haystack.” [5] So as not to present a problem without a potential solution, Hartge provides a roadmap to additional factors that may help future researchers develop early screening methods to identify those rare cases of ovarian cancer in the general population.  Notably, SEER data also indicates that incidence of ovarian cancer steadily increases with age from 21 cases per 100,000 women per year within the 50-54 age range to 57 cases per 100,000 women per year within the 80-84 age range. [6] Furthermore, family history, low parity, and more ovulations over a woman’s lifetime predict additional risk, with the strongest but least common predictor being a mutation in the BRCA1 or BRCA2 gene. Thus, the general approach suggested by Hartge focuses on women with higher baseline risks, for whom the predictive value of a positive serum test tends to increase. Dr. Hartge believes that the performance of an overall screening program will improve by targeting higher-risk subgroups of women for screening by combining personal history, genetic abnormality status, and levels of serum markers in one prediction model. With ongoing advances in understanding the origin and causes of ovarian cancer, Hartge states that the risk models that are useful for screening programs should also improve.

Further technology advancements may also improve future ovarian cancer early detection screening models, says Hartege. For example, a screening program that is based on a panel of biomarkers can be improved by developing new medical imaging technology that is more specific than current ultrasound technology.  If better imaging existed, fewer women would undergo surgery following a suspicious biomarker finding.  Similarly, development of less invasive surgery could further reduce harmful side effects.  Although Hartge observes that a highly accurate biomarker(s) or an overall screening program does not yet exist, she also explains that the current study by Anderson et. al., with its sobering implications, brings future researchers closer to understanding the crucial elements in designing an effective early detection program for ovarian cancer.

References:

1/Anderson GL , McIntosh M, Wu L, et. al. Assessing Lead Time of Selected Ovarian Cancer Biomarkers: A Nested Case–Control Study. Journal of the National Cancer Institute Advance Access published on January 6, 2010, DOI 10.1093/jnci/djp438. J. Natl. Cancer Inst. 102: 26-38.

2/Hartge P. Designing Early Detection Programs for Ovarian Cancer. Journal of the National Cancer Institute Advance Access published on January 6, 2010, DOI 10.1093/jnci/djp450. J. Natl. Cancer Inst. 102: 3-4.

3/Partridge E, Kreimer AR, Greenlee RT, et al. Results from four rounds of ovarian cancer screening in a randomized trial. Obstet Gynecol (2009) 113(4):775–782. [PMCID: PMC2728067; PMID: 19305319].

4/Menon U, Gentry-Maharaj A, Hallett R, et al. 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). Lancet Oncol (2009) 10(4):327–340. [PMID: 19282241]

5/ Horner MJ, Ries LAG, Krapcho M, et al, eds. SEER Cancer Stat Fact Sheets (2009) Bethesda, MD: National Cancer Institute. http://seer.cancer.gov/statfacts/html/ovary.html. Accessed December 2, 2009.

6/Horner MJ, Ries LAG, Krapcho M, et. al., eds. SEER Cancer Statistics Review, 1975-2006, National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/csr/1975_2006, based on November 2008 SEER data submission, posted to the SEER web site, 2009 [See Table 21.6: Incidence & Mortality Rates By Age].

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Princeton Scientists Find Way To Catalog All That Goes Wrong In A Cancer Cell

Posted by Paul Cacciatore on December 15, 2009

A team of Princeton University scientists has produced a systematic listing of the ways a particular cancerous cell has “gone wrong,” giving researchers a powerful tool that eventually could make possible new, more targeted therapies for patients.

A team of Princeton University scientists has produced a systematic listing of the ways a particular cancerous cell has “gone wrong,” giving researchers a powerful tool that eventually could make possible new, more targeted therapies for patients.

Saeed Tavazoie is a professor in the Princeton University Department of Molecular Biology & the Lewis-Sigler Institute for Integrative Genomics

“For a very long time, cancer therapies have been developed by trial and error to essentially kill a broad variety of rapidly dividing cells, good and bad — that’s why they have massive side effects,” said Saeed Tavazoie, a professor in the Department of Molecular Biology and the Lewis-Sigler Institute for Integrative Genomics, who led the research. “The goal of cancer biology is to come up with therapies that are much more rational in terms of attacking the pathways that have been co-opted by cancer cells. The big challenge is to discover these pathways so that we can restore them to their normal state.”

Writing in the Dec. 11 issue of Molecular Cell, Tavazoie, along with his colleagues Hani Goodarzi, a graduate student in molecular biology, and Olivier Elemento, a former postdoctoral researcher in the department, found they were able to systematically categorize and pinpoint the alterations in cancer pathways and to reveal the underlying regulatory code in DNA. Elemento is now on the faculty of Weill Cornell Medical College in New York.

“We are discovering that there are many components inside the cell that can get mutated and give rise to cancer,” Tavazoie said. “Future cancer therapies have to take into account these specific pathways that have been mutated in individual cancers and treat patients specifically for that.”

The researchers developed an algorithm, a problem-solving computer program that sorts through the behavior of each of 20,000 genes operating in a tumor cell. When genes are turned “on,” they activate or “express” proteins that serve as signals, creating different pathways of action. Cancer cells often act in aberrant ways, and the algorithm can detect these subtle changes and track all of them.

“At the present moment, we lump a lot of cancers together and use the same therapy,” Tavazoie said. “In the future, we are aiming to be much more precise about treating the exact processes that were perturbed by the mutations.”

Pathologists presently examining the tumors of sick patients analyze a small set of tumor characteristics in order to determine the diagnostic and prognostic class to which the cells belong. This new method could give practitioners an encyclopedic accounting of the alterations in problem cells, spelling out the nature of the disease in much greater detail.

The algorithm devised by the group scans the DNA sequence of a given cell — its genome — and deciphers which sequences are controlling what pathways and whether any are acting differently from the norm. By deciphering the patterns, the scientists can conjure up the genetic regulatory code that is underlying a particular cancer.

The scientists developed the technique by employing modern methods of systems biology, where researchers seek to understand how components of living systems like cells work together to orchestrate processes, using powerful computers to sort vast arrays of data.

“Part of the promise of genomics and systems biology is the discovery of specific pathways of disease and finding ways to target them precisely,” Tavazoie said. “We have focused on revealing what these pathways are.”

The challenge for others, he said, will be to design specific therapies for such diseases, a process that could take many years. “This is an important first step,” Tavazoie added.

The method ultimately could work for any type of cancer and paves the way for rational approaches to treating a host of other diseases from diabetes to neurological disorders, the scientists said.

The research was funded by the National Human Genome Research Institute of the National Institutes of Health.

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Making A Difference: L’Oréal Paris Honors Women of Worth at Special Ceremony in New York City

Posted by Paul Cacciatore on December 11, 2009

L’Oréal Paris Honors Women of Worth at Special Ceremony in New York City. Ten Women Recognized for Making a Difference in their Communities with Special Guests including Mary J. Blige, Holly Robinson Peete and Erica Hill.  Shannon Lambert Named Women of Worth National Honoree by Public Vote

L'Oréal Paris' 2009 Women of Worth Honorees with Mary J. Blige, L'Oréal Paris President Karen T. Fondu and Senior Vice President of Marketing Anne Talley at the CNN Inspire Summit.

L'Oréal Paris President, Karen T. Fondu, with Mary J. Blige at the CNN Inspire Summit in New York City.

L’Oréal Paris’ fourth annual Women of Worth program honored ten women for their exceptional achievements and tireless volunteerism efforts at the CNN Inspire Summit in New York City. The event was held December 8th in celebration of the ten 2009 L’Oréal Paris Women of Worth honorees and featured an awards presentation by Karen T. Fondu, President, L’Oréal Paris Division. Special guests speakers included, Mary J. Blige, Holly Robinson Peete, and Erica Hill. The Women of Worth honorees represent a wide range of causes including education, female and youth empowerment, military support and healing for survivors of cancer and sexual violence. Each of the ten honorees received $5,000 from L’Oréal Paris for their charitable organizations, plus a $5,000 matching donation made in their name to the Ovarian Cancer Research Fund, the twelve-year charitable partner of L’Oréal Paris.

Women of Worth Program

The Women of Worth initiative celebrates women who passionately embody the spirit of volunteerism. The initiative empowers and celebrates women everywhere and brings the L’Oréal Paris “Because I’m Worth It” philosophy to life.

“We are so honored to welcome each of the 2009 Women of Worth honorees to this very special community,” said Karen T. Fondu, President, L’Oréal Paris Division. “Each of these amazing women embodies the L’Oréal Paris philosophy and supports our unwavering belief in every woman’s worth and in her power to make a difference in the world.”

Women of Worth Honorees

The ten 2009 L’Oréal Paris Women of Worth honorees are dedicated to a range of causes and are phenomenal examples of the power of volunteerism. Each honoree is an extraordinary community leader representing and inspiring women all across America.

  • Lillian Collins – Clinton, OK, founded Eastside Academy to assist African American children who need help in reading and math, providing a positive after-school program.
  • Anne Ginther – Sammamish, WA, founded RandomKid, which provides staff and services to youth of all backgrounds and abilities for the development, management and accomplishment of their goals to help others.
  • Maimah Karmo – Aldie, VA, established Tigerlily Foundation, which provides meals, financial assistance, empowerment and inspiration to younger women affected by breast cancer.
  • Brenda Murray – Chevy Chase, MD, has been transforming conditions and providing educational opportunities for thousands of women behind bars for the past 20 years.
  • Ora Rakestraw – Sacramento, CA, tutors third graders with special needs, helping these young people have a chance to experience success and stay committed to their education.
  • Carol Reza – Whitter, CA, founded Bridge of Faith to provide families of incarcerated women with mentoring and social service referral services.
  • Halle Tecco – San Francisco, CA, created Yoga Bear, an organization that provides free yoga classes to cancer patients.
  • Rhonda Ulmer – Denton, MD, provides local community resources to parents in her school to obtain their GED, housing, food and health assistance, transforming the school into the hub of the community.

The Women of Worth honorees were chosen from nearly 2,500 applicants by an elite group of judges, which includes Jacqueline Hernandez, Chief Operating Officer of Telemundo Communications Group; Soledad O’Brien, CNN Anchor; Dayle Haddon, L’Oréal Paris spokesperson; Elizabeth Howard, former Chief Executive Officer of the Ovarian Cancer Research Fund; Cindy Kerr, Founder and President of ConKerr Cancer and Anne Talley, Senior Vice President of Marketing for L’Oréal Paris.

Women of Worth National Honoree

Shannon Lambert, founder of Pandora’s Project, a community where women who have survived rape can connect and support one another.

The National Honoree, Shannon Lambert, recognized for her work with Pandora’s Project, which provides support, information and resources to sexual violence survivors received an additional $25,000 from L’Oréal Paris as a result of a national online vote at womenofworth.com.

“My own experience inspired me to create an innovative way for survivors of sexual violence to connect with each other and find the resources they need and deserve to heal.” — Shannon Lambert

It is estimated that at least one in six individuals will experience rape or sexual abuse in their lifetime, and for many, the aftermath of sexual violence is isolating and devastating. Pandora’s Project offers an online resource moderated by a team of volunteers that provides peer-to-peer support for male and female victims of sexual violence. The organization also operates a free sexual assault lending library, maintains resource lists for those in need of face-to-face support, and organizes retreat weekends for women ready to take their healing one step farther.

“I am delighted to be honored as a L’Oréal Paris Woman of Worth,” said Lambert. “The support L’Oréal Paris has given to Pandora’s Project will enable us to continue to help victims of sexual violence and to support their recovery.”

For more information about the Women of Worth program and honorees, please visit womenofworth.com.

About L’Oréal Paris

The L’Oréal Paris division of L’Oréal USA, Inc. is a total beauty care company that combines the latest in technology with the highest in quality for the ultimate in luxury beauty at mass. The L’Oréal Paris brand encompasses the four major beauty categories – haircolor, haircare, skincare and cosmetics – and includes such well-known brands as Preference, Excellence and Féria haircolors; EverPure, VIVE Pro, Studio Line and L’Oréal Kids haircare; Revitalift, Age Perfect, Skin Genesis, Collagen, Sublime Bronze and Men’s Expert skincare; and the Colour Riche, True Match, Infallible, Bare Naturale and HIP High Intensity Pigments cosmetics collections, along with a portfolio of mascara including Voluminous, Double Extend and Telescopic among many others.

L’Oréal Paris is dedicated to women around the world and the company has been inspired to give back and make a difference in their lives. In 1997, L’Oréal Paris made a long-term commitment to raising awareness for ovarian cancer, which continues to build. To date, L’Oréal Paris has helped raise over $18 million dollars to further research and build awareness with fundraising efforts such as the L’Oréal Legends Gala and L’Oréal’s annual “Color of Hope” cosmetics collection.

Source:  L’Oréal Paris Honors Women of Worth at Special Ceremony in New York City, Press Release, L’Oréal Paris, December 9, 2009.

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MAGP2 Gene Expression Signature: A Potential Ovarian Cancer Personalized Treatment Target

Posted by Paul Cacciatore on December 8, 2009

A multi-institutional study has identified a potential personalized treatment target for the most common form of ovarian cancer. In the December 8 issue of Cancer Cell, the research team describes finding that a gene called MAGP2 – not previously associated with any type of cancer – was overexpressed in papillary serous ovarian tumors of patients who died more quickly. They also found evidence suggesting possible mechanisms by which MAGP2 may promote tumor growth.

A multi-institutional study has identified a potential personalized treatment target for the most common form of ovarian cancer. In the December 8 issue of Cancer Cell, the research team describes finding that a gene called MAGP2 (microfibril-associated glycoprotein 2) – not previously associated with any type of cancer – was overexpressed in papillary serous ovarian tumors of patients who died more quickly. They also found evidence suggesting possible mechanisms by which MAGP2 may promote tumor growth.

Michael Birrer, MD, Ph.D., Professor, Department of Medicine, Harvard Medical School; Director GYN/Medical Oncology, Medicine, Massachusetts General Hospital

“Ovarian cancer is typically diagnosed at an advanced stage when it is incurable, and the same treatments have been used for virtually all patients,” says Michael Birrer, MD, PhD, director of medical gynecologic oncology in the Massachusetts General Hospital (MGH) Cancer Center, and the study’s corresponding author. “Previous research from my lab indicated that different types and grades of ovarian tumors should be treated differently, and this paper now shows that even papillary serous tumors have differences that impact patient prognosis.” Birrer was with the National Institutes of Health when this study began but later joined the MGH Cancer Center.

The fifth most common malignancy among U.S. women, ovarian cancer is expected to cause approximately 15,000 deaths during 2009. Accounting for 60 percent of ovarian cancers, papillary serous tumors are typically diagnosed after spreading beyond the ovaries. The tumors typically return after initial treatment with surgery and chemotherapy, but while some patients die a few months after diagnosis, others may survive five years or longer while receiving treatment.

To search for genes expressed at different levels in ovarian cancer patients with different survival histories, which could be targets for new treatments, the researchers conducted whole-genome profiling of tissue samples that had been microdissected – reducing the presence of non-tumor cells – from 53 advanced papillary serous ovarian cancer tumors. Of 16 genes that appeared to have tumor-associated expression levels, MAGP2 had the strongest correlation with reduced patient survival.

Further analysis confirmed that MAGP2 expression was elevated in another group of malignant ovarian cancer tumors but not in normal tissue. MAGP2 gene expression was also reduced in patients whose tumors responded to chemotherapy. Recombinant expression of MAGP2 in samples of the endothelial cells that line blood vessels caused the cells to migrate and invade normal tissue.  In addition, MAGP2 gene overexpression increased microvessel density — a measurement used to determine the extent of tumor angiogenesis. The latter two observations suggest a potential role for MAGP2 gene overexpression in the growth of an ovarian cancer tumor’s blood supply.

“By confirming that different ovarian tumors have distinctive gene signatures that can predict patient prognosis, this study marks the beginning of individualized care for ovarian cancer,” says Birrer, a professor of Medicine at Harvard Medical School. “MAGP2 and the biochemical pathways it contributes to are definitely targets for new types of therapies, and we plan to pursue several strategies to interfere with tumor-associated pathways. But first we need to validate these findings in samples from patients treated in clinical trials.”

About The Study

Co-lead authors of the Cancer Cell paper are Samuel Mok, M.D., M.D. Anderson Cancer Center, and Tomas Bonome, National Cancer Institute (NCI). Additional co-authors are Kwong-Kowk Wong, M.D. Anderson; Vinod Vathipadiekal, Aaron Bell, Howard Donninger, Laurent Ozbun, Goli Samimi, John Brady, Mike Randonovich, Cindy Pise-Masison, and Carl Barrett, NCI; Michael Johnson, Dong-Choon Park, William Welch and Ross Berkowitz, Brigham and Women’s Hospital; Ke Hao and Wing Wong, Harvard School of Public Health; and Daniel Yip, University of South Florida. The study was supported by grants from the National Institutes of Health, the Ovarian Cancer Research Fund and the National Cancer Institute.

About Massachusetts General Hospital

Massachusetts General Hospital, established in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH conducts the largest hospital-based research program in the United States, with an annual research budget of more than $600 million and major research centers in AIDS, cardiovascular research, cancer, computational and integrative biology, cutaneous biology, human genetics, medical imaging, neurodegenerative disorders, regenerative medicine, systems biology, transplantation biology and photomedicine.

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OU’s Non-Toxic Drug Makes Ovarian Cancer Cells Respond To New Treatment & Undergo Cell Suicide

Posted by Paul Cacciatore on December 8, 2009

“Cancer researchers at the University of Oklahoma Health Sciences Center have found a way to turn ineffective new cancer drugs into cancer-fighters. By using their patented chemical compound, SHetA2, researchers tricked cancer cells into responding to new treatments and undergoing cell suicide. … [T]he compound will work with several cancers, including lung, kidney, ovarian, colon and pancreatic cancer. … [The] research team … patented the SHetA2 Flex-Het and hope[s] to start clinical trials for the compound within a year. …“

Cancer researchers at the University of Oklahoma Health Sciences Center have found a way to turn ineffective new cancer drugs into cancer-fighters. By using their patented chemical compound, SHetA2, researchers tricked cancer cells into responding to new treatments and undergoing cell suicide. The research appears in the journal Gynecologic Oncology.

Doris Mangiaracina Benbrook, Ph.D., is in her lab at the University of Oklahoma Health Sciences Center in Oklahoma City. (Photo: Univ. of Oklahoma Health Sciences Center)

“This discovery means that we can use our non-toxic cancer prevention pill to improve treatment for people who already have cancer,” said Doris Mangiaracina Benbrook, Ph.D., principal investigator on the project. “All studies to date have not found any side effects of taking our drug, giving hope that we can prevent cancer in healthy people, and improve treatment for cancer patients, without increasing toxicity.”

The latest study looked at an upcoming class of cancer treatment drugs that worked well in experimental models, but proved ineffective against many human tumors. Dr. Benbrook and her team decided to test their compound’s ability to “fix” the problem. It worked.

“The new chemotherapy drugs are antibodies that bind to cell surface receptors called ‘Death Receptors.’ The binding of the antibodies activates the death receptors in cancer cells and causes cell suicide with little harm to normal cells. Many cancers, however, are resistant to the antibodies,” Benbrook said. “We’ve shown that SHetA2 treatment can make ovarian and kidney cancer cells sensitive to the death receptor antibodies and kill the cancer.”

Benbrook said the compound will work with several cancers, including lung, kidney, ovarian, colon and pancreatic cancer.

“It would be a significant advancement in health care if we could avoid the severe toxicity and suffering that late stage cancer patients have to experience,” Benbrook said.

The synthetic compound, SHetA2, a Flex-Het drug, was created by Benbrook with the help of chemist Darrell Berlin at Oklahoma State University. The compound directly targets abnormalities in cancer cell components without damaging normal cells. The disruption causes cancer cells to die and keeps tumors from forming.

Flex-Hets or flexible heteroarotinoids are synthetic compounds that can change certain parts of a cell and affect its growth. Benbrook and her research team have patented the SHetA2 Flex-Het and hope to start clinical trials for the compound within a year. If the compound continues to be found safe, it would be developed into a pill to be taken daily like a multi-vitamin to prevent cancer. This new discovery means that the pill also could be used to make patients, who already have cancer, better respond to treatment.

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MIT Develops New Platinum Compound As Powerful As Cisplatin But Better Able To Destroy Tumor Cells

Posted by Paul Cacciatore on December 7, 2009

MIT chemists have developed a new platinum compound that is as powerful as the commonly used anticancer drug cisplatin but better able to destroy tumor cells.

A diagram of cisplatin which is a platinum chemotherapy drug.

Massachusetts Institute of Technology chemists have developed a new platinum compound that is as powerful as the commonly

Stephen J. Lippard Ph.D., Arthur Amos Noyes Professor of Chemistry, Massachusetts Institute of Technology

used anticancer drug cisplatin but better able to destroy tumor cells.

The new compound, mitaplatin, combines cisplatin with another compound, dichloroacetate (DCA), which can alter the properties of mitochondria selectively in cancer cells. Cancer cells switch their mitochondrial properties to change the way they metabolize glucose compared to normal cells, and DCA specifically targets the altered mitochondria, leaving normal cells intact.

“This differential effect conveys on mitaplatin the ability to kill cancer cells selectively in a co-culture with normal fibroblast cells, the latter being unaffected at the doses that we apply,” says Stephen Lippard, the Arthur Amos Noyes Professor of Chemistry.

How they did it: The chemists designed mitaplatin so that when it enters a cell, it releases cisplatin and two units of DCA by intracellular reduction. Therefore, mitaplatin can attack nuclear DNA with cisplatin and mitochondria with DCA. DCA promotes the release of cell-death-promoting factors from the mitochondria, enhancing the cancer cell-killing abilities of cisplatin.

Next steps: Lippard’s laboratory has shown that in rodents, mitaplatin can be tolerated at much higher doses than cisplatin, and they have begun studies in mice transplanted with human tissues. If those results are promising, the researchers plan more studies for further demonstration of mitaplatin’s ability in cancer therapy.

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“Too Often We Underestimate The Power Of A Touch”*

Posted by Paul Cacciatore on November 22, 2009

One of the most comforting forms of support you can give a person with cancer is the use of touch. Family caregivers can significantly reduce symptoms in cancer patients at home through use of simple touch and massage techniques. These findings were recently reported at the 6th International Conference of the Society for Integrative Oncology.

Study Shows Family Caregivers’ Simple Touch Techniques Reduce Symptoms in Cancer Patients

One of the most comforting forms of support you can give a person with cancer is the use of touch.  Family caregivers can significantly reduce symptoms in cancer patients at home through use of simple touch and massage techniques. These findings were recently reported at the 6th International Conference of the Society for Integrative Oncology.

The study, sponsored by the National Cancer Institute, evaluated outcomes of a 78 minute DVD instructional program and illustrated manual in a sample of 97 patients and their caregivers. The multi-ethnic sample represented 21 types of cancer (nearly half with breast cancer) and all stages of disease. Caregivers included spouses, adult children, parents, siblings and friends. The project was conducted in Boston, Massachusetts, Portland, Maine, and Portland, Oregon using English, Spanish and Chinese languages.

“Too often we underestimate the power of a touch, a smile, a kind word, a listening ear, an honest compliment, or the smallest act of caring, all of which have the potential to turn a life around.”  — Leo F. Buscaglia, from his book entitled, Living, Loving & Learning.

William Collinge, Ph.D., MPH, President, Collinge and Associates. Dr. Collinge is a consultant, author, speaker and researcher in the field of integrative health care. He has served as a scientific review panelist for the National Institutes of Health in mind/body medicine, complementary therapies & health care services

According to the principal investigator, William Collinge, PhD, MPH, president of Collinge and Associates states, “Touch and massage are among the most effective forms of supportive care in cancer, but most patients cannot access professional practitioners of these methods on a regular basis. This study sought to determine whether family caregivers receiving brief home-based instruction could deliver some of the same benefits as professionals. It appears they can.”

In the study, couples were randomized to either an experimental group using the program, or an attention control group. Caregivers in the experimental group were asked to apply the instruction for at least 20 minutes, three or more times per week for a month. Those in the control group were assigned to read to the patient for the same amounts of time. Patients completed report cards before and after sessions rating their levels of pain, fatigue, stress/anxiety, nausea, depression, and other symptoms.

Results indicated significant reductions for all symptoms after both activities, indicating that companionship alone has a positive effect. However, while symptoms were reduced from 12-28% after reading, massage from the caregiver led to reductions of 29-44%. The greatest impact was on stress/anxiety (44% reduction), followed by pain (34%), fatigue (32%), depression (31%), and nausea (29%). Patients reporting an optional “other” symptom (e.g., headaches) saw reductions of 42% with massage. Caregivers in the massage group also showed gains in confidence and comfort with using touch and massage as forms of caregiving.

According to Collinge, “It appears that family members who receive simple instruction in safety and techniques can achieve some of the same results as professional practitioners. This has important implications not just for patient well-being, but for caregivers as well. Caregivers are at risk of distress themselves – they can feel helpless and frustrated when seeing a loved one suffer. This gives a way to make a difference for the patient, and at the same time increase their own satisfaction and effectiveness as a caregiver. It also appears to strengthen the relationship bond, which is important to both.”

The DVD program, titled Touch, Caring and Cancer: Simple Instruction for Family and Friends,  is expected to be released to the public during the week of November 22, 2009. The DVD program will be available in English, Spanish and Chinese. More information and video trailers are available at www.partnersinhealing.net.

About Collinge and Associates

Collinge and Associates is an independent research and consulting organization based in Kittery, Maine. The group conducts research in complementary therapies for the National Institutes of Health, and does scientific review consulting for NIH and other organizations. Website: www.collinge.org.

Sources:

*Title Source:

The title was excerpted from the words of Leo F. Buscaglia that appear in his book Living, Loving & Learning. Buscaglia was a teacher in the Department of Special Education at the University of Southern California (USC) in the late 1960’s. During his tenure at USC, one of Buscaglia’s students committed suicide.  The incident had a great impact on Buscaglia and led him to establish a non-credit class titled, Love 1A. The class led to lectures and a manuscript loosely based on what was shared in those weekly classes. The manuscript led to the publication of a book entitled, LOVE:  What life is all about.  Shortly thereafter, Leo Buscaglia’s presentations were taped by the Public Broadcasting System (PBS) and shown on television.  The PBS television presentations touched the hearts of many television viewers.  Buscaglia is often referred to as the granddaddy of motivational speakers. During his lifetime, Buscaglia was a popular speaker on television talk shows and the lecture circuit.  There was one point in time when five of his books appeared simultaneously on The New York Times Best Sellers List.

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PI3K Pathway: A Potential Ovarian Cancer Therapeutic Target?

Posted by Paul Cacciatore on November 20, 2009

…[T]here are several PI3K signaling pathway targeting drugs in clinical development for use against ovarian cancer and solid tumors, including GDC-0941, BEZ235, SF1126, XL-147, XL-765, BGT226, and PX-866.  The results of two recent medical studies suggest that the use of PI3K-targeted therapies may offer an effective therapeutic approach for patients with advanced-stage and recurrent ovarian cancer, including a generally chemotherapy-resistant histological subtype of epithelial ovarian cancer known as “ovarian clear cell cancer” (OCCC).  The targeting of the PI3K pathway in endometrial, ovarian, and breast cancer is also being investigated by a Stand Up To Cancer “Dream Team.” …

PI3K Cellular Signaling Pathway — An Overview

PI3K/AKT cellular signaling pathway (Photo: Cell Signaling Technology(R))

In 2004 and 2005, multiple researchers identified mutations in the PIK3CA  gene with respect to multiple cancers.[1]  The PIK3CA gene encodes the PI3K catalytic subunit p110α. PI3K (phosphoinositide 3- kinase) proteins have been identified in crucial signaling pathways of ovarian cancer cells. PI3Ks are also part of the PI3K-AKT-mTOR signaling pathway which promotes cellular glucose metabolism, proliferation, growth, survival, and invasion and metastasis in many cancers. PIK3CA gene mutations can increase PI3K signaling, thereby activating the PI3K-AKT-mTOR pathway within cancer cells.

As of this writing, there are several PI3K signaling pathway targeting drugs in clinical development for use against ovarian cancer and solid tumors, including GDC-0941, BEZ235, SF1126, XL-147, XL-765, BGT226, and PX-866. [2]  The results of two recent medical studies suggest that the use of PI3K-targeted therapies may offer an effective therapeutic approach for patients with advanced-stage and recurrent ovarian cancer, including a generally chemotherapy-resistant histological subtype of epithelial ovarian cancer known as “ovarian clear cell cancer” (OCCC).  The targeting of the PI3K pathway in endometrial, ovarian, and breast cancer is also being investigated by a Stand Up To Cancer “Dream Team.”

Frequent Mutation of PIK3CA Gene In Recurrent & Advanced Clear Cell Ovarian Cancer

OCCC is one of the five major subtypes of epithelial ovarian cancer. OCCC accounts for only 4% to 12% of epithelial ovarian cancer in Western countries and, for unknown reasons, it comprises more than 20% of such cancers in Japan [3,4,5]. OCCC possesses unique clinical features such as a high incidence of stage I disease, a large pelvic mass, an increased incidence of venous thromboembolic complications, and hypercalcemia. It is frequently associated with endometriosis.  Compared to serous ovarian cancer, OCCC is relatively resistant to conventional platinum and taxane-based chemotherapy. For these reasons, new effective therapies are desperately needed for OCCC.

Researchers from Johns Hopkins and the University of California, Los Angeles (UCLA) analyzed 97 OCCC tumors for genetic sequence mutations in KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog), BRAF (v-raf murine sarcoma viral oncogene homolog B1), PIK3CA (phosphoinositide-3-kinase, catalytic, alpha polypeptide), TP53 (tumor protein p53), PTEN (phosphatase and tensin homolog), and CTNNB1 (Catenin, Beta-1) as these mutations frequently occur in other major types of ovarian cancers.[6] The samples tested included the following:

  • 18 OCCCs for which affinity-purified tumor cells from fresh specimens were available;
  • 10 OCCC tumor cell lines.

Upon test completion, the researchers discovered that sequence mutations of PIK3CA, TP53, KRAS, PTEN, CTNNB1, and BRAF occurred in 33%, 15%, 7%, 5%, 3%, and 1% of OCCC cases, respectively.

Clear cell carcinoma of the ovary (Photo: Geneva Foundation For Medical Education & Research)

The sequence analysis of the 18 affinity purified OCCC tumors and the 10 OCCC cell lines showed a PIK3CA mutation frequency of 46%. Based upon these findings the researchers concluded that the use of PIK3CA-targeting drugs may offer a more effective therapeutic approach compared with current chemotherapeutic agents for patients with advanced-stage and recurrent OCCC. As noted above, there are several PI3K-targeting drugs in clinical development for use against ovarian cancer and solid tumors.[2]

Notably, one of the researchers involved with this OCCC study is Dennis J. Slamon, M.D., Ph.D. Dr. Slamon serves as the Director of Clinical/Translational Research, and as Director of the Revlon/UCLA Women’s Cancer Research Program at the Jonsson Comprehensive Cancer Center. Dr. Slamon is also a professor of medicine, chief of the Division of Hematology/Oncology and Executive Vice Chair of Research for UCLA’s Department of Medicine. Dr. Slamon is a co-discoverer of the breast cancer drug Herceptin®. Herceptin is a monoclonal antibody targeted therapy used against HER-2 breast cancer, an aggressive breast cancer subtype that affects 20% to 30% of women with the disease. Herceptin’s development was based, in part, upon the unique genetic profile of HER-2 breast cancer as compared to other forms of breast cancer. Herceptin® revolutionized the treatment of HER-2 postive breast cancer and is recognized worldwide as the standard of care for that subtype of breast cancer.  The approach taken by Johns Hopkins and UCLA researchers in this study — the identification of  a subtype within a specific form of cancer that may be susceptible to a targeted therapy –  bears a striking similarity to the overarching approach taken in the development of Herceptin®.

Ovarian Cancer & Other Solid Tumors With PIK3CA Gene Mutations Respond To PI3K-AKT-mTOR Pathway Inhibitors In Phase I Clinical Testing.

Testing patients with cancer for PIK3CA gene mutations is feasible and may allow targeted treatment of the PI3K-AKT-mTOR cellular signaling pathway, according to the results of a University of  Texas, M.D. Anderson Cancer Center study presented on November 17, 2009 at the 2009 AACR (American Association for Cancer Research)-NCI (National Cancer Institute)-EORTC (European Organization For Research & Treatment of Cancer) International Conference on Molecular Targets and Cancer Therapeutics.[7]

mTOR cellular signaling pathway (Photo: Cell Signaling Technology(R))

Filip Janku, M.D., Ph.D, a clinical research fellow with the M.D. Anderson Cancer Center’s department of investigational cancer therapeutics, and colleagues conducted a mutational analysis of exon 9 and exon 20 of the PI3KCA gene using DNA from the tumors of patients referred to targeted therapy clinical trials. Patients with PIK3CA mutations were preferably treated whenever possible with regimens utilizing PI3K-AKT-mTOR signaling pathway inhibitors.

As part of this study 117 tumor samples were analyzed. PIK3CA mutations were detected in 14 (12%) patients.  In tumor types with more than 5 patients tested, PIK3CA mutations were identified in endometrial cancer (43%, 3 out of 7 patients), ovarian cancer (22%, 5 out of 23 patients), squamous head and neck cancer (14%, 1 out of 7 patients), breast cancer (18%, 2 out of 11 patients), and colon cancer (15%, 2 out of 13 patients). No mutations were identified in patients with melanoma or cervical cancer.

Of the 14 patients found to possess PIK3CA mutations, 10 were treated based upon a clinical trial protocol that included a drug targeting the PI3K-AKT-mTOR pathway.  A partial response to treatment was experienced by 4 (40%) patients. Although the total number of patients is small, there were 2 (67%) patient responses in 3 endometrial cancer cases, 1 (25%) patient response in 4 ovarian cancer cases, 1 (100%) patient response in 1 breast cancer, and no patient response in 1 colorectal cancer case.  Although the total number of study patients is small, the researchers conclude that the response rate appears high (40%) in tumors with PIK3CA mutations treated with PI3K-AKT-mTOR pathway inhibitors.

“The implications of this study are twofold,” said Dr. Janku.  “We demonstrated that PIK3CA testing is feasible and may contribute to the decision-making process when offering a patient a clinical trial. Although this study suffers from low numbers, the response rate observed in patients treated with inhibitors of PI3K/AKT/mTOR pathway based on their mutational status was well above what we usually see in phase-1 clinical trials.”  “These results are intriguing but at this point should be interpreted with caution,” said Janku. “The promising response rate needs to be confirmed in larger groups of patients. We expect to learn more as this project continues to offer PIK3CA screening to patients considering a phase-1 clinical trial.”

Stand Up 2 Cancer Dream Team: Targeting the PI3K Pathway in Women’s Cancers

The potential importance of the PI3K pathway in the treatment of ovarian cancer is emphasized by the two medical studies above.  This issue is also receiving considerable attention from one of the Stand Up 2 Cancer (SU2C) “Dream Teams,” which is going to evalute  the potential for targeting the PI3K pathway in women’s cancer.  SU2C assigned $15 million of cancer research funding to this critical issue.  The scientists involved in this SU2C Dream Team are the pioneers who discovered the PI3K pathway and validated its role in human cancers, and they will focus on breast, ovarian and endometrial cancers, all of which possess the PI3K mutation.

The leader and co-leaders of the PI3K pathway SU2C team are set forth below.

Leader:

Lewis C. Cantley, Ph.D., Director, Cancer Center at Beth Israel Deaconess Medical Center.

Co-Leaders:

Charles L. Sawyers, M.D., Director, Human Oncology and Pathogenesis Program, Memorial Sloan-Kettering Cancer Center.

Gordon B. Mills, M.D., Ph.D., Chair, Department of Systems Biology, University of Texas, M.D. Anderson Cancer Center.

The specific SU2C Dream Team research goal with respect to targeting the PI3K pathway in women’s cancers is stated as follows:

The PI3K pathway is mutated in more cancer patients than any other, and these mutations are the most frequent events in women’s cancers, making it an attractive molecular target for agents that inhibit these genetic aberrations. If successful, this project will allow clinicians to use biomarkers and imaging techniques to predict which patients will benefit from PI3K pathway inhibitors and lead to the development of therapeutic combinations that will hit multiple targets in the complex pathways that contribute to cancer cell growth.  This work will help assure that these therapies are given to patients who will benefit from them, and it will also increase the overall pace of clinical trials targeting PI3K inhibitors.

Based upon the two studies discussed, and the creation and funding of the SU2C Dream Team for the purpose of targeting the PI3K pathway in women’s cancer, the future holds great promise in the battle against ovarian cancer (including OCCC).  It is our hope that more clinical study investigators will offer PI3K pathway mutation screening to all ovarian cancer patient volunteers.  Libby’s H*O*P*E*™ will continue to monitor the clinical development of PI3K pathway inhibitors, and make our readers aware of all future developments.

________________________________

References:

1/Yuan TL, Cantley LC. PI3K pathway alterations in cancer: variations on a theme. Oncogene. 2008 Sep 18;27(41):5497-510. PubMed PMID: 18794884
Samuels Y, Ericson K. Oncogenic PI3K and its role in cancer. Curr Opin Oncol. 2006 Jan;18(1):77-82. PubMed PMID: 16357568.
Levine DA, Bogomolniy F, Yee CJ, et. al. Frequent mutation of the PIK3CA gene in ovarian and breast cancers. Clin Cancer Res. 2005 Apr 15;11(8):2875-8. PubMed PMID: 15837735.
Samuels Y, Wang Z, Bardelli A, et. al. High frequency of mutations of the PIK3CA gene in human cancers. Science. 2004 Apr 23;304(5670):554. Epub 2004 Mar 11. PubMed PMID: 15016963.

2/For open ovarian cancer clinical trials using a PI3K-targeted therapy; CLICK HERE; For open solid tumor clinical trials using a PI3K-targeted therapy, CLICK HERE.

3/ Itamochi H, Kigawa J & Terakawa N.  Mechanisms of chemoresistance and poor prognosis in ovarian clear cell carcinoma. Can Sci 2008 Apr;99(4):653-658. [PDF Document]

4/Schwartz DR, Kardia SL, Shedden KA, et. al.  Gene Expression in Ovarian Cancer Reflects Both Morphology and Biological Behavior, Distinguishing Clear Cell from Other Poor-Prognosis Ovarian Carcinomas.  Can Res 2002 Aug; 62, 4722-4729.

5/Sugiyama T & Fujiwara K.  Clear Cell Tumors of the Ovary – Rare Subtype of Ovarian Cancer, Gynecologic Cancer, American Society of Clinical Oncology (ASCO) Educational Book, 2007 ASCO Annual Meeting, June 2, 2007 (Microsoft Powerpoint presentation).

6/Kuo KT, Mao TL, Jones S, et. al. Frequent Activating Mutations of PIK3CA in Ovarian Clear Cell Carcinoma. Am J Pathol. 2009 Apr 6. [Epub ahead of print]

7/Janku F, Garrido-Laguna I, Hong D.S.  PIK3CA mutations in patients with advanced cancers treated in phase I clinical trials, Abstract #B134, Molecular Classification of Tumors, Poster Session B, 2009 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference. [PDF Document].

Posted in Biological Therapies, Clinical Trials, Conferences, Discoveries, Genetics, Medical Study Results, Meeting Highlights, Novel Therapies, Pipeline Drugs, Targeted Therapies | Tagged: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 2 Comments »

“Decisions Are Made By Those Who Show Up”*

Posted by Paul Cacciatore on November 14, 2009

Responding to a threat of a funding reduction to the Department of Defense’s Ovarian Cancer Research Program, during the last week of October the Ovarian Cancer National Alliance urged advocates to contact their Members of Congress to appeal to the Appropriations Defense Subcommittee to increase funding for the research program. As a result of the Ovarian Cancer National Alliance’s advocacy efforts, 14 Senators and 77 Representatives showed their opposition to the funding cut by signing a Dear Colleague letter sent to the Subcommittee Tuesday, November 3, 2009. …

Advocates Work To Prevent Slash In Ovarian Cancer Research Funding

Responding to a threat of a funding reduction to the Department of Defense’s Ovarian Cancer Research Program, during the last week of October the Ovarian Cancer National Alliance (OCNA) urged advocates to contact their Members of Congress to appeal to the Appropriations Defense Subcommittee to increase funding for the research program.

OCNAadvocates1

Advocates lobbying on Capitol Hill for increased funds for ovarian cancer research. (Photo: Ovarian Cancer National Alliance)

As a result of OCNA’s advocacy efforts, 14 Senators and 77 Representatives showed their opposition to the funding cut by signing a Dear Colleague letter sent to the Subcommittee Tuesday, November 3, 2009.

The Dear Colleague letter, written by Senator Robert Menendez (D-NJ) and Congresswoman Rosa DeLauro (D-CT), requested that the Subcommittee allocate the $25 million set forth in the U.S. House of Representatives‘ version of the Defense bill, and not the $10 million outlined in the U.S. Senate version of the bill. The Senate funding level represented a 50 percent reduction from the $20 million appropriated in fiscal year (FY) 2009.

The date of the conference subcommittee meeting has yet to be announced.

Established in 1997, the Department of Defense’s Ovarian Cancer Research Program has received $10 million in funding annually from FY 1998 until FY 2008. However, for FY 2009, the program’s funding was doubled to $20 million. The Ovarian Cancer Research Program works to eliminate ovarian cancer by conducting innovative, multidisciplinary research on early detection, screening and treatment of ovarian cancer.

To read the full text of the letter and see if your elected officials signed, please click here.

The Ovarian Cancer Action Network periodically sends out action alerts to notify advocates of pressing issues that need constituent support. To sign up, please click here.

About the Ovarian Cancer National Alliance

OCNA is the advocacy arm of the ovarian cancer movement. OCNA works with federal policy makers, including the  U.S. President, U.S. Congress, and federal agencies like the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). OCNA commits its resources to be a voice for ovarian cancer survivors and significantly reduce the number of deaths from this deadly disease by advocating at the federal level for the following:

• Adequate and sustained funding for ovarian cancer research and awareness programs, and

• Legislation that improves quality of life and access to care for ovarian cancer patients.

Since 1997, when OCNA was founded, death rates from ovarian cancer have not significantly changed. However, OCNA has worked to increase funding for ovarian cancer research, with the goal that this funding will support breakthroughs to help detect ovarian cancer early, treat it more thoroughly, and allow women with ovarian cancer to survive, and thrive.

OCNA has worked to ensure that (i) necessary treatments are covered by Medicare, (ii) drugs and tests on the market are safe and effective, and (iii) federal policy makers are aware of the importance of the ovarian cancer community.

Join OCNA to fight for women with ovarian cancer, and policies that help support them and their families.

Source: Advocates Work To Prevent Slash In Ovarian Cancer Research Funding, News Update, Ovarian Cancer National Alliance, November 11, 2009.

*Title Quote:  Fictional U.S. President Josiah Edward Bartlet, What Kind of Day Has It Been Episode, The West Wing, created by Aaron Sorkin, originally aired May 17, 2000 [Sorkin attributes his teleplay quote to Woody Allen ("80% of success in life is just showing up")].

Posted in Advocacy, Cancer Research, Federal Legislation, Research Grant | Tagged: , , , , , , , , , , , , , , , , , , | Leave a Comment »

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