Dana-Farber Oncologists Differ Widely on the Use of Multiplex Tumor Genomic Testing

A new study by researchers at the Dana-Farber Cancer Institute suggests that not all doctors are ready to embrace tests that may identify hundreds of genomic changes in a patient’s tumor sample for the purpose of determining appropriate treatment.

Many cancer researchers believe that cutting-edge advances in genomics will pave the way for personalized or “precision” cancer medicine for all patients in the near future. A new study by researchers at the Dana-Farber Cancer Institute, however, suggest that not all doctors are ready to embrace tests that look for hundreds of genomic changes in a patient’s tumor sample, while others plan to offer this type of cancer genomic tumor testing to most of their patients. The study findings were published recently in the Journal of Clinical Oncology [1], along with an accompanying editorial. [2]

The wide variation in attitudes was in part determined by physicians’ “genomic confidence.” Physicians who had a lot of confidence in their ability to use and explain genomic findings were more likely to want to prescribe the test and consider using test results when making treatment recommendations. Other physicians had lower levels of genomic confidence and were more reluctant to offer such testing. These findings are particularly interesting because the survey was carried out at the Dana-Farber/Brigham and Women’s Cancer Center (DF/BWCC), which has a comprehensive research program. The DF/BWCC research program allows all consenting patients to have genomic tumor testing, which is capable of finding gene mutations and other DNA alternations that drive a patient’s cancer. In some cases, the genomic tumor profiles identify “druggable” targets that may allow doctors to use specific drugs known to be effective against particular gene mutations or alterations.

The researchers were perplexed by another key study survey finding: 42 percent of responding oncologists approved of telling patients about genomic tumor test results even when their significance for the patient’s outlook and treatment is uncertain. This issue comes with the growing use of predictive multiplex genomic testing, which can identify tens or hundreds of gene mutations simultaneously and often detects rare DNA variants that may or may not be relevant to the treatment of an individual’s cancer.

“Some oncologists said we shouldn’t return these results to the patient, and others say ‘of course we should give them to the patient’,” said Stacy W. Gray, M.D., AM, of Dana-Farber, first author of the report. “I think the fact that we found so much variation in physicians’ confidence about their ability to use genetic data at a tertiary care, National Cancer Institute-designated Comprehensive Cancer Center makes us pause and wonder about how confident physicians in the community are about dealing with this,” she said. “It begs the question at a national level, how are we going to make sure that this technology for cancer care is adequately delivered?”

The study survey was conducted in 2011 and early 2012 as a baseline assessment of physicians’ attitudes prior to the rollout of the genomic tumor testing project referred to as “Profile” (which formerly utilized a technology platform called “OncoMap“) at DF/BWCC.

For purposes of the study, a total of 160 Dana-Farber adult cancer physicians – including medical oncologists (43%), surgeons (29%), and radiation oncologists (19%) – participated in the survey. They were asked about their current use of multiplex tumor genomic testing, their attitudes about multiplex testing, and their confidence in the ability to understand and use genomic data. The survey did not include a direct test of the physicians’ knowledge.

Among the many intriguing findings of this study, a wide variability in interest in multiplex tumor genomic testing was identified—25% of respondents anticipated testing more than 90% of their patients, whereas 17% of respondents anticipated testing 10% or less. Beliefs related to the potential value of multiplex tumor genomic testing were largely positive; most expressed belief that this form of testing would increase treatment (73%) and research options (90%) for patients, as well as both physician (80%) and patient satisfaction (80%).

Despite the foregoing, less than 50% of the physicians planned to view the multiplex tumor genomic testing results routinely. Moreover, the majority of respondents planned only to “rarely” or “sometimes” use the clinically relevant results (58%), called “Tier 1” by the study authors, and potentially actionable results (88%), called “Tier 2,” to assist them in the treatment of patients. However, the respondents more often indicated that results of multiplex tumor genomic tests should be shared with patients, particularly findings revealing the presence of a Tier 1 (clinically relevant) genomic variant—87% believed that these findings should be discussed—versus a Tier 2 (potentially actionable) genomic variant (50%), or a Tier 3 (uncertain significance) genomic variant (40%). A substantial minority (39%) also disagreed with a Dana-Farber Cancer Institute policy prohibiting the disclosure of Tier 3 genomic variants to patients.

Interestingly, despite limited exposure to routine genomic tests for a large portion of the respondents, the stated “genomic confidence” of participating physicians was quite high. The majority of participants reported that they were “somewhat” or “very” confident in their (i) knowledge of genomics (78%), (ii) ability to explain genomics (86%), and (iii) ability to use genomic results to guide treatment (74%); however, a substantial minority of the Dana-Farber physicians (28%) reported genomic confidence of “not very” or “not at all confident.”

Based upon the study survey findings, Dr. Gray and her colleagues conclude that there is “little consensus” on how physicians plan to use multiplex tumor genomic testing for personalized cancer care, and they suggest the need for evidence-based guidelines to help doctors determine when testing is indicated.

“I think one of the strengths of this study is that its information comes from an institution where ‘precision cancer medicine’ is available to everyone,” commented Barrett Rollins, M.D., Ph.D., Dana-Farber’s Chief Scientific Officer and a co-author of the paper. “It highlights the fact there’s a lot of work to be done before this can be considered a standard approach in oncology.”

The senior author of the study is Jane Weeks, M.D., MSc, of Dana-Farber; additional authors include Angel Cronin, MS, of Dana-Farber and Katherine Hicks-Courant, BA, of the University of Massachusetts Medical School.

The research was supported by the Dana-Farber Cancer Institute. Dr. Gray also receives support from the American Cancer Society (120529-MRSG-11-006-01-CPPB) and the National Human Genome Research Institute (U01HG006492)

Pursuant to a new phase of Profile, initiated by Dana-Farber in 2013, a more advanced technology platform (called “OncoPanel“) utilizes “massively parallel” or “next-generation” sequencing to read the genetic code of approximately 300 genes in each patient’s tumor sample. “Massively parallel” refers to the technology’s capacity for sequencing large numbers of genes simultaneously. The 300 genes evaluated in connection with the OncoPanel were chosen because they have been implicated in a variety of cancers.

In addition to the complete DNA sequencing of more than 300 genomic regions to detect known and unknown cancer-related mutations, the OncoPanel technology can also examine those regions for gains and losses of DNA sequences and rearrangements of DNA on chromosomes. The results are entered into a database for research purposes, but, if a patient agrees, the clinically important findings can also be returned to their doctor for use in the clinic.

The OncoPanel advanced sequencing platform is an important update to Dana-Farber’s original OncoMap platform. OncoPanel can detect not only commonly known gene mutations, but also other critical types of cancer-related DNA alterations not previously identified. In contrast, OncoMap was limited to screening for known cancer-related gene mutations. The OncoPanel testing is done at the Center for Advanced Molecular Diagnostics, a CLIA-certified laboratory operated by the Department of Pathology at Brigham and Women’s Hospital.

References:

1./ Gray SW, et al. Original Reports – Health Services and OutcomesPhysicians’ Attitudes About Multiplex Tumor Genomic TestingJ. Clin. Oncol., published online before print on March 24, 2014, doi:10.1200/JCO.2013.52.4298.

2./ Hall MJ. Conflicted Confidence: Academic Oncologists’ Views on Multiplex Tumor Genomic Testing. J. Clin. Oncol. Editorial, published online before print March 24, 2014, doi:10.1200/JCO.2013.54.8016

 

U.S. President Barack Obama Proclaims September 2011 As National Ovarian Cancer Awareness Month — What Should You Know?

Today, U.S. President Barack Obama designated September 2010 as National Ovarian Cancer Awareness Month. During National Ovarian Cancer Awareness Month, Libby’s H*O*P*E*™ will honor the women who have lost their lives to the disease, support those who are currently battling the disease, and celebrate with those who have beaten the disease. 

Today, U.S. President Barack Obama designated September 2010 as National Ovarian Cancer Awareness Month. During National Ovarian Cancer Awareness Month, Libby’s H*O*P*E*™ will honor the women who have lost their lives to the disease, support those who are currently battling the disease, and celebrate with those who have beaten the disease. This month, medical doctors, research scientists, and ovarian cancer advocates renew their commitment to develop a reliable early screening test, improve current treatments, discover new groundbreaking therapies, and ultimately, defeat the most lethal gynecologic cancer.

Let us begin this month with several important facts relating to ovarian cancer. Please take time to review these facts — they may save your life or that of a loved one.

Ovarian Cancer Facts

  • Ovarian cancer causes more deaths than any other cancer of the female reproductive system.
  • In 2011, the American Cancer Society (ACS) estimates that there will be approximately 21,990 new ovarian cancer cases diagnosed in the U.S. ACS estimates that 15,460 U.S. women will die from the disease, or about 42 women per day or 1 women every 30 minutes.
  • Ovarian cancer is not a “silent” disease; it is a “subtle” disease. Recent studies indicate that women with ovarian cancer are more like to experience four persistent, nonspecific symptoms as compared with women in the general population, such as (i) bloating, (ii) pelvic or abdominal pain, (iii) difficulty eating or feeling full quickly, or (iv) urinary urgency or frequency. Women who experience such symptoms daily for more than a few weeks should seek prompt medical evaluation.
  • Several other symptoms have been commonly reported by women with ovarian cancer. These symptoms include fatigue, indigestion, back pain, pain with intercourse, constipation and menstrual irregularities. However, these other symptoms are not as useful in identifying ovarian cancer because they are also found in equal frequency in women in the general population who do not have the disease.
  • Pregnancy and the long-term use of oral contraceptives reduce the risk of developing ovarian cancer.
  • Women who have had breast cancer, or who have a family history of breast cancer or ovarian cancer may have increased risk. Inherited mutations in the BRCA1 or BRCA2 gene increase a woman’s lifetime risk of breast and ovarian cancer. Women of Ashkenazi (Eastern European) Jewish ancestry are at higher risk (1 out of 40) for inherited BRCA gene mutations.
  • There is no reliable screening test for the detection of early stage ovarian cancer. Pelvic examination only occasionally detects ovarian cancer, generally when the disease is advanced. A Pap smear cannot detect ovarian cancer. However, the combination of a thorough pelvic exam, transvaginal ultrasound, and a blood test for the tumor marker CA-125 may be offered to women who are at high risk of ovarian cancer and to women who have persistent, unexplained symptoms like those listed above.
  • If diagnosed at the localized stage, the 5-year ovarian cancer survival rate is 92%; however, only about 19% of all cases are detected at this stage, usually fortuitously during another medical procedure.
  • The 10-year relative survival rate for all disease stages combined is only 38%.

Help Spread the Word To “B-E-A-T” Ovarian Cancer 

Please help us “B-E-A-T” ovarian cancer by spreading the word about the early warning signs & symptoms of the disease throughout the month of September.

B = bloating that is persistent and does not come and go

E = eating less and feeling fuller

A =abdominal or pelvic pain

T = trouble with urination (urgency or frequency)

Women who have these symptoms almost daily for more than a few weeks should see their doctor. Prompt medical evaluation may lead to detection at the earliest possible stage of the disease. Early stage diagnosis is associated with an improved prognosis.

Presidential Proclamation–National Ovarian Cancer Awareness Month

The White House

Office of the Press Secretary

For Immediate Release September 01, 2011

Presidential Proclamation–National Ovarian Cancer Awareness Month

NATIONAL OVARIAN CANCER AWARENESS MONTH, 2011

BY THE PRESIDENT OF THE UNITED STATES OF AMERICA

A PROCLAMATION

Ovarian cancer continues to have one of the highest mortality rates of any cancer, and it is a leading cause of cancer deaths among women in the United States. This month, we remember the mothers, sisters, and daughters we have lost to ovarian cancer, and we extend our support to those living with this disease. We also reaffirm our commitment to raising awareness about ovarian cancer, and to advancing our screening and treatment capabilities for the thousands of American women who will be diagnosed this year.

Ovarian cancer touches women of all backgrounds and ages. Because of a lack of early symptoms and effective screening tests, ovarian cancer is often not detected in time for successful interventions. It is crucial that women know how to recognize the warning signs of gynecological cancers and can detect the disease as early as possible. I encourage all women to learn about risk factors, including family history, and to discuss possible symptoms, including abdominal pain, with their doctor. Now, because of the Affordable Care Act, a wide range of preventive screenings are available to women without any copayments, deductibles, or coinsurance.

My Administration is committed to supporting the women, families, and professionals working to end this disease. The Centers for Disease Control and Prevention and the Department of Health and Human Services have started a campaign to educate women on cancers affecting reproductive organs. The National Cancer Institute is researching new ways to detect ovarian cancer, publishing a comprehensive study of the most aggressive types of ovarian cancer, and conducting clinical trials for new combinations of therapy. And this year, agencies across the Federal Government, from the National Institutes of Health to the Department of Defense, have committed to supporting ovarian cancer prevention and treatment research.

So many lives have been touched by ovarian cancer — from the women who fight this disease, to the families who join their loved ones in fighting their battle. In the memory of all the brave women who have lost their lives to ovarian cancer, and in support of generations of women to come, let us recommit to reaching a safer, healthier future for all our citizens.

NOW, THEREFORE, I, BARACK OBAMA, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim September 2011 as National Ovarian Cancer Awareness Month. I call upon citizens, government agencies, organizations, health-care providers, and research institutions to raise ovarian cancer awareness and continue helping Americans live longer, healthier lives. And I urge women across the country to talk to their health-care providers and learn more about this disease.

IN WITNESS WHEREOF, I have hereunto set my hand this first day of September, in the year of our Lord two thousand eleven, and of the Independence of the United States of America the two hundred and thirty-sixth.

BARACK OBAMA

Sources:

  • Presidential Proclamation–National Ovarian Cancer Awareness Month 2011, issued September 1, 2011.
  • Ovarian Cancer Symptoms Consensus Statement, Originating Organizations — Gynecologic Cancer Foundation, Society of Gynecologic Oncology & American Cancer Society, January – April, 2007.


PBS Documentary, “The Whisper: The Silent Crisis of Ovarian Cancer.”

To raise ovarian cancer awareness, Long Island’s Public Broadcasting Service (PBS) affiliate WLIW-Channel 21 will present the exclusive New York metro area premiere of a half-hour television documentary entitled, “The Whisper: the silent crisis of ovarian cancer.” The program will debut at 7 P.M. (EDT) on Friday, September 24 in the New York metro area, and will be rolled out to other PBS affiliates across the country over the next 12 months.

More than 13,000 women this year will be struck down by ovarian cancer, which is the most lethal gynecologic cancer. Ovarian cancer statistics are staggering; nearly three out of every four women with this disease will die because of it. Chances of survival can improve if it is detected early and confined to the ovaries. Unfortunately, only about 25 percent of women are diagnosed with early stage disease because there is no reliable early stage screening test available. Victims of ovarian cancer include President Obama’s mother Ann Soetoro, Coretta Scott King and comedienne Gilda Radner.

To raise awareness of this devastating disease, Long Island’s Public Broadcasting Service (PBS) affiliate WLIW-Channel 21 will present the exclusive New York metro area premiere of a half-hour television documentary entitled, The Whisper: The Silent Crisis of Ovarian Cancer.  A preview trailer of the documentary is provided below.

The Whisper:  the silent crisis of ovarian cancer — PBS Documentary

The program will debut at 7 P.M. (EDT) on Friday, September 24, with encore presentations scheduled for 10:30 P.M. on Monday, September 27, and 11:30 P.M. on Friday, October 1. The program will be rolled out to other PBS affiliates across the country over the next 12 months.

The documentary was made possible by a generous grant from the Sonia L. Totino Foundation and the Rocco Totino family. Mr. Totino, a New York resident, lost his wife Sonia to ovarian cancer several years ago, and wished to honor her with an initiative that seeks to raise awareness among women of the warning signs of ovarian cancer, and by doing so, reduce the number of women lost to this devastating disease.

Sharon Blynn is the founder of Bald is Beautiful & the host of “The Whisper: the silent crisis of ovarian cancer” (a PBS documentary)

The host featured in the documentary is Sharon Blynn, who is an ovarian cancer survivor and the founder of the Bald Is Beautiful campaign. Through this campaign, Sharon wants to send a message to women that they can “flip the script” on the many traumatic aspects of the cancer experience, and embrace every part of their journey with self-love, empowerment, and a deep knowing that their beauty and femininity radiate from within and are not diminished in any way by the effects of having cancer.  As an “actorvist,” Sharon communicates the Bald Is Beautiful message through acting, writing, modeling and spokesperson appearances, and she continues to do patient outreach through one-on-one correspondence via her website, hospital visitations, being a chemo buddy and other such activities.

Other Bald Is Beautiful highlights include an international print campaign for the Kenneth Cole “We All Walk in Different Shoes” campaign, an international print and TV campaign for Bristol-Myers Squibb, appearances in “Sex and the City” and a principal role in Seal’s music video “Love’s Divine.” She has been featured in magazine and newspaper articles in Glamour, Vogue, Marie Claire (US & Italia), Organic Style, BUST, the Miami Herald and other publications. Sharon has also performed onstage as part of the “Off the Muff” collective, and she was commissioned to write and perform her one-woman theatrical piece “How Are We Feeling Today?” which saw its world premiere in Los Angeles and was presented in New York City. A QuickTime video compilation of Sharon’s past projects can be viewed here.

Blynn was awarded the prestigious 2010 Lilly Tartikoff/Entertainment Industry Foundation Hope Award at the 2010 National Coalition for Cancer SurvivorshipRays of Hope Gala” held in Washington, D.C. Sharon has also been selected to be part of Lifetime Television Network’s Every Woman Counts “Remarkable Women” campaign, and will appear in a 30-second spot that will run the week of Sept 17–23, 2010.

The nationally-renowned ovarian cancer experts featured in the documentary include:

Barbara A. Goff, M.D., Professor, Gynecologic Oncology, University of Washington School of Medicine. Dr. Goff is the principal investigator responsible for critical ovarian cancer research which revealed that ovarian cancer is generally accompanied by four primary warning signs or symptoms — bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, and urinary symptoms (urgency or frequency).  Goff’s research became the foundation for the Ovarian Cancer Symptoms Consensus Statement, which was sponsored and co-authored by the American Cancer Society, Gynecologic Cancer Foundation, and Society of Gynecologic Oncologists in July 2007.

Beth Y. Karlan, M.D., Board of Governors Endowed Chair, Director, Women’s Cancer Research Institute and Division of Gynecologic Oncology, Cedars-Sinai Medical Center; Professor, Obstetrics and Gynecology, David Geffen School of Medicine ,University of California, Los Angeles (UCLA). Dr. Karlan is a world-renowned expert in the field of gynecologic oncology, specifically ovarian cancer surgery, early detection, targeted therapies and inherited cancer susceptibility. She is a past-president of the Society of Gynecologic Oncologists, the Editor-in-Chief of Gynecologic Oncology, and has held many international leadership positions.  She is committed to both scientific advancement and enhancing public awareness about gynecologic cancers.

John Lovecchio, M.D., Chief of Gynecologic Oncology, North Shore-Long Island Jewish Health System; Leader of the North Shore-LIJ Cancer Institute; Professor of Obstetrics and Gynecology, the New York University School of Medicine.  Dr. Lovecchio’s major areas of research are in uterine and ovarian cancers, and he holds administrative and leadership positions in regional and national professional organizations and has published extensively in peer-reviewed journals. Lovecchio is widely regarded as a leading physician-surgeon and has received numerous awards in recognition of his academic and professional achievements.  In the documentary, Dr. Lovecchio offers his insight on ways to combat this deadly form of cancer. He is also credited as the technical advisor for the documentary.

Maurie Markman, M.D., Vice President of Patient Oncology Services & National Director of Medical Oncology, Cancer Treatment Centers of America.  For more than 20 years, Dr. Markman has been engaged in clinical research in the area of gynecologic malignancies, with a particular focus on new drug development and exploring novel management strategies in female pelvic cancers.  Dr. Markman’s many accomplishments include serving as Editor-In-Chief for the Current Oncology Reports journal and Oncology (Karger Publishers) journal, and serves as Chairman of the Medical Oncology Committee of the national Gynecologic Oncology Group.  In addition, Dr. Markman has served on numerous editorial boards, including the Journal of Clinical Oncology and Gynecologic Oncology.  Dr. Markman has been the primary author, or co-author, on more than 1,000 published peer-reviewed manuscripts, reviews, book chapters, editorials or abstracts, and he has edited or co-edited 14 books on various topics in the management of malignant disease, including Atlas of Oncology and the most recent edition of Principles and Practice of Gynecologic Oncology.

“Taking part in this program was a labor of love and concern for my patients,” said Dr. Lovecchio, who is based at North Shore University Hospital in Manhasset. “I wanted to make sure that women are getting the right information, and are aware of the signs and symptoms of ovarian cancer. They must be alert to their own bodies and recognize that abdominal bloating, abdominal pain, pelvic pain, urinary symptoms, difficulty in eating, and feeling full quickly may not be the norm.”

“I wanted to make sure that women are getting the right information, and are aware of the signs and symptoms of ovarian cancer. They must be alert to their own bodies and recognize that abdominal bloating, abdominal pain, pelvic pain, urinary symptoms, difficulty in eating, and feeling full quickly may not be the norm.”

— John Lovecchio, M.D., Chief of Gynecologic Oncology, North Shore-Long Island Jewish Health System

“Women should seek the advice of experts trained in this field and not think that they are being alarmists. Other medical experts and patients interviewed in this documentary are all seeking the same outcome — to make every woman aware of her own body and to encourage every woman to seek help if she feels that something is not quite right,” said Dr. Lovecchio, who was interviewed for the documentary along with Drs. Goff, Karlan, and Markman.

Source:  PBS Documentary on Ovarian Cancer, News Release, North Shore-Long Island Jewish Health System, September 9, 2010.

“Smile, Open Your Eyes, Love and Go On.”

Today marks the 2nd anniversary of Libby’s death from ovarian cancer at the age of 26. Although the family healing process continues, we celebrate Libby’s life formally on this day to honor her memory, and remind ourselves that life is precious and should not be taken for granted.

Today marks the 2nd anniversary of Libby’s death from ovarian cancer at the age of 26. Although the family healing process continues, we celebrate Libby’s life formally on this day to honor her memory, and remind ourselves that life is precious and should not be taken for granted.  This day also reminds us that there is a considerable amount of work yet to be done in raising ovarian cancer awareness and finding a reliable screening test, and ultimately a cure, for this unforgiving disease.

As reported by the American Cancer Society earlier this month, the estimated number of newly diagnosed ovarian cancer cases and related deaths in the U.S. during 2010 will be 21,880 and 13,850, respectively.  Simply stated, a U.S. woman will die every 38 minutes from ovarian cancer in 2010. Cancer Research U.K. also reported this month that the 10-year ovarian cancer survival rate nearly doubled since the 1970s. Unfortunately, this much heralded statistical “doubling” represents an increase of the long-term ovarian cancer survival rate from 18% to only 35%. Ovarian cancer still remains the most lethal gynecologic cancer in women. I know that if Libby were alive today, she would say, “we must do better.”

Although the vast majority of visitors to this website never knew Libby, it is because of her that Libby’s H*O*P*E*™ was created and shared with the general public. What began as a family website used to exchange ovarian cancer and cancer-related information within the family during Libby’s illness, has rapidly become a global information resource for ovarian cancer survivors and their families after her death. It is my greatest hope that Libby would be proud of the following accomplishments achieved over the past two years, which are dedicated to her memory:

  • Created Libby’s H*O*P*E*™ mission statement to be carried out by a future nonprofit, tax-exempt organization.
  • Generated approximately 145,000 website visitors, from 60 countries around the world.
  • Generated 5% to 10% of daily website visitors from major U.S. and international cancer centers and elite academic institutions actively engaged in cancer research.
  • Established a website library containing over 500 videos relating to ovarian cancer and cancer-related topics.
  • Responded to approximately 700 ovarian cancer survivor (and family) general informational inquiries, which were answered within 96 hours of website posting or email receipt.
  • Created Vox Populi website article features which provide the general public with a better understanding of how ovarian cancer impacts the daily life of a woman diagnosed with the disease and her family. These stories have been well-received by our readers as a source of inspiration and hope.
  • Highlighted in the Eyes on Advocacy section of the 2010 University of Washington Tumor Vaccine Group (UWTVG) quarterly (Winter) newsletter entitled, TVG Focus. The UWTVG is headed by Mary L. (Nora) Disis, M.D., a Professor of Medicine and Adjunct Professor of Pathology and Obstetrics & Gynecology at the University of Washington, and a Member of the Fred Hutchinson Cancer Research Center. Dr. Disis is a world-renowned cancer immunologist.
  • Established a new working relationship with Women’s Oncology Research & Dialogue (WORD), a non-profit, tax-exempt organization dedicated to raising gynecological cancer awareness.  To promote this new relationship, WORD recently shot a video of Paul Cacciatore, the Libby’s H*O*P*E* founder.  In the video, Paul addresses the genesis of the website, the Libby’s H*O*P*E* mission statement, and why it is important for all women to educate themselves about the early warning signs of ovarian cancer.  WORD will be launching a new website before the end of 2010, and it is anticipated that this video will appear on both the WORD and Libby’s H*O*P*E* websites at that time.

“Remember Me”

Based upon instructions from Her Majesty Queen Elizabeth II (“Her Majesty”), a poem entitled, She Is Gone, was recited at the Queen Mother’s funeral, which was held in Westminster Abbey on April 9, 2002. The poem recitation sparked a glut of media interest because of its simple, upbeat nature – and mystery author, who was credited in the service program as “Anon” [i.e., Anonymous].  Apparently, Her Majesty found the poem while leafing through old memorial service books and she chose it to be read at her mother’s funeral, where it struck a chord with millions of mourners.

After the conclusion of the Queen Mother’s funeral, the BBC, The Times, and other U.K. media outlets took great effort to identify the author, with attributions going to, among others, Immanuel Kant and Joyce Grenfell. Eventually, it was discovered that the true author was Mr. David Harkins, who wrote the poem in 1981 while working at a bakery.  Mr. Harkins, who now works as an artist selling paintings over the Internet, said he “couldn’t believe his eyes” when he saw his poetry published in several newspapers after the funeral.

Quite shocked by all of the media attention, David Harkins sent the original manuscript of the poem to Prince Charles (of Wales), and St. James’s Palace replied thanking Mr. Harkins for explaining its origin. As it turned out, the poem was originally written by David Harkins in homage to an unrequited love. Mr. Harkins recalled: “I was 23 when I first met Anne Lloyd, my inspiration for the poem I called Remember Me.”  The reply received by David Harkins from the Prince of Wales’s office stated: “I have no doubt that it [Remember Me] will be reproduced on many occasions over the years to come. The Prince of Wales has asked me to send you his very best wishes.”

I chose to include Remember Me as part of our tribute to Libby for two reasons.  First, the poem is instructive as to how Libby would want all of us to continue on with our lives, energized by our loving memories of her.  Second, Libby would no doubt find great joy and humor in the fact that a talented baker from a small U.K. town became famous worldwide for his literary prowess rather than his pastries. The full text of Remember Me is provided below.

Remember Me

You can shed tears that she is gone

Or you can smile because she has lived

You can close your eyes and pray that she will come back

Or you can open your eyes and see all that she has left

Your heart can be empty because you can’t see her

Or you can be full of the love that you shared

You can turn your back on tomorrow and live yesterday

Or you can be happy for tomorrow because of yesterday

You can remember her and only that she is gone

Or you can cherish her memory and let it live on

You can cry and close your mind, be empty and turn your back

Or you can do what she would want: smile, open your eyes, love and go on.

— written by David Harkins, Silloth, Cumbria, U.K. (1981)

Did You Ever Hear An Angel Sing?

The inspirational story of Rhema Marvanne provides further proof that it is possible to “smile, open your eyes, love and go on,” after the death of a family member from ovarian cancer. It is difficult to believe that the life lesson highlighted by this touching story is provided to us through the example of a 7-year old child, albeit it a very talented one.

Rhema Marvanne was born on September 15, 2002.  Rhema lives with her father Teton Voraritskul, and a family pet dog named, “Mojo.” According to her father, Rhema began singing at the same time she began talking.

Rhema’s mother, Wendi Marvanne Voraritskul, loved Rhema with all of her heart. Wendi was diagnosed with ovarian cancer when Rhema was just 3 years old. Succumbing to the disease three years later, Wendi Marvanne died at the age of 36 on November 8, 2008.  According to Teton Voraritskul, most of Rhema’s memories with her mom were pleasant ones, but revolved around surgery, multiple chemotherapy treatments, sickness and struggle. Wendi was a strong believer in God and never complained about or questioned God during her illness. Teton explains that Wendi always encouraged those around her, even in the midst of her cancer battle. During Wendi’s final months, Rhema and Teton took care of her. Rhema spent almost every hour with her mother. When asked what her greatest accomplishment was prior to her death, Wendi simply replied, “Rhema.” A YouTube video featuring Wendi and her original songs is provided below. You can learn more about Wendi Marvanne’s life and music at www.jchouseofmercy.org.

It was less than a year ago that Rhema recorded her first song, Amazing Grace, and quickly became an Internet singing sensation. She obtains great inspiration from her mother, Wendi.  It is Rhema’s greatest hope to make her mother proud, both as a singer and as a “servant of God,” which is why she also performs for church congregations, non-profit organizations, charities, hospitals and special events.

Already a supremely talented singer, recording artist, and actor, Rhema counts the following among her recent accomplishments:

  • Acted in 1st featured film entitled Machine Gun Preacher, a Lionsgate production set to release in Fall 2011. The movie Machine Gun Preacher is based upon the true story of Sam Childers (portrayed by well-known actor Gerard Butler), a drug-dealing biker who finds religion and dedicates his life to helping Sudanese children escape the Lord’s Resistance Army (LRA) in Africa. Childers founded the Angels of East Africa, a children’s village located in southern Sudan, for the children he saves from the LRA.

During her free time Rhema enjoys playing with her friends and dolls, and loves to watch movies. The best description of Rhema is provided by her father:

…The best way to describe Rhema is that she has a beautiful heart and soul. She is sweet, kind, caring and most importantly pure in heart. Most people who have dealt with or are currently dealing with cancer, disease, challenges, etc…..see hope and inspiration in Rhema. The little girl who should have been scared or harmed by seeing her mother suffer and gone, is strong and perfect. I see Rhema as a cancer survivor. She gives me hope for goodness in mankind. God gave her a beautiful heart and the voice of an angel. Most people that hear her sing can not deny that God does speak through a child. Her voice touches people’s hearts.

Whenever we remember Libby, or any woman who lost her battle to ovarian cancer, we should follow Rhema’s example and heed the call to action set forth in the last line of the poem Remember Me, ” … smile, open your eyes, love and go on.”

Libby, we will always love you and keep your memory alive in our hearts and minds.

How Can You Help?

To support Libby’s H*O*P*E*™, you can make a donation ($10 minimum) through our Facebook Cause page.  All donations made to the Libby’s H*O*P*E*™ Facebook cause are designated for the benefit of the Ovarian Cancer Research Fund (OCRF). OCRF is one of the largest U.S. private, non-profit organizations dedicated to finding an early detection test, and ultimately a cure, for ovarian cancer.

If you are not a Facebook member, you can still make a donation through the Libby’s H*O*P*E*™ Facebook donation page (no membership or registration required).

If you are unable to donate, you can nevertheless support OCRF without any out-of-pocket cost by clicking on our “SocialVibe” widget that appears on the website homepage right sidebar, or by using our designated SocialVibe website. For each reader that clicks on the SocialVibe widget (or goes to our designated SocialVibe website), and watches the video presented and/or answers the question(s) listed, our current SocialVibe sponsor will donate money to OCRF on your behalf for ovarian cancer research. It’s fast & it’s free!

Special Thanks:

We would like to extend special thanks to Teton Voraritskul for allowing us to feature Rhema’s story and music videos, as well as the video of Wendi’s life.  To learn more about Rhema Marvanne and her music, go to www.RhemaMarvanne.com. Rhema’s songs are sold on iTunes®, Amazon.com, and RhemaMarvanne.com.

Sources:

  • Jemal A., Siegel R., Xu J. et. al. Cancer Statistics, 2010.  CA Cancer J Clin. 2010 Jul 7. [Epub ahead of print] [PMID: 20610543].
  • Remember Me, written by David Harkins, Silloth, Cumbria, U.K., PoeticExpressions.co.uk.

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*“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 writings and 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 video 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 writings and visual media suitable for publication as Vox Populi features.

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

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. alA 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.

Young Early-Stage Ovarian Cancer Patients Can Preserve Fertility

A new study finds that young women with early-stage ovarian cancer can preserve future fertility by keeping at least one ovary or the uterus without increasing the risk of dying from the disease. The study is published in the September 15, 2009 issue of CANCER, a peer-reviewed journal of the American Cancer Society.

A new study finds that young women with early-stage ovarian cancer can preserve future fertility by keeping at least one ovary or the uterus without increasing the risk of dying from the disease. The study is published in the September 15, 2009 issue of CANCER, a peer-reviewed journal of the American Cancer Society.

fertility

... “Given the potential reproductive and nonreproductive benefits of ovarian and uterine preservation, the benefits of conservative surgical management should be considered in young women with ovarian cancer” ...

Most cases of ovarian cancer are diagnosed at later stages and in older women. However, up to 17 percent of ovarian tumors occur in women 40 years of age or younger, many of whom have early stage disease. Surgery for ovarian cancer usually involves complete removal of the uterus (hysterectomy) and ovaries, which not only results in the loss of fertility, but also subjects young women to the long-term consequences of estrogen deprivation.

Jason Wright

Jason Wright, M.D., Assistant Professor, OB/GYN, Columbia University College of Physicians & Surgeons, New York City, NY

Researchers led by Jason Wright, M.D., of Columbia University College of Physicians and Surgeons in New York City conducted a study to examine the safety of fertility-conserving surgery in premenopausal women with ovarian cancer. This type of surgery conserves at least one ovary or the uterus.

The investigators analyzed data from women 50 years of age or younger who were diagnosed with early stage (stage I) ovarian cancer between 1988 and 2004 and who were registered in the National Cancer Institute’s Surveillance, Epidemiology and End Results database, a population-based cancer registry that includes approximately 26 percent of the US population. Patients who had both of their ovaries removed were compared with those who had only the cancerous ovary removed. A second analysis examined uterine conservation verus hysterectomy.

For their first analysis, the researchers identified 1,186 ovarian cancer patients. While most had both ovaries removed, about one in three (36 percent) had one ovary conserved. They found those in whom one ovary was saved had similar survival for up to at least five years.

To examine the effect of uterine preservation, the investigators studied a total of 2,911 women. While most of the women underwent hysterectomy, about one in four (23 percent) had uterine preservation. Uterine preservation also had no effect on survival.

Women who were younger, who were diagnosed in more recent years, and who resided in the eastern or western United States were more likely to undergo ovarian or uterine conservation.

These results are promising for the many young women who are diagnosed with ovarian cancer each year. An estimated 21,650 women in the United States were diagnosed with the disease in 2008. “Given the potential reproductive and nonreproductive benefits of ovarian and uterine preservation, the benefits of conservative surgical management should be considered in young women with ovarian cancer,” the authors concluded.

Source:  Wright JD, Shah M, Mathew L, et. al.  Fertility preservation in young women with epithelial ovarian cancer. CANCER; Published Online: August 10, 2009 (DOI: 10.1002/cncr.24461); Print Issue Date: September 15, 2009.

Comment: The key to this study is the concept that fertility preservation “should be considered in young women with ovarian cancer.”  As part of this consideration, the patient’s subtype of ovarian cancer may play an important role as well.  For example, a diagnosis of ovarian clear cell adenocarcinoma (OCCA) in a young adult woman should create a moment of pause in regard to fertility-sparing. The OCCA subtype of epithelial ovarian cancer can be extremely chemoresistant (even during first-line treatment), especially if the tumor histology indicates that the tumor possesses a dominant clear cell component or is a pure form of OCCA.  In addition, OCCA is a rare form of epithelial ovarian cancer in women worldwide (with the exception of Japanese foreign nationals). My hypothetical does not mean that fertility sparing should not be considered in the event of a OCCA diagnosis, it simply means that each woman should carefully discuss fertility-sparing with her board-certified gynecologic oncologist based upon the specific facts of her case, including tumor histology.

New Study Shows Four-Year Window for Early Detection of Ovarian Cancer

A new study by Howard Hughes Medical Institute researchers shows that most early stage ovarian tumors exist for years at a size that is a thousand times smaller than existing tests can detect reliably.  But the researchers say their findings also point to new opportunities for detecting ovarian cancer—a roughly four-year window during which most tumors are big enough to be seen with a microscope, but have not yet spread.

Tiny Early-Stage Ovarian Tumors Define Early Detection Challenge

Currently available tests detect ovarian cancer when it is about the size of the onion in the photograph. To reduce ovarian cancer mortality by 50 percent, an early detection test would need to be able to reliably detect tumors the size of the peppercorn. (Photo Source:  Patrick O. Brown, Howard Hughes Medical Institute Investigator, Research News Release, July 28, 2009)

Currently available tests detect ovarian cancer when it is about the size of the onion in the photograph. To reduce ovarian cancer mortality by 50 percent, an early detection test would need to be able to reliably detect tumors the size of the peppercorn. (Photo Source: Patrick O. Brown, Howard Hughes Medical Institute Investigator, Research News Release, July 28, 2009)

A new study by Howard Hughes Medical Institute researchers shows that most early stage ovarian tumors exist for years at a size that is a thousand times smaller than existing tests can detect reliably.

But the researchers say their findings also point to new opportunities for detecting ovarian cancer—a roughly four-year window during which most tumors are big enough to be seen with a microscope, but have not yet spread.

“Our work provides a picture of the early events in the life of an ovarian tumor, before the patient knows it’s there,” says Howard Hughes Medical Institute researcher Patrick O. Brown. “It shows that there is a long window of opportunity for potentially life-saving early detection of this disease, but that the tumor spreads while it is still much too small to be detected by any of the tests that have been developed or proposed to date.”

According to the American Cancer Society, some 15,000 women in the United States and 140,000 women worldwide die from ovarian cancer each year. The vast majority of these deaths are from cancers of the serous type, which are usually discovered only after the cancer has spread.

“Instead of typically detecting these cancers at a very advanced stage, detecting them at an early stage would be enormous in terms of saving lives,” says Brown, who is at Stanford University School of Medicine. Early detection would enable surgeons to remove a tumor before it spreads, he adds.

The article—co-authored by Chana Palmer of the Canary Foundation, a nonprofit organization focused on early cancer detection—was published July 28, 2009, in the open access journal PLoS Medicine.

“Like almost everything with cancer … the more closely you look at the problem, the harder it looks,” Brown says. “That’s not to say that I don’t believe it’s a solvable problem. It’s just a difficult one.” — Patrick O. Brown, M.D. Ph.D.

Patrick O. Brown, M.D. Ph.D., Howard Hughes Medical Institute Investigator, Stanford University School of Medicine

Patrick O. Brown, M.D. Ph.D., Howard Hughes Medical Institute Investigator, Stanford Univ. School of Medicine

“Like almost everything with cancer … the more closely you look at the problem, the harder it looks,” Brown says. “That’s not to say that I don’t believe it’s a solvable problem. It’s just a difficult one.”

In the quest to develop early detection methods for ovarian cancer, Brown says, science hasn’t had a firm grasp on its target. So he and Palmer took advantage of published data on ovarian tumors to generate a better understanding of how the cancer progresses in its earliest stages.

The team analyzed data on serous-type ovarian tumors that were discovered when apparently healthy women at high genetic [BRCA1 gene mutation] risk for ovarian cancer had their ovaries and fallopian tubes removed prophylactically. Most of the tumors were microscopic in size; they were not detected when the excised tissue was examined with the naked eye.

The analysis uncovered a wealth of unexplored information. Thirty-seven of the early tumors had been precisely measured when they were excised – providing new details about the size of the tumors when they were developing prior to intervention, Brown says. By extrapolating from this “occult” size distribution to the size distribution of larger, clinically evident tumors, the researchers were able to develop a model of how the tumors grew and progressed. “We are essentially trying to build a story for how these tumors progress that fits the data,” Brown explains.

Among the study’s findings:

  • Serous ovarian tumors exist for at least four years before they spread.
  • The typical serous cancer is less than three millimeters across for 90 percent of this “window of opportunity for early detection.”
  • These early tumors are twice as likely to be in the fallopian tubes as in the ovaries.
  • To cut mortality from this cancer in half, an annual early-detection test would need to detect tumors five millimeters in diameter or less – about the size of a black peppercorn and less than a thousandth the size at which these cancers are typically detected today.

Brown’s lab is now looking for ways to take advantage of that window of opportunity to detect the microscopic tumors and intervene before the cancer spreads.

One strategy the laboratory is pursuing is to examine tissues near the ovaries, in the female reproductive tract, for protein or other molecular markers that could signify the presence of cancer. Brown says answering another question might also prove helpful: whether there is any reliable flow of material from the ovaries and fallopian tubes through the uterus and cervix into the vagina—material that might be tested for a specific cancer marker.

Despite science’s broad understanding of cancer at a molecular level, it has been challenging to identify simple molecular markers that signal the presence of early disease. One current blood marker, CA-125, has proven useful in monitoring later-stage ovarian cancer, but it has not been helpful for early detection. So Brown’s lab is also looking for biomarkers that are present only in ovarian tumors and not in healthy cells, instead of relying on tests that look for unusually high levels of a molecule that is part of normal biology (like CA-125).

The researchers are doing extensive sequencing of all messenger RNA molecules (which carry information for the production of specific proteins) in ovarian cancer cells, searching for evidence of proteins in these cells that would never be found in non-cancer cells. These variant molecules could be produced as a result of chromosome rearrangements—when the genome is cut and spliced in unusual ways—in ovarian cancers. “It’s a long shot,” says Brown, “but it’s important enough to try.”

Source: Tiny Early-Stage Ovarian Tumors Define Early Detection Challenge, Research News, Howard Hughes Medical Institute, July 29, 2009 [summarizing Brown PO, Palmer C, 2009 The Preclinical Natural History of Serous Ovarian Cancer: Defining the Target for Early Detection. PLoS Med 6(7): e1000114. doi:10.1371/journal.pmed.1000114].