NBOCC Run/Walk for Her — September 21, 2008

On Sunday, September 21, 2008, the National Breast and Ovarian Cancer Coalition (NBOCC) will conduct its annual 5K Run/3K Walk for Her. This walk is dedicated to those who have lost the battle to breast or ovarian cancer, and celebrates those who continue to fight. The event will start at 8:00 A.M. EDT and is being held at Quiet Waters Park, located in Annapolis, Maryland.

2008 NBOCC Run/Walk for Her

On Sunday, September 21, 2008, the National Breast and Ovarian Cancer Coalition (NBOCC) will conduct its annual 5K Run/3K Walk for Her. This walk is dedicated to those who have lost the battle to breast or ovarian cancer, and celebrates those who continue to fight. Libby’s H*O*P*E*™ would like to thank Paula Kozik (an inspirational ovarian cancer survivor and volunteer organizer of the Run/Walk for Her event) for dedicating her walk in this event to Elizabeth (Libby) Remick.

The event will start at 8:00 A.M. EDT and is being held at Quiet Waters Park, located in Annapolis, Maryland.

  • For online registration, CLICK HERE.
  • For a copy of the 2008 NBOCC Run/Walk for Her brochure, CLICK HERE.
  • The event schedule and additional details are listed below.

8:00 A.M.

Registration- Red Maple Pavilion

NBOCC Run/Walk for HER - Breast & Ovarian Cancer Survivors

NBOCC Run/Walk for HER - Breast & Ovarian Cancer Survivors

On-site registration
Pre-registered walkers/runners
Pick up t-shirt and program

8:30 A.M.

Survivor Hand Banner

8:45 A.M.

Survivor Group Photos

9:00 A.M.

Warm Up, Run/Walk Begins

10:00 A.M.

Closing Ceremonies

Prices:

Quiet Waters Park, Annapolis, Maryland

Quiet Waters Park, Annapolis, Maryland

Adult – $35.00
Child Under 12 – $15.00

Online Registration Closes:

September 18, 2008 at 9:00 P.M.

Website:

http://www.NBOCC.org

About the NBOCC

The National Breast and Ovarian Cancer Coalition (NBOCC) is a growing non-profit organization dedicated to education, awareness and research developments for breast and ovarian cancer. Specifically, the mission of NBOCC is to raise awareness and educate the general public about the link between breast and ovarian cancer.

The founder and executive director of NBOCC is Nikki Karl. Nikki is a lifelong supporter of the fight against breast and ovarian cancer. She established the National Ovarian Cancer Coalition (NOCC) Maryland Chapter in November 2003. However, having lost ten family members to breast and ovarian cancer, she realizes the importance of pairing these two diseases together so that women may understand the potentially life-saving facts regarding hereditary breast and ovarian cancer. NBOCC is dedicated to Nikki’s grandmother, who died of ovarian cancer, and her mother, who is a breast cancer survivor.

Notably, Robert E. Bristow, M.D., is a board member of, and the chief medical advisor to, NBOCC. Dr. Bristow serves as Director of the Kelly Gynecologic Oncology Service Department of Gynecology and Obstetrics at The Johns Hopkins Medical Institutions (Johns Hopkins), as well as the Johns Hopkins Ovarian Cancer Center of Excellence. His primary research interests include radiographic imaging of gynecologic cancers, the surgical management of cancers of the ovary and endometrium, and patterns of health care delivery for women with gynecologic cancer. In addition to having received numerous awards for teaching excellence, Dr. Bristow directs the American Board of Obstetrics and Gynecology approved F. J. Montz Fellowship Training Program in Gynecologic Oncology at the Johns Hopkins Hospital and Greater Baltimore Medical Center. On July 10, 2008, U.S. News & World Report ranked Johns Hopkins as the #1 U.S. hospital (defined by highest scores in at least six medical specialties), #2 U.S. gynecology practice, and #3 U.S. oncology practice.

Presidential Proclamation Begins National Ovarian Cancer Awareness Month, September 2008

“During National Ovarian Cancer Awareness Month, we remember those whose lives have been affected by this deadly disease, and we underscore our commitment to battling ovarian cancer for the sake of women around the world. …”


“For Immediate Release
Office of the Press Secretary
August 26, 2008

National Ovarian Cancer Awareness Month, 2008
A Proclamation by the President of the United States of America

During National Ovarian Cancer Awareness Month, we remember those whose lives have been affected by this deadly disease, and we underscore our commitment to battling ovarian cancer for the sake of women around the world.

Each year, thousands of American women are diagnosed with ovarian cancer. Many will lose their lives to this disease. Because ovarian cancer is often diagnosed at an advanced stage, it is vital for women to make regular visits to their doctors for screenings and to discuss risk factors and warning signs. Early detection is the best way to help doctors diagnose cancer before it has a chance to spread. It also makes treatment more effective and increases the chances for survival. I encourage all women to learn more about preventive measures and screening options that may help to save their lives.

America leads the world in medical research, and my Administration remains dedicated to the fight against ovarian cancer. I signed the “Gynecologic Cancer Education and Awareness Act of 2005,” or “Johanna’s Law,” that helps to raise awareness among women and health care providers about female reproductive cancers. Additionally, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention are conducting important research to help make the innovative advances we need in order to eradicate this disease. NIH’s Cancer Genome Atlas is also helping researchers gain a greater understanding of the genetic sources of cancer. Together, we will continue building on our progress until there is a cure for cancer.

As we observe National Ovarian Cancer Awareness Month, we honor those who have fought this disease. We also recognize the compassionate caregivers, doctors, and researchers who are dedicated to preventing, detecting, and treating ovarian cancer.

NOW, THEREFORE, I, GEORGE W. BUSH, 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 2008 as National Ovarian Cancer Awareness Month. I call upon government officials, businesses, communities, health care professionals, educators, volunteers, and the people of the United States to continue our Nation’s strong commitment to preventing and treating ovarian cancer.

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

GEORGE W. BUSH”

Quoted Source: National Ovarian Cancer Awareness Month, 2008, Proclamations Archive, Office of the Press Secretary, The White House, August 26, 2008

Lost In Translation? FDA Believes That LabCorp’s Ovarian Cancer Early Detection Test (OvaSure) Lacks Adequate Clinical Validation

The U.S. Food and Drug Administration (FDA) sent a letter to the Laboratory Corporation of America (LabCorp) on August 7, 2008, stating that it believes the Yale ovarian cancer early detection test (marketed by LabCorp under the name OvaSure™) ” … has not received adequate clinical validation, and may harm the public health.” In that letter, the FDA invites LabCorp to discuss all validation studies that support the marketing of the OvaSure™ test.

The U.S. Food and Drug Administration (FDA) sent a letter to the Laboratory Corporation of America (LabCorp) on August 7, 2008, stating that it believes the Yale ovarian cancer early detection test (marketed by LabCorp under the name OvaSure™) “… has not received adequate clinical validation, and may harm the public health.” In the letter, the FDA invites LabCorp to discuss all validation studies that support the marketing of the OvaSure™ test. The August 7 FDA letter appears to reflect a previously announced, yet controversial, change in FDA policy. Libby’s H*O*P*E*™ reported previously on the development of the Yale ovarian cancer early detection test [March 14, 2008], and LabCorp’s subsequent market release of that test under the name OvaSure™ [June 23, 2008].

On August 19, 2008, the Oncology STAT™ news service reported that the August 7 FDA letter was posted on the website of the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) on August 15, but was removed from the site a few days later. On August 22, 2008, we identified the “cached” copy of the August 7 FDA letter on the OIVD website. The August 7 FDA letter is provided below in its entirety.

The August 7 FDA letter was issued by OIVD and informs LabCorp that “[i]t appears that you are marketing the Ovasure™ Test with performance characteristics (specifically, 95.3% sensitivity and 99.4% specificity) that are identical to those reported in a research study published by Visintin, I. et al., in the February 15 edition of Clinical Cancer Research (Visintin, I. et al., Clin Cancer Res. 2008 Feb 15;14(4):1065-72.).” The OIVD Director, Steven Gutman, M.D., M.B.A., states that the Visintin, I. et. al ” … research was carried out, and performance derived, on two populations that are strongly clinically biased for being healthy and normal, and for having already experienced ovarian cancer.” Based upon this rationale, the OIVD concludes that it does not believe “… the scientific community would consider the reported study sufficient to establish performance characteristics of a test in high risk women who might have ovarian cancer, i.e., in a clinical setting, as claimed in your intended use and promotional materials.”

Historical FDA Policy Regarding Laboratory-Developed (“Home Brew”) Tests

Based upon historical FDA policy, LapCorp would not be required to obtain FDA premarket or postmarket approval for the OvaSure™ test because the early detection test would be categorized as a “laboratory-developed test” (also referred to as a “home brew” test) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). In general, the CLIA establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test is performed.

Prior to 2006, the FDA did not exercise its authority to regulate home brew tests, which are developed by a laboratory for in-house use as a test service. The reasons are likely twofold. First, the FDA believed that the regulatory oversight exercised by the Centers for Medicare & Medicaid Services (CMS) with respect to the laboratories (under CMS jurisdiction pursuant to CLIA), ensured that such laboratories were competent to properly manufacture and use home brew tests without additional FDA intervention. Second, the FDA possessed regulatory authority to review the primary ingredients or components in the home-brew tests (known as “analyte specific reagents” (ASRs)), and did not believe that further test regulation was necessary.

Announcement of FDA Policy Change For Select In Vitro Diagnostic Assays

In 2006, and again in 2007, the FDA issued draft guidance (entitled, Draft Guidance for Industry, Clinical Laboratories, and FDA Staff: In Vitro Diagnostic Multivariate Index Assays) in which, for the first time, the agency exercised its authority to regulate select in vitro diagnostic multivariate index assays (“IVDMIAs”) that are developed and manufactured by clinical laboratories for their own use (i.e., laboratory-developed tests/home brew tests). An IVDMIA is a diagnostic laboratory assay or test that utilizes mathematical formulae to interpret genetic and protein data required for the generation of information used to make critical diagnosis and treatment decisions for patients. IVDMIAs, for FDA regulatory purposes, are classified as medical devices under the Federal Food, Drug & Cosmetic Act (FDCA), and therefore, can be subject to premarket and postmarket regulation. IVDMIAs developed and manufactured by commercial, non-laboratory-based companies are currently regulated by the FDA. The majority of IVDMIAs, however, are developed and manufactured by laboratories for their own use as home brew tests.

Under the FDA draft guidance, home brew IVDMIAs would in many cases require 510(k) pre-market clearance or Pre-Market Approval (PMA). In addition, these same IVDMIAs would have to comply with “device” post-market manufacturing and reporting requirements. The August 7 FDA letter does not state that a 510(k) pre-market clearance or Pre-Market Approval is required; rather OIVD invites LabCorp to discuss any “validation strategies” undertaken beyond the research results reported by Visintin, I. et. al. LabCorp is not the only company affected by the FDA policy change. The FDA also used its change in regulatory policy to prevent Correlogic Systems, Inc. from marketing its ovarian cancer early detection test, known as OvaCheck®, without prior FDA approval. Arguably, the FDA is placing the OvaSure™ and OvaCheck® ovarian cancer early detection tests on equal regulatory footing.

Ever-Increasing Sophistication of Genetic and Proteomic Assay Technology

The emergence and increased use of IVDMIAs using novel technology (e.g., proteomics) as an integral part of patient diagnosis and treatment, and their direct advertisement to consumers, may have influenced the FDA to conclude more recently that the current level of oversight with respect to genetic and proteomic testing by laboratories was inadequate. Assuming the FDA position is correct, inadequate federal oversight could lead to significant issues related to the quality and validity of IVDMIAs.

LabCorp Amendment of OvaSure™ “Use” Information

LabCorp recently amended its intended use and promotional materials to provide that the OvaSure™ test cannot be used by a woman who has had both ovaries removed (i.e., a woman who previously had a bilateral oophorectomy). Specifically, LabCorp intends that the OvaSure™ test be used to identify a woman who is at “high-risk” for ovarian cancer; however, an ovarian cancer survivor who is currently in remission, cannot use the OvaSure™ test to screen for a recurrence of the disease if her ovaries were removed as part of her first-line treatment after the initial ovarian cancer diagnosis. CLICK HERE to view Libby’s H*O*P*E* post (with updates) dated June 23, 2008, regarding the OvaSure™ test use and limitation information as amended.

Letter to the President and Chief Executive Officer of LabCorp

August 7, 2008
Via FedEx

David P. King
President and Chief Executive Officer
Laboratory Corporation of America
430 South Spring Street
Burlington, North Carolina 27215

Dear Mr. King:

It has come to our attention that you are currently marketing the OvaSure™ Yale Ovarian Cancer Test, also advertised as the OvaSure™ For Women at High-Risk for Ovarian Cancer, and OvaSure™ For Women at High-Risk for Ovarian Cancer, (Serial Monitor), (collectively referred to hereafter as the OvaSure™ Test) which is intended to be used as a tool to identify high-risk women who might have ovarian carcinoma. It appears that you are marketing the OvaSure™ Test with performance characteristics (specifically, 95.3% sensitivity and 99.4% specificity) that are identical to those reported in a research study published by Visintin, I., et al., in the February 15 edition of Clinical Cancer Research (Visintin, I. et al., Clin Cancer Res. 2008 Feb 15;14(4):1065-72.). We note that this research was carried out, and performance derived, on two populations that are strongly clinically biased for being healthy and normal, and for having already experienced ovarian cancer. Based on the available information, we do not believe the scientific community would consider the reported study sufficient to establish performance characteristics of a test in high risk women who might have ovarian cancer, i.e., in a clinical setting, as claimed in your intended use and promotional materials.

Based on our review of your promotional materials and the research publication cited above, we believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health. We would like to discuss with you your offer of this test, and any validation strategies you have undertaken beyond those reported in the publication cited above.

We look forward to discussing this with you, and are committed to working with you as we strive to protect the public health without unnecessarily imposing regulatory burdens on the marketing of products of potential clinical importance.

Sincerely yours,

/S/

Steven I. Gutman, M.D., M.B.A.
Office Director
Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health

Comments:

  • The corporate and governmental intrigue surrounding the FDA regulatory issues with respect to the OvaSure™ and OvaCheck® ovarian cancer early detection tests would make for a thrilling Hollywood screenplay, except for the catastrophic fact that approximately 15,000 U.S. women die annually from ovarian cancer due to the lack of a reliable early detection test. Because of the latter, approximately 80 percent of women are not diagnosed until they are in advance stages of the disease.
  • The FDA’s current – and still evolving – policy signals a strong possibility that previously unregulated diagnostics could require FDA approval or clearance prior to marketing as well as being subject to other medical device requirements under the FDCA.
  • It is critical for the FDA to take whatever action is necessary to protect U.S. public health. It is also essential that ovarian cancer survivors, clinicians and all affected corporate entities receive clear, consistent regulatory guidance and prompt action from the FDA with respect to this potential life-saving matter.

Sources:

Updates:

  • September 9, 2008: The FDA recently reposted on its website, a copy of the August 7th letter to the President and Chief Executive Officer of LabCorp regarding OvaSure™. To view a copy of the letter, CLICK HERE.

Imatinib & Docetaxel Produce Modest Response Against Recurrent Platinum Resistant/Refractory Ovarian Cancer

A combination of imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) produced only a modest response in patients with recurrent, platinum-resistant or refractory ovarian cancer, according to the results of a Phase II clinical trial conducted by the Hoosier Oncology Group at Indiana University Cancer Center.

Background

A combination of imatinib mesylate (Gleevec®) and docetaxel (Taxotere®) produced only a modest response in patients with recurrent, platinumresistant or refractory ovarian cancer, according to the results of a Phase II clinical trial conducted by the Hoosier Oncology Group at Indiana University Cancer Center.

Imatinib mesylate (Imatinib) is an inhibitor of the (i) receptor tyrosine kinases (RTKs) for platelet-derived growth factor (PDGF) and stem cell factor (SCF), and (ii) c-Kit. RTKs are key regulators of normal cellular processes, and may play a critical role in the development and progression of many types of cancer. PDGF is one of the numerous growth factors, or proteins, that regulate cell growth and division. In particular, it plays a significant role in new blood vessel formation (angiogenesis) from existing blood vessels. SCF is a growth factor, or protein, important for the survival, proliferation, and differentiation of hematopoietic stem cells that give rise to all types of blood cells. C-kit is a protein that is expressed on the surface of hematopoietic stem cells as well as other cell types, and binds to stem cell factor (a substance that causes certain types of cells to grow). Docetaxel, a chemotherapy drug, promotes cell growth arrest.

Based upon the foregoing, the trial investigators hypothesized that use of imatinib (in tandem with docetaxel) would inhibit or block the RTKs for PDGF & SCF and the c-kit receptor, and cause tumor disruption by enhancing the effect of chemotherapy while controlling tumor angiogenesis. Also, the combination of imatinib and docetaxel previously produced synergistic effects in-vitro (in the laboratory) and in-vivo (in mice). As a monotherapy, and prior to this trial, docetaxel produced single agent activity in ovarian cancer with response rates of 30% to 40% in the platinum refractory setting.

The Imatinib/Docetaxel Phase II Clinical Trial

Pursuant to trial eligibility criteria, all patients had recurrent, platinum-resistant, or refractory epithelial ovarian cancer that expressed PDGFR or c-kit, as determined by immunohistochemistry. This screening resulted in the enrollment of 23 patients with the following tumor characteristics: 4 patients had c-kit-positive/PDGFR-negative tumors, 11 patients had PDGFR-positive/c-kit-negative tumors, and 8 patients had c-kit-positive/PDGFR-positive tumors. The median patient age was 56 years (ranging from 33 to 76 years). Enrolled patients had received a median of 3 prior lines of treatment.

The overall response rate was 21.7%, which included 1 complete response (CR) and 4 partial responses (PR). An additional 3 patients had stable disease for more than 4 months. The trial investigators determined that the expression of PDGFR and/or c-kit, did not predict response to this combination therapy. The most common adverse events encountered were fatigue (83%), nausea (74%), diarrhea (61%), anorexia (52%), and edema (65%), and the majority of those events were grade 1 or 2 events.

Based upon the foregoing, the trial investigators concluded that the combination treatment of imatinib and docetaxel was tolerated in patients with heavily pretreated epithelial ovarian cancer that expressed c-kit or PDGF, but found that few patients had sustained responses or stable disease, when compared with the 30% to 40% response rate of docetaxel used as a monotherapy in a platinum refractory setting.

Sources:

Patty Franchi Flaherty Loses Battle to Ovarian Cancer, But Deserves a Long Standing Ovation

It is with deep regret that I must inform you that, Patty Franchi Flaherty, founder of the nonprofit organization Ovations for the Cure of Ovarian Cancer, peacefully succumbed to her nine-year battle with the disease on August 18, 2008, surrounded by friends and family. She was 53 years old. Patty was a legendary ovarian cancer advocate, who spoke for ovarian cancer survivors that lacked a voice. Inspired by the death of her mother from ovarian cancer nearly 35 years ago and driven by her personal struggle, she founded the Natick-based nonprofit Ovations for the Cure in 2005. The organization has since comforted countless women and donated over $1 million to various ovarian cancer research programs at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, including the world-renowned Desensitization Program, through fundraising programs such as the annual Stuart Weitzman Fashion Show.

It is with deep regret that I must inform you that, Patty Franchi Flaherty, founder of the nonprofit organization Ovations for the Cure of Ovarian Cancer (Ovations For the Cure), peacefully succumbed to her nine-year battle with the disease on August 18, 2008, surrounded by friends and family. She was 53 years old. Patty was a legendary ovarian cancer advocate, who spoke for ovarian cancer survivors that lacked a voice.

Inspired by the death of her mother from ovarian cancer nearly 35 years ago and driven by her personal struggle, she founded the Natick-based nonprofit Ovations for the Cure in 2005. The organization has since comforted countless women and donated over $1 million to various ovarian cancer research programs at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, including the world-renowned Desensitization Program, through fundraising programs such as the annual Stuart Weitzman Fashion Show.

We provide below a bylined article about Patty Franchi Flaherty that was graciously provided to us by Ovations For the Cure. If you would like to learn more about the warnings signs and symptoms of ovarian cancer, CLICK HERE (Ovarian Cancer Symptoms Consensus Statement (Adobe Reader PDF Document)

“Patty Franchi Flaherty loses battle to ovarian cancer

Patty Franchi Flaherty, Founder of Ovations For the Cure of Ovarian Cancer (February 26, 1955 – August 18, 2008)

Patty Franchi Flaherty, Founder of Ovations For the Cure of Ovarian Cancer (February 26, 1955 – August 18, 2008)

Natick, MA (August 19, 2008) – Patty Franchi Flaherty, Founder and President of Ovations for the Cure, lost her courageous 9-year battle with ovarian cancer and died peacefully at home on August 18, 2008, surrounded by family and friends.

Patty was a native of Weston who graduated from Bentley College in Waltham. Afterward, she joined Natick-based Franchi Management Company, Inc., where she worked as General Manager for over 30 years overseeing all business operations. She was also a long-standing trustee at Boston’s Dana-Farber Cancer Institute.

Diagnosed with ovarian cancer in early 1999, Patty lived 9 years before succumbing to the same disease that took her mother Madeline’s life 25 years earlier. After a promising remission, the cancer resurfaced in 2005. Frustrated by how little ovarian cancer diagnosis and treatment had changed in a quarter-century, Patty was certain that she wasn’t alone in her fight with ovarian cancer or in her frustration over medical insufficiencies. She was determined to help improve the odds for all ovarian cancer patients.

In early 2006, Patty co-hosted the Stuart Weitzman Fashion Show and Luncheon as a fundraiser. Proceeds from the show helped fund the Madeline Franchi Ovarian Cancer Research Fund at the Dana-Farber Cancer Institute. Then, with the help and support of her dearest friends, Patty launched a non-profit organization called Ovations for the Cure to fuel other research initiatives around the country and actively change the face of ovarian cancer.

In the 9 years she lived with ovarian cancer, Patty Franchi Flaherty turned a very personal crusade into a meaningful legacy for all women facing the disease. Thanks to Patty, women can now share information the likes of which her mother never had, and have hope where before there had been none. In just over 3 years’ time, Patty led Ovations’ growth from a lingering idea to a thriving organization-with momentum that continues to build across North America.

In July of 2008, The Savings Bank Life Insurance Company of Massachusetts awarded Patty its highest community honor, the prestigious Brandeis Award, which Patty’s husband Paul accepted on her behalf. The award pays homage to [U.S. Supreme Court] Justice Louis Brandeis and his defense of the rights of individuals, and was given to Patty in recognition of her innovation, bravery, and commitment to furthering the research and awareness of ovarian cancer.

Known for her unshakable determination, Patty turned her mission to beat ovarian cancer into a nationwide entity. In so doing, she created a living legacy of hope for everyone who faces the disease. Patty’s personal contributions to the fight against ovarian cancer have earned her a champion’s status in the hearts of those she has forever touched.

Creating a brighter future

Compared with other diseases making headlines today, ovarian cancer is far from attention-grabbing. Its foremost symptoms are so common and nonspecific that they are often mistaken for something else, if not ignored. Meanwhile, early detection methods are still in their infancy and late-stage diagnosis makes for only a limited number of successfully treated patients. Perhaps most surprisingly, ovarian cancer has the highest mortality rate of all gynecologic cancers.

Contributing to the high mortality rates of ovarian cancer is the lack of accurate screening and clear symptoms. As a result, only 19 percent of cases are detected before the cancer has spread beyond the ovaries, when treatment options are limited.

‘Ovarian cancer is often misunderstood, misinterpreted, and unfortunately misdiagnosed,’ said Dr. Ursula Matulonis, attending physician at Dana-Farber Cancer Institute and Brigham and Women’s Hospital and medical advisor to Ovations for the Cure.

‘In an effort to overcome this silent killer, Ovations for the Cure is dedicated to supporting cancer research centers to find accurate and early detection screenings. If caught in the early stages of diagnosis, ovarian cancer patients have a 90 percent chance of survival beyond five years and increased odds of beating the disease,’ Matulonis added. ‘Ovations for the Cure has helped change the dynamics of the medical profession by contributing valuable research funds for detection and treatment while educating women on its subtle symptoms.’

Today, Ovations continues to help make miracles possible for all women with ovarian cancer by shedding light on a disease that is still full of darkness. They have launched an aggressive ovarian cancer educational program, distributing awareness brochures to more than 3,000 physicians’ offices across the nation. Additionally, the development of their television and radio public service announcements outlining ovarian cancer symptoms has helped women identify the disease before it spreads to advanced stages. By spring of 2008, Ovations had already dedicated nearly one million dollars to ovarian cancer initiatives through the Dana-Farber Cancer Institute, Brigham and Women’s Hospital, City of Hope Hospital in L.A., and the University of Pennsylvania.

From loss to legacy

‘Patty started Ovations for the Cure with the idea of saving women from this horrible disease,’ said Debbie Soprano, one of Patty’s closest friends and first Executive Director of Ovations for the Cure. ‘While she could not save herself, her everlasting optimism and spirit will forever lead the fight against ovarian cancer until we find a cure.’

Patty Franchi Flaherty may have lost her own battle against ovarian cancer, yet through Ovations for the Cure, she’ll continue to help thousands of women to win the war. For more information about ovarian cancer visit www.ovationsforthecure.org”

About Ovations for the Cure

The Ovations for the Cure Foundation, a 501(c)(3) non-profit organization, is dedicated to the relentless pursuit of a cure for ovarian cancer. Ovations for the Cure has donated over $1 million to various ovarian cancer research initiatives such as the Dana-Farber Cancer Institute, Children’s Hospital Boston, City of Hope, University of Pennsylvania, and Brigham and Women’s Hospital. The Foundation spreads awareness of the most deadly gynecological disease through national events including the renowned Happy Feet Program, fashion shows with celebrity designers Stuart Weitzman and Carmen Marc Valvo, regional golf outings, 5k runs/walks, and various other initiatives. For more information about Ovations, please visit www.ovationsforthecure.org.

Working Smarter, Not Harder: Use of Anti-Estrogen Therapy to Battle Recurrent Ovarian Cancer

The Gynecologic Oncology department of the University of Texas, M.D. Anderson Cancer Center took a page out of the breast cancer treatment “playbook,” and conducted a single institution Phase II clinical trial using letrozole (Femara®) to treat recurrent, platinum and taxane resistant, high-grade cancer of the ovary and peritoneum. …The trial investigators concluded that 26% (8/31 pts.) of patients with ER+ … ovarian and primary peritoneal cancer derived a clinical benefit (stable disease (SD) + partial response (PR)) after treatment with letrozole (Femara®).

Pursuant to the breast cancer standard of care, breast tissue tumor is routinely analyzed to determine if it is “estrogen receptor positive” (ER positive or ER+), meaning that tumor growth is fueled by the hormone estrogen. It is well-known in the breast cancer area that hormonal therapy is a very effective treatment against breast cancer that is ER+. Sometimes referred to as “anti-estrogen therapy,” hormonal therapy blocks the ability of the hormone estrogen to turn on and stimulate the growth of breast cancer cells.

For decades, the anti-estrogen therapy of choice for treatment of ER+ breast cancer was tamoxifen. In 2005, several world-wide clinical trials reported that aromatase inhibitors (specifically, anastrozole (Arimidex®), exemestane (Aromasin®), and letrozole (Femara®) were more effective than tamoxifen in post-menopausal women with ER+ breast cancer. Aromatase inhibitor drug use is currently the standard of care for treatment of post-menopausal women with ER+ breast cancer, while tamoxifen remains the hormonal treatment of choice for pre-menopausal women.

The Gynecologic Oncology department of the University of Texas, M.D. Anderson Cancer Center took a page out of the breast cancer treatment “playbook,” and conducted a single institution Phase II clinical trial using letrozole (Femara®) to treat recurrent, platinum and taxane resistant, high-grade cancer of the ovary and peritoneum.

Thirty-three patients enrolled in the Phase II clinical trial, and each had measurable disease that tested ER+ pursuant to trial eligibility criteria. Twenty-three patients (74%) had received three or more prior chemotherapy regimens. Letrozole (Femara®) was administered at a dose of 2.5 mg orally once daily until disease progression or toxicity occurred. The median patient age was 63 years (ranging from 38 to 83 years).

The 31 patients evaluable for response received a total of 81 cycles (4 weeks per cycle) of therapy (ranging from 1 to 14 cycles per patient). The median treatment duration was 8 weeks (ranging from 4 to 52 weeks). The trial investigators reported that (i) none of the patients had a complete response (CR), (ii) 1 (3%) had a partial response (PR), and (iii) 7 (23%) had stable disease (SD). The median duration of clinical benefit (SD and PR) was 9 weeks (ranging from 7 to 46 weeks). The median follow-up for all patients was 25 weeks. All evaluable patients were monitored for toxicity. The most common adverse effects were fatigue (36%) and diaphoresis (21%). No grade 3 or 4 toxicities were reported, and no patients discontinued treatment owing to adverse effects. Eighteen patients (58%) went on to receive additional therapy with other agents.

Based upon the results above, the trial investigators concluded that 26% (8/31 pts.) of patients with ER+, platinum- and taxane-resistant, high-grade ovarian and primary peritoneal cancer derived a clinical benefit (stable disease (SD) + partial response (PR)) after treatment with letrozole (Femara®).

Sources:

Comment: Based upon the references listed above and below, it appears that the opening of clinical trials that utilize anti-estrogen therapy to treat ER+ ovarian cancer is long overdue. The “take away” from the M.D. Anderson clinical trial study results is that an ovarian cancer survivor should request her doctor to test the ovarian cancer tumor tissue obtained from surgery or biopsy for estrogen receptor positivity, so as to determine if she is eligible to use anti-estrogen therapy (within the context of a clinical trial) as part of an overall cancer treatment plan.

It is important to note that letrozole is a low side effect, oral drug. Moreover, M.D. Anderson’s letrozole monotherapy produced a 26% clinical benefit rate among ER+, platinum- and taxane-resistant, ovarian and peritoneal cancer patients, despite the fact that approximately three-quarters of the clinical trial patients were heavily pretreated with multiple lines of chemotherapy prior to their trial enrollment. It is promising to consider the potential clinical benefit that could be generated by anti-estrogen therapy in a neoadjuvant or adjuvant ovarian cancer treatment setting.

Additional Anti-Estrogen Therapy/Ovarian Cancer References:

  • Estrogen-regulated gene expression predicts response to endocrine therapy in patients with ovarian cancer, Walker G et. al.; Gynecol Oncol. 2007 Sep;106(3):461-8. Epub 2007 Jul 10. (“OBJECTIVE: To explore the predictive value of estrogen-regulated gene changes as indicators of sensitivity in ovarian cancer patients treated with the aromatase inhibitor Letrozole. … CONCLUSION: These results suggest that expression levels of certain proteins in ovarian cancers are estrogen-regulated and could help identify patients who would benefit from endocrine therapy.” [i.e., anti-estrogen therapy])
  • Antiestrogen therapy is active in selected ovarian cancer cases: the use of letrozole in estrogen receptor-positive patients, Smyth JF et. al.; Clin Cancer Res. 2007 Jun 15;13(12):3617-22 (“PURPOSE: To evaluate the efficacy of the aromatase inhibitor letrozole in preselected estrogen receptor (ER)-positive relapsed epithelial ovarian cancer patients and to identify markers that predict endocrine-sensitive disease. EXPERIMENTAL DESIGN: This was a phase II study of letrozole 2.5 mg daily until clinical or marker evidence of disease progression in previously treated ER-positive ovarian cancer patients with a rising CA125 that had progressed according to Rustin’s criteria. The primary end point was response according to CA125 and response evaluation criteria in solid tumors (RECIST) criteria. Marker expression was measured by semiquantitative immunohistochemistry in sections from the primary tumor. RESULTS: Of 42 patients evaluable for CA125 response, 7 (17%) had a response (decrease of >50%), and 11 (26%) patients had not progressed (doubling of CA125) following 6 months on treatment. The median time taken to achieve the CA125 nadir was 13 weeks (range 10-36). Of 33 patients evaluable for radiological response, 3 (9%) had a partial remission, and 14 (42%) had stable disease at 12 weeks. Eleven patients (26%) had a PFS of >6 months. Subgroup analysis according to ER revealed CA125 response rates of 0% (immunoscore, 150-199), 12% (200-249), and 33% (250-300); P = 0.028, chi(2) for trend. Expression levels of HER2, insulin-like growth factor binding protein 5, trefoil factor 1, and vimentin were associated with CA125 changes on treatment. CONCLUSIONS: This is the first study of a hormonal agent in a preselected group of ER-positive ovarian cancer patients. A signature of predictive markers, including low HER2 expression, predicts response.)
  • The efficacy of tamoxifen in patients with advanced epithelial ovarian cancer, Karagol H et. al.; Med Oncol. 2007;24(1):39-43 (“BACKGROUND: Activity of tamoxifen as a salvage therapy in patients with advanced epithelial ovarian cancer was evaluated by a number of studies. In this study, we evaluated efficacy of tamoxifen in our patients with platinum-resistant epithelial ovarian carcinoma. … RESULTS: Twenty-nine eligible patients were included to the study. There were 1 (3%) complete response, 2 (7%) partial response, 6 (21%) stable disease, and 20 (69%) progressive disease. All patients were progressed after initiation of tamoxifen. Median progression-free survival was 4 mo (95% CI: 2.98-5.02). Disease progression of 19 (65%) patients were shown within the first 6 mo after initiation of tamoxifen. Progression-free survival was between 6 and 12 mo for 7 (24%) patients and > or =12 mo for 3 (10%) patients. The median survival after initiation of tamoxifen was 15 mo (95% CI: 7.2-22.8). No toxicity attributable to tamoxifen was seen in any of the patients. The only independent prognostic factor that had a significant predictive value for progression- free survival was the response to tamoxifen treatment (p = 0.043, hazard ratio: 0.12, 95% CI: 0.01-0.94). CONCLUSION: Considering minimal side effects and ability to cause objective responses, there is a place for tamoxifen in treatment of patients with platinum-resistant ovarian cancer. A phase III trial is required to confirm the value of the drug in patients presenting these clinical settings.”)
  • Anastrozole therapy in recurrent ovarian adult granulosa cell tumors: a report of 2 cases, Freeman SA, Modesitt SC; Gynecol Oncol. 2006 Nov;103(2):755-8. Epub 2006 Jul 25 (“BACKGROUND: Ovarian sex cord stromal tumors are frequently hormonally active, and adult granulosa cell tumors often demonstrate estrogen receptor positivity. Thus, hormonal agents have been evaluated as potential treatments for advanced stage or recurrent adult granulosa cell tumors. CASE: Two cases of patients with recurrent adult granulosa cell tumors are presented. Each patient received multiple treatment modalities including chemotherapy and had previously progressed on leuprolide. Both patients were started on anastrozole with subsequent normalization of inhibin B levels and clinical exams. They have been maintained on treatment for 14 and 18 months, respectively, and have tolerated the drug without difficulty. CONCLUSION: Aromatase inhibitors may be a viable treatment option for women with advanced stage or recurrent ovarian adult granulosa cell tumors.”)
  • Hormonal therapy in epithelial ovarian cancer, Rao GG, Miller DS; Expert Rev Anticancer Ther. 2006 Jan;6(1):43-7. (“The ovary is an endocrine and end organ. Hormones and their receptors have been associated with ovarian cancer and may be related to its causation. Some data suggest that hormonal therapies may have an effect on ovarian cancer in palliative settings. The most well studied anticancer drugs are tamoxifen, megestrol acetate, medroxyprogesterone acetate, leuprolide acetate, anastrozole and letrozole. Presently, no hormonal therapy is approved by the US FDA for the treatment of any type of ovarian malignancy or is listed as an active agent by any of the authoritative compendia. Owing to the endocrine associations with ovarian cancer, the minimal side effects of hormonal therapy and the demonstrated activity of hormonal therapies in other endocrine organ-associated malignancies, further study of hormonal therapies for ovarian cancer is warranted.”)
  • Aromatase expression in ovarian epithelial cancers, Cunat S et. al.; J Steroid Biochem Mol Biol. 2005 Jan;93(1):15-24 (” … Aromatase activity was evaluated in ovarian epithelial cancer (OEC) cell lines by the tritiated water assay and the effects of third-generation aromatase inhibitors (AIs) on aromatase activity and growth were studied. Letrozole and exemestane were able to completely inhibit aromatase activity in BG1 and PEO14 cell lines. Interestingly, both AI showed an antiproliferative effect on the estrogen responsive BG1 cell line co-expressing aromatase and ERalpha. Aromatase expression was found in ovarian epithelial normal tissues and in some ovarian epithelial cancer cells and tissues. This finding raises the possibility that some tumors may respond to estrogen and provides a basis for ascertaining an antimitogenic effect of AI in a subgroup of ovarian epithelial cancers.”)
  • Hormone therapy in epithelial ovarian cancer, Makar AP; Endocr Relat Cancer. 2000 Jun;7(2):85-93 (“Although epidemiologic studies, animal experiments and receptor studies have shown that not only normal ovaries but also many malignant ovarian tumors can be considered as endocrine related and hormone dependent, the place of hormonal therapy in the management of patients with ovarian cancer remains unsettled. Most trials of hormonal treatment in ovarian cancer have been retrospective, involved only limited numbers of patients, and lacked important patient-related data and information pertaining to tumor characteristics. In addition, a variety of hormonal preparations with different degrees of potency and in different dosages were included in these studies. A literature review shows that response to hormonal therapy even in a preterminal setting, is modest, with about 8% objective response but almost no side effects. In a similar patient setting, more toxic therapeutic agents do not yield a better response. The place of hormonal therapy in the management of patients with epithelial ovarian cancer needs more thorough evaluation in well-designed randomized trials.”)

Winners Walk of Hope — Ovarian Cancer Canada Takes Steps to Eradicate The Disease That Whispers

“On Sunday, September 7th, 14 Canadian cities will join in the only national fundraising event dedicated to overcoming ovarian cancer – the Winners Walk of Hope. … The annual walk has raised more than $3-million for ovarian cancer support and awareness programs across the country, including resources for newly diagnosed women; awareness campaigns targeted at well women; education sessions for medical students and health professionals, and research in ovarian cancer.”

“On Sunday, September 7th, 14 Canadian cities will join in the only national fundraising event dedicated to overcoming ovarian cancer – the Winners Walk of Hope.

Every three and a half hours, a woman in Canada is diagnosed with ovarian cancer. The Winners Walk of Hope raises crucial funds for Ovarian Cancer Canada – the country’s only national organization dedicated solely to advancing ovarian cancer awareness, education and research.

Parliament has officially recognized September as National Ovarian Cancer Awareness Month. Today, the five year survival rate for ovarian cancer is about 30% – making it the most deadly gynecologic cancer. There is no reliable screening test for ovarian cancer and symptoms can be subtle or mistaken for less serious conditions.

Ovarian Cancer Canada endorses the United States consensus on ovarian cancer symptoms. These symptoms are common to many women with the disease: swelling or bloating of the abdomen, abdominal pain, difficulty eating, feeling full quickly and frequent or urgent urination. Although the average woman’s likelihood of getting ovarian cancer is low – about one in 70 – any woman experiencing these symptoms persistently for longer than three weeks is urged to visit a doctor. Early diagnosis and referral to a gynecologic oncologist – a specialist in treating ovarian cancer – can increase the likelihood of surviving the disease. [emphasis added by Libby’s H*O*P*E*™]

Third time national title sponsor, Winners, and host sponsors, HomeSense and KPMG, are joined this year by new national presenting sponsor, Electrolux. ‘Winners is honoured to be the National Title sponsor of the Winners Walk of Hope for its third consecutive year,’ says Shannon Johnson, Winners Spokesperson. ‘The thousands of associates and customers who have walked this journey exemplify the values we live at Winners everyday: being a responsive and involved community partner. We are honoured by the support of participants in regions across the country and are hopeful that this year’s Walk will raise significant awareness and record funds needed in support of overcoming ovarian cancer.’

Ovarian Cancer Canada’s mission is to provide support and education to women with ovarian cancer and their families, raise public awareness and fund research that will ultimately lead to a cure for the disease. To date, the organization has committed more than $2.7 million to research in Canada. For more information about educational programs or to get involved, call 1-877-413-7970 or visit www.ovariancanada.org for a list of regional offices.

About the Walk

The Winners Walk of Hope in support of Ovarian Cancer Canada will be held on Sunday, September 7, 2008 in 14 locations across the country: Comox Valley, Victoria and Vancouver, BC; Calgary and Edmonton, AB; Saskatoon, SK; Winnipeg, MB; Windsor, Toronto and Ottawa, ON; Montreal, QC; Halifax, NS; Moncton, NB and St. John’s, NL.

Ovarian Cancer Canada volunteer, Peggy Truscott, planted the seeds for the Winners Walk of Hope by organizing the first walk in 2002. Her legacy continues to grow:

  • The annual walk has raised more than $3-million for ovarian cancer support and awareness programs across the country, including resources for newly diagnosed women; awareness campaigns targeted at well women; education sessions for medical students and health professionals, and research in ovarian cancer.
  • The event is non-competitive and held in park settings. Walks are organized by volunteer committees in each community. Registration is $25 and is waived for registrants who raise $100 or more in pledges. For more information, to register or to pledge a walker, visit www.winnerswalkofhope.ca / www.randonneewinners.ca or call toll-free 1-877-413-7970, ext. 232.
  • OCC extends its thanks to sponsors:

Winners – title sponsor
Electrolux – national presenting sponsor
HomeSense – national host sponsor
KPMG – national host sponsor
U Weight Loss – national premier sponsor
Chatelaine Magazine – national media sponsor

  • For more information, please contact

Ovarian Cancer Canada
Anne Williams
Communications Director
1-800-749-9310
Email: awilliams@ovariancanada.org
Website: www.ovariancanada.org

or

Winners Merchants Intl.
Natalie Jikerjian
Public Relations Manager
(905) 405-2455
Email: natalie_jikerjian@winners.ca”

Quoted Source: Ovarian Cancer Canada: Taking Steps to Overcome a Silent Disease – Winners Walk of Hope to raise awareness of ovarian cancer, Marketwire Press Release, August 12, 2008.

The 2008 Winners Walk of Hope public service announcement video is provided below.

2008 Winners Walk of Hope Public Service Announcement