Macmillan Cancer Support Launches On-Line Personalized Assessment For Risk of Inherited Breast or Ovarian Cancer

With so many women concerned about the possibility of inherited breast or ovarian cancer, Macmillan Cancer Support launched “OPERA” (On-line Personal Education and Risk Assessment) – the first United Kingdom on-line interactive software program which gives personalized information regarding a woman’s risk with respect to hereditary breast and ovarian cancer. Macmillan Cancer Support is based in London, England and merged with Cancerbackup in April 2008.

Dr Andrea Pithers, Genetic Information Project Manager at Macmillan Cancer Support, says: “By simply typing in some details of your family medical history, OPERA can provide personalised information and advice on whether there might be an inherited genetic link and where to go for further information and support.”

Upon the OPERA launch, Mike Richards, the United Kingdom Government’s National Cancer Director said: “This is an important resource for all those who have concerns over breast and ovarian cancer in their family. For many it will provide reassurance that the risk is not as high as they feared. For others it will provide the information which prompts them to see their GP [General Practitioner] and get tested for the BRCA gene or to be referred appropriately for further genetic assessment.”

Jan Buckle discovered that she inherited a BRCA gene mutation after her sister died of breast cancer and her mother was diagnosed with the same disease. She had her ovaries removed and a double mastectomy with reconstructive surgery as a preventative measure against developing cancer herself. When asked to comment about OPERA, Jan said: “OPERA will be very useful for families like mine, and those who are worried that inherited breast and ovarian cancer runs in their family. It was really important for me to know the risks and to find out if I had the gene so I could make informed decisions on how to prevent breast and ovarian cancer occurring. Knowing your risk from inherited breast or ovarian cancer and getting good advice on what to do is much better than burying your head in the sand and just hoping that you don’t get breast cancer. I urge anyone who has any concerns to go on-line and try OPERA out for themselves.”

For additional resources regarding hereditary breast and ovarian cancer, click on the “Genetics” caption tab located at the top of the H*O*P*E* homepage.

OPERA Genetic Breast/Ovarian Cancer Risk Assessment Tool

[Source: “Macmillan Cancer Support launch on-line personalised assessment for risk of inherited breast or ovarian cancer,” Macmillian Cancer Support Press Release dated April 23, 2008.]

The Life Saving Effect of Johanna’s Law

Johanna’s Law is named after Johanna Silver Gordon, a dynamic woman and former schoolteacher, who lost her life to ovarian cancer despite being a health conscious woman who visited the gynecologist regularly. Sadly, Johanna did not recognize the early symptoms and warning signs of ovarian cancer until AFTER being diagnosed with an advanced stage of the disease. Lack of symptom recognition contributed to a lengthy —and ultimately lethal — delay in Johanna’s diagnosis. Tragically, Johanna’s story of delayed diagnosis is all too common. Thousands of U.S. women annually are stunned not only by diagnoses of gynecologic cancer, but also learn after the fact that the symptoms experienced in the months prior to their diagnoses were common symptoms of these cancers. The problem is particularly common with respect to ovarian cancer, where a pervasive lack of knowledge regarding symptoms commonly leads to lengthy delays in disease diagnosis. Additionally, women are frequently misdiagnosed with benign conditions before the correct diagnosis is made by a health care professional.

Source: [ Johanna’s Law Alliance for Women’s Cancer Awareness, Sheryl Silver (Johanna’s sister), Founder/President].

Johanna’s Law

The Gynecologic Cancer Education and Awareness Act (P.L. 109-475) was passed by the 109th Congress and signed into law in early 2007. This law provides up to $16.5 million for awareness and education through a national public service campaign that will include written materials and public service announcements.

The passage of Johanna’s Law was required because too many women are diagnosed in later stages of gynecologic cancers; if these women were diagnosed earlier, their chances of survival would be greater. Women with ovarian cancer have a five-year relative survival rate of more than 90 percent if diagnosed in Stage I. Unfortunately, less than 20 percent of ovarian cancer cases are diagnosed in Stage I. The overall five-year relative survival rate for ovarian cancer is 45 percent. Due to the lack of an early screening test for ovarian cancer (however, see Yale Blood Test Detects Early Stage Ovarian Cancer with 99% Accuracy), women and health care providers must be aware of the signs and symptoms of gynecologic cancers to act in the best interests of women.

Legislative History

In 2004, the bill was introduced in the U.S. House of Representativies (House). In 2005, the bill was introduced in the U.S. Senate (Senate). The House held a hearing on the bill in 2006. It was passed by unanimous consent of the Senate in 2006 and signed into law by President George W. Bush in early 2007. The Ovarian Cancer National Alliance (the Alliance) worked to secure the implementation funding of Johanna’s Law through the U.S. Congressional appropriations process. The Alliance requested $9 million to implement Johanna’s Law. In the 2008 fiscal year, this program was appropriated $6.5 million by the U.S. Congress. The Alliance will request the U.S. Congress to fully fund Johanna’s Law program for $10 million in the 2009 fiscal year.

Adoption of the Ovarian Cancer Symptoms Consensus Statement

In mid-2007, a number of medical organizations and related groups agreed upon and released a Consensus Statement listing the primary symptoms of ovarian cancer. These symptoms, long recognized by patients, and scientifically documented in the medical literature, are:

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

A woman who experiences these symptoms persistently for several weeks should consult with her doctor, preferably a gynecologist. Prompt medical evaluation may lead to detection at the earliest possible stage of the disease. Early stage diagnosis is associated with an improved prognosis.

Often, women and health care providers mistake ovarian cancer for gastrointestinal disorders or early menopause. While symptoms may seem vague, they can be lethal without proper medical intervention. Johanna’s Law provides for an education and awareness campaign that will educate health care providers with respect to, and increase women’s awareness of, this disease.

Source: [Johanna’s Law: The Gynecologic Cancer Education and Awareness Act of 2007, Ovarian Cancer National Alliance website]

Comment: The impetus for adoption of Johanna’s Law can be traced to Sheryl Silver, Johanna’s sister. Sheryl is the founder and president of the Johanna’s Law Alliance for Women’s Cancer Awareness. The adoption of Johanna’s Law should heighten the awareness of women in the U.S. regarding the primary symptoms and warning signs associated with ovarian cancer in the earliest stages of the disease. Sheryl Silver’s perseverance on behalf of the memory of her sister led to the adoption of a law that will undoubtedly save thousands of lives in the future.

Yale Blood Test Detects Early Stage Ovarian Cancer With 99% Accuracy

“Researchers at Yale School of Medicine have developed a blood test with enough sensitivity and specificity to detect early stage ovarian cancer with 99 percent accuracy.Results of this new study are published in the February 15 issue of the journal Clinical Cancer Research. The results build on work done by the same Yale group in 2005 showing 95 percent effectiveness of a blood test using four proteins.

‘The ability to recognize almost 100 percent of new tumors will have a major impact on the high death rates of this cancer,’ said lead author Gil Mor, M.D., associate professor in the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale. ‘We hope this test will become the standard of care for women having routine examinations.’

Epithelial ovarian cancer is the leading cause of gynecologic cancer deaths in the United States and three times more lethal than breast cancer. It is usually not diagnosed until its advanced stages and has come to be known as the “silent killer.”

This new phase II clinical trial included 500 patients; 350 healthy controls and 150 ovarian cancer patients. Mor and colleagues validated the previous research and used a new platform called multiplex technology to simplify the test into one single reaction using very small amounts of serum from the blood. The new platform uses six protein biomarkers instead of four, increasing the specificity of the test from 95 to 99.4 percent. The team looked for the presence of specific proteins and quantified the concentration of those proteins in the blood.

The Early Detection Research Network (EDRN) of the National Cancer Institute (NCI) independently evaluated the results of the test.

‘This is the most sensitive and specific test currently available,’ said Mor. ‘Previous tests recognized 15 to 20 percent of new tumors. Proteins from the tumors were the only biomarkers used to test for ovarian cancer. That is okay when you have big masses of tumors, but it is not applicable in very early phases of the tumor. Testing the proteins produced by the body in response to the presence of the tumor as well as the proteins the tumors produce, helped us to create a unique picture that can detect early ovarian cancer.’

Mor and colleagues have begun a phase III evaluation in a multi-center clinical trial. In collaboration with EDRN/NCI and Laboratories Corporation of America (LabCorp), they are testing close to 2,000 patients.

The test is available at Yale through the Discovery to Cure program. Yale has licensed the test to three companies: Lab Corp in the United States, Teva in Israel and SurExam in China.”

Quoted Source: [Yale University Press Release entitled, “Yale Test Detects Early Stage Ovarian Cancer With 99% Accuracy,” dated February 13, 2008 (citing source as Clinical Cancer Research Journal 14 (4) February 15, 2008.) ]