Faulty gene has no impact on breast cancer survival say scientists

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The FDA based its approval on data from the open-label phase 3 OlympiAD study (ClinicalTrials.gov Identifier: NCT02000622), for which researchers randomly assigned 302 patients with a germline BRCA mutation and HER2-negative metastatic breast cancer to receive olaparib 300 mg twice daily as monotherapy or investigator's choice (IC) standard single-agent therapy (capecitabine, eribulin, or vinorelbine) in 3-week cycles.

A study of nearly 3,000 British women found that preventative surgery - like a double mastectomy - straight after being diagnosed with this type of breast cancer did not improve survival over 10 years.

'Women diagnosed with early breast cancer who carry a BRCA mutation are often offered double mastectomies soon after their diagnosis or chemotherapy treatment, however, our findings suggest that this surgery does not have to be immediately undertaken along with the other treatment. Lynparza can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.

The study of 2,700 women found women with a mutated BRCA gene had a 97 percent chance of surviving two years after diagnosis, compared to 96.6 percent for other breast cancer patients. Recruitment stopped in 2008, and long-term follow-up is continuing. Almost 90% underwent chemotherapy.

"However, risk-reducing surgery will still likely be beneficial for BRCA mutation carriers to prevent another new breast or ovarian cancer from developing in the longer term". The trial measured the length of time the tumors did not have significant growth after treatment (progression-free survival). Of the total sample, 558 women (20%) had triple-negative breast cancer.

The median follow-up was 8.2 years. After 10 years, faulty gene carrier survival was 73.4% compared with 70.1% for non-carriers.

This was not affected by the women's body mass index or ethnicity.

Immediate bilateral mastectomy also was not associated with improved survival.

The patients, 12% of whom were found to have faulty genes, were followed up for an average of just over eight years.

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Eccles and her colleagues noted that the findings might not apply to older breast cancer patients with a BRCA mutation.

The gene has come to be known as the "Jolie gene", after the actress Angelina Jolie, who revealed in a New York Times article that she'd had a double mastectomy after testing positive for BRCA 1. "This study confirms these findings".

The results were the same whether mutations were in the BRCA1 or BRCA2 gene, according to the study published January 11 in The Lancet Oncology.

Therefore, he concluded, "This important topic needs more prospective research, as preventive surgical measures might have an effect on what might be a very long life after a diagnosis of breast cancer at a young age".

BRCA mutations are inherited and increase the risk of breast and ovarian cancers. In addition, because triple-negative breast cancer was not well understood when the study was designed, it was therefore not powered for this as a primary outcome.

The faulty genes are also linked to an increased risk of ovarian and prostate cancers, as well as breast cancer.

The authors reported financial relationships with Roche, GSK, Pfizer, AstraZeneca, and Pierre Fabre.

The study was funded by Cancer Research UK, the UK National Cancer Research Network, the Wessex Cancer Trust, Breast Cancer Now, and the PPP Healthcare Medical Trust Grant.

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