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Return to Studies Reveal Effectiveness of Breast Cancer Treatments Overview

More on Studies Reveal Effectiveness of Breast Cancer Treatments

Studies Reveal Effectiveness of Breast Cancer Treatments

News about taking hormonal therapy and a drug derived from sea sponge

New York (Oct 20, 2010)

pink breast cancer ribbon

Three studies authored by NewYork-Presbyterian investigators have the capacity to improve the treatment of women with breast cancer. Two were presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO), held in early June in Chicago. Another was published online on June 28 in the Journal of Clinical Oncology (JCO).

The JCO study, led by Dawn Hershman, M.D., and Alfred Neugut, M.D., Ph.D., of NewYork-Presbyterian/Columbia University Medical Center, found that less than half of women prescribed hormonal therapy to reduce their risk of breast cancer recurrence actually finished the full course of treatment. The study presented at the ASCO Annual Meeting, which looked at the same patient population, found that not completing hormonal treatment as prescribed reduced overall survival.

The third study, co-authored by Linda Vahdat, M.D., of NewYork-Presbyterian/Weill Cornell Medical Center and presented at the ASCO Annual Meeting, demonstrated that the investigational drug eribulin extended median overall survival by 19 percent among women with locally recurrent or metastatic breast cancer who had already been heavily treated with conventional therapies.

Failure to Comply with Hormonal Therapy

Dr. Hershman and her colleagues analyzed automated pharmacy records of 8,769 women with stage I, II or III hormone receptor-positive breast cancer diagnosed between 1996 and 2007 and enrolled in Kaiser Permanente of Northern California. The investigators identified prescriptions and refill dates for hormonal therapies such as tamoxifen (43 percent of prescriptions), aromatase inhibitors (26 percent) or both (30 percent) within one year of diagnosis.

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In the study published in the JCO, they reported that only 49 percent of women completed the full course of hormonal therapy. By 4.5 years, 32 percent of all patients in the study had stopped taking hormonal therapy; among those who continued treatment, only 72 percent finished on schedule.

Risk of early discontinuation was greatest among women under age 40, and was also elevated among women over age 75, those who had breast-conserving surgery, and those with co-morbidities. Women who completed therapy were more likely to be of Asian/Pacific Islander ethnicity, have a history of receiving prior chemotherapy, and be married.

Dawn L. Hershman, M.D.
Dawn L. Hershman, M.D.

In the study presented at the ASCO Annual Meeting, the investigators reported that during a median follow-up of 4.4 years, 813 women had died. Estimated survival at 10 years was 81 percent in women who continued therapy versus 74 percent in those who discontinued. Of those who continued, survival at 10 years was 82 percent in women who adhered and 78 percent in those who did not.

"Drugs such as tamoxifen and aromatase inhibitors have been proven to significantly reduce the risk of breast cancer recurrence, but their value is diminished if they are not taken as prescribed," Dr. Hershman contended. "We may need to do a better job of making patients aware that in order to get the full benefit of this potentially lifesaving treatment, they need to take their medications on time and for the full duration of therapy."

New Drug Shown to Lengthen Survival in Advanced Breast Cancer

Women with advanced breast cancer typically receive multiple chemotherapy drugs, such as anthracyclines, taxanes, and many other classes of drugs. Recent studies have shown that some new approaches have the potential to slow disease progression, but all have failed to demonstrate a survival benefit.

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The phase III EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus Eribulin E7389) was an international randomized study comparing overall survival between 508 women with locally recurrent or metastatic breast cancer who received eribulin mesylate and 254 who received a treatment of physician's choice (standard therapy). All of the women in the study had breast cancer refractory to prior therapy, and had received between two and five previous treatments for advanced breast cancer.

Linda T. Vahdat, M.D.
Linda T. Vahdat, M.D.

Eribulin, which is derived from a sea sponge called Halichondria okadai, works by inhibiting microtubules and sequestering tubulin into aggregates, leading to cell death. It is administered intravenously.

The investigators found that women who received eribulin had a median overall survival of 13.1 months versus 10.7 months for those in the standard therapy group. Eribulin was also well tolerated: the most common side effects were asthenia/fatigue (7.6 percent of patients), neutropenia (44 percent), and peripheral neuropathy (8.4 percent).

"The fact that this study showed a survival benefit is wonderful for patients. Most studies of new therapies for metastatic breast cancer have not demonstrated a survival benefit," said Dr. Vahdat, who led the U.S. and the NewYork-Presbyterian/Weill Cornell Medical Center's participation in the international multi-center study.

Eribulin has been fast-tracked for review by the U.S. Food and Drug Administration. Its efficacy and safety profile make it likely that it will receive approval before the end of 2010.

Contributing faculty for this article:

Dawn L. Hershman, M.D., is the Co-Director of the Breast Cancer Program of the Herbert Irving Comprehensive Cancer Center at NewYork-Presbyterian/Columbia University Medical Center and an Associate Professor of Medicine and Epidemiology at Columbia University College of Physicians and Surgeons.

Linda T. Vahdat, M.D., is an Attending Physician at NewYork-Presbyterian/Weill Cornell Medical Center and a Professor of Medicine at Weill Cornell Medical College.

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