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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. ASCO's Annual Meeting is the largest gathering of cancer professionals each year in the United States. 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 helped women with heavily pre-treated advanced breast cancer live longer than those who received standard therapies.

Many Women Do Not Take Hormonal Therapy as Prescribed

Hormonal therapy is frequently prescribed for up to five years for women with breast cancers that contain receptors for estrogen and progesterone – hormones which can fuel breast cancer growth. Dr. Hershman and her colleagues analyzed automated pharmacy records of 8,769 women with such hormone receptor-positive breast cancer (stage I, II or III) diagnosed between 1996 and 2007 and enrolled in the Kaiser Permanente health-care system 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.

The risk of stopping hormonal therapy early was greatest among women under age 40, and was also elevated among women over age 75, those who had lumpectomy, and those with other illnesses and conditions. 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 took their therapy as prescribed 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 a combination of chemotherapy drugs, such as doxorubicin, paclitaxel, and cyclophosphamide. Recent studies have shown that some new approaches have the potential to slow disease growth, but have failed to demonstrate that they can help patients live longer.

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The phase III EMBRACE study compared overall survival between 508 women with advanced breast cancer who received eribulin mesylate and 254 who received a physician's choice of standard therapy. All of the women in the study had breast cancer that persisted despite 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, works by inhibiting microtubules (which provide scaffolding in cancer cells), leading to cell death. It is administered intravenously (by vein).

The investigators found that women who received eribulin lived a median 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 feeling tired (7.6 percent of patients), low white blood cell counts (44 percent), and nerve problems (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 effectiveness and low rate of side effects 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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