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| |  Exemestane for 5 Years Not Superior to Tamoxifen Followed by Exemestane for Breast Cancer: Presented at SABCS By Ed Susman SAN ANTONIO, Tex -- December 11, 2009 -- Two different strategies to prevent breast cancer recurrence using hormonal treatments in postmenopausal women showed that a split treatment that starts with tamoxifen and continues with exemestane achieve almost exactly the same results as starting originally with exemestane and continuing treatment for 5 years. In reporting the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial, Daniel Rea, MD, University of Birmingham, Birmingham, United Kingdom, said, “This is also the only study with sufficient power to reliably determine if an aromatase inhibitor as initial therapy is superior to a sequential approach starting with tamoxifen.” However, the trial failed to show that superiority. In fact, the overall survival in the study showed that the hazard ratio (HR) between the 2 arms of the study was 1.0 -- meaning there was no difference in strategies (P = .999), Dr. Rea said here on December 11 at the 32nd Annual San Antonio Breast Cancer Symposium (SABCS). Researchers enrolled 9,775 women with hormone receptor-positive early breast cancer and assigned 4,898 to exemestane 25 mg per day and 4,868 women to tamoxifen 20 mg per day. The trial began in 2001, and in 2004 the researchers reassigned all women who were initially receiving tamoxifen to switch to exemestane after 2.5 to 3 years. All women had undergone surgery with curative intent for invasive breast cancer, 50% were node negative, and 36% had received chemotherapy. In a press briefing, Dr. Rea said there was no significant difference in the trial’s primary endpoint of disease-free survival at 5 years for women initially receiving exemestane versus those who switched from tamoxifen to exemestane. The researchers found no differences between the 2 arms (HR = 0.97; P = .604). When the researchers scrutinised results by nodal status, the pattern was unbroken. The events curve virtually overlapped for women who were node negative and those who were node positive. “For postmenopausal patients with endocrine sensitive early breast cancer the use of either 5 years of upfront exemestane or tamoxifen followed by exemestane are appropriate options,” said Dr. Rea. There were differences in adverse side effects. For the exemestane-treated patients side effects included osteoporosis, fractures, arthralgia, nerve compression, vaginal dryness, hypertension, and hyperlipidaemia. Those on tamoxifen generally experienced hot flushes, vaginal blooding and discharge, endometrial pathology, venous thrombosis, and muscle cramps. Funding for this study was provided by Pfizer. [Presentation title: Five Years of Exemestane as Initial Therapy Compared to 5 Years of Tamoxifen Followed by Exemestane: The TEAM Trial, a Prospective, Randomized, Phase III Trial in Postmenopausal Women With Hormone-Sensitive Early Breast Cancer. Abstract 11]
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