Tuesday, January 18, 2011 (Last Updated: 01/19/2011)
TUESDAY, Jan. 18 (HealthDay News) -- Adjuvant breast cancer therapy with an aromatase inhibitor (exemestane) alone, or used following tamoxifen, offers similar disease-free survival rates but different side-effect profiles, according to a study published online Jan. 18 in The Lancet.
Cornelis J.H. van de Velde, M.D., of Leiden University Medical Centre in the Netherlands, and colleagues conducted the Tamoxifen Exemestane Adjuvant Multinational (TEAM) phase-3 clinical trial in nine countries, which studied the effects of exemestane alone (25 mg daily) or following tamoxifen (20 mg daily), in postmenopausal women with hormone-receptor-positive breast cancer. A total of 9,779 women were randomized 1:1 to each group and followed for five years.
The researchers found similar disease-free rates in the two groups at five years: 85 percent in the sequential group and 86 percent in the exemestane-alone group (hazard ratio, 0.97; P = 0.60). In the safety analysis, sequential treatment was associated with a higher incidence of gynecological symptoms (20 versus 11 percent), venous thrombosis (2 versus 1 percent), and endometrial abnormalities (4 versus <1 percent) than with exemestane alone. Exemestane alone was associated with a higher incidence of musculoskeletal adverse events (50 versus 44 percent), hypertension (6 versus 5 percent), and hyperlipidemia (5 versus 3 percent).
"Because of the differences in profiles of the adverse events between exemestane monotherapy and sequential treatment (tamoxifen followed by exemestane), consideration of the safety of these treatment strategies might play an important part in treatment decisions," the authors write.
The study was funded by Pfizer; several authors disclosed financial ties to pharmaceutical companies.
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