No Significant QOL Differences for Raloxifene and Tamoxifen

ASCO — Five-year follow-up data from the STAR (Study of Tamoxifen and Raloxifene) trial show that the drugs are similarly effective for preventing invasive breast cancer in postmenopausal women at high risk for the disease, that raloxifene (Evista) was somewhat less effective at preventing noninvasive breast cancer, and that raloxifene is associated with a 30% lower risk of thromboembolic events than tamoxifen, researchers reported at the American Society of Clinical Oncology 42nd Annual Meeting (abstract LBA5). [See ONI May 2006, page 18, for a report of the findings.]

"We now have two drugs that are effective for reducing breast cancer risk in women at high risk for this disease, neither of which impairs overall quality of life [QOL] significantly," said Patricia A. Ganz, MD, of UCLA's Jonsson Comprehensive Cancer Center. "The choice of the appropriate drug for each patient should be made by considering her medical history, current symptoms, and personal preference," said Dr. Ganz, who directed the QOL assessment in the STAR trial (abstract LBA561).

At ASCO, she presented the patient-reported outcomes from the study. Questionnaires were administered at baseline, then every 6 months for 60 months and again at 72 months. Symptoms were assessed in all participants. The QOL study included 1,983 STAR participants; median follow-up was 6.5 years.

Dr. Ganz reported that means scores on the CES-D depression scale and SF-36 physical and mental component scales worsened slightly in both groups, with no significant differences between tamoxifen and raloxifene. There were significant differences for severity of symptoms. Women taking raloxifene reported worse musculoskeletal problems, dyspareunia, and weight gain; those taking tamoxifen reported worse hot flashes, leg cramps, and bladder and gynecologic problems.

"There were no significant differences between tamoxifen and raloxifene in patient-reported outcomes for physical health, mental health, or depression," Dr. Ganz concluded. "While symptom severity was generally low, the pattern of symptoms differed between raloxifene and tamoxifen."