Patient-Reported Symptoms and Quality of Life During Treatment With Tamoxifen or Raloxifene for Breast Cancer Prevention. The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial

Abstract

The investigators assessed quality of life for 19,747 participants in a double-blind, randomized trial comparing tamoxifen (20 mg daily) and raloxifene (60 mg daily), both given for 5 years, for their ability to lower the risk of invasive breast cancer in postmenopausal women. Patients were followed at nearly 200 centers throughout North America for a median potential time of 4.6 years. Participants completed a 36-item symptom checklist. Quality of life was estimated using the Medical Outcomes Study Short-Form Health Survey and the Medical Outcomes Study Sexual Activity Questionnaire. Depressive symptoms were measured using the Center for Epidemiologic Studies-Depression scale, a 20-item self-report scale. The questionnaires were administered before treatment and every 6 months for 5 years. Quality-of-life scores worsened modestly over 5 years of follow up but did not differ significantly between the 2 treatment groups. Sexual function was slightly better for women assigned to tamoxifen therapy. Raloxifene-treated women reported more severe symptoms over the 5-year study period for musculoskeletal problems, dyspareunia, and weight gain. Women taking tamoxifen reported more severe symptoms from gynecologic problems and more marked vasomotor symptoms, leg cramps, and symptoms of bladder control disorders. There were no significant group differences in mental health problems, including depression. In general, differences in symptom severity between the 2 treatment groups were small.