In the STAR trial, patient-reported symptoms were collected from all participants using a 36-item symptom checklist (Land et al 2006
). Quality of life was measured with the Medical Outcomes Study Short-Form Health Survey (SF-36) (McHorney et al 1992
; Ware and Sherbourne 1992
), the Center for Epidemiologic Studies-Depression (CES-D) (Radloff 1977
), and the Medical Outcomes Study Sexual Activity Questionnaire (Sherbourne 1992
) in a substudy of 1983 participants with a median follow-up of 5.4 years (range, 4.6–6.0 years). Questionnaires were administered before treatment, every 6 months for 60 months and at 72 months. Primary quality of life end points were the SF-36 physical (PCS) and mental (MCS) component summaries.
Among women in the quality of life analysis in STAR, mean PCS, MCS, and CES-D scores worsened modestly throughout the study with no significant difference between the tamoxifen and raloxifene groups. Sexual function was slightly better for participants assigned to tamoxifen. Of the women in the symptom assessment analyses, those in the raloxifene group reported greater mean symptom severity over 60 months of assessments than the women in the tamoxifen group for musculoskeletal problems, dyspareunia, and weight gain. Women in the tamoxifen group reported greater mean symptom severity for gynecological problems, vasomotor symptoms, leg cramps, and bladder control symptoms. No significant differences existed, however, between the tamoxifen and raloxifene groups in patient-reported outcomes for physical health, mental health, and depression, although the tamoxifen group reported better sexual function. Although mean symptom severity was low among these postmenopausal women, those in the tamoxifen group reported more gynecological problems, vasomotor symptoms, leg cramps, and bladder control problems, whereas women in the raloxifene group reported more musculoskeletal problems, dyspareunia, and weight gain.
There were 36 cases of uterine cancer with tamoxifen and 23 with raloxifene (RR, 0.62; 95% CI, 0.35–1.08). No differences were found for other invasive cancer sites, for ischemic heart disease events, or for stroke.
Thromboembolic events (ie, pulmonary embolism and deep venous thrombosis) occurred less often in the raloxifene group (RR, 0.70; 95% CI, 0.54–0.91). The absolute rate of venous thromboembolism was significantly lower among women assigned to raloxifene (2.6 per 1000) than among those assigned to tamoxifen (3.7 per 1000). The cumulative incidence of serious clotting events at 6 years was 21.0 per 1000 for the raloxifene group and 16.0 per 1000 for raloxifene group. Pulmonary embolism and DVT occurred in 54 vs 35 women (RR = 0.64; 95% CI, 0.41–1.00) and in 87 vs 65 women (RR = 0.74; 95% CI, 0.53–1.03) assigned to tamoxifen and raloxifene, respectively.
There were 53 strokes associated with tamoxifen in the STAR trial and 51 stroke events among the women taking raloxifene. The number of osteoporotic fractures in the groups was similar. There were fewer cataracts (RR, 0.79; 95% CI, 0.68–0.92) and cataract surgeries (RR, 0.82; 95% CI, 0.68–0.99) in the women taking raloxifene. There was no difference in the total number of deaths or in causes of death.