10597 Background: To determine how menopausal symptoms and quality of life changed when adjuvant tamoxifen has been suspended for any reason in favor of anastrozole in early breast cancer (BC) patients (pts). Methods: Major inclusion criteria: severe side effects or serious potential diseases caused by tamoxifen (20 mg die) that switched to anastrozole (1 mg die); confirmed early BC radically resected and with positive hormonal receptors; postmenopausal status; adjuvant chemo and/or radiotherapy suspended at least 4 wks before the hormonal switch. Exclusion criteria: discontinuation of tamoxifen for endocrine symptoms. Menopausal symptoms and health-related quality of life were assessed by the series of Functional Assessment of Cancer Therapy-Breast (FACT-B) plus endocrine subscale (ES) questionnaires at the switch and 3, 6, 9, and 12 months later. Sample size was decided by the effect size method (SD fixed as 0.5, effect of medium value). Score modifications were evaluated by one-way ANOVAS. Results: From Feb 2002 to Jun 2003, a total of 44 women were enrolled into the study. Discontinuation of tamoxifen was for: asymptomatic uterine problems (endometrium thickening or fibromatosis) in 56% of pts; cardiovascular disorders (mainly leg thrombosis and phlebitis) in 18%; patient’s refusal in 9%; GI persistent side effects in 5%; other reasons in 12% of pts. Endocrine symptoms ameliorated between baseline and 3 months, and stabilized thereafter. Mean ES scores improvement from baseline test was +3 (95% CI, 1 to 5), +4 (95% CI, 3 to 6), +5 (95% CI, 3 to 7), and +4 (95% CI, 3 to 6) at 3, 6, 9 and 12 months, respectively. FACT-ES global score had a mean improvement during 1-yr period of 9 points (95% CI 6 to 13, p < .0005), with 22 patients (50%) ever reaching an increase ≥ 5% of the baseline score. There also was a significant improvement in TOI score (+4 points, 95% CI 2 to 6, p < .0005), and physical and breast cancer subscales (+2, 95% CI 1 to 2, p < .001, and +1, 95% CI, 1 to 2, p < .001, respectively). Pts receiving anastrozole reported higher rate of mild arthritic and bone pain (27% vs 7%, p = .021). Conclusion: When a patient develops an endocrine symptom while on tamoxifen, a change in favor of anastrozole should be considered to minimize those symptoms and to improve quality of patient’s life. No significant financial relationships to disclose.
Comparison of patient reported quality of life and impact of treatment side effects experienced with a taxane-containing regimen and standard anthracycline based chemotherapy for early breast cancer: 6year results from the UK TACT trial (CRUK/01/001)