Health-related quality of life and tamoxifen in breast cancer prevention: A report from the National Surgical Adjuvant Breast and Bowel Project P-1 study

Purpose: This is the initial report from the health-related quality of life (HRQL) component of the National Surgical Adjuvant Breast and Bowel projec t Breast Cancer Prevention Trial. This report provides an overview of HRQL findings, comparing tamoxifen and placebo groups, and advice to clinicians counseling women about the use of tamoxifen in a prevention setting. Patients and Methods: This report covers the baseline and the first 36 mont hs of follow-up data on 11,064 women recruited over the first 24 months of the study Findings are presented from the Center for Epidemiological Studie s-Depression Scale (CES-D), the Medical Outcomes Study 36-item Short Form H ealth Status Survey (MOS SF-36) and sexual functioning scale, and a symptom checklist. Results: No differences were found between placebo and tamoxifen groups for the proportion of participants scoring above a clinically significant leve l on the CES-D, No differences were found between groups for the MOS SF-36 summary physical and mental scores. The mean number of symptoms reported wa s consistently higher in the tamoxifen group and was associated with vasomo tor and gynecologic symptoms. Significant increases were found in the propo rtion of women on tamoxifen reporting problems of sexual functioning at a d efinite or serious level, although overall rates of sexual activity remaine d similar. Conclusion: Women need to be informed of the increased frequency of vasomot or and gynecologic symptoms and problems of sexual functioning associated w ith tamoxifen use. Weight gain and depression, two clinical problems anecdo tally associated with tamoxifen treatment, were not increased in frequency in this trial in healthy women, which is good news that also needs to be co mmunicated. (C) 1999 by Americcn Society of Clinical Oncology.