Lymphedema and quality of life in survivors of early-stage breast cancer.

BACKGROUND: The standard of care for early-stage breast cancer includes surgical removal of the tumor and axillary lymph node dissection (ALND). Despite increased use of breast-conserving surgery, lymphedema rates are similar to those with more radical surgery. HYPOTHESIS: Women who experience breast cancer-related lymphedema have a measurable reduction in quality of life compared with women without lymphedema. DESIGN: In a retrospective cohort study, we explored the association between lymphedema and quality of life, controlling for patient demographics, surgical factors, and treatment types. SETTINGS: An urban academic medical center and a community hospital. PARTICIPANTS: A total of 151 women surgically treated for early-stage breast cancer (stages 0-II) were assessed at least 1 year after their ALND. The women had been treated with either conservative surgery and radiation or mastectomy without radiation. MAIN OUTCOME MEASURES: Arm volume was measured by water displacement. Grip strength and range-of-motion measurements assessed arm function. The Functional Assessment of Cancer Therapy-Breast (FACT-B) quality-of-life instrument assessed breast, emotional, functional, physical, and social well-being. RESULTS: Lymphedema (an arm volume difference > or =200 cm(3)) was measured in 42 women (27.8%). Mastectomy or conservative surgery patients had similar lymphedema rates. Women with lymphedema in both surgical groups scored significantly lower on 4 of the 5 subsections than women without lymphedema, even after adjusting for other factors influencing quality of life. CONCLUSIONS: Lymphedema occurs at appreciable rates, and its impact on long-term quality of life in survivors of early-stage breast cancer should not be underestimated.

Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study.

BACKGROUND: Initial findings from the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial (P-1) demonstrated that tamoxifen reduced the risk of estrogen receptor-positive tumors and osteoporotic fractures in women at increased risk for breast cancer. Side effects of varying clinical significance were observed. The trial was unblinded because of the positive results, and follow-up continued. This report updates our initial findings. METHODS: Women (n = 13,388) were randomly assigned to receive placebo or tamoxifen for 5 years. Rates of breast cancer and other events were compared by the use of risk ratios (RRs) and 95% confidence intervals (CIs). Estimates of the net benefit from 5 years of tamoxifen therapy were compared by age, race, and categories of predicted breast cancer risk. Statistical tests were two-sided. RESULTS: After 7 years of follow-up, the cumulative rate of invasive breast cancer was reduced from 42.5 per 1000 women in the placebo group to 24.8 per 1000 women in the tamoxifen group (RR = 0.57, 95% CI = 0.46 to 0.70) and the cumulative rate of noninvasive breast cancer was reduced from 15.8 per 1000 women in the placebo group to 10.2 per 1000 women in the tamoxifen group (RR = 0.63, 95% CI = 0.45 to 0.89). These reductions were similar to those seen in the initial report. Tamoxifen led to a 32% reduction in osteoporotic fractures (RR = 0.68, 95% CI = 0.51 to 0.92). Relative risks of stroke, deep-vein thrombosis, and cataracts (which increased with tamoxifen) and of ischemic heart disease and death (which were not changed with tamoxifen) were also similar to those initially reported. Risks of pulmonary embolism were approximately 11% lower than in the original report, and risks of endometrial cancer were about 29% higher, but these differences were not statistically significant. The net benefit achieved with tamoxifen varied according to age, race, and level of breast cancer risk. CONCLUSIONS: Despite the potential bias caused by the unblinding of the P-1 trial, the magnitudes of all beneficial and undesirable treatment effects of tamoxifen were similar to those initially reported, with notable reductions in breast cancer and increased risks of thromboembolic events and endometrial cancer. Readily identifiable subsets of individuals comprising 2.5 million women could derive a net benefit from the drug.