Late follow-up of a randomized trial of surgery plus tamoxifen versus tamoxifen alone in women aged over 70 years with operable breast cancer.

BACKGROUND: Breast cancer has been considered a more indolent disease in the elderly, who are less tolerant of aggressive therapy. This trial tested the hypothesis that tamoxifen without surgery would provide adequate control of breast cancer for the remainder of life in elderly women, thereby sparing them surgery.
METHOD: Women aged over 70 years with operable, invasive breast cancer were randomized to receive either tamoxifen alone or surgery plus tamoxifen. Time to treatment failure (TTF), indicating initial primary treatment failure, was the primary endpoint. Overall mortality, and death from breast cancer were also compared between the two groups.
RESULTS: Between 1984 and 1991, 455 patients were included in the trial. The analysis was based on a median follow-up of 12.7 years. The TTF was significantly shorter in the tamoxifen alone group: hazard ratio (HR) 4.41 (95 per cent confidence interval (c.i.) 3.31 to 5.88). Ninety-three (40.4 per cent) of 230 patients randomized to tamoxifen alone underwent surgery for the management of their disease. Both overall mortality and mortality from breast cancer were significantly increased in the tamoxifen alone group, although the survival curves did not diverge for the first 3 three years: HR 1.29 (95 per cent c.i. 1.04 to 1.59) and 1.68 (95 per cent c.i. 1.15 to 2.47) respectively.
CONCLUSION: Omission of primary surgery in unselected elderly women with operable breast cancer who were fit for the procedure resulted in an increased rate of progression, therapeutic intervention and mortality. Copyright 2004 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

RCT Entities:   Population Interventions Outcomes