DIBROMODULCITOL AND ADRIAMYCIN +/-TAMOXIFEN IN ADVANCED BREAST-CANCER

Abstract

The therapeutic effectiveness of combining tamoxifen with a combination chemotherapy regimen was tested in 135 patients with advanced breast cancer previously treated with chemotherapy. Patients were randomly allocated to receive dibromodulcitol + Adriamycin (DA, 55 patients) or DA + tamoxifen (DAT, 67 patients). An additional 13 patients < 50 yr of age were assigned to DAT (DATN). Pretreatment characteristis were similar across both regimens. DAT and DATN yielded similar results in the < 50-yr-old cohort. DAT tended to be superior to DA with respect to response rate (55% vs. 36%, P = 0.004), time to treatment failure (medians: 170 days vs. 110 days, log rank P = 0.001), responders'' time to treatment failure (360 days vs. 220 days, P = 0.035), and survival (340 days vs. 270 days, P = 0.18). Toxicity was similar in both regimens. Addition of tamoxifen to a second-line DA regimen appears to increase the therapeutic effectiveness. The addition of this antiestrogen to other chemotherapy regimens would also be beneficial.