Comparison of DES vs DES + chlorambucil in women with first recurrence of breast cancer

Thirty-four women with first recurrence of breast cancer were randomized into two groups, and received either Diethylstilbestrol (DES) 5 mg orally (PO) t.i.d. alone, or in combination with Chlorambucil (CB) 0.1--0.2 mg/kg/day PO. All patients randomized were greater than 5 years postmenopausal at the time of the study and had no prior chemical or hormonal therapy. Estrogen receptors were not available. There was no significant difference between Groups A and B with respect to frequency of objective response or mean duration of that response, with the values for Group A being 46.2% and 4.8 months, respectively, and for Group B, 46.7% and 4.8 months (P greater than 0.05). The most common toxicities noted for both groups were nausea and vomiting, edema, weakness, and thrombophlebitis. The risk of major toxicity necessitating withdrawal from the study was greater in Group B due to the added danger of thrombocytopenia/pancytopenia. The addition of CB to DES does not appear to offer any significant advantage over DES alone in women with first recurrence of breast cancer.