Adrenalectomy-oophorectomy and combined chemotherapy for carcinoma of the breast with metastases.

Thirty-one patients with carcinoma of the breast with metastases were treated by adrenalectomy-oophorectomy and randomized either for combined chemotherapy, vincristine, fluorouracil, methotrexate and thiotepa, beginning within one week after operation and continuing for three months or no chemotherapy. Statistical analyses were Gehan's modification of the Wilcoxon test for censored data, chi-square tests and life table analysis. Pretreatment characteristics--menopausal status, age, disease-free interval, prior hormone treatment and sites of metastases--of both groups were similar. Objective response occurred in 73 per cent of 11 patients in the treatment. A group compared with 47 per cent of 15 patients in the treatment B group, p greater than 0.50. Median duration to relapse in responders was 16 months in the treatment A group and 15 months in the treatment B group, p greater than 0.50. Median survival was 19 months in the treatment A group and 20 months in the treatment B group, p greater than 0.50. Results were not significant, and inclusion of five patients with less than three months of treatment, did not alter the results. Hence, the group receiving early symptomatic treatment did not show an improved response rate, improved duration of remission or enhanced survival time from ablative treatment.

RCT Entities:   Population Interventions Outcomes