Combined cytotoxic and progestogen therapy for advanced breast cancer.

Sixty-nine patients with advanced breast cancer treated with cytotoxic chemotherapy were randomized to receive concomitantly either norethisterone acetate (progestogen group) or a placebo (placebo group). Objective responses were seen in 53% of patients in the progestogen group and 61% of patients in the placebo group. The median duration of response was the same for both groups (38 weeks). Three out of ten patients in the placebo group, who received subsequently the progestogen on relapse, had a further objective regression. The overall survival in the two groups was similar, although in a sub-group of patients who had operable tumors, but a subsequent short disease-free interval, survival was significantly better in the placebo group. There was less myelosuppression in the progestogen group, who were able to receive higher doses of cytotoxic drugs. Less nausea and vomiting occurred in the progestogen group, but subjective side effects were similar. It is concluded that there is no advantage therapeutically in combining cytotoxic chemotherapy and progestogen therapy and, in some patients, better results are obtained using the two treatments sequentially.

RCT Entities:   Population Interventions Outcomes