Treatment of node-negative breast cancer patients with short course of chemotherapy immediately after surgery.

In our first study, one short course of chemotherapy (cyclophosphamide, 5 mg/kg/day for 6 days iv) was given perioperatively to 507 patients with operable primary breast cancer; there were 519 control subjects. Randomization was done by telephone from the operating theater, and stratification was by hospital only. The side effects were negligible. With 20-year follow-up, the relapse rate was 60.5% in the control group and 48% in the treatment group (P less than 0.001). The overall survival benefit was marginally significant, but with correction for deaths not related to cancer, P was less than 0.02. A total of 309 patients in the treatment group and 301 in the control group were histologically node negative. The observed benefit in this subgroup was as good as in the node-positive subgroup, but the relapses were too few for testing of meaningful significance. In our second study, all patients received one short perioperative course, and the node-positive patients were randomized between control or continued chemotherapy for 1 year. This improved the beneficial results but also considerably increased the side effects.

RCT Entities:   Population Interventions Outcomes