ABSTRACT
This trial registered 250 women with metastatic breast cancer to be treated with six courses of CAF (cyclophosphamide, doxorubicin, and 5-fluourouracil (5-FU)) given every 3 weeks. After completion of this induction period, women whose disease either regressed or remained stable were randomly assigned to receive either continued treatment with CMF (cyclophosphamide, methotrexate, and 5-FU) (maintenance therapy) or no further treatment (observation) followed by treatment with CMF when disease progression occurred. Of 250 women who entered the induction period, 145 were randomized. The median time to progression following randomization was 9.4 months for patients in the maintenance therapy group and 3.2 months for patients in the observation group (p < 0.001). After re-induction therapy, the median time to progression was 3.5 months. Thus, the median time without progression was 9.4 months versus 6.7 months in favour of the maintenance therapy group. The median length of survival from the time of initial therapy was 21.1 months for the maintenance therapy group and 19.6 months for the observation group (p 0.67). Multivariate analysis showed that maintenance therapy was the most important determinant of time to progression, but was not significantly associated with prolonged survival. Performance status changes were similar in both groups, but nausea, vomiting, and mucositis were more frequent with maintenance therapy.
