ABSTRACT

This randomized trial comparing high-dose chemotherapy plus haematopoietic stem cell rescue with a prolonged course of monthly conventional-dose chemotherapy in women with metastatic breast cancer enrolled 553 patients, of whom 310 had complete or partial responses to induction chemotherapy. Of these 310 patients, 110 were randomized to high-dose therapy plus haematopoietic stem cells and 89 to conventional-dose chemotherapy. There was no difference in overall survival rate at 3 years between the two treatment groups (32% in the transplantation group and 38% in the conventional chemotherapy group). Nor was there any significant difference between the two treatments in median time to progression (9.6 months for high-dose chemotherapy plus haematopoietic stem cells and 9 months for conventional-dose chemotherapy).