A critique of the eleven randomised trials of high-dose chemotherapy for breast cancer

Data from 11 randomised studies on high-dose chemotherapy for breast cancer are currently available. Most investigators, patients and insurers would a gree that the two discredited South African trials are uninterpretable, and that the Scandinavian trial (which compares one very high-dose cycle versu s six escalated dose cycles) does not ask the question of high-dose therapy versus conventional-dose therapy. Only two of the eight remaining studies randomised more than 200 patients (783 patients for the Cancer and Leukaemi a Group B (CALGB) and 885 for the Dutch study). Both of these studies have trends in relapse-free survival favouring high-dose therapy. In a planned a nalysis of the first 284 patients entered into the Dutch study, with a medi an follow-up approximately 7 years, both disease-free and overall survival were significantly improved in the high-dose therapy arm. These and the oth er trials are discussed in detail below. (C) 2001 Elsevier Science Ltd. All rights reserved.