Clinical results in 2001 show high dose therapy and hematopoietic progenitor cell transplantation as a therapeutic option for breast cancer.

we review and comment on the data from ran-domized studies so far reported and try to indicate what could be next in this story. We also suggest what may be the attitude we should take in our everyday clinical practice. Operable, high-risk breast cancer (adjuvant therapy) In the early 1990s phase II studies from several centers and the European and American registries showed a 60-65% disease-free survival (DFS) for patients with high-risk operable BC at 4-5 years post-transplant. 13-15 Since these data appeared better than those following standard dose therapy , several centers and cooperative groups began phase III trials, comparing transplant to best available conventional therapy. Two early phase III ran-domized studies from the Netherlands Cancer Institute and the MD Anderson Cancer Center have been published. 16,17 No advantage of HDC has emerged. However, both studies were designed to detect an optimistic 30% difference in relapse-free survival (RFS) between high-dose versus conventional adjuvant therapy and were too small (81 and 78 patients randomized, respectively) to assess smaller differences that cannot be excluded. 18 In this regard it is interesting to note that, in the subsequent larger Netherlands Cancer Institute phase III study, the HDC arm gave an overall survival (OS) benefit of about 10% in the first 284 patients studied, as detailed below in this article. After excluding a misleading and unreliable trial, 11 to date 5 randomized studies with large patient accrual have been either published or presented at the 2000 and 2001 ASCO Meetings (Table 1). The Scandinavian Study Group multicenter trial 19 randomized 525 high risk primary BC patients to receive 3 cycles of fluorouracil (5-FU), cyclophos-P resentations of phase III trials evaluating high dose therapy (HDC) with autologous hemato-poietic progenitor cell transplantation (APCT) for breast cancer (BC) at the recent American Society of Clinical Oncology (ASCO) Meetings prompted us to comment on their results and review previously available clinical data. In the last decade, we have observed very peculiar highs and lows in the enthusiasm of clinicians for HDC with APCT for treatment of BC. Early trials of HDC, based on favorable laboratory and clinical indicators, 1,2 initiated in the 1980s, suggested that HDC with APCT might favorably affect the course of operable high-risk and metastatic BC. 3 Phase II studies created positive expectations among physicians and their patients, to such an extent that HDC with APCT became widely used as a therapeutic option also …