ABSTRACT
In this large single-arm phase II study of high-risk breast cancer ( 10 nodes positive), 85 patients were treated with standard-dose CAF for 3 cycles, followed by bone marrow harvest (with or without peripheral blood stem cell collection), a fourth CAF, and finally with high-dose chemotherapy (cyclophosphamide, cisplatin, and carmustine) and autologous bone marrow support (ABMS). All estrogen receptor-positive patients received tamoxifen, and locoregional radiotherapy was added to all patients after 3 locoregional recurrences were observed. The DFS and OS rates after 2.5 years median follow-up were considered substantially superior when compared to a historical population of high-risk breast cancer patients with similar characteristics ( 10 nodes positive, 56 years old) who were treated with standard-dose CMF or CAF in clinical trials. A very thorough description of treatment-related toxicity made it clear that both morbidity (especially infectious and pulmonary) and mortality were high with this high-dose regimen. Post-transplant QOL assessment suggested no long-term sequelae from the treatment.
