The use of high-dose cyclophosphamide, carmustine, and thiotepa plus autologous hematopoietic stem cell transplantation as consolidation therapy for high-risk primary breast cancer after primary surgery or neoadjuvant chemothermpy

We assessed the 5-year results of a high-dose cyclophosphamide, carmustine, and thiotepa (CBT) regimen plus autologous hematpoietic stem cell transplantation (AHST) as an adjuvant consolidation therapy for high-risk primary breast cancer patients with greater than or equal to10 positive axillary lymph nodes after primary surgery or greater than or equal to4 positive axillary lymph nodes after neoadjuvant chemotherapy and surgery. The associations of various potential prognostic factors with the relapse-free survival (RFS) rate and overall survival (OS) rate were determined. Between October 1992 and March 2000, 177 eligible patients (median age, 46 years) were given high-dose CBT followed by AHST. At a median follow-up of 63 months, the acute treatment-related mortality was 4.5%. Estimated 5-year RFS and OS rates were 62% and 68%, respectively, for all patients. For patients with greater than or equal to10 positive axillary lymph nodes after primary surgery, the 5-year RFS and OS rates were 71% and 70%, respectively, and for patients with greater than or equal to4 positive axillary lymph nodes after neoadjuvant chemotherapy, the 5-year RFS and OS rates were 53% and 66%, respectively. In 2-sided log-rank tests, earlier disease stage, a lower lymph node ratio, and a lower tumor score were associated with a prolonged RFS and OS. In a multivariate proportional hazards model, disease stage and lymph node ratio remained significant. We concluded that high-dose CBT with AHST for high-risk primary breast cancer is feasible, with comparable efficacy to other phase H studies. More than a 50% estimated 5-year survival rate was seen in all high-risk primary breast cancer patients. In accordance with results from recent randomized studies, we need to continue high-dose chemotherapy with AHST for patients with high-risk primary breast cancer in the phase III randomized setting. (C) 2004 American Society fir Blood and Marrow Transplantation.