title: 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 chemotherapy.
abstract: We assessed the 5-year results of a high-dose cyclophosphamide, carmustine, and thiotepa (CBT) regimen plus autologous hematopoietic stem cell transplantation (AHST) as an adjuvant consolidation therapy for high-risk primary breast cancer patients with > or =10 positive axillary lymph nodes after primary surgery or > or =4 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 > or =10 positive axillary lymph nodes after primary surgery, the 5-year RFS and OS rates were 71% and 70%, respectively, and for patients with > or =4 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 II 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.
authors.affiliation: Department of Blood and Marrow Transplantation, The University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030, USA.
authors.forename: Yee Chung
authors.initials: YC
authors.lastname: Cheng
authors.forename: Gabriela
authors.initials: G
authors.lastname: Rondón
authors.forename: Ying
authors.initials: Y
authors.lastname: Yang
authors.forename: Terry L
authors.initials: TL
authors.lastname: Smith
authors.forename: James L
authors.initials: JL
authors.lastname: Gajewski
authors.forename: Michele L
authors.initials: ML
authors.lastname: Donato
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Shpall
authors.forename: Roy
authors.initials: R
authors.lastname: Jones
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
authors.forename: Richard E
authors.initials: RE
authors.lastname: Champlin
authors.forename: Naoto T
authors.initials: NT
authors.lastname: Ueno
mesh_terms: D000328:Adult; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000628:therapy*; D002330:Carmustine / Q000008:administration & dosage; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008875:Middle Aged; D013852:Thiotepa / Q000008:administration & dosage; D014184:Transplantation, Homologous
chemical_list: D018906:Antineoplastic Agents, Alkylating; D003520:Cyclophosphamide; D013852:Thiotepa; D002330:Carmustine