title: Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer: Southwest Oncology Group/Intergroup study 9623.
abstract: OBJECTIVE
  Southwest Oncology Group (SWOG)/Intergroup study 9623 was undertaken to compare treatment with an anthracycline-based adjuvant chemotherapy regimen followed by high-dose chemotherapy (HDC) with autologous hematopoietic progenitor cell support (AHPCS) with a modern dose-dense dose-escalated (nonstandard) regimen including both an anthracycline and a taxane.
  
  
  METHODS
  Participants in this phase III randomized study had operable breast cancer involving four or more axillary lymph nodes and had completed mastectomy or breast-conserving surgery. Patients were randomly assigned to receive four cycles of doxorubicin and cyclophosphamide followed by HDC with AHPCS or to receive sequential dose-dense and dose-escalated chemotherapy with doxorubicin, paclitaxel, and cyclophosphamide. The primary end point of this study was disease-free survival (DFS).
  
  
  RESULTS
  Among 536 eligible patients, there was no significant difference between the two arms for DFS or overall survival (OS). Estimated five-year DFS was 80% (95% CI, 76% to 85%) for dose-dense therapy and 75% (95% CI, 69% to 80%) for transplantation. Estimated 5-year OS was 88% (95% CI, 84% to 92%) for dose-dense therapy and 84% (95% CI, 79% to 88%) for transplantation.
  
  
  CONCLUSIONS
  There is no evidence that transplantation was superior to dose-dense dose-escalated therapy. Transplantation was associated with an increase in toxicity and a possibly inferior outcome, although the hazard ratios were not significantly different from 1.
authors.affiliation: Cleveland Clinic Foundation, Cleveland, OH, USA.
authors.forename: Halle C F
authors.initials: HC
authors.lastname: Moore
authors.forename: Stephanie J
authors.initials: SJ
authors.lastname: Green
authors.forename: Julie R
authors.initials: JR
authors.lastname: Gralow
authors.forename: Scott I
authors.initials: SI
authors.lastname: Bearman
authors.forename: Danika
authors.initials: D
authors.lastname: Lew
authors.forename: William E
authors.initials: WE
authors.lastname: Barlow
authors.forename: Clifford
authors.initials: C
authors.lastname: Hudis
authors.forename: Antonio C
authors.initials: AC
authors.lastname: Wolff
authors.forename: James N
authors.initials: JN
authors.lastname: Ingle
authors.forename: Helen K
authors.initials: HK
authors.lastname: Chew
authors.forename: Anthony D
authors.initials: AD
authors.lastname: Elias
authors.forename: Robert B
authors.initials: RB
authors.lastname: Livingston
authors.forename: Silvana
authors.initials: S
authors.lastname: Martino
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008875:Middle Aged; D012008:Recurrence; D033581:Stem Cell Transplantation; D016019:Survival Analysis