title: Long-term outcomes after adjuvant treatment of sequential versus combination docetaxel with doxorubicin and cyclophosphamide in node-positive breast cancer: BCIRG-005 randomized trial.
abstract: The optimal regimen for adjuvant breast cancer chemotherapy is undefined. We compared sequential to concurrent combination of doxorubicin and cyclophosphamide with docetaxel chemotherapy in women with node-positive non-metastatic breast cancer. We report the final, 10-year analysis of disease-free survival (DFS), overall survival (OS), and long-term safety.
  
  
  
  A total of 3298 women with HER2 nonamplified breast cancer were randomized to doxorubicin and cyclophosphamide every 3 weeks for four cycles followed by docetaxel (AC → T) every 3 weeks for four cycles or docetaxel, doxorubicin, and cyclophosphamide (TAC) every 3 weeks for six cycles. The patients received standard radiotherapy and endocrine therapy and were followed up for 10 years with annual clinical evaluation and mammography.
  
  
  
  The 10-year DFS rates were 66.5% in the AC → T arm and 66.3% in the TAC arm (P = 0.749). OS was 79.9% in the AC → T arm and 78.9% in the TAC arm (P = 0.506). TAC was associated with higher rates of febrile neutropenia, although G-CSF primary prophylaxis greatly reduced this risk. AC → T was associated with a higher rate of myalgia, hand-foot syndrome, fluid retention, and sensory neuropathy.
  
  
  
  This 10-year analysis of the BCIRG-005 trial confirmed that the efficacy of TAC was not superior to AC → T in women with node-positive early breast cancer. The toxicity profiles differ between arms and were consistent with previous reports. The TAC regimen with G-CSF support provides shorter adjuvant treatment duration with less toxicity.
  
  
  
  ClinicalTrials.gov Identifier NCT00312208.
authors.affiliation: Department of Oncology, Cross Cancer Institute, Edmonton, Canada. Electronic address: john.mackey@trioncology.org.
authors.forename: J R
authors.initials: JR
authors.lastname: Mackey
authors.affiliation: Department of Oncology, Postgraduate Medical Education Centre, Warsaw, Poland.
authors.forename: T
authors.initials: T
authors.lastname: Pieńkowski
authors.affiliation: All-Ireland Co-Operative Oncology Research Group, Dublin City University, Dublin, Ireland.
authors.forename: J
authors.initials: J
authors.lastname: Crown
authors.affiliation: Department of Oncology, University of California, Los Angeles, USA.
authors.forename: S
authors.initials: S
authors.lastname: Sadeghi
authors.affiliation: Department of Oncology, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Martin
authors.affiliation: Breast Cancer Research Centre, WA & Curtin University, Perth, Australia.
authors.forename: A
authors.initials: A
authors.lastname: Chan
authors.affiliation: Department of Oncology, University of Alabama Comprehensive Cancer Center, Birmingham, USA.
authors.forename: M
authors.initials: M
authors.lastname: Saleh
authors.affiliation: Department of Oncology, William Osler Health Center, Brampton Civic Hospital, Brampton.
authors.forename: S
authors.initials: S
authors.lastname: Sehdev
authors.affiliation: Department of Oncology, CHU de Québec/Université Laval, Québec, Canada.
authors.forename: L
authors.initials: L
authors.lastname: Provencher
authors.affiliation: Department of Oncology, Research Institute of Oncology N.N. Petrov Rosmedtechnologiy, St Petersburg, Russian Federation.
authors.forename: V
authors.initials: V
authors.lastname: Semiglazov
authors.affiliation: Department of Pathology, University of Southern California, Los Angeles, USA.
authors.forename: M F
authors.initials: MF
authors.lastname: Press
authors.affiliation: Department of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Sauter
authors.affiliation: Translational Research in Oncology, Edmonton, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Lindsay
authors.affiliation: Translational Research in Oncology, Paris, France.
authors.forename: V
authors.initials: V
authors.lastname: Houé
authors.affiliation: Biostatistics, International Drug Development Institute Statistics, Leuven, Belgium.
authors.forename: M
authors.initials: M
authors.lastname: Buyse
authors.affiliation: Translational Research in Oncology, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Drevot
authors.affiliation: Clinical Studies, Sanofi, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Hitier
authors.affiliation: Clinical Studies, Sanofi, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Bensfia
authors.affiliation: Gynecology and Obstetrics, Isarklinikum & IOZ, Munich, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Eiermann
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000145:classification / Q000503:physiopathology*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000235:genetics; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D003520:Cyclophosphamide; D000077143:Docetaxel; D004317:Doxorubicin; D016179:Granulocyte Colony-Stimulating Factor; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; C508053:ERBB2 protein, human
keywords: adjuvant chemotherapy; cyclophosphamide; docetaxel; doxorubicin; early stage breast cancer