title: Neoadjuvant therapy with paclitaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide chemotherapy and concurrent trastuzumab in human epidermal growth factor receptor 2-positive operable breast cancer: an update of the initial randomized study population and data of additional patients treated with the same regimen.
abstract: OBJECTIVE
  Findings from our previously published phase III randomized trial showed a high pathologic complete remission (CR) rate in patients with human epidermal growth factor receptor 2-positive breast cancer after the concurrent administration of trastuzumab and paclitaxel, followed by concurrent trastuzumab and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) preoperative chemotherapy. The safety and efficacy data of initial population were updated, with inclusion of additional experience with the same therapy.
  
  
  METHODS
  The initial randomized study population of 42 patients were randomly assigned to either four cycles of paclitaxel followed by four cycles of FEC or to the same chemotherapy with simultaneous weekly trastuzumab for 24 weeks. All data were updated through November 2005.
  
  
  RESULTS
  Pretreatment characteristics of the initial patients and of the second cohort were similar. In the second cohort, pathologic CR rate was 54.5% (95% confidence interval, 32.2-75.6%) and the pathologic CR rate among all patients treated with chemotherapy plus trastuzumab was 60% (95% confidence interval, 44.3-74.3%). Three patients in the chemotherapy only group have recurred, and one has died. There has been no recurrences in the patients randomized to chemotherapy plus trastuzumab, and the estimated disease-free survival at 1 and 3 years was 100% (P = 0.041). In additional cohort treated with chemotherapy and trastuzumab at the median follow-up of 16.3 months, no patients had recurred. No new safety concerns were observed in this study.
  
  
  CONCLUSIONS
  Our expanded cardiac safety data and the updated efficacy data showed that the natural history of this subset of breast cancer patients can be substantially modified by this treatment approach.
authors.affiliation: Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas 77030, USA. abuzdar@mdanderson.org
authors.forename: Aman U
authors.initials: AU
authors.lastname: Buzdar
authors.forename: Vicente
authors.initials: V
authors.lastname: Valero
authors.forename: Nuhad K
authors.initials: NK
authors.lastname: Ibrahim
authors.forename: Deborah
authors.initials: D
authors.lastname: Francis
authors.forename: Kristine R
authors.initials: KR
authors.lastname: Broglio
authors.forename: Richard L
authors.initials: RL
authors.lastname: Theriault
authors.forename: Lajos
authors.initials: L
authors.lastname: Pusztai
authors.forename: Marjorie C
authors.initials: MC
authors.lastname: Green
authors.forename: Sonja E
authors.initials: SE
authors.lastname: Singletary
authors.forename: Kelly K
authors.initials: KK
authors.lastname: Hunt
authors.forename: Aysegul A
authors.initials: AA
authors.lastname: Sahin
authors.forename: Francisco
authors.initials: F
authors.lastname: Esteva
authors.forename: William F
authors.initials: WF
authors.lastname: Symmans
authors.forename: Michael S
authors.initials: MS
authors.lastname: Ewer
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Buchholz
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D003520:Cyclophosphamide / Q000627:therapeutic use*; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage*; D066246:ErbB Receptors / Q000096:biosynthesis*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage*; D018719:Erb-b2 Receptor Tyrosine Kinases; D013997:Time Factors; D000068878:Trastuzumab; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003520:Cyclophosphamide; D015251:Epirubicin; D066246:ErbB Receptors; D005472:Fluorouracil; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human