title: A Phase II trial of docetaxel and carboplatin administered every 2 weeks as preoperative therapy for stage II or III breast cancer: NCCTG study N0338.
abstract: OBJECTIVE
  We conducted a multicenter phase II trial to assess the efficacy and toxicity of docetaxel and carboplatin combination as neoadjuvant therapy for stage II or III breast cancer (BC).
  
  
  METHODS
  Patients received 75 mg/m of docetaxel and AUC 6 of carboplatin on day 1 followed by pegfilgrastim on day 2, every 14 days for 4 cycles, followed by definitive breast surgery. The primary endpoint was the proportion of patients achieving pathologic complete remission (pCR), defined as disappearance of all invasive and in situ tumors in the breast and axilla after chemotherapy.
  
  
  RESULTS
  A total of 57 women (median age, 53 y) were enrolled. Thirty-eight (67%) had ER+, 31 (54%) PR+, and 6 (11%) HER2+ disease; 9 had triple negative BC (TNBC). Forty-three (75%; 95% confidence interval, 62%-86%) of 57 eligible patients had clinical response (15 clinical complete response, 28 clinical partial response). Nine (16%; 90% confidence interval, 10%-28%) patients achieved pCR. Four of 9 (44%) patients with TNBC achieved pCR. Thrombocytopenia (5%) was the only grade 4 adverse event. The most common grade 3 adverse events were thrombocytopenia (19%), fatigue (12%), and anemia (9%).
  
  
  CONCLUSIONS
  Four cycles of 2-weekly Docetaxel and Carboplatin are feasible with acceptable toxicity and a pCR rate of 16%. This regimen can be considered for neoadjuvant therapy of BC, particularly for patients not eligible for anthracycline therapy. A high pCR rate of 44% noted in a subset of patients with TNBC is encouraging and needs to be validated in large prospective trials.
authors.affiliation: *Hematology-Oncology Division, Mayo Clinic Florida, Jacksonville, FL †Mayo Clinic Arizona, Scottsdale, AZ ‡Mayo Clinic, Rochester §Duluth CCOP, Duluth, MN ∥Wichita CCOP, Wichita, KS.
authors.forename: Vivek
authors.initials: V
authors.lastname: Roy
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Pockaj
authors.forename: Jacob B
authors.initials: JB
authors.lastname: Allred
authors.forename: Heidi
authors.initials: H
authors.lastname: Apsey
authors.forename: Donald W
authors.initials: DW
authors.lastname: Northfelt
authors.forename: Daniel
authors.initials: D
authors.lastname: Nikcevich
authors.forename: Bassam
authors.initials: B
authors.lastname: Mattar
authors.forename: Edith A
authors.initials: EA
authors.lastname: Perez
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects*; D000077143:Docetaxel; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D011092:Polyethylene Glycols; D057234:Preoperative Period; D011994:Recombinant Proteins / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects*; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D016190:Carboplatin; D000069585:Filgrastim