title: A phase II study of paclitaxel plus carboplatin as first-line chemotherapy for women with metastatic breast carcinoma.
abstract: BACKGROUND
  This Phase II multicenter study evaluated the efficacy and toxicity of paclitaxel (200 mg/m(2) by 3-hour infusion) with carboplatin (area under the curve 6 mg/mL per minute) administered every 3 weeks as first-line therapy for women with metastatic breast carcinoma.
  
  
  METHODS
  Eligible patients had measurable metastatic disease and an Eastern Cooperative Oncology Group performance status of 0-2. Prior adjuvant chemotherapy, including anthracycline-based therapy, was allowed, as was prior hormonal therapy as part of either adjuvant treatment or treatment for metastasis. Prior therapy with taxanes or platinum was not allowed.
  
  
  RESULTS
  A total of 53 patients were enrolled in this study, with 50 patients evaluable for response and toxicity. The overall response rate was 62% (95% confidence interval ¿CI, 48-75%); 16% of patients had complete responses and 46% had partial responses. The median time to progression was 7.3 months (95% CI, 5.9-12.9), and the 12-month survival estimate was 72% (95% CI, 61-86%). Therapy was generally well tolerated. Grade 3-4 neutropenia was the predominant toxicity, observed in 82% of patients, but there were no episodes of febrile neutropenia or sepsis. Hematopoietic growth factors were not routinely necessary. Grade 3 peripheral neuropathy occurred in 16% of patients.
  
  
  CONCLUSIONS
  Paclitaxel (200 mg/m(2)) with carboplatin (area under the curve 6 mg/mL per minute) demonstrated substantial efficacy in patients with metastatic breast carcinoma, and the 12-month survival rate of 72% was encouraging. This therapy represents a viable option for patients with metastatic disease.
authors.affiliation: Division of Hematology/Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota, USA.
authors.forename: E A
authors.initials: EA
authors.lastname: Perez
authors.forename: D W
authors.initials: DW
authors.lastname: Hillman
authors.forename: P J
authors.initials: PJ
authors.lastname: Stella
authors.forename: J E
authors.initials: JE
authors.lastname: Krook
authors.forename: L C
authors.initials: LC
authors.lastname: Hartmann
authors.forename: T R
authors.initials: TR
authors.lastname: Fitch
authors.forename: A K
authors.initials: AK
authors.lastname: Hatfield
authors.forename: J A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: S
authors.initials: S
authors.lastname: Nair
authors.forename: C G
authors.initials: CG
authors.lastname: Kardinal
authors.forename: J N
authors.initials: JN
authors.lastname: Ingle
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016190:Carboplatin / Q000008:administration & dosage; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D016190:Carboplatin; D017239:Paclitaxel