title: Phase II study of cisplatin and 5-fluorouracil in previously treated metastatic breast cancer: an Eastern Cooperative Oncology Group study (PA 185).
abstract: OBJECTIVE
  The present study was conducted to investigate the efficacy and toxicity of a cisplatin and 5-fluorouracil (5-FU) combination in previously treated advanced breast cancer.
  
  
  METHODS
  Thirty-six women with recurrent metastatic breast cancer were entered on a phase II study of 5-FU 1000 mg/m2/day given intravenously as a continuous infusion on days 1-3 and cisplatin 30 mg/m2/day given intravenously over 1 h on days 2-4, repeated every 21 days. All subjects had received one previous chemotherapy regimen for metastatic disease and either progressed during treatment or relapsed after responding to previous chemotherapy. Fourteen patients had also received previous adjuvant chemotherapy, 17 patients had previous radiation therapy, and 29 patients had previous hormonal therapy.
  
  
  RESULTS
  Among 32 response-evaluable patients, there were 10 partial remissions (31%) and 1 complete remission (3%), with an overall objective response rate of 34%. Median duration of response was 4 months. Median survival was 10.5 months for responders and 9.5 months for the entire group. Toxicity was mild to moderate in most patients. Overall twelve patients experienced grade 3 toxicity (10 hematologic, 1 mucositis, and 2 nausea). There were no grade 4 or 5 toxicities.
  
  
  CONCLUSIONS
  Infusional cisplatin and 5-FU is a well tolerated and active regimen in women with previously treated advanced breast cancer.
authors.affiliation: Karmanos Cancer Institute, Wayne State University Detroit, Michigan, USA. kucuko@karmanos.org
authors.forename: O
authors.initials: O
authors.lastname: Kucuk
authors.forename: K J
authors.initials: KJ
authors.lastname: Pandya
authors.forename: R T
authors.initials: RT
authors.lastname: Skeel
authors.forename: H
authors.initials: H
authors.lastname: Hochster
authors.forename: M D
authors.initials: MD
authors.lastname: Abeloff
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005060:Europe; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin; D005472:Fluorouracil