title: Oxaliplatin and 5-fluorouracil for heavily pretreated metastatic breast cancer: a preliminary phase II study.
abstract: Oxaliplatin shows in vitro and in vivo synergism with 5-fluorouracil (5-FU). In this study we evaluate the clinical efficacy of oxaliplatin and 5-FU in heavily pretreated metastatic breast cancer. Eligible patients had to be pretreated with both anthracyclines and taxanes. Pretreatment with capecitabine was recommended but not mandatory. Chemotherapy: oxaliplatin 85 mg/m2/2 h day 1, folinic acid 400 mg/m2/2 h day 1, 5-FU 400 mg/m2 i.v. push day 1, 5-FU 2400 mg/m2 continuous infusion/48 h day 1, q2w. Fourteen patients were included: one male and 13 females; age: median 53 years (38-62); ECOG 0: three patients, 1: nine patients, 2: two patients; all patients were pretreated with anthracyclines and taxanes, capecitabine: nine patients, vinorelbine: six patients, trastuzumab: four patients, hormonal therapy: 12 patients; lines of prior palliative chemotherapy: 0: one patient, 1: three patients, 2: one patient, 3: three patients, 4: four patients, 5: two patients.
  
  
  RESULTS
  median number of cycles: 8 (range 1-17). Toxicity (14 patients evaluable; no. of patients with Common Toxicity Criteria grade 3/4): asthenia: 2/-, paraesthesia 3/-, leuko/neutropenia: 1/2, no neutropenic fever, other (alopecia, skin): 2/-. Response (12 patients evaluable, all with bidimensionally measurable disease): complete remission: no patients, partial remission: four patients (33%, all confirmed), stable disease: five patients, progressive disease: three patients. We conclude that despite the small number of patients, the combination of 5-FU and oxaliplatin shows promising efficacy in this heavily pretreated population.
authors.affiliation: Charité, Humboldt University Berlin, Campus Virchow Klinikum, Berlin, Germany.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Thuss-Patience
authors.forename: Gunter
authors.initials: G
authors.lastname: von Minckwitz
authors.forename: Albrecht
authors.initials: A
authors.lastname: Kretzschmar
authors.forename: Sibylle
authors.initials: S
authors.lastname: Loibl
authors.forename: Gerhard
authors.initials: G
authors.lastname: Schaller
authors.forename: Bernd
authors.initials: B
authors.lastname: Dörken
authors.forename: Peter
authors.initials: P
authors.lastname: Reichardt
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004357:Drug Synergism; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D005472:Fluorouracil