title: Phase II study of an oxaliplatin/vinorelbine combination in patients with anthracycline- and taxane-pre-treated metastatic breast cancer.
abstract: A phase II study was conducted to evaluate the safety and efficacy of an oxaliplatin (OXA)/vinorelbine (VNB) combination in metastatic breast cancer (MBC) patients pre-treated with anthracyclines and taxanes. Patients received OXA at 130 mg/m (2-h i.v.), day 1, and VNB days 1 and 8 at 24-26 mg/m repeated every 3 weeks. Forty-two patients (median age 54; 64% with liver metastasis, 67% taxane resistant/refractory and 38% anthracycline resistant/refractory) were treated. A median of 4 cycles of treatment was given per patient, with 31% receiving 6 or more. Eleven partial responses and 16 patients with stable disease (five lasting more than 4 months) in 41 eligible patients were seen, for an overall response rate of 26.8% (95% confidence interval 14.2-42.9). Median follow-up was 15.9 months (7.2-30.6), median time to progression was 3.4 months and estimated overall survival was 12.7 months (20 events). Thirty-three patients experienced (National Cancer Institute Common Toxicity Criteria version 2) grade 3-4 neutropenia (one case of febrile neutropenia) and three patients had severe constipation requiring hospitalization. Nine patients developed grade 3 OXA-specific neurotoxicity. There were no treatment-related deaths. We conclude that OXA 130 mg/m (day 1) and VNB 24 mg/m (day 1 and 8) combination given every 3 weeks is effective with a good safety profile in MBC patients previously treated with anthracyclines and taxanes.
authors.affiliation: Centre Paul Strauss, Strasbourg, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Petit
authors.forename: Abdellatif
authors.initials: A
authors.lastname: Benider
authors.forename: Alejandro
authors.initials: A
authors.lastname: Yovine
authors.forename: Philippe
authors.initials: P
authors.lastname: Bougnoux
authors.forename: Dominique
authors.initials: D
authors.lastname: Spaeth
authors.forename: Frédérique
authors.initials: F
authors.lastname: Maindrault-Goebel
authors.forename: Daniel
authors.initials: D
authors.lastname: Serin
authors.forename: Jean-Dominique
authors.initials: JD
authors.lastname: Tigaud
authors.forename: Jean Christophe
authors.initials: JC
authors.lastname: Eymard
authors.forename: Hélène
authors.initials: H
authors.lastname: Simon
authors.forename: Brigitte
authors.initials: B
authors.lastname: Bertaux
authors.forename: Silvano
authors.initials: S
authors.lastname: Brienza
authors.forename: Esteban
authors.initials: E
authors.lastname: Cvitkovic
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000494:pharmacology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018432:Drug Resistance, Multiple; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D043823:Taxoids / Q000494:pharmacology; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D018943:Anthracyclines; D009944:Organoplatinum Compounds; D043823:Taxoids; D000077150:Oxaliplatin; D014747:Vinblastine; D000077235:Vinorelbine