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: Thierry Petit, Abdellatif Benider, Alejandro Yovine, Philippe Bougnoux, Dominique Spaeth, Frédérique Maindrault-Goebel, Daniel Serin, Jean-Dominique Tigaud, Jean Christophe Eymard, Hélène Simon, Brigitte Bertaux, Silvano Brienza, Esteban Cvitkovic
• Journal: Anti-cancer drugs (Anticancer Drugs) Vol. 17 Issue 3 Pg. 337-43 (Mar 2006) ISSN: 0959-4973 [Print] England
• PMID: 16520663 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Anthracyclines
• Organoplatinum Compounds
• Taxoids
• Oxaliplatin
• Vinblastine
• Vinorelbine

Topics

• Adult
• Aged
• Anthracyclines (pharmacology)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, pathology)
• Drug Resistance, Multiple
• Drug Resistance, Neoplasm
• Female
• Humans
• Middle Aged
• Neoplasm Metastasis
• Organoplatinum Compounds (administration & dosage, adverse effects)
• Oxaliplatin
• Taxoids (pharmacology)
• Vinblastine (administration & dosage, adverse effects, analogs & derivatives)
• Vinorelbine