title: Phase I/II study of biweekly vinorelbine and oxaliplatin as first-line treatment in patients with metastatic breast cancer.
abstract: The objective of this phase I/II study was to establish the recommended dose of biweekly vinorelbine and oxaliplatin in patients with metastatic breast cancer and to evaluate the efficacy and safety profile of this schedule as first-line treatment. Four different dose levels of vinorelbine and oxaliplatin were selected for the phase I study: (i) 25 and 80 mg/m²; (ii) 25 and 90 mg/m²; (iii) 25 and 100 mg/m²; and (iv) 30 and 90 mg/m²; respectively. At least three patients were treated at each dose level. Overall, 12 patients were included in the phase I trial. No dose-limiting toxicities occurred at any dose level. Therefore, the fourth dose level (30 mg/m² of vinorelbine and 90 mg/m² of oxaliplatin) every 2 weeks was selected for the phase II trial. In this part, 44 patients were included and 61% completed the eight 2-week cycles of study treatment. On an intention-to-treat basis, overall response rate was 59%, and median progression-free survival and overall survival were 9.2 months (95% confidence interval: 7.6-10.9) and 18.6 months (95% confidence interval: 14.4-22.9), respectively. The main severe toxicities were neutropenia (46%) and fatigue (14%). We conclude that the biweekly combination of vinorelbine and oxaliplatin at doses of 30 mg/m² and 90 mg/m², respectively, is highly active and well tolerated as first-line treatment for patients with metastatic breast cancer.
authors.affiliation: Instituto Valenciano de Oncologia, Medical Oncology Service, Valencia, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: Guerrero
authors.forename: Sonia
authors.initials: S
authors.lastname: Servitja
authors.forename: Alvaro
authors.initials: A
authors.lastname: Rodríguez-Lescure
authors.forename: Lourdes
authors.initials: L
authors.lastname: Calvo
authors.forename: Sonia
authors.initials: S
authors.lastname: del Barco
authors.forename: María Teresa
authors.initials: MT
authors.lastname: Quintanar
authors.forename: José Ignacio
authors.initials: JI
authors.lastname: Juárez
authors.forename: Javier
authors.initials: J
authors.lastname: Gayo
authors.forename: Antonio
authors.initials: A
authors.lastname: Llombart
authors.forename: Ignasi
authors.initials: I
authors.lastname: Tusquets
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001940:Breast / Q000473:pathology; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000077150:Oxaliplatin; D013030:Spain; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D014747:Vinblastine; D000077235:Vinorelbine