Annals of Oncology 13:103-107, 2002
© 2002 European Society for Medical Oncology
Oxaliplatin plus vinorelbine in advanced non-small-cell lung cancer: final results of a multicenter phase II study
1Centre Hospitalier Intercommunal, France; 2Centre Hospitalier, Argenteuil; 3Centre René Huguenin, St Cloud; 4Centre Hospitalier, Corbeil; 5Hôpital Paul Brousse, Villejuif; 6CAC, Kremlin-Bicêtre; 7Clinique Claude Bernard, Metz; 8Sanofi-Synthélabo, Plessis-Robinson, France
Received 20 March 2001; revised 12 July 2001; accepted 14 August 2001.
Background
Oxaliplatin and vinorelbine are both active agents against non-small-cell lung cancer (NSCLC). In a previous phase I trial, we showed that oxaliplatin (130 mg/m2, day 1) and vinorelbine (26 mg/m2/day, days 1 and 8) can be safely combined when given every 21 days. We completed the evaluation of this new platinum-based doublet in advanced NSCLC patients in a multicenter phase II study.
Patients and methods
Twenty-eight chemotherapy-naïve patients (22 men and six women; median age 58 years, range 33–70), including 20 with stage IV disease, received this out-patient combination, with 5-hydroxytryptamine-3-receptor agonists as the only prophylactic measure.
Results
A total of 117 cycles were given, for a median of three per patient (range 1–8). Of 26 eligible patients, nine achieved a partial response (WHO criteria), giving an objective response rate of 35% [95% confidence interval (CI) 17% to 56%]. The median progression free survival was 5.0 months (95% CI 3.1 to 6.9), median overall survival was 9.8 months (95% CI 2.2 to 17.5) and the 1-year survival rate was 37%. Neutropenia was the principal toxicity, grade 4 occurring in 11 patients (39%) and 25 cycles (22%). Four patients (14%) experienced one episode of febrile neutropenia each. Acute oxaliplatin-related neurosensory toxicity was prevalent, but was mild to moderate in the majority of patients (82%) and reversible. Grade 1/2 vomiting (65% of patients) and diarrhea (32% of patients) were easily managed.
Conclusions
The oxaliplatin–vinorelbine doublet is a safe and active out-patient combination. It may represent an interesting alternative in the management of patients with NSCLC, and serve as a new doublet to which other active agents could be added.
Key words: combination, non-small-cell lung cancer, oxaliplatin, phase II, vinorelbine
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