A phase II study of metronomic oral vinorelbine administered in the second line and beyond in non-small cell lung cancer (NSCLC): a phase II study of the Hellenic Oncology Research Group

Introduction: Frequent administration of low doses of cytotoxic drugs (metronomic chemotherapy) has been suggested to suppress tumour growth possibly by inhibiting angiogenesis. We evaluated a metronomic regimen of oral vinorelbine in pre-treated patients with advanced non-small cell lung cancer (NSCLC). Methods: Forty-six pre-treated NSCLC patients received oral vinorelbine at a fixed dose of 50 mg three times a week. Results: Treatment was administered as second-line in 12 (26.1%) patients and as third-or further-line in 34 (73.9%). Grade 3-4 neutropenia was observed in 23.9% and febrile neutropenia in 10.9%. Grade 3 fatigue was the most common severe non-hematologic toxicity (10.9%). Response rate was 10.9%; 19.6% achieved disease stabilization. Median tumour progression (TTP) was 2.2 months, median overall survival 9.4 months and the 1-year survival rate was 30.1%. Conclusion: The administration of metronomic oral vinorelbine is feasible and results in acceptable clinical efficacy associated with manageable toxicity in a population consisting mostly of heavily pre-treated NSCLC patients.