Oral vinorelbine plus cisplatin followed by maintenance oral vinorelbine as first-line treatment for advanced non-small cell lung cancer.

PURPOSE

Vinorelbine plus cisplatin is a commonly used doublet for the treatment of advanced non-small cell lung cancer (NSCLC). This study aimed to investigate the efficacy of oral vinorelbine as maintenance therapy in advanced NSCLC.

METHODS

This multicenter phase II open-label, non-comparative study was designed to evaluate the three-weekly combination of cisplatin 80 mg/m(2) on day 1 in combination with oral vinorelbine on day 1 and 8 in advanced NSCLC.

RESULTS

Thirty-nine patients were enrolled; median age was 63 years (range 42-82). In the response-evaluable population (n = 38), objective response after induction therapy was observed in 18 (47 %) patients with two (5 %) patients achieving complete response. Stable disease was observed in nine (24 %) patients. The median duration of response was 6 months. Eighteen (46 %) patients received oral vinorelbine as maintenance therapy. The median PFS for the whole population and for the maintenance therapy group was 4.9 [95 % CI (2.8-6.9)] and 6.7 [95 % CI (3.7-9.7)] months, respectively, while the overall survival was 8.7 [95 % CI (5.4-11.9)] and 11 [95 % CI (8.3-13.7)] months, respectively. The main observed overall hematologic toxicities were grade 3 anemia (8 %) and grade 3/4 neutropenia (8 %).

CONCLUSION

Maintenance therapy with single-agent oral vinorelbine is feasible and well tolerated; it seems to extend the efficacy of the combination regimen with the advantage of being convenient to patients.