Phase II study of a biweekly regimen of vinorelbine and cisplatin in advanced non-small cell lung cancer

Background: Many novel agents, including vinorelbine, gemcitabine, paclitaxel and docetaxel, have been administrated in combination with cisplatin to patients with advanced non-small cell lung cancer (NSCLC). Of these drugs, vinorelbine is reported to have a high response rate and acceptable toxicity level. In an attempt to increase treatment activity, a biweekly regimen using vinorelbine and cisplatin was designed. Methods: From March 2001 to July 2003, 43 patients with NSCLC, who met the selection criteria, were enrolled. Of the 43 patients, 28 were male and 15 were female. All of them had their diagnosis confirmed histologically and were in an advanced stage, i.e., stage IIIB with pleural effusion or stage IV. Vinorelbine 30 or 35 mg/m² and cisplatin 50 mg/m² were given intravenously every 2 weeks. Results: Of the 43 assessable patients, 11 achieved a Partial Response (PR) and 13 had a Stable Disease (SD). Overall response was 25.6% (95% CI 12.0%-39.2%). Median survival was 9.0 months (95% CI: 6.2-11.8) and the 1-year survival rate was 32.6%. Median time to disease progression was 3.9 months (95% CI 2.4-5.4 months). The major hematological toxicity was neutropenia. Seven patients (16.3%) developed grade 3 neutropenia and 17 patients (39.5%) developed grade 4 neutropenia. Eight patients developed febrile neutropenia, 4 patients had confirmed sepsis, 2 of which died due to sepsis. One patient had grade 3 thrombocytopenia. Six patients (7%) developed severe anemia. Ten patients (23.3%) had grade 3/4 nausea and vomiting. Only 2 patients developed grade 3 neuropathy. Conclusions: This biweekly regimen of vinorelbine and cisplatin is effective against advanced NSCLC. Due to the high incidence of neutropenia, this regimen did not improve therapeutic efficacy and its dose intensity is less than that of a conventional schedule.