Gemcitabine and vinorelbine in the second-line treatment of nonsmall cell lung carcinoma patients - A minnie pearl cancer research network Phase II trial

BACKGROUND. Second-line chemotherapy for patients with nonsmall cell lung c arcinoma has been ineffective due To the lack of activity of older agents f ollowing platinum-based therapy. This Phase II trial evaluated the feasibil ity, toxicity, and efficacy of two active new agents, gemcitabine and vinor elbine, used in combination as second-line therapy for patients with nonsma ll cell lung carcinoma. METHODS. Patients with advanced nonsmall cell lung carcinoma who had progre ssive disease after previous chemotherapy or combined-modality therapy were eligible for this trial. All patients received vinorelbine 20 mg/m(2) foll owed by gemcitabine 1000 mg/m(2) on Days 1, 8, and 15 of each 28-day cycle. Patients were reevaluated for a response after two treatment courses: resp onding patients and those with stable disease received a maximum of six cou rses. Fifty-five patients were treated between January 1998 and November 19 98; 47 patients (85%) had previously received both a taxane and a platinum agent. RESULTS. Objective responses were seen in 9 of 50 evaluable patients (18%), including 8 partial responses and 1 complete response. Twenty-four additio nal patients (48%) had either minor response or stable disease. The median time to progression for patients with objective response or stable disease was 5 months. The median survival was 6.5 months with an actuarial 1-year s urvival of 20%. The treatment was well tolerated with uncommon nonhematolog ic toxicity and no alopecia. Grade 3 neutropenia and thrombocytopenia occur red in 27% and 22% of patients, respectively, but Grade 4 neutropenia was u ncommon (occurring in 9% of patients) and only 4 patients required hospital ization for treatment of neutropenia and fever. CONCLUSIONS. The combination of vinorelbine and gemcitabine is active and w ell tolerated as second-line therapy for patients with advanced nonsmall ce ll lung carcinoma. This regimen merits further evaluation as a first-line t herapy for patients with this disease. Cancer 2000;88:1353-8, (C) 2000 Amer ican Cancer Society.