Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma - A phase II study

BACKGROUND, The authors conducted a Phase II study to evaluate the activity of the combination of gemcitabine and vinorelbine in patients with advance d non-small cell lung carcinoma (NSCLC). METHODS, Patients were eligible if they had Stage IIIB (malignant pleural e ffusion) or Stage TV NSCLC, no prior chemotherapy, and Cancer and Leukemia Group B performance status (PS) 0-2. Patients with brain metastases were el igible if they were neurologically stable after brain irradiation. Thirty-t hree patients from participating institutions were enrolled. One patient wa s ineligible due to untreated brain metastases. Patients were treated with gemcitabine 1250 mg/m(2) over 30 minutes (1000 mg/m(2) for the first 6 pati ents) and vinorelbine 25 mg/m(2) over 6 minutes, both administered intraven ously on Days 1 and 8 every 21 days. Treatment was planned for a total of s ix cycles or more if the patient had persistent benefit. Growth factors wer e not allowed. RESULTS, Among all 32 eligible patients, there were 8 partial responses, fo r an overall response race of 25% (95% confidence interval [CI], 11.5-43.4% ). The median survival time was 8.3 months and the 1-year survival rate was 38% (95% CI, 24-59%). Patients with PS 0-1 had a median survival of 11.7 m onths and a 1-year survival rate of 48%. Grade 3 and 4 neutropenia was obse rved in 13% and 25% of the 148 treatment cycles, respectively. One patient died of neutropenic sepsis. Only 2 episodes of Grade 3 and 4 thrombocytopen ia were observed. Nonhematologic toxicity was minimal. CONCLUSIONS, Gemcitabine and vinorelbine is an active and well-tolerated re gimen in patients with advanced NSCLC, with response and survival rates at least comparable to those achieved with standard platinum-based regimens. T his combination may be particularly suitable for the elderly or for patient s who cannot tolerate more toxic platinum-based regimens. (C) 2000 American Cancer Society.