A phase II trial of intravenous vinorelbine in previously untreated patients with extensive small cell lung cancer, a Southwest Oncology Group study.

Twenty-two eligible patients with previously untreated extensive small cell lung cancer received intravenous vinorelbine 30 mg/M2 each week until progression. Response was assessed every 4 weeks by chest x-ray or every 8 weeks by CT scan. All responses had to be "confirmed" at all involved sites at least 4 weeks later. Fourteen patients were male and 8 were female with a median age of 64.5 years (range 38-76). Fifteen patients were Caucasian and 7 were African-American. One patient had a "confirmed" partial response, 3 had unconfirmed responses, 13 had stable or progressive disease, and 5 did not have adequate data. The median progression-free survival was 3 months with a median overall survival of 8 months. Thirteen patients experienced 22 episodes of grade 3 toxicity, more than half due to leukopenia and neutropenia, and 1 due to paresthesias. Of 4 episodes of grade 4 toxicity, 1 was due to leukopenia and 3 were due to hyponatremia which was not due to vinorelbine. Significant thrombocytopenia did not occur. The activity of single agent vinorelbine in untreated small cell lung cancer was disappointing when analyzed by Southwest Oncology Group (SWOG) criteria. The median survival in this trial was similar to that found in other SWOG trials using cisplatin based front line therapy and thus confirms previously reported findings that initial treatment with a phase II agent followed by a cisplatin based regimen at progression does not adversely affect overall survival in this population of patients.