[Phase II study of combination of gemcitabine and carboplatin in advanced non-small cell lung cancer (an interim report)].

A phase II study of combination therapy with gemcitabine and carboplatin was performed in 24 patients with advanced non-small cell lung cancer to evaluate the efficacy and safety of the therapy. Patients were treated at 3-week intervals with two courses or more of the regimen consisting of gemcitabine 1,000 mg/m(2) and carboplatin AUC 2 on day 1 and day 8. Response rate was 37.5% (9/24) (95% confidence interval: 18.8-59.4%). The median number of courses was 3(range 1-8). The time to progressive disease was 147 days and the median survival was 338 days. The one-year survival rate was 45.8%. The major toxicity was hematotoxicity, and >or=grade 3 neutropenia(58.3%)and thrombocytopenia (45.8%) occurred. None of >or=grade 3 non-hematotoxicities were evident, but grade 2 rash (8.3%) and fever (8.3%), nausea (4.2%), vomiting (4.2%) occurred. None of the other severe toxicities appeared. In conclusion, this combination therapy was suggested to be tolerable with a high response rate and safety, and we plan to continue testing.