Phase II study of paclitaxel (Genaxol) and cisplatin combination in treating Chinese patients with advanced non-small cell lung cancer (NSCLC).

PURPOSE: To assess the efficacy of 3-h paclitaxel infusion (Genaxol) combined with cisplatin as the first line chemotherapy for patients with advanced/metastatic non-small cell lung cancer (NSCLC). The aim of the present study is to evaluate the efficacy, safety, and quality of life of the combination of paclitaxel (Genaxol) and cisplatin on Chinese patients.

METHODS: Forty-five patients with histology confirmed NSCLC, who met the selection criteria were enrolled in this study between June 1999 and May 2000. They were all at an advanced stage, i.e. stage IIIB with pleural effusion, or stage IV. Paclitaxel (Genaxol) at a dose of 175 mg/m(2) and cisplatin at a dose of 75 mg/m(2) were administered every 3 weeks.

RESULTS: Of the 45 eligible patients, one had a CR and 19 achieved a PR. The overall response was 44.4% (95% CI: 29.3-59.5%). Eleven (24.4%) patients were in stable disease. The median time to disease progression for all patients was 5.5 months (95% CI: 4.0-7.0 months). The median survival was 11.1 months (95% CI: 6.6-15.6 months), the 1-year survival probability was 46.5%. Major non-hematology toxicities were asthenia, paresthesias, nausea, and vomiting. Hematological toxicity results showed 18 (40%) patients experienced grade 3/4 neutropenia but there was no febrile neutropenia, three (6.6%) patients experienced Grade 3 anemia, and one (2.2%) patient experienced Grade 3 thrombocytopenia.

CONCLUSIONS: The combined paclitaxel and cisplatin regimen is safe and effective in the treatment of NSCLC but the quality of life is disappointed.