Phase II study of weekly docetaxel combined with cisplatin in patients with advanced non-small-cell lung cancer.

Purpose: To evaluate the safety and efficacy of the combination of cisplatin on day 1 and docetaxel on days 1, 8 and 15 every 4 weeks for the treatment of previously untreated patients with non-small-cell lung cancer (NSCLC).

Patients And Methods: A group of 38 patients with advanced or metastatic NSCLC who had not received prior treatment and who were aged under 75 years were enrolled. The patients received intravenous infusions of docetaxel (25 mg/m2, days 1, 8, 15) and cisplatin (80 mg/m2, day 1), followed by a week of rest.

Results: Six patients had grade 3/4 neutropenia (18%), but there were no episodes of neutropenic fever. Nonhematologic toxicities were also mild. There were 12 partial responses for an objective response rate of 31.6%. The median survival was 11.8 months, and the 1-year survival rate was 46.5%.

Conclusion: Cisplatin combined with weekly administration of docetaxel is efficacious against NSCLC with low hematotoxicity, and this schedule may be an alternative for the treatment of NSCLC.