Preliminary analysis of a phase II study of weekly paclitaxel and concurrent radiation therapy for locally advanced non-small cell lung cancer.

Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is an attractive agent to combine with radiation for non-small cell lung cancer. We have been conducting clinical trials of weekly paclitaxel and concurrent radiation therapy. In a phase I study in non-small cell lung cancer, we determined the maximum tolerated dose of paclitaxel to be 60 mg/m2/wk with radiation. Patients received paclitaxel 60 mg/m2/wk as a 3-hour infusion for 6 weeks with radiation to the primary tumor and regional lymph nodes (40 Gy) followed by a boost to the tumor (20 Gy). From March 1994 to February 1995, 33 patients have been entered by the Clinical Oncology Group of Rhode Island. The overall response rate (complete plus partial responses) of 25 evaluable patients as of March 1995 was 84%, with a confidence interval of 68 to 96. The major toxicity was esophagitis. Twenty percent of patients had grade 4 esophagitis. Only 8% of patients had grade 3 neutropenia. Combined-modality therapy with paclitaxel and radiation is a promising treatment for locally advanced non-small cell lung cancer with a high response rate and acceptable toxicity.