Phase I study of weekly docetaxel and cisplatin concurrent with thoracic radiotherapy in stage III non-small-cell lung cancer

Abstract

Purpose: This is the first report of a Phase I study on concomitant weekly cisplatin and docetaxel chemotherapy with thoracic radiation for Stage III non-small-cell lung cancer (NSCLC). The study objectives were to determine the maximum tolerable dose (MTD) and dose-limiting toxicity (DLT) of docetaxel used in this regimen, and to evaluate the feasibility of weekly concurrent chemoradiotherapy. Methods and Materials: Patients with histologically proven and unresectable Stage III NSCLC were the subjects of this study. Cisplatin was administered at a fixed dose of 20 mg/m(2), while the dose of docetaxel was increased from 0 to 30 mg/m(2) in increments of 10 mg/m(2). Chemotherapy was given on the first day of each week for 6 weeks. The primary tumor and regional lymph nodes were irradiated to 54 Gy, followed by an additional 9 Gy boost to the primary tumor, making the total dose 63 Gy at 1.8 Gy/fraction. Results: Sixteen men and 2 women with advanced NSCLC without prior treatment were enrolled. The median age of the group was 58 years (range 49-67). Three patients had Stage IIIa disease and 15 patients had IIIb disease. Dose-limiting Grade 3 esophagitis was encountered at a docetaxel dose level of 30 mg/m2 in 2 of 3 patients. No dose-limiting, nonhematologic toxicity occurred in the other patients and no dose-limiting hematologic toxicity occurred in any patient. Conclusion: The treatment schedule for NSCLC was feasible, with the DLT being esophagitis. We determined the recommended dose of docetaxel to be 20 mg/m(2) for a Phase II study when combined with weekly cisplatin and concomitant thoracic RT. (C) 2002 Elsevier Science Inc.