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/m 2 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.