Phase I Study to Determine MTD of Docetaxel and Cisplatin with Concurrent Radiation Therapy for Stage Ⅲ Non-Small Cell Lung Cancer

Objective： To evaluate the maximum tolerated dose （MTD） of docetaxel （DCT） and cisplatin （DDP） concurrently with three dimensional （3D） conformal radiotherapy or IMRT for patients with locally advanced non-small cell lung cancer （stage IIIa and IIIb） after 2–4 cycles of induction chemotherapy. Methods： Fourteen patients with histological/cytological proven stage III non–small-cell lung cancer were eligible. 3D or IMRT radiotherapy （60-70Gy in 30-35 fractions, 6-7weeks, 2 Gy/fraction） was delivered concurrently with cisplatin and docetaxel, 2 cycles during concurrent chemoradiotherapy （CCRT）. The level I dosage was composed of 56 mg/m2 DCT, on day 1 and 28mg/m2 DDP, on day 1 and day 2. The level II was composed of 60 mg/m2 DCT, on day 1 and 30 mg/ m2 DDP, on day 1 and day 2. The level III was composed of 64 mg/m2 DCT, on day 1 and 32 mg/ m2 DDP, on day 1 and day 2. Results： Fourteen patients were allocated and finished concurrent chemoradiotherapy. The dose-limiting neutropenia was at the dose Level III （64 mg/m2） and occurred in 2 of 5 patients. No dose limiting non-hematologic or hematologic toxicity occurred in the other patients. Conclusions： Patients with locally advanced non-small cell lung cancer may tolerate 60mg/m2 docetaxel and 60mg/m2 cisplatin for 2 cycles during concurrent radiotherapy after 2-3 cycles of induction chemotherapy.