Phase I Study of Concurrent and Consolidation Cisplatin and Docetaxel Chemotherapy with Thoracic Radiotherapy in Non-Small Cell Lung Cancer

Background: We designed a phase I study of concurrent chemoradiotherapy (CCRT) with docetaxel (D) and cisplatin (C), followed by consolidation DC, for unresectable stage III non-small cell lung cancer (NSCLC). Methods: Patients with histologically proven and unresectable stage III NSCLC were eligible. During CCRT, C was given every 3 weeks (75 mg/m²) and D given weekly. The starting dose of D was 20 mg/m², escalated in cohorts of 3 to define the maximum tolerated dose (MTD). Radiotherapy was prescribed to a dose of 60 Gy in 30 fractions. This was followed by 2 cycles of consolidation DC, which were dose escalated if CCRT was tolerated. Results: Twenty-six patients were enrolled, with 1 excluded following evidence of metastatic disease. Nineteen patients completed both phases of treatment. There were 7 grade 3 events during CCRT (5 esophagitis, 2 nausea), and 8 grade 3 events during consolidation (2 neutropenia, 2 leukopenia, 1 esophagitis, 2 nausea, and 1 pneumonitis). Three patients had grade 4 neutropenia. No patients died due to toxicities. The MTD of concurrent weekly D was 20 mg/m². Consolidation D and C were each dose escalated to 75 mg/m² in 8 patients. The median overall survival (OS) and progression-free survival (pfs) of all patients were 33.6 months and 17.2 months, respectively, with median follow-up of 26.6 months (range 0.43–110.8). Conclusions: The use of docetaxel 20 mg/m² weekly and cisplatin 75 mg/m² every 3 weeks concurrent with thoracic radiotherapy, followed by consolidation docetaxel and cisplatin, both given at 75 mg/m² every 3 weeks, appears to be safe in this phase I trial.