Twice-Weekly P aclitaxel a nd W eekly C arboplatin W ith Concurrent T horacic R adiation F ollowed b y C arboplatin/ Paclitaxel C onsolidation f or S tage I II N on-Small-Cell Lung C ancer: A C alifornia C ancer C onsortium P hase I I Trial

Purpose: Recent studies have suggested the superiority of concurrent chemoradiotherapy and the efficacy of paclitaxel/carboplatin in advanced non‐small-cell lung cancer (NSCLC). In view of those results, we sought to examine the safety and efficacy of administration of radiosensitizing paclitaxel twice weekly and carboplatin weekly with concurrent thoracic radiation therapy (XRT) followed by consolidation paclitaxel and carboplatin for stage III NSCLC in a multi-institutional phase II trial. Patients and Methods: Induction chemoradiotherapy consisted of paclitaxel 30 mg/m 2 delivered intravenously (IV) for 1 hour twice weekly for 6 weeks, carboplatin at a dose based on an area under the concentration-time curve (AUC) of 1.5 mg/mL 3 min, given IV once weekly for 6 weeks, and concomitant XRT of 1.8 to 2.0 Gy daily for a total of 61 Gy. Patients who achieved a complete response, partial response, or stable disease received two 21-day cycles of consolidation chemotherapy consisting of paclitaxel 200 mg/m 2 IV for 3 hours and carboplatin at a dose based on an AUC of 6 mg/mL 3 min. Results: Thirty-four patients were eligible. Their median age was 62 years (range, 39 to 73 years), 59% were female, 41% were male, 94% had a performance status of 0 or 1, 38% had stage IIIA NSCLC, and 62% had stage IIIB NSCLC. Common grade III and IV toxicities during the induction chemoradiation phase included esophagitis (38%) and neutropenia (12%). The most common adverse reaction during consolidation chemotherapy was grade III neutropenia in five patients (15%). The overall response rate was 71%, which was achieved in the induction phase. The median follow-up was 20 months, the median survival was 17 months, and 2-year actuarial survival rate was 40% (95% confidence interval, 20% to 65%). Conclusion: This regimen is tolerable and results are promising. We recommend further evaluation of this regimen in a phase III trial. J Clin Oncol 19:442-447. © 2001 by American Society of Clinical Oncology.