A Phase II Study of Concurrent Chemoradiation with Weekly Docetaxel, Carboplatin, and Radiation Therapy Followed by Consolidation Chemotherapy with Docetaxel and Carboplatin for Locally Advanced Inoperable Non-small Cell Lung Cancer (NSCLC)

Anshu K. Jain, Randall S. Hughes, Alan B. Sandler, Afshin Dowlati, Lee S. Schwartzberg, Tracy Dobbs, Larry Schlabach, Jean Wu, Nancy J. Muldowney, Hak Choy
2009 Journal of Thoracic Oncology  
The current standard of care for good performance status patients with locally advanced non-small cell lung carcinoma is concurrent chemoradiation, although a clearly superior regimen has not been identified. Docetaxel has been shown to possess good single-agent activity against non-small cell lung cancer (NSCLC) and radiosensitizing properties, both alone and synergistically with carboplatin. We undertook this phase II study to determine the safety and efficacy of weekly docetaxel-carboplatin
more » ... nd concurrent radiation therapy followed by docetaxel-carboplatin consolidation for the treatment of locally advanced NSCLC. Methods: Sixty-seven patients having previously untreated stage IIIA or IIIB unresectable NSCLC were enrolled, with 61 patients evaluated for endpoints. Docetaxel 20 mg/m 2 IV infusion over 30 minutes followed by carboplatin area under the curve ϭ 2 over 30 minutes was administered weekly during concurrent thoracic radiotherapy. After 3 week rest, consolidation docetaxel 75 mg/m 2 IV infusion over 60 minutes and carboplatin area under the curve ϭ 6 over 30 minutes was administered every 3 weeks for two cycles. Concurrent thoracic radiation consisted of 45 Gy (1.8 Gy fractions 5 d/wk for first 5 weeks) followed by 18 Gy boost (2.0 Gy fractions 5 d/wk for 2 weeks) for a total dose of 63 Gy. Results: One and 2 years overall survival rates were 45 and 20%, respectively. Progression free survival at 1 year was 27%. Median survival time was 12 months. Median time to progression was 8 months. The primary hematologic toxicity was leukopenia. The primary nonhematologic toxicity was esophagitis. Conclusion: The administered regimen of weekly docetaxel-carboplatin and concurrent radiation therapy followed by docetaxelcarboplatin consolidation has acceptable toxicity profile. However, the overall survivals at 1 and 2 years are somewhat disappointing.
doi:10.1097/jto.0b013e3181a5275c pmid:19404213 fatcat:vvwhyk3u25cddg7foepfsx6hvq