MULTIINSTITUTIONAL PHASE-II TRIAL OF PACLITAXEL, CARBOPLATIN, AND CONCURRENT RADIATION-THERAPY FOR LOCALLY ADVANCED NON-SMALL-CELL LUNG-CANCER

Purpose: Combined modality therapy for non-small-cell lung cancer (NSC LC) has produced promising results, A multiinstitutional phase II clin ical trial was conducted to evaluate the activity and toxicity of pacl itaxel, carboplatin, and concurrent radiation therapy on patients with locally advanced NSCLC, Patients and Methods: Forty previously untrea ted patients with inoperable locally advanced NSCLC entered onto a pha se II study from March 1995 to December 1996. On an outpatient basis f or 7 weeks, patients received paclitaxel 50 mg/m(2) weekly over 1 hour ; carboplatin at (area under the curve) AUC 2 weekly; and radiation th erapy of 66 Gy in 33 fractions. After chemoradiation therapy, patients received an additional two cycles of paclitaxel 200 mg/m(2) over 3 ho urs and carboplatin at AUC 6 every 3 weeks. Results: Thirty-nine patie nts were eligible for the study. The survival rates at 1 2 months were 56.3%, and at 24 months, 38.3%, with a median overall survival of 20. 5 months. The progression-free survival rates at 12 months were 43.6%, and at 24 months, 34.7%, with a median progression free survival of 9 .0 months. Two patients did not receive more than 2 weeks of concurren t chemoradiotherapy and were not assessable for toxicity and response. The overall response rate (partial plus complete response) of 37 asse ssable patients was 75.7%, The major toxicity was esophagitis. Sevente en patients (46%) developed grade 3 or 4 esophagitis. However, only tw o patients developed late esophageal toxicity with stricture at 3 and 6 months posttreatment. Conclusion: Combined modality therapy with pac litaxel, carboplatin, and radiation is ct promising treatment for loca lly advanced NSCLC that has a high response rare and acceptable toxici ty and survival rates. A randomized trial will be necessary to fully e valuate the usefulness of these findings. (C) 1998 by American Society of Clinical Oncology.