ABSTRACT
To evaluate the addition of consolidation chemotherapy to concurrent Chemoradiotherapy in patients with locally advanced unresectable stage III non-small-cell lung cancer as regard efficacy and safety. Forty one patients were randomly assigned to either concomitant Chemoradiotherapy alone [arm 1, n = 19] or concomitant Chemoradiotherapy followed by consolidation chemotherapy [arm 2, n = 22]. In the concurrent arm, patients received weekly paclitaxel [45 mg/m[2]], carboplatin [100 mg/m[2]] and concomitant thoracic radiotherapy at a dose of 63 Gy in 34 fractions over 7 weeks. In the concurrent/consolidation arm, the same regimen was administered followed by two additional courses of paclitaxel [200 mg/m[2]] and carboplatin [300 mg/m[2]] every 3 weeks. Pre-treatment characteristics were well balanced between the two arms. Median survival was 13 months in the concurrent arm and 16.5 months in the concurrent/consolidation arm [p = 0.59]. One-, 2-, and 3- year survival rates were better in the concurrent/consolidation arm [63.6%, 36.4%, and 13.6% respectively] than in the concurrent arm [52.6%, 26.3%, and 10.5% respectively], p = 0.48. Grade 3/4 granulocytopenia occurred in 16% and 27% of patients on the concurrent and concurrent/consolidation arms respectively [p = 0.38]. The most common grade 3/4 non-hematological toxicity was esophagitis. It was more frequent in the consolidation arm than in the concurrent arm [32% v 21%], p = 0.43. Concurrent Chemoradiotherapy followed by consolidation chemotherapy represent the preferred regimen for the treatment of unresected stage III NSCLC. However, toxicity, particularly, non-hematological toxicity, remains a major obstacle