Exclusive chemoradiation with carboplatin-paclitaxel versus FOLFOX-4 in locally advanced esophageal cancer: A matched-pair analysis.

145 Background: The PRODIGE 5 trial has demonstrated the safety and the efficacy of FOLFOX-4 combined with exclusive 50Gy external RT while the CROSS trial showed an improvement in overall survival with Carboplatin-Taxol (C-TAX) when combined with 41.4Gy before surgery. We sought to determine the feasibility and efficacy of exclusive RT with C-TAX compared to FOLFOX-4 regimen. Methods: 46 patients with locally advanced esophageal cancer who were treated with exclusive chemoradiation were matched 1:1 : 23 patients were treated with FOLFOX-4 regimen (group A) and 23 patients with C-TAX (group B). Comparison between the 2 groups was performed using Mac Nemar test for paired data. All tests were two sided and Pvalues were considered significant when less than 0.05. Results: The mean age in group A was 69.4 years (12.5) and 72.4 years (12.6) in group B (p = ns). In each group, 11 patients had a stage III disease at diagnosis (47.8%) with only 2 stage IV in group A (8.7%) vs none in group B. The median delivered RT doses were 50Gy [14-60] in group A while it was 50Gy [20-70] in group B. 6 courses of chemotherapy were delivered in 12 patients in group A (52.2%) and 14 patients in group B (60.9%) (p = 0.51). After chemoradiation, G1 or higher esophagitis was observed in 5 patients (26.3%) in group A and 3 patients (13.0%) in group B of whom 0 vs 2 G3 were observed in group A and B, respectively. Four patients (21.1%) had a pulmonary infection in group A and 3 in group B (13.0%). Two patients (8.7%) vs 4 patients (17.4%) had G3 neutropenia, with only 0 and 2 neutropenic fever in group A and B, respectively. Neither G3 anemia, nor G3 thrombopenia occured. After a median follow-up of 17.7 months [0.0-46.9], 25 patients had died, 14 in group A (60.9%) and 11 in group B (47.8%). The median PFS rates were 14.0 months in group A [7.7-NR] vs 12.1 months [4.4-NR] in group B (p = 0.32). The median OS rates were 20.3 months in group A [6.2-39.3] vs 17.0 months [4.8-NR] in group B (p = 0.82). Conclusions: Exclusive chemoradiation with C-TAX seems feasible with similar toxicity and survival outcomes than FOLFOX-4. The safety and efficacy of the CROSS regimen needs to be tested prospectively with RT doses > 41.4Gy in a phase II or III trial.