A phase III multicenter randomized clinical trial of 60 Gy vs 50 Gy radiation dose in concurrent chemoradiotherapy for inoperable esophageal squamous cell carcinoma
Mené sur 319 patients atteints d'un carcinome épidermoïde de l'oesophage inopérable (durée médiane de suivi : 34 mois), cet essai de phase III compare l'efficacité, du point de vue de la survie globale, et la toxicité de deux doses de radiothérapie (60 Gy ou 50 Gy) avec une chimiothérapie concomitante à base de docétaxel et de cisplatine
Purpose: In this multicenter, phase 3 trial, the efficacy and safety of 60 Gy and 50 Gy doses delivered with modern radiation technology for definitive concurrent chemoradiation (CCRT) in patients with inoperable esophageal squamous cell carcinoma (ESCC) were evaluated. Patients and Methods: Patients with pathologically confirmed stage IIA‒IVA ESCC were randomized 1:1 to receive conventional fractionated 60 Gy or 50 Gy to the tumor and regional lymph nodes. Concurrent weekly chemotherapy (docetaxel 25 mg/m<sup>2</sup>; cisplatin 25 mg/m<sup>2</sup>) and two cycles of consolidation chemotherapy (docetaxel 70 mg/m<sup>2</sup>; cisplatin 25 mg/m<sup>2 </sup>d1‒3) were administered. Results: A total of 319 patients were finally analyzed for survival, and the median follow-up was 34.0 months. The 1-, and 3-year locoregional progression-free survival rates for the 60 Gy group were 75.6% and 49.5% vs 72.1% and 48.4%, respectively, for the 50 Gy group (HR, 1.00; 95%CI, 0.75‒1.35; <em>P </em>= 0.98). The overall survival rates were 83.7% and 53.1% vs 84.8% and 52.7%, respectively (HR, 0.99; 95%CI, 0.73‒1.35; <em>P </em>= 0.96), while the progression-free survival rates were 71.2% and 46.4% vs 65.2% and 46.1%, respectively (HR, 0.97; 95%CI, 0.73‒1.30; <em>P </em>= 0.86). The incidence of grade 3+ radiation pneumonitis was higher in the 60 Gy group (nominal <em>P</em> = 0.03) than in the 50 Gy group. Conclusions: The 60 Gy arm had similar survival endpoints but a higher severe pneumonitis rate compared with the 50 Gy arm. 50 Gy should be considered as the recommended dose in CCRT for ESCC.