A randomized phase III trial on the role of esophagectomy in complete responders to preoperative chemoradiotherapy for esophageal squamous cell carcinoma (ESOPRESSO)

Abstract

Background/Aim: We investigated the role of esophagectomy after clinical complete response (cCR) to chemoradiotherapy for esophageal squamous cell carcinoma (ESCC). Patients and Methods: Patients with resectable cT3-T4a/anyN/M0 or anyT/N+/M0 thoracic ESCC received two cycles of induction chemotherapy and then chemoradiotherapy (50.4 Gy/28 fractions). Patients with cCR were randomized to surgery or observation. Results: Among 86 patients, 38 (44.2%) achieved cCR after chemoradiotherapy; 37 were randomized to surgery (n=19) or observation (n=18). Although there were trends of better disease-free survival (DFS) toward the surgery arm in the intent-to-treat analysis (2-year DFS, 66.7% vs. 42.7%; p=0.262) or as-treated analysis (66.7% vs. 50.2%; p=0.273), overall survival was not different between the two arms in the intent-to-treat (HR=1.48; p=0.560) or as-treated analysis (HR=1.09; p=0.903). Among the 11 patients having recurrence during observation, 8 underwent surgery (n=7) or endoscopic dissection (n=1). Conclusion: Close observation with salvage surgery might be a reasonable option in resectable ESCC patients achieving cCR after chemoradiation.