A Randomized Phase III Trial on the Role of Esophagectomy in Complete Responders to Preoperative Chemoradiotherapy for Esophageal Squamous Cell Carcinoma (ESOPRESSO)

• Published in: Anticancer research 2019-09, Vol.39 (9), p.5123-5133
• Main Authors: Park, Sook Ryun, Yoon, Dok Hyun, Kim, Jong Hoon, Kim, Yong-Hee, Kim, Hyeong Ryul, Lee, Hyun Joo, Jung, Hwoon-Yong, Lee, Gin-Hyug, Song, Ho June, Kim, DO Hoon, Choi, Kee Don, Lee, Jeong Hoon, Ahn, Ji Yong, Ryu, Jin-Sook, Cho, Kyung-Ja, Kim, Sung-Bae
• Format: Article
• Language: English
• Subjects: Chemoradiotherapy; Chemotherapy; Esophageal cancer; Esophagus; Patients; Radiation therapy; Randomization; Squamous cell carcinoma; Surgery; Survival; Thorax
• ISSN: 0250-7005; 1791-7530
• DOI: 10.21873/anticanres.13707

We investigated the role of esophagectomy after clinical complete response (cCR) to chemoradiotherapy for esophageal squamous cell carcinoma (ESCC). 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. 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). Close observation with salvage surgery might be a reasonable option in resectable ESCC patients achieving cCR after chemoradiation.