Parallel-group controlled trial of surgery versus chemoradiotherapy in patients with stage I esophageal squamous cell carcinoma.

Abstract

BACKGROUND & AIMS\nSurgery is the standard of care for T1bN0M0 esophageal squamous cell carcinoma (ESCC), while chemoradiotherapy (CRT) is a treatment option. This trial aimed to investigate the non-inferiority of CRT relative to surgery for T1bN0M0 ESCC.\n\n\nMETHODS\nClinical T1bN0M0 ESCC patients were eligible for enrollment in this prospective non-randomized controlled study of surgery versus CRT. The primary endpoint was overall survival (OS), which was determined using inverse probability weighting with propensity scoring. Surgery consisted of an esophagectomy with two- or three-field lymph node dissection. CRT consisted of two courses of 5-FU (700 mg/m2) on days 1-4 and cisplatin (70 mg/m2) on day 1 every 4 weeks with concurrent radiation (60 Gy).\n\n\nRESULTS\nFrom December 20, 2006, to February 5, 2013, a total of 368 patients were enrolled in the non-randomized portion of the study. The patient characteristics in surgery arm and CRT arm, respectively, were as follows: median age, 62 and 65 years; proportion of males, 82.8% and 88.1%; and proportion of PS 0, 99.5% and 98.1%. Comparisons were made using the non-randomized groups. The 5-year OS was 86.5% in surgery arm and 85.5% in CRT arm (adjusted hazard ratio, 1.05; 95% CI, 0.67-1.64 [<1.78]). The complete response rate in CRT arm was 87.3% (95% CI, 81.1-92.1). The 5-year PFS was 81.7% in surgery arm and 71.6% in CRT arm. Treatment-related deaths occurred in two patients in surgery arm and none in CRT arm.\n\n\nCONCLUSIONS\nCRT is non-inferior to surgery and should be considered for the treatment of T1bN0M0 ESCC.