A trial was carried out to investigate the noninferiority of CRT (chemoradiotherapy) relative to surgery for T1bN0M0 (ESCC) esophageal squamous cell carcinoma. The primary endpoint was overall survival, which was determined using inverse probability weighting with propensity scoring. Surgery consisted of an esophagectomy with 2- or 3-field lymph node dissection. CRT consisted of 2 courses of 5-FU on days 1-4 and cisplatin on day 1, every 4 weeks, with concurrent radiation.
From December 20, 2006 to February 5, 2013, a total of 368 patients were enrolled in a nonrandomized 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%; proportion of performance status 0, 99.5% and 98.1%. Comparisons were made using nonrandomized groups.
The 5-year overall survival rate was 86.5% in the surgery arm and 85.5% in the CRT arm. The complete response rate in the CRT arm was 87.3%. The 5-year progression-free survival was 81.7% in the surgery arm and 71.6% in the CRT arm. Treatment-related deaths occurred in 2 patients in the surgery arm and none in the CRT arm.
It was concluded that CRT is noninferior to surgery and should be considered for the treatment of T1bN0M0 (ESCC).
Kato, K., Ito, Y., Nozaki, I., et al for the Japan Esophageal Oncology Group of the Japan Clinical Oncology Group. “ParallelGroup Control Trial of Surgery Versus Chemoradiotherapy in Patients with Stage 1 Esophageal Squamous Cell Carcinoma.” Gastroenterology 2021; Vol. 161, pp 1878-1886.