Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Division of Gastroenterology and Hepatology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Endoscopy. 2020 Dec;52(12):1066-1074. doi: 10.1055/a-1198-5232. Epub 2020 Jul 15.
Endoscopic submucosal dissection (ESD) is effective for treating T1a early esophageal squamous cell carcinoma (ESCC). However, occasional recurrences are inevitable. This trial was designed to clarify the efficacy of combining ESD with additional radiotherapy in the treatment of T1a ESCC.
Between January 2015 and September 2018, patients with early ESCC (T1aN0M0) following ESD were randomly assigned (1:1) to the radiotherapy group or non-radiotherapy group. Patients in the radiotherapy group received a median radiation dose of 59.4 Gy within 2 months after ESD. In the non-radiotherapy group, patients underwent regular follow-up only. Recurrence-free survival, cancer-specific survival, overall survival, and complications were evaluated.
70 patients completed the per-protocol treatment. Three patients in the non-radiotherapy group experienced intraluminal mucosal recurrence compared with none in the radiotherapy group. No local lymph node or distant metastases occurred in either group. The 3-year cumulative recurrence-free survival was 100 % in the radiotherapy group and 85.3 % in the non-radiotherapy group ( = 0.04; hazard ratio 0.08, 95 % confidence interval [CI] 0.01 - 0.86). However, there was no significant difference in RFS between the treatments within the T1a invasion subgroups ( > 0.05). No patient died in either group. Mucosal defects of more than three-quarters of the esophageal circumference were positively correlated with stenosis ( < 0.01; odds ratio 23.26, 95 %CI 4.04 - 133.86). No severe radiation toxicities were recorded.
Radiotherapy after ESD might be a safe and effective optional therapeutic strategy to prevent recurrence of T1a ESCC.
内镜黏膜下剥离术（ESD）是治疗 T1a 期早期食管鳞状细胞癌（ESCC）的有效方法。然而，偶尔仍会发生复发。本试验旨在明确 ESD 联合辅助放疗治疗 T1a ESCC 的疗效。
2015 年 1 月至 2018 年 9 月，对 ESD 治疗后的早期 ESCC（T1aN0M0）患者进行随机分组（1:1），分为放疗组或非放疗组。放疗组患者在 ESD 后 2 个月内接受中位剂量为 59.4 Gy 的放疗。非放疗组仅进行常规随访。评估无复发生存率、癌症特异性生存率、总生存率和并发症。
70 例患者完成了方案治疗。非放疗组 3 例患者出现管腔内黏膜复发，而放疗组无患者出现复发。两组均未发生局部淋巴结或远处转移。放疗组 3 年累积无复发生存率为 100%，非放疗组为 85.3%（=0.04；风险比 0.08，95%置信区间 0.010.86）。然而，在 T1a 浸润亚组内，两种治疗方法的 RFS 无显著差异（>0.05）。两组均无患者死亡。食管周长超过四分之三的黏膜缺损与狭窄呈正相关（<0.01；优势比 23.26，95%置信区间 4.04133.86）。未记录到严重的放射性毒性。
ESD 后放疗可能是预防 T1a ESCC 复发的一种安全有效的治疗策略。
