Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, China; Department of Radiation Oncology, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin's Clinical Research Center for Cancer, China.
Radiother Oncol. 2022 Sep;174:1-7. doi: 10.1016/j.radonc.2022.06.015. Epub 2022 Jun 25.
More than 40% of patients with esophageal squamous cell carcinoma (ESCC) exhibit pathological complete responses (pCR) after neoadjuvant chemoradiotherapy (nCRT), and theoretically, these patients may be cured by CRT and omit surgery. This prospectively randomized pilot study compared definitive chemoradiotherapy (dCRT) with nCRT in patients with locally advanced ESCC who achieved clinical complete responses (cCRs) to nCRT.
Single center, randomized, open phase 2 study of 256 patients with locally advanced ESCC enrolled between April 2016 and November 2018. Immediately when nCRT finished, patients enrolled underwent response evaluations within 1 week. Patients with cCR were randomly allocated to undergo surgery (arm A) or complete CRT up to the definitive radiation dose (arm B). The primary end point was 3-year disease-free survival (DFS).
Finally, 71 patients were randomly assigned to the nCRT (n = 36) and dCRT (n = 35) arms. The median observation time was 35.7 months. The 3-year DFS rate was 56.43 % in arm A versus 54.73 % in arm B (hazard ratio [HR] = 0.862, 95 % confidence interval [CI] = 0.452 to 1.645, P = 0.652). The 3-year overall survival (OS) rates in arms A and B were 69.5 % and 62.3 % (HR = 0.824, 95 % CI = 403-1.688, P = 0.597), respectively.
According to our treatment response evaluation criteria, survival of the patients with cCR after nCRT was not significant different between nCRT group and dCRT group. An optimized response evaluation strategy soon after nCRT may guide next therapy decisions for patients with locally advanced ESCC.
超过 40%的食管鳞癌（ESCC）患者在新辅助放化疗（nCRT）后表现出病理完全缓解（pCR），理论上这些患者可以通过 CRT 治愈并省略手术。本前瞻性随机试验研究比较了 nCRT 后达到临床完全缓解（cCR）的局部晚期 ESCC 患者接受根治性放化疗（dCRT）与 nCRT 的疗效。
2016 年 4 月至 2018 年 11 月，单中心、随机、开放的 2 期研究共纳入 256 例局部晚期 ESCC 患者。nCRT 结束后立即在 1 周内进行反应评估。cCR 患者随机分配接受手术（A 组）或完成至根治性放疗剂量的 CRT（B 组）。主要终点为 3 年无病生存（DFS）。
最终，71 例患者被随机分配至 nCRT（n=36）和 dCRT（n=35）组。中位观察时间为 35.7 个月。A 组和 B 组的 3 年 DFS 率分别为 56.43%和 54.73%（风险比[HR]0.862，95%置信区间[CI]0.452 至 1.645，P=0.652）。A 组和 B 组的 3 年总生存率（OS）分别为 69.5%和 62.3%（HR 0.824，95%CI 403-1.688，P=0.597）。
根据我们的治疗反应评估标准，nCRT 后 cCR 患者的生存在 nCRT 组和 dCRT 组之间没有显著差异。nCRT 后尽快优化反应评估策略可能指导局部晚期 ESCC 患者的下一步治疗决策。
