Introduction. RCTs support neoadjuvant chemoradiotherapy (nCRT) followed by surgery in Locally Advanced Esophago-Gastric Junction (LA-EGJ) adenocarcinoma. However, RCTs are performed in highly controlled settings with limited representativeness of real-life patients (RLS). Aim: To compare the outcomes in RLS and clinical trial settings. Methods. The outcomes of RLS, which comprised 125 patients consequently treated for LA-EGJ adenocarcinoma between 2012 and 2017, were compared with the phase II trial (PIIS), performed on 65 patients from 2003 to 2011. Results. About half of RLS (51.2%) were treated with nCRT according to VR-protocol, 20.8% with standard-CRT according to CROSS/Al-Sarraf, 20% with CT alone. pCR was 36.8%, 28.6% and 9.1% after VR-protocol, standard-CRT, and chemotherapy respectively (p=0.082), while three-year overall survival (OS) was 58.6% (95% CI 43.2-71.1%), 32.8% (14.6-52.4%) and 44.8% (21.3-65.9%) respectively (p=0.030). With respect to PIIS, RLS had a higher proportion of cN+ (94% versus 54%; p<0.001), and a lower proportion of pCR after CT/CRT (23% versus 39%; p=0.041). Three-year OS was slightly higher, although not significantly, in PIIS (58.9%, 45.1-70.2%) than RLS (47.9%, 37.4-57.7%) and nearly identical to 3-year OS in RLS treated with VR-protocol. Discussion/Conclusion. Real-life patients with EGJ adenocarcinoma have more advanced cancer at baseline, lower pathologic response to neoadjuvant treatment than patients enrolled in clinical trials, but similar survival.


中文翻译：

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临床试验内或外的 EGJ 癌症治疗：环境重要吗？一项单中心前瞻性观察研究。

介绍。随机对照试验支持对局部晚期食管胃结合部 (LA-EGJ) 腺癌进行新辅助放化疗 (nCRT)，然后进行手术。然而，随机对照试验是在高度受控的环境中进行的，对现实生活中患者 (RLS) 的代表性有限。目的：比较 RLS 和临床试验环境中的结果。方法。RLS 的结果由 2012 年至 2017 年期间因 LA-EGJ 腺癌接受治疗的 125 名患者组成，与 2003 年至 2011 年期间对 65 名患者进行的 II 期试验 (PIIS) 进行了比较。结果。大约一半的 RLS (51.2%) 根据 VR 方案接受 nCRT 治疗，20.8% 根据 CROSS/Al-Sarraf 采用标准 CRT 治疗，20% 仅采用 CT 治疗。VR 方案、标准 CRT 和化疗后的 pCR 分别为 36.8%、28.6% 和 9.1% (p=0.082)，而三年总生存 (OS) 为 58.6% (95% CI 43.2-71.1%)，分别为 32.8% (14.6-52.4%) 和 44.8% (21.3-65.9%) (p=0.030)。就 PIIS 而言，RLS 的 cN+ 比例较高（94% 对比 54%；p<0.001），CT/CRT 后 pCR 比例较低（23% 对比 39%；p=0.041）。PIIS 的三年 OS（58.9%、45.1-70.2%）略高于 RLS（47.9%、37.4-57.7%），但与 VR 方案治疗的 RLS 的 3 年 OS 几乎相同。讨论/结论。与参加临床试验的患者相比，现实生活中的 EGJ 腺癌患者在基线时患有更晚期的癌症，对新辅助治疗的病理反应较低，但生存率相似。