Treatment of EGJ Cancer within or outside Clinical Trials: Does the Setting Matter? A Monocentric Prospective Observational Study.

IF 1.8 3区医学 Q3 GASTROENTEROLOGY & HEPATOLOGY

Digestive Surgery Pub Date : 2023-01-01 DOI:10.1159/000529199

Simone Giacopuzzi, Lorena Torroni, Maria Bencivenga, Jacopo Weindelmayer, Maria Clelia Gervasi, Giuseppe Verlato, Michele Pavarana, Gabriella Rossi, Giovanni de Manzoni

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引用次数: 0

Abstract

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). The aim of the study was 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 chemotherapy (CT) alone. pCR was 36.8%, 28.6%, and 9.1% after VR protocol, standard CRT, and CT, respectively (p = 0.082), while 3-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% vs. 54%; p < 0.001) and a lower proportion of pCR after CT/CRT (23% vs. 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.

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.

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临床试验内外EGJ癌的治疗:环境重要吗?单中心前瞻性观察研究。

简介:随机对照试验支持局部晚期食管胃结(LA-EGJ)腺癌的新辅助放化疗(nCRT)后手术治疗。然而，随机对照试验是在高度控制的环境中进行的，对现实患者(RLS)的代表性有限。该研究的目的是比较RLS和临床试验环境的结果。方法:将2012年至2017年期间接受LA-EGJ腺癌治疗的125例RLS患者的结果与2003年至2011年进行的65例II期试验(PIIS)患者的结果进行比较。结果:约一半(51.2%)的RLS患者采用VR方案的nCRT治疗，20.8%的RLS患者采用CROSS/Al-Sarraf标准CRT治疗，20%的RLS患者采用单独化疗(CT)治疗。VR方案、标准CRT和CT后的pCR分别为36.8%、28.6%和9.1% (p = 0.082)， 3年总生存率(OS)分别为58.6% (95% CI 43.2-71.1%)、32.8%(14.6-52.4%)和44.8% (21.3-65.9%)(p = 0.030)。相对于PIIS, RLS中cN+的比例更高(94% vs. 54%;p < 0.001)， CT/CRT后pCR比例较低(23% vs. 39%;P = 0.041)。PIIS的3年OS(58.9%， 45.1-70.2%)略高于RLS(47.9%， 37.4-57.7%)，但不显著，与VR方案治疗的RLS的3年OS几乎相同。结论:与临床试验患者相比，现实生活中的EGJ腺癌患者在基线时更晚期，对新辅助治疗的病理反应更低，但生存期相似。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Digestive Surgery 医学-外科

CiteScore

4.90

自引率

3.70%

发文量

审稿时长

3 months

期刊介绍： ''Digestive Surgery'' presents a comprehensive overview in the field of gastrointestinal surgery. Interdisciplinary in scope, the journal keeps the specialist aware of advances in all fields that contribute to improvements in the diagnosis and treatment of gastrointestinal disease. Particular emphasis is given to articles that evaluate not only recent clinical developments, especially clinical trials and technical innovations such as new endoscopic and laparoscopic procedures, but also relevant translational research. Each contribution is carefully aligned with the need of the digestive surgeon. Thus, the journal is an important component of the continuing medical education of surgeons who want their practice to benefit from a familiarity with new knowledge in all its dimensions.