Department of General, Visceral, Vascular, Thoracic and Pediatric Surgery, Kempten Clinic, Kempten, Germany.
Working Group "Healthcare Research", Germany. ; Department of General and Visceral Surgery, Ulm University Clinic, Ulm, Germany.
J Gastric Cancer. 2014 Mar;14(1):39-46. doi: 10.5230/jgc.2014.14.1.39. Epub 2014 Mar 31.
According to current guidelines, perioperative chemotherapy is an integral part of the treatment strategy for advanced gastric cancer. Randomized controlled studies have been conducted in order to determine whether perioperative chemotherapy leads to improved R0 resection rates, fewer recurrences, and prolonged survival. The aim of our project was to critically appraise three major studies to establish whether perioperative chemotherapy for advanced, potentially resectable gastric cancer can be recommended on the basis of their findings.
We analyzed the validity of the three most important studies (MAGIC, ACCORD, and EORTC) using a standardized questionnaire. Each study was evaluated for the study design, patient selection, randomization, changes in protocol, participating clinics, preoperative staging, chemotherapy, homogeneity of subjects, surgical quality, analysis of the results, and recruitment period.
All three studies had serious shortcomings with respect to patient selection, homogeneity of subjects, changes in protocol, surgical quality, and analysis of the results. The protocols of the MAGIC and ACCORD-studies were changed during the study period because of insufficient recruitment, such that carcinomas of the lower esophagus and the stomach were examined collectively. In neither the MAGIC study nor the ACCORD study did patients undergo adequate lymphadenectomy, and only about half of the patients in the chemotherapy group could undergo the treatment specified in the protocol. The EORTC study had insufficient statistical power.
We concluded that none of the three studies was sufficiently robust to justify an unrestrained recommendation for perioperative chemotherapy in cases of advanced gastric cancer.
根据现行指南,围手术期化疗是治疗进展期胃癌的综合治疗策略的一部分。已经进行了随机对照研究,以确定围手术期化疗是否能提高 R0 切除率、减少复发和延长生存。我们的项目旨在批判性地评价三项主要研究,以确定基于这些研究结果,是否可以推荐对进展期、可能可切除的胃癌进行围手术期化疗。
我们使用标准化问卷分析了三项最重要的研究(MAGIC、ACCORD 和 EORTC)的有效性。每项研究都根据研究设计、患者选择、随机化、方案改变、参与诊所、术前分期、化疗、受试者同质性、手术质量、结果分析和招募期进行评估。
所有三项研究在患者选择、受试者同质性、方案改变、手术质量和结果分析方面都存在严重缺陷。MAGIC 和 ACCORD 研究的方案在研究期间因招募不足而发生改变,即食管下段和胃的癌症一起进行检查。在 MAGIC 研究和 ACCORD 研究中,均未进行充分的淋巴结清扫,且只有约一半化疗组的患者能接受方案规定的治疗。EORTC 研究的统计效力不足。
我们的结论是,三项研究均不够稳健,无法在进展期胃癌中无限制地推荐围手术期化疗。