Department of Surgical Oncology, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.
Department of Surgical Oncology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Eur J Surg Oncol. 2018 May;44(5):613-619. doi: 10.1016/j.ejso.2018.02.004. Epub 2018 Feb 9.
In order to determine the optimal combination of perioperative chemotherapy and chemoradiotherapy for Western patients with advanced resectable gastric cancer, the international multicentre CRITICS trial (ChemoRadiotherapy after Induction chemotherapy In Cancer of the Stomach) was initiated. In this trial, patients with resectable gastric cancer were randomised before start of treatment between adjuvant chemotherapy or adjuvant chemoradiotherapy following neoadjuvant chemotherapy plus gastric cancer resection. The purpose of this study was to report on surgical morbidity and mortality in this trial, and to identify factors associated with surgical morbidity.
Patients who underwent a gastrectomy with curative intent were selected. Logistic regression analyses were used to assess risk factors for developing postoperative complications.
Between 2007 and 2015, 788 patients were included in the CRITICS trial, of whom 636 patients were eligible for current analyses. Complications occurred in 296 patients (47%). Postoperative mortality was 2.2% (n = 14). Complications due to anastomotic leakage was cause of death in 5 patients. Failure to complete preoperative chemotherapy (OR = 2.09, P = 0.004), splenectomy (OR = 2.82, P = 0.012), and male sex (OR = 1.55, P = 0.020) were associated with a greater risk for postoperative complications. Total gastrectomy and oesophago-cardia resection were associated with greater risk for morbidity compared with subtotal gastrectomy (OR = 1.88, P = 0.001 and OR = 1.89, P = 0.038).
Compared to other Western studies, surgical morbidity in the CRITICS trial was slightly higher whereas mortality was low. Complications following anastomotic leakage was the most important factor for postoperative mortality. Important proxies for developing postoperative complications were failure to complete preoperative chemotherapy, splenectomy, male sex, total gastrectomy, and oesophago-cardia resection.
为了确定西方可切除局部晚期胃癌患者围手术期化疗和放化疗的最佳联合方案,启动了国际多中心 CRITICS 试验(诱导化疗后化疗和放疗在胃癌中的应用)。在这项试验中,在开始治疗前,将可切除的胃癌患者随机分为新辅助化疗加胃癌切除术后辅助化疗或辅助放化疗。本研究旨在报告该试验中的手术发病率和死亡率,并确定与手术发病率相关的因素。
选择了接受根治性胃切除术的患者。使用逻辑回归分析评估发生术后并发症的危险因素。
在 2007 年至 2015 年间,CRITICS 试验共纳入 788 例患者,其中 636 例符合当前分析标准。296 例(47%)患者发生并发症。术后死亡率为 2.2%(n=14)。因吻合口漏导致的并发症是 5 例死亡的原因。未完成术前化疗(OR=2.09,P=0.004)、脾切除术(OR=2.82,P=0.012)和男性(OR=1.55,P=0.020)与术后并发症风险增加相关。全胃切除术和食管胃切除术与胃次全切除术相比,发病率更高(OR=1.88,P=0.001 和 OR=1.89,P=0.038)。
与其他西方研究相比,CRITICS 试验中的手术发病率略高,而死亡率较低。吻合口漏并发症是术后死亡的最重要因素。未完成术前化疗、脾切除术、男性、全胃切除术和食管胃切除术是发生术后并发症的重要因素。