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Title: [Safety evaluation of hyperthermic intraperitoneal chemotherapy in patients with local advanced gastric cancer after radical resection for prevention of peritoneal metastasis].
Author: Lin Y, Shen C, Guo XK, Li Y, Wang DD, Chen X, Wang Z, Wu K, Tao KX, Wu CQ.
Journal: Zhonghua Wei Chang Wai Ke Za Zhi; 2022 Jan 25; 25(1):48-55. PubMed ID: 35067034.
Abstract:
Objective: Patients with advanced gastric cancer have a poor prognosis and a possibility of peritoneal metastasis even if receiving gastrectomy. Hyperthermic intraperitoneal chemotherapy (HIPEC) can effectively kill free cancer cells or small lesions in the abdominal cavity. At present, preventive HIPEC still lacks safety evaluation in patients with locally advanced gastric cancer. This study aims to explore the safety of radical resection combined with HIPEC in patients with locally advanced gastric cancer. Methods: A descriptive case series study was carried out. Clinicopathological data of 130 patients with locally advanced gastric cancer who underwent radical resection + HIPEC at the Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology from January 2020 to February 2021 were retrospectively analyzed. Inclusion criteria: (1) locally advanced gastric adenocarcinoma confirmed by postoperative pathology; (2) no distant metastasis was found before surgery; (3) radical resection; (4) at least one HIPEC treatment was performed. Exclusion criteria: (1) incomplete clinicopathological data; (2) tumor metastasis was found during operation; (3) concomitant with other tumors. HIPEC method: all the patients received the first HIPEC immediately after D2 radical resection, and returned to the ward after waking up from anesthesia; the second and the third HIPEC were carried out according to the patient's postoperative recovery and tolerance; interval between two HIPEC treatments was 48 h. Observation indicators: (1) basic information, including gender, age, body mass index, etc.; (2) treatment status; (3) perioperative adverse events: based on the standard of common adverse events published by the US Department of Health and Public Health (CTCAE 5.0), the adverse events of grade 2 and above during the treatment period were recorded, including hypoalbuminemia, bone marrow cell reduction, wound complications, abdominal infection, lung infection, gastroparesis, anemia, postoperative bleeding, anastomotic leakage, intestinal obstruction, pleural effusion, abdominal distension, impaired liver function, and finally a senior professional title chief physician reviewed the above adverse events and made a safety evaluation of the patient; (4) association between times of HIPEC treatment and adverse events in perioperative period; (5) analysis of risk factors for adverse events in perioperative period. Results: Among the 130 patients, 79 were males and 51 were females with a median age of 59 (54, 66) years and an average body mass index of (23.9±7.4) kg/m(2). The tumor size was (5.4±3.0) cm and 100 patients (76.9%) had nerve invasion. All the 130 patients received radical resection + HIPEC and 125 (96.2%) patients underwent laparoscopic surgery. The mean operative time was (345.6±52.3) min and intraoperative blood loss was (82.0±36.5) ml. One HIPEC treatment was performed in 54 patients (41.5%), 2 HIPEC treatments were in 57 (43.8%), and 3 HIPEC treatments were in 19 (14.6%). The average postoperative hospital stay was (13.1±7.5) d. A total of 57 patients (43.8%) had 71 cases of postoperative complications of different degrees. Among them, the incidence of hypoalbuminemia was 22.3% (29/130), and the grade 2 and above anemia was 15.4% (20/130), lung infection was 3.8% (5/130), bone marrow cell suppression was 3.7% (4/130), abdominal cavity infection was 2.3% (3/130), and liver damage was 2.3% (3/130), wound complications was 1.5% (2/130), abdominal distension was 1.5% (2/130), anastomotic leakage was 0.8% (1/130), gastroparesis was 0.8% (1/130) and intestinal obstruction was 0.8% (1/130), etc. These adverse events were all improved by conservative treatments. There were no statistically significant differences in the incidence of adverse events during the perioperative period among patients undergoing 1, 2, and 3 times of HIPEC treatments (all P>0.05). Univariate and multivariate logistic analyses showed that age > 60 years (OR: 2.346, 95%CI: 1.069-5.150, P=0.034) and neurological invasion (OR: 2.992, 95%CI: 1.050-8.523, P=0.040) were independent risk factors for adverse events in locally advanced gastric cancer patients undergoing radical resection+HIPEC (both P<0.05). Conclusions: Radical surgery + HIPEC does not significantly increase the incidence of perioperative complications in patients with advanced gastric cancer. The age >60 years and nerve invasion are independent risk factors for adverse events in these patients. 目的： 局部进展期胃癌患者既使接受根治性手术，预后依然欠佳且易发生腹膜转移。腹腔热灌注化疗（HIPEC）可有效地清除或杀灭腹腔内游离的癌细胞或微小病灶，但当前预防性HIPEC在局部进展期胃癌患者中仍缺乏安全性评价。故本研究旨在探讨胃癌D(2)根治术联合HIPEC在预防局部进展期胃癌腹膜转移中的安全性。 方法： 采用描述性病例系列研究方法，回顾性分析2020年1月至2021年2月于华中科技大学同济医学院附属协和医院胃肠外科130例行标准胃癌D(2)根治术+HIPEC治疗的局部进展期胃癌患者资料。病例纳入标准：（1）经术后病理证实为局部进展期胃腺癌；（2）术前未发现远处转移病灶；（3）根治性切除；（4）至少接受1次HIPEC治疗。排除标准：（1）围手术期临床病理资料不全；（2）术中发现肿瘤转移；（3）伴发其他肿瘤。HIPEC治疗方法：所有患者D(2)根治术后均立即行首次HIPEC治疗，麻醉清醒后返回病房；第2次及第3次HIPEC则根据患者术后恢复情况及耐受程度开展，每2次HIPEC治疗间隔为48 h。本研究观察指标：（1）患者基本资料，包括性别、年龄、体质指数等；（2）治疗情况；（3）围手术期不良事件情况：采用美国卫生及公共卫生部公布的常见不良事件评价标准（CTCAE 5.0）记录患者治疗观察期间出现的2级及以上不良事件，包括低白蛋白血症、骨髓细胞减少、创口并发症、腹腔感染、肺感染、胃肌软瘫、贫血、术后出血、吻合口漏、肠梗阻、胸腔积液、腹胀、肝功能受损，最终由一名高级职称主任医师对上述不良事件进行审核，并对患者做出安全性评价；（4）HIPEC治疗次数与围手术期不良事件的关系；（5）围手术期发生不良事件的危险因素分析。 结果： （1）基本资料：130例患者中男性79例（60.8%），中位年龄59（54，66）岁，体质指数（23.9±7.4）kg/m(2)，肿瘤大小为（5.4 ± 3.0）cm，100例（76.9%）患者神经受侵犯。（2）治疗情况：130例患者均行根治术+HIPEC治疗，125例（96.2%）患者行腹腔镜手术；全部患者手术时间为（345.6±52.3）min，术中失血量为（82.0 ± 36.5）ml。行1次HIPEC者54例（41.5%）、2次HIPEC者57例（43.8%）、3次HIPEC者19例（14.6%）。患者术后住院时间为（13.1 ± 7.5）d。（3）围手术期不良事件情况：共有57例（43.8%）患者在HIPEC治疗后发生71例次不同程度的不良事件，以术后低白蛋白血症（29/130，22.3%）、中度及以上贫血（20/130，15.4%）为主，其余包括肺部感染5例（3.8%）、骨髓细胞减少4例（3.1%）、腹腔感染3例（2.3%）、肝功能受损3例（2.3%）、创口并发症2例（1.5%）、腹胀2例（1.5%）、吻合口漏1例（0.8%）、胃肌软瘫1例（0.8%）、肠道梗阻1例（0.8%），无术后出血不良事件发生；不良反应症状经保守治疗后均获得缓解。（4）HIPEC治疗次数与围手术期不良事件的关系：接受1次、2次和3次HIPEC治疗的局部进展期胃癌患者围手术期各项不良事件发生率差异无统计学意义（均P>0.05）。（5）围手术期发生不良事件的危险因素分析：年龄>60岁（OR：2.346，95%CI：1.069~5.150，P=0.034）及神经侵犯（OR：2.992，95%CI：1.050~8.523，P=0.040）是局部进展期胃癌患者行根治术+HIPEC治疗发生不良事件的独立危险因素（均P<0.05）。 结论： D(2)根治术+HIPEC的治疗策略并不会显著增加局部进展期胃癌患者围手术期并发症的发生率，但年龄>60岁和神经受侵犯者不良事件发生率较高，应给予重视。.

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