Laparoscopic cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for gastric cancer with intraoperative detection of limited peritoneal metastasis: a Phase II study of CLASS-05 trial.

IF 3.8 3区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Gastroenterology Report Pub Date : 2024-02-21 eCollection Date: 2024-01-01 DOI:10.1093/gastro/goae001
Tian Lin, Xinhua Chen, Zhijun Xu, Yanfeng Hu, Hao Liu, Jiang Yu, Guoxin Li
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Abstract

Background: Systemic chemotherapy for gastric cancer with peritoneal metastasis has limited clinical benefit; for those with intraoperative detection of occult peritoneal metastasis, cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC) is an alternative treatment. However, the feasibility and effects of this modality and criteria for selecting suitable groups remain unclear. This study aimed to explore the safety and efficacy of laparoscopic cytoreductive surgery (L-CRS) followed by HIPEC in gastric cancer with limited peritoneal metastasis, and this study also aimed to determine the optimized cut-off of the peritoneal cancer index.

Methods: Between March 2017 and November 2019, patients diagnosed with gastric cancer peritoneal metastases by using laparoscopy and the Sugarbaker peritoneal cancer index of ≤12 were eligible for inclusion. All patients received L-CRS (including gastrectomy with D2 lymph node dissection) and resection of visible peritoneal metastasis, followed by post-operative HIPEC, and systemic chemotherapy. The primary end points were median progression-free survival and median survival time, and the secondary outcomes were morbidity and mortality within 30 days after surgery.

Results: Thirty patients were eligible for analysis, of whom 19 (63.3%) were female, and the overall mean age was 53.0 years. The post-operative morbidity was 20% and the severe complication rate was 10%. The median survival time was 27.0 months with a 2-year overall survival rate of 52.3% and median progression-free survival was 14.0 months with a 2-year progression-free survival of 30.4%.

Conclusions: L-CRS followed by HIPEC can be safely performed for gastric cancer with limited peritoneal metastasis and potential survival benefits.

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术中发现局限性腹膜转移的胃癌腹腔镜细胞减灭术和腹腔内热化疗:CLASS-05试验的II期研究。
背景:对于术中发现有隐匿性腹膜转移的胃癌患者,细胞减灭术后腹腔热化疗(HIPEC)是一种可供选择的治疗方法。然而,这种方法的可行性和效果以及选择合适人群的标准仍不明确。本研究旨在探讨腹腔镜细胞减灭术(L-CRS)后HIPEC治疗胃癌局限性腹膜转移的安全性和有效性,本研究还旨在确定腹膜癌指数的优化临界值:2017年3月至2019年11月期间,通过腹腔镜检查确诊为胃癌腹膜转移且Sugarbaker腹膜癌指数≤12的患者符合纳入条件。所有患者均接受了L-CRS(包括胃切除术和D2淋巴结清扫术)和可见腹膜转移灶切除术,术后接受HIPEC和全身化疗。主要终点是中位无进展生存期和中位生存时间,次要终点是术后30天内的发病率和死亡率:30名患者符合分析条件,其中19人(63.3%)为女性,平均年龄为53.0岁。术后发病率为 20%,严重并发症发生率为 10%。中位生存期为27.0个月,2年总生存率为52.3%,中位无进展生存期为14.0个月,2年无进展生存率为30.4%:结论:L-CRS后HIPEC可安全用于胃癌腹膜转移有限的患者,并具有潜在的生存益处。
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来源期刊
Gastroenterology Report
Gastroenterology Report Medicine-Gastroenterology
CiteScore
4.60
自引率
2.80%
发文量
63
审稿时长
8 weeks
期刊介绍: Gastroenterology Report is an international fully open access (OA) online only journal, covering all areas related to gastrointestinal sciences, including studies of the alimentary tract, liver, biliary, pancreas, enteral nutrition and related fields. The journal aims to publish high quality research articles on both basic and clinical gastroenterology, authoritative reviews that bring together new advances in the field, as well as commentaries and highlight pieces that provide expert analysis of topical issues.
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