腹腔内热灌注化疗（HIPEC）联合全身化疗对比 D2 根治术后局部进展期胃癌单纯全身化疗的随机对照研究。
Hyperthermic intraperitoneal chemotherapy (HIPEC) plus systemic chemotherapy versus systemic chemotherapy alone in locally advanced gastric cancer after D2 radical resection: a randomized-controlled study.
机构信息
Department of Gastric Surgery, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, 310022, Zhejiang, China.
Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences, Hangzhou, 310022, Zhejiang, China.
出版信息
J Cancer Res Clin Oncol. 2023 Oct;149(13):11491-11498. doi: 10.1007/s00432-023-05019-z. Epub 2023 Jul 1.
BACKGROUND
Currently, there is a lack of an effective strategy for the prevention of peritoneal metastasis (PM) from locally advanced gastric cancer (AGC). This randomized-controlled study aimed to evaluate the outcome of D2 radical resection with hyperthermic intraperitoneal chemotherapy (HIPEC) plus systemic chemotherapy versus systemic chemotherapy alone in locally AGC patients.
METHODS
All enrolled patients were randomly assigned to receive HIPEC plus systemic chemotherapy (HIPEC group) or systemic chemotherapy alone (non-HIPEC group) after radical gastrectomy. HIPEC was performed intraperitoneally with cisplatin (40 mg/m) within 72 h after surgery, while systemic chemotherapy based on the SOX regimen (S-1 combined with oxaliplatin) was administered 4-6 weeks after radical surgery. Patterns of recurrence, adverse events, 3-year disease-free survival (DFS), and overall survival (OS) were analyzed.
RESULTS
A total of 134 patients were enrolled in the present study. The 3-year DFS rate was 73.8% in the HIPEC group, which was significantly higher than that in the non-HIPEC group (61.2%, P = 0.031). The 3-year OS rate was 73.9% in the HIPEC group and 77.6% in the non-HIPEC group, with no significant difference (P = 0.737). PM was the most common distant metastasis in both groups. The occurrence rate of PM in the HIPEC group was statistically lower than that in the non-HIPEC group (20.9% vs. 40.3%, P = 0.015). Grade 3 or 4 adverse events occurred in 19 (14.2%) patients, and there was no significant difference between the two groups.
CONCLUSION
Radical surgery followed by HIPEC combined with systemic chemotherapy is a safe and feasible strategy for locally AGC patients and could effectively improve DFS and reduce the occurrence of PM. However, more prospective randomized studies with a large sample size are warranted.
TRIAL REGISTRATION
This study was registered with www.medresman.org.cn as ChiCTR2200055966 on 10/12/2016.
背景
目前，对于局部晚期胃癌（AGC）患者，缺乏预防腹膜转移（PM）的有效策略。本随机对照研究旨在评估根治性胃切除术后接受腹腔热灌注化疗（HIPEC）联合全身化疗与单纯全身化疗治疗局部晚期 AGC 患者的疗效。
方法
所有入组患者在根治性胃切除术后随机分为 HIPEC 联合全身化疗组（HIPEC 组）和单纯全身化疗组（非 HIPEC 组）。术后 72 小时内行腹腔内顺铂（40mg/m）HIPEC，根治术后 4-6 周行 SOX 方案（替吉奥联合奥沙利铂）全身化疗。分析复发模式、不良反应、3 年无病生存（DFS）率和总生存（OS）率。
结果
本研究共纳入 134 例患者。HIPEC 组的 3 年 DFS 率为 73.8%，明显高于非 HIPEC 组的 61.2%（P=0.031）。HIPEC 组的 3 年 OS 率为 73.9%，非 HIPEC 组为 77.6%，两组无显著差异（P=0.737）。PM 是两组最常见的远处转移。HIPEC 组的 PM 发生率明显低于非 HIPEC 组（20.9% vs. 40.3%，P=0.015）。3 级或 4 级不良反应发生率为 19 例（14.2%），两组间无显著差异。
结论
根治性手术联合 HIPEC 联合全身化疗是局部晚期 AGC 患者安全可行的治疗策略，可有效提高 DFS 率，降低 PM 发生率。然而，需要更多的前瞻性随机研究来验证。
试验注册
本研究于 2016 年 10 月 12 日在中国临床试验注册中心（ChiCTR2200055966）注册。
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