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Randomized Controlled Trial
. 2023 Oct;149(13):11491-11498.
doi: 10.1007/s00432-023-05019-z. Epub 2023 Jul 1.

Hyperthermic intraperitoneal chemotherapy (HIPEC) plus systemic chemotherapy versus systemic chemotherapy alone in locally advanced gastric cancer after D2 radical resection: a randomized-controlled study

Pengfei Yu #  1 , Xingmao Huang #  1 , Ling Huang #  1 , Gaiguo Dai  1 , Qi Xu  2 , Jingquan Fang  1 , Zeyao Ye  1 , Tengjiao Chai  1 , Yian Du  3
Affiliations
Randomized Controlled Trial

Hyperthermic intraperitoneal chemotherapy (HIPEC) plus systemic chemotherapy versus systemic chemotherapy alone in locally advanced gastric cancer after D2 radical resection: a randomized-controlled study

Pengfei Yu et al. J Cancer Res Clin Oncol. 2023 Oct.

Abstract

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/m2) 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.

Keywords: Chemotherapy; Gastric cancer; Hyperthermic intraperitoneal chemotherapy (HIPEC); Peritoneal metastasis; Prognosis.

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Conflict of interest statement

The authors have no relevant financial or nonfinancial interests to disclose.

Figures

Fig. 1
Fig. 1
Treatment schedule for advanced gastric cancer patients randomized into the HIPEC group and the non-HPIEC group
Fig. 2
Fig. 2
Overall survival of patients with advanced gastric cancer according to different treatments
Fig. 3
Fig. 3
Disease-free survival of patients with advanced gastric cancer according to different treatments
See this image and copyright information in PMC

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