Categories
Nevin Manimala Statistics

Hyperthermic intraperitoneal chemotherapy plus SOX chemotherapy versus SOX chemotherapy alone in patients with gastric cancer and peritoneal metastasis: a phase II randomized clinical trial

J Gastrointest Oncol. 2025 Feb 28;16(1):17-26. doi: 10.21037/jgo-24-807. Epub 2025 Jan 9.

ABSTRACT

BACKGROUND: The prognosis of patients with gastric cancer with peritoneal metastasis (GCPM) is exceedingly poor. This study evaluated the efficacy and safety of hyperthermic intraperitoneal chemotherapy (HIPEC) with paclitaxel combined with S-1 and oxaliplatin (SOX) in the treatment of GCPM.

METHODS: Patients with pathologically confirmed primary gastric adenocarcinoma and laparoscopy-confirmed peritoneal metastasis were enrolled and randomized to receive either HIPEC plus SOX (HIPEC group) or SOX alone (SOX group). The primary endpoint was progression-free survival (PFS), and the secondary endpoints were 1-year survival rate, overall survival (OS), and safety.

RESULTS: Among the included patients, 30 were assigned to the HIPEC group and 29 to the SOX group. Compared to the HIPEC group, the SOX group had a significantly higher median PFS (SOX: median 8.5 months, IQR, 3.8-21.8 months; HIPEC: median 6.1 months, IQR, 3.3-10.8 months; P=0.004) and OS (SOX: median 13.0 months, IQR, 6.3-16.6 months; HIPEC: median 10.0 months, IQR, 5.2-24.0 months; P=0.02). The 1-year survival rate was 50.0% in the SOX group and 37.9% in HIPEC group, but the difference was not statistically significant. No serious adverse events related to the protocol treatment occurred in any patients.

CONCLUSIONS: This trial failed to show the superiority of HIPEC with SOX over SOX alone. Further research into this regimen is needed.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03604614.

PMID:40115934 | PMC:PMC11921333 | DOI:10.21037/jgo-24-807

By Nevin Manimala

Portfolio Website for Nevin Manimala