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

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.