Comparative safety of postoperative HIPEC with recombinant mutant TNF-α versus paclitaxel for gastric cancer peritoneal metastasis: a randomized controlled trial.

BACKGROUND/

OBJECTIVES

Peritoneal metastasis (PM) of gastric cancer (GC) is frequently resistant to systemic chemotherapy, which leads to a poor prognosis. This study was designed to compare the safety and tolerability of hyperthermic intraperitoneal chemotherapy (HIPEC) with recombinant mutant human tumor necrosis factor-α (rmhTNF) versus paclitaxel after radical surgery for GC.

METHODS

Patients with locally advanced or metastatic GC who underwent surgical exploration at the Department of Gastrointestinal Surgery, Zhongnan Hospital of Wuhan University were prospectively enrolled and randomly assigned to three groups. All patients received HIPEC on the 1st and 3rd postoperative day. The HIPEC regimens were as follows: rmhTNF (Group A), paclitaxel (Group B), and rmhTNF + paclitaxel (Group C).

RESULTS

A total of 30 patients were enrolled in this study, with 10 patients each in groups A, B and C. There were no statistically significant differences in postoperative first activity, gastrointestinal function recovery, catheter removal, and length of hospital stay (P > 0.05). Postoperative complications, including abdominal distension, discomfort, anastomotic leakage, myelosuppression, infection, and fever, did not demonstrate statistically significant differences among the three groups (P > 0.05). Similarly, no statistically significant differences were observed in hematology, liver and kidney function, and postoperative coagulation function among the three groups of patients before surgery, after the first HIPEC treatment, before the second HIPEC treatment, and after the second HIPEC treatment (P > 0.05). After a median follow-up of 14 months, a total of 10 patients (34.5%) experienced recurrence.

CONCLUSION

The safety and tolerability of rmhTNF for HIPEC in GC were confirmed. Additionally, rmhTNF did not impede gastrointestinal recovery or increase postoperative complication rates.