Background and objectives: We conducted a dose-finding study for 5-fluorouracil (5-FU) administered with cisplatin (CDDP) and mitomycin C (MMC) to find an improved regimen for hyperthermic intraperitoneal chemotherapy (HIPEC) for advanced gastric cancer (GC).
Methods: The appropriate HIPEC regimen previously determined in vitro was 5-FU (200 µg/mL), MMC (2 µg/mL), and CDDP (10 µg/mL) at hyperthermic conditions (42°C) for 30 min. This was a clinical study to determine the recommended dose of 5-FU in combination with MMC and CDDP at 42°C for 30 min and to evaluate HIPEC safety in patients at high risk of developing peritoneal metastases following GC surgery.
Results: Twelve patients were treated with surgery plus HIPEC using 5-FU at 0, 500, 750, and 1000 mg combined with MMC (10 mg) and CDDP (50 mg) in the perfusate (5 L). Dose-limiting toxicities did not develop until 1000 mg 5-FU was reached. Four patients experienced grade 1 or 2 adverse events. The recommended dose was 1000 mg 5-FU/5 L perfusate. Eight (66.7%) patients demonstrated no recurrence of peritoneal metastases; 5-year overall survival rate was 83.3%.
Conclusion: Gastrectomy and HIPEC with MMC, CDDP, and 5-FU is feasible, safe, and may protect against peritoneal metastasis following surgery for advanced GC.
Keywords: 5-FU; HIPEC; peritoneal dissemination; phase I study; surgery.
© 2017 Wiley Periodicals, Inc.