An evaluation of cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy on patients with peritoneal carcinomatosis: Final results of a phase II prospective and randomized clinical trial.

Abstract

4051 Background: Our phase I study indicates that cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) is feasible and may help improve the outcomes of pts with peritoneal carcinomatosis (PC). This randomized and prospective phase II study was to evaluate the efficacy and safety of CRS + IPHC using cisplatin (CDDP) and mitomycin C (MMC) for the PC. Methods: Pts eligibility criteria were: (1) PC from gastric and colorectal cancers without evidence of distant metastasis and expected survival of > 8 wk; (2) age between 25-70 yr old; (3) KPS>50; (4) routine laboratory workup found no significant changes limiting aggressive intervention; (5) good tolerance for major surgery; and (6) written informed consent. After randomization, pts were treated with CRS alone or CRS + IPHC using CDDP 120 mg and MMC 30 mg in 12,000 mL of normal saline at 43±0.5°C for 60-90 min. Survival and safety were studied. Results: A total of 89 pts with PC (68 from gastric cancer and 21 from colorectal cancer) were randomized into CRS group (n=44) and CRS + HIPEC group (n=45). The 2 groups were well-balanced in terms of major demographic data, KPS and PCI. At a median follow-up of 32.5 mo (7-83 mo), the median survival was 6.5 mo (95% CI 5.2-7.8 mo) in CRS group and 13.0 months (95% CI 9.0-17.0 mo) in the CRS + HIPEC group (P=0.001, log rank test). For gastric PC pts, the median survival was 6.5 months (95% CI 4.9-8.2 mo) in CRS group (n=34) and 11.0 mo (95% CI 9.0-12.9 mo) in the CRS+HIPEC group (n=34) (P=0.002, log rank test). For CRC PC pts, the median survival was 7.0 mo (95% CI 3.5-10.5 mo) in CRS group (n=11) and 15.5 mo (95% CI 4.9-26.1 mo) in the CRS+HIPEC group (n=10) (P=0.003, log rank test). HIPEC could increase the median survival by over 60%. No perioperative death occurred. Four pts (10.3%) in the CRS+HIPEC group and 2 (5.0%) pts in the CRS group developed SAE. Conclusions: For PC pts from gastric and colorectal cancers, CRS plus HIPEC with MMC 30 mg and CDDP 120 mg could improve survival with acceptable safety.