Multicenter phase 3 trial of efficacy and safety of intraoperative HIPEC for locally advanced colon cancer

Peritoneal metastasis in patients with locally advanced colon cancer (LACC, T4 stage) is estimated to recur at a rate of approximately 25% at 3 years from surgical resection, and is associated with poor prognosis. A phase 3 trial at 17 centers of the Grupo Español de Carcinomatosis Peritoneal evaluated efficacy and safety of intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) for LACC. Patients were randomized to receive cytoreduction plus HIPEC with mitomycine C (investigational group) or cytoreduction alone (comparator group). The 3-year locoregional control (LC) rate was 97.6% in the investigational group versus 87.6% in the comparator group (HR 0.21; p=0.03).The subgroup with pT4 disease showed a pronounced benefit in 3-year LC rate with HIPEC (98.3% versus 82.1%; HR 0.09; p=0.003). There were no diffences in morbidity or toxic effects between the treatment groups. The authors conclude that addition of HIPEC to complete surgical resection for LACC was associated with significant improvement of 3-year LC (visual abstract).