Prophylactic hyperthermic intraperitoneal chemotherapy in patients with locally advanced gastric cancer after curative surgery: Final results of a phase II trial.

Abstract

Objective: The trial was designed to evaluate the efficacy of prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin for patients with locally advanced gastric cancer (LAGC).

Methods: Between March 2015 and November 2016, a phase II clinical trial was performed. Fifty consecutive patients with LAGC were randomly assigned to two groups: the experimental group (radical gastrectomy + HIPEC with cisplatin + adjuvant chemotherapy) and the control group (radical gastrectomy + adjuvant chemotherapy). Survival rates were closely monitored.

Results: The 5-year overall survival (OS) rate of all patients was 80.0%. The 5-year OS rate in the experimental group was lower than that in the control group, at 75.8% and 88.2%, respectively, with no statistical significance. In addition, 5-year recurrence-free survival (RFS) rates of patients who underwent HIPEC or not were also 75.8% and 88.2%, respectively. In the multivariate analysis, only pT stage [risk ratio (RR)=7.079, P=0.018] was significantly associated with prognosis. The most common recurrence pattern was peritoneal recurrence in both groups. The experimental group had a lower incidence of peritoneal recurrence than the control group with no statistical significance.

Conclusions: This trial clearly revealed that prophylactic HIPEC with cisplatin neither decrease the risk of peritoneal recurrence nor improve the prognosis of patients with LAGC. Thus, HIPEC with cisplatin is not recommended as a prophylactic treatment for peritoneal recurrence of LAGC after radical gastrectomy.