Clinical Trials for Peritoneal Metastases and Emerging Trends Session
CT4 - Is There Benefit from Hyperthermic Intraperitoneal Chemotherapy in Advanced Gastric Cancer: Early Results from a Phase II Clinical Trial
Monday, February 17, 2020
11:15 AM – 11:30 AM
Location: Sebastian I 1/2
Introduction Gastric cancer (GC) with peritoneal carcinomatosis (PC) has a very poor overall survival (OS). However, data suggests that gastrectomy in combination with cytoreduction (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) may improve survival. The aim of this study is to evaluate disease-free survival (DFS), OS, and major morbidity in patients with GC and limited PC who underwent gastrectomy with CRS/HIPEC. Methods A phase II single institution clinical trial was initiated in June 2017 for patients with GC and low volume PC, defined as peritoneal carcinomatosis index (PCI) ≤10 and/or positive peritoneal cytology at staging laparoscopy (SL). Patients underwent neoadjuvant chemotherapy, SL, and gastrectomy with CRS/HIPEC. Prospective data collection included demographics, PCI, extent of surgical resection, complications, recurrence, and OS. Results Fourteen patients underwent gastrectomy with CRS/HIPEC. Majority were Caucasian (50%) and male (64%) with a median age of 47 years (range 32-67). The median PCI at SL was 4 (range 0-10). Most patients (12/14) achieved complete cytoreduction (CC-0), one CC-1, and one CC-2. Five patients (43%) experienced an adverse event (Clavien-Dindo 3b): 5 anastomotic leaks and 1 duodenal stump leak. The median follow-up for our cohort was 7 months, and overall six patients died of recurrent disease between 2.5-12 months; 4 are alive with recurrent disease, and 4 remain disease free. Conclusion Preliminary results of this trial demonstrate major morbidity is common in patients undergoing gastrectomy with CRS/HIPEC for advanced GC. Continued accrual is required to determine the impact upon survival endpoints.