Cytoreductive surgery and Hyperthermic intra-operative peritoneal chemotherapy with Cisplatin for gastric peritoneal Carcinomatosis Monocentric phase-2 nonrandomized prospective clinical trial

Baki Topal, Karel Demey, Halit Topal, Joris Jaekers, Eric Van Cutsem, Vincent Vandecaveye, Xavier Sagaert, Hans Prenen

Cytoreductive surgery (CRS) plus hyperthermic intra-operative peritoneal chemotherapy (HIPC) for gastric peritoneal carcinomatosis (PC) is controversial, and selection criteria for this treatment modality are lacking. Thirty-two patients (F/M ratio 12/20; median (range) age 58 (32-75) years) underwent CRS + HIPC with cisplatin for PC from gastric adenocarcinoma in 2010-2014. This monocentric phase-2 nonrandomized prospective study with a power of 90% aimed to improve the 1-year overall survival (OS) rate with 40% (historical reference of 52% to 72%). Median PCI score was 8 (range 1-20), number of regions involved was 6 (range 1-11). The impact of 16 prognostic factors on survival was evaluated using univariable and multivariable Cox regression models. Follow-up was complete in all patients, and closed 2 years after patient inclusion. All patients had complete cytoreduction (CCR-0) and histopathological R0 resection. PCI </= 12 without PC on any small bowel region with 4 or more non-small bowel regions resulted in a median OS time of 24.7 months (15.6-29.4), and 1, 2, 5-year OS rates of 90%, 55%, 5.6%, respectively. Independent predictors of OS were PC on the small bowel combined with PC on 4 or more non-small bowel regions (p = 0.0004), number of regions involved (p = 0.0029), and overall PCI score (p = 0.0104). CRS + HIPC with cisplatin to treat gastric PC, providing complete cytoreduction and R0 resection, should be restricted to patients with PCI of 12 or less. Patients having PC on any small bowel region with 4 or more non-small bowel regions should be refused for CRS + HIPC. Registration number: NCT01116791 . Registration date: May 5, 2010.