CHICAGO – , according to findings from the randomized phase 3 UNICANCER Prodige 7 trial.
At a median follow up of 63.8 months, median overall survival – the primary endpoint of the study – was “completely comparable” at 41.7 and 41.2 months, respectively, in 133 patients randomized to receive HIPEC with oxaliplatin after cytoreductive surgery and 132 randomized to the cytoreductive surgery–only arm, François Quenet, MD, reported during a press briefing at theof the American Society of Clinical Oncology.
The postoperative mortality rate was 1.5% at 30 days in both groups, he said, noting that no difference was seen between the groups in the rate of side effects during the first 30 days after surgery.
“However, we did find a difference between the two arms concerning late, severe complications within 60 days,” said, explaining that the 60-day complication rate was nearly double in the HIPEC group vs. the no-HIPEC group (24.1% vs. 13.6%).
Patients in the trial had stage IV colorectal cancer with isolated peritoneal carcinomatosis and a median age of 60 years. They were enrolled and randomized at 17 centers in France between February 2008 and January 2014.
The survival rate of the surgery-alone group was unexpectedly high, Dr. Quenet said, adding that all colorectal cancer patients with an isolated peritoneal carcinomatosis should therefore be considered for surgery.