Conference Coverage

Prodige 7: No survival benefit with HIPEC for advanced colorectal cancer

 

Key clinical point: HIPEC with oxaliplatin after surgery offers no survival benefit in patients with advanced colorectal cancer.

Major finding: Median overall survival was comparable at 41.7 and 41.2 months, respectively, in the HIPEC and no-HIPEC groups.

Study details: The randomized phase 3 Prodige 7 trial of 265 patients.

Disclosures: Prodige 7 was funded by UNICANCER. Dr. Quenet has received honoraria from Sanofi/Aventis, Ethicon, and Gamida Cell, as well as travel/accommodations/expenses from Sanofi, Novartis, and Ethicon.

Source: Quenet F et al. ASCO 2018, LBA3503.


 

REPORTING FROM ASCO 2018

Hyperthermic intraperitoneal chemotherapy (HIPEC) following surgery for colorectal peritoneal carcinomatosis provides no survival benefit and may cause harm, 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 the annual meeting of the American Society of Clinical Oncology.

Sharon Worcester/MDedge News

Dr. François Quenet

Median overall relapse-free survival was 13.1 and 11.1 months in the groups, respectively, said Dr. Quenet, head of the hepatobiliary and peritoneal surface malignancy unit at the Regional Cancer Institute, Montpellier, France.

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.

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