We talked to Professor François Quenet, Institut du Cancer de Montpellier Val d’Aurelle, Montpellier, France, who will be presenting the outcomes from Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at this year’s meeting.
“The theoretic advantages of HIPEC after cytoreductive surgery is that it would have an impact on the microscopic disease when treating colorectal peritoneal carcinomatosis,” Professor Quenet explained. “However, PRODIGE 7, the first trial to evaluate the specific role of HIPEC after cytoreductive surgery against surgery alone, showed that there was no benefit of HIPEC as it did not influence the overall survival rate of patients after 64 months.”
Prodige 7 randomised 265 patients with histologically proven and isolated peritoneal cancer to surgery plus HIPEC (n=133) with oxaliplatin or surgery alone (n=132), in association with systemic chemotherapy. The primary endpoint was the overall survival and the secondary endpoints were relapse-free survival (RFS) and toxicity. The results showed no different between the two groups regarding the overall post-operative mortality rate at 30-days and 60-days, respectively (1.5% and 2.6%).
“The outcomes from PRODIGE 7 have triggered a debate within the colorectal community about whether we should continue to provide HIPEC plus surgery, as there is no evidence of its benefit in terms of survival,” he added. “It is difficult to argue for a procedure when the median overall survival curves identical showing 41.7 months for HIPEC and 41.2 months without HIPEC. There was clearly no difference, so there is no benefit. Beside this we showed a survival benefit in a sub group analysis for median range PCI patients (from 10 to16).”
In addition to the lack of benefit regarding the overall survival rate, he also explained that relapse-free survival (RFS) rate was also similar in both groups with the median RFS 13.1 months among patients treated with HIPEC and 11.1 months among those treated with surgery. Although there was a non-significant difference in the 30-day complication favouring HIPEC plus surgery (1.5% vs 2.6%), patients who had HIPEC plus surgery were more likely to develop postoperative complications at 60 days, compared with the patients in the non-HIPEC group (24.1% vs 13.6%). The mean hospital stay was also five days longer for patients in the HIPEC group, compared with patients in the non-HIPEC group (18.0 days versus 13.0 days).
He said that this study only used the oxaliplatin agent and that perhaps a future direction would be to use different agents other than oxaliplatin that may prove to be more. However, he explained that currently there are no drugs that have shown to be effective in this group of patients.
“In this study, we did not break one leg but two, we don’t know whether HIPEC in general is bereft of efficacy or specifically this high dose and short duration of oxaliplatin HIPEC protocol. This was surprising because in the intravenous setting oxaliplatin is one of the most effective drugs for colorectal patients,” he concluded. “Overall, I would say that it is time we reconsidered incorporating abdominal chemotherapy into the standard treatment regimen for patients with colorectal peritoneal carcinomatosis.”