Randomized Study

There is only one randomized study comparing the HIPEC approach with conventional treatment of PC of colorectal origin (34). In this study from the Netherlands Cancer Institute, patients with proven PC were randomized either to undergo limited palliative surgery, followed by systemic treatment with 5-FU/leucovorin, or to undergo CRS and HIPEC, followed by the same systemic chemotherapy. In a 3-yr period, 105 patients were randomized: 51 in the standard arm and 54 in the experimental arm. Only 44 patients in the standard arm started their chemotherapy. Two patients refused the result of the randomization and went abroad to undergo HIPEC treatment. The other patients did not start, mainly because of early progression.

In the experimental arm, 5 patients did not get their HIPEC therapy. One patient died while on the waiting list, one patient refused at the last minute, and 3 patients developed distant metastases between randomization and the planned operation date. Thirty-five patients started their systemic chemotherapy after recovery from the HIPEC treatment. The main reason for not starting was complicated postoperative period. Detailed information on the extent of PC was only available in the patients undergoing HIPEC. Many patients had very extensive PC, with 54% having 5 or more out of 7 abdominal regions involved and >30% having 6 or 7 regions involved.

It was possible to resect all macroscopic PC in 38% of patients. In 43% of patients, small residues (<2.5 mm) were left behind, while in 19% larger residues remained. To achieve this level of cytoreduction, a multitude of surgical resections had to be done, including omentectomy and multiple bowel resections in most patients. In accordance with this extensive surgery, complications have been frequent, the most common of which were infections related to small bowel leakage. In 17 patients, mild leukopenia occurred, with a nadir on day 10. Regardless, 30-d mortality was only 2% and the mean hospital stay 26 d. However, 8 patients died within 3 mo, most often because of long-term postoperative complications and early cancer recurrence. All early deaths, and the majority of complications, occurred in patients with extensive PC (6 or 7 regions involved).

All patients were analyzed according to the "intention to treat" principle. Survival data showed that patients in the HIPEC arm lived significantly longer than patients undergoing conventional therapy (Fig. 3). The median survival almost doubled from 12 mo to 22 mo. Also in this study, a survival plateau developed at 20%, with no additional death after 5 yr.

standard treatment standard treatment

12 18 24

survival in months

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