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Use of heated chemotherapy during surgery does not improve colorectal cancer survival
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CHICAGO — The addition of hyperthermic intraperitoneal chemotherapy to surgical resection did not provide a survival benefit for patients with metastatic peritoneal colorectal cancer, according to results of the phase 3 PRODIGE 7 trial presented at ASCO Annual Meeting.
Also, long-term adverse events occurred more frequently with hyperthermic intraperitoneal chemotherapy.
“This study is the first to question the role of hyperthermic intraperitoneal chemotherapy in combination with surgical resection for peritoneal colorectal cancer,” Francois Quenet, MD, head of the hepato-biliary and peritoneal surface malignancy unit at Regional Cancer Institute in Montpellier, France, said during the press conference.
Approximately 20% of patients with metastatic colorectal cancer have peritoneal carcinomatosis — metastatic tumors on the lining of the peritoneum. When used in combination with surgery, hyperthermic intraperitoneal chemotherapy (HIPEC) has been shown to increase survival compared with systemic therapy alone.
For the purpose of this study, HIPEC consisted of chemotherapy oxaliplatin heated to 43°C in an attempt to increase chemotherapy efficacy, Quenet noted.
The PRODIGE 7 trial enrolled 265 patients (median age, 60 years; range, 30-74) with stage IV colorectal cancer with peritoneal carcinomatosis and no other metastases treated across 17 centers in France.
Researchers randomly assigned patients in a 1:1 fashion to receive surgery plus HIPEC or surgery alone. The majority of patients received systemic chemotherapy, before surgery, after surgery or both.
OS served as the study’s primary outcome; secondary outcomes included RFS and toxicity.
At a median follow-up of 64 months, median OS was 41.2 months in the surgery alone arm vs. 41.7 months in the HIPEC arm (HR = 1; 95% CI, 0.73-1.37).
“We found no differences in our primary endpoint of overall survival. The rates were completely comparable between the two arms,” Quenet said. “However, the survival rate of the surgery alone group was significantly high, and this was not expected at all.”
RFS also was similar between the two arms, with a median RFS of 11.1 months with surgery alone vs. 13.1 months with the addition of HIPEC (HR = 0.9; 95% CI, 0.69-1.9). One-year RFS rates were 59% with HIPEC vs. 46.1% with surgery alone, and 5-year RFS was 14.8% in the HIPEC arm vs. 13.1% with surgery alone.
Thirty-day postoperative overall mortality was 1.5% across both arms.
Researchers observed no differences in the rate of adverse events during the first 30 days. However, adverse events increased nearly twofold at 60 days in the HIPEC arm compared with the surgery alone arm (24.1% vs. 13.6%).
In a subgroup analysis, the researchers observed a survival benefit with HIPEC specifically among patients with a medium amount of disease in the peritoneal cavity.
“HIPEC with oxaliplatin may be beneficial for patients with a medium amount of disease in the peritoneal cavity,” Quenet said. – by Jennifer Southall
Reference:
Quenet F, et al. LBA3503. Presented at: ASCO Annual Meeting; June 1-5, 2018; Chicago.
Disclosures: R&D UNICANCER funded the study. Quenet reports honoraria from Ethicon, Novartis and Sanofi/Aventis; consultant/advisory roles with Ethicon, Gamida Cell and Sanofi/Aventis; and payment for travel/accommodations/expenses from Ethicon, Novartis and Sanofi. Please see the abstract for all other author’s relevant financial disclosures.
Perspective
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Manish Shah, MD
An interesting unanswered question in colon cancer is to how to treat peritoneal disease. This abstract looked at the role of maximum debunking and chemotherapy and the role of HIPEC in these patients. It was a difficult study to conduct, and so this is a very important randomized controlled trial.
The researchers found that there was not a significant improvement in OS when HIPEC was added. Of note, not all peritoneal metastases are the same, there is a scale for disease burden. The researchers suggest that patients with really high-volume peritoneal disease or very low-volume peritoneal disease may not benefit, because HIPEC will probably not penetrate as much as needed. However, for the intermediate-volume group, there does appear to be a benefit. The challenge is that the system to describe what is low or high volume — based on the Peritoneal Cancer Index — is somewhat subjective.
Based on these results, I do not think that there will be a significant appetite to do more HIPEC clinical trials. There are some patients who may benefit, but it is hard to tease out who really will benefit.
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