Adding hyperthermic intraperitoneal chemotherapy (HIPEC) and mitomycin C to surgical resection significantly improves the locoregional control rate for patients with locally advanced colon cancer, according to a study published in JAMA Surgery.
The 3-year locoregional control rate for patients who received HIPEC with mitomycin C was 10% higher than that for patients who received only surgery, and the difference was even more pronounced in patients with pT4 disease, researchers reported.
The phase 3 HIPECT4 trial (ClinicalTrials.gov Identifier: NCT02614534) enrolled 184 patients with locally advanced colon cancer. The mean age of the patients was 61.5 years, and 60.3% were men.
The patients were randomly assigned to undergo cytoreductive surgery alone (n=95) or undergo surgery and receive HIPEC and mitomycin C (n=89). Most patients (69.6%) received systemic adjuvant chemotherapy (63 in the HIPEC arm and 65 in the control arm).
The median follow-up was 36 months. The 3-year locoregional control rate was 97.6% for patients in the HIPEC arm and 87.6% for those in the control arm (hazard ratio [HR], 0.21; 95% CI, 0.05-0.95; P =.03).
There was no significant difference between the 2 groups in terms of 3-year disease-free survival (81.2% with HIPEC/mitomycin C vs 78.0% with surgery alone; P =.22) or 3-year overall survival (91.7% vs 92.9%; P =.68).
In an exploratory analysis, patients with pT4 disease had a 3-year locoregional control rate of 98.3% with HIPEC/mitomycin C and 82.1% with surgery alone (HR, 0.09; 95% CI, 0.01-0.70; P =.003).
In those patients who received adjuvant treatment, HIPEC/mitomycin C significantly improved locoregional control (HR, 0.11; 95% CI, 0.01-0.87).
The researchers noted that neutropenia occurred more frequently in the HIPEC group than in the control group, at 9.0% and 2.2%, respectively. Severe neutropenia occurred in 2 patients (2.2%) in the HIPEC group.
“In our trial, simultaneous adjuvant HIPEC avoided the inherent morbidity associated with a secondary procedure, and no differences were observed between groups in postoperative complications or toxic effects,” the researchers concluded. “Longer follow-up is required to evaluate disease-free survival and overall survival after HIPEC with cytoreductive surgery vs surgery alone.”
Disclosures: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Arjona-Sánchez A, Espinosa-Redondo E, Gutiérrez-Calvo A, et al. Efficacy and safety of intraoperative hyperthermic intraperitoneal chemotherapy for locally advanced colon cancer: A phase 3 randomized clinical trial.JAMA Surg. Published online April 26, 2023. doi:10.1001/jamasurg.2023.0662