Efficacy and safety of intraoperative hyperthermic intraperitoneal chemotherapy for locally advanced colorectal cancer (HIPECT4): final analysis of randomized clinical trial
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Despite adjuvant systemic chemotherapy after surgical resection in patients with pT4 stage colon cancer, a high percentage of them will develop peritoneal metastases. Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) is a treatment option with the goal of preventing metachronous peritoneal metastases. The aim of this study was to report the longer-term outcomes of peritoneal control with the use of intraoperative HIPEC based on mitomycin C after the last enrolled patient of the HIPECT4 trial reached 36 months follow-up. METHODS: Between November 2015 and March 2021, patients with resectable primary clinical T4 N0-2M0 were included and randomized (1:1) to either adjuvant HIPEC with mitomycin C (30 mg/m2, 60 minutes) or standard treatment. The primary endpoint was locoregional control at 36 months. Kaplan-Meier survival analysis with a log-rank test was used to compare the two study groups. RESULTS: A total of 184 patients were included and followed up at 36 months. The locoregional control rate was improved with HIPEC compared with adjuvant chemotherapy alone (hazard ratio 0.19, 95% confidence interval 0.04 to 0.86; P = 0.031). Three years overall survival and disease-free survival did not differ between patients assigned to the HIPEC and control groups. Subgroup analysis showed better locoregional control with the use of HIPEC for patients with definitive pT4 colon cancer (hazard ratio 0.08, 0.01 to 0.65; P = 0.017) and per protocol (receiving adjuvant chemotherapy) patients (hazard ratio 0.18, 0.04 to 0.83; P = 0.028). The pattern of recurrence was modified significantly using HIPEC with less peritoneal relapse. CONCLUSION: The long-term outcome analysis of the HIPECT4 trial demonstrated that using mitomycin C-based HIPEC reduced peritoneal recurrence in patients with locally advanced colon cancer without increasing toxicity. However, there was no difference in overall survival and disease-free survival. REGISTRATION NUMBER: NCT02614534 (https://clinicaltrials.gov/).
Source: BJS Open
Authors: Alvaro Arjona-Sánchez, Alberto Gutiérrez-Calvo, Juan J Segura-Sampedro, Rafael Morales, Estibalitz Pérez-Viejo, Vanessa Concepción-Martín, Susana Sánchez-García, Alfonso García-Fadrique, Isabel Prieto-Nieto, Lana Bijelic, Juan Torres-Melero, Maria Ramirez-Faraco, Arancha Prada-Villaverde, Joaquin Carrasco-Campos, Manuel Artiles-Armas, Pedro Villarejo-Campos, Gloria Ortega-Pérez, Enrique Boldo-Roda, Juan M Sánchez-Hidalgo, Angela Casado-Adam, Lidia Rodríguez-Ortiz, Blanca Rufian-Andújar, Enrique Aranda, Maria T Cano-Osuna, Cesar Díaz-López, Antonio Romero-Ruiz, Maria Carmen Vazquez-Borrego, Sebastian Rufián-Peña
Institutions: Instituto Maimónides de Investigación Biomédica de Córdoba, Hospital Universitario Reina Sofía, University of Córdoba, Hospital Universitario Príncipe de Asturias, Universidad San Pablo CEU, Hospital Universitario La Paz, Hospital Universitario Son Espases, Hospital Universitario de Fuenlabrada, Hospital Universitario Nuestra Señora de Candelaria, Hospital General Universitario de Ciudad Real, Fundación Instituto Valenciano de Oncología, Hospital de Sant Joan Despí Moisès Broggi, Complejo Hospitalario Torrecárdenas, Hospital Reina Sofía de Murcia, Hospital Regional Universitario de Málaga, Universidad de Málaga, Hospital Universitario de Gran Canaria Doctor Negrín, Hospital Universitario Fundación Jiménez Díaz, MD Anderson Cancer Center Madrid, Consorcio Hospitalario Provincial de Castellón, Fundación Hospital Provincial de Castellón
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,881
Funder: Junta de Andalucía
OpenAlex ID: W7141542869