As reported in the Journal of Clinical Oncology by Zwanenburg et al, 5-year findings from the Dutch COLOPEC trial indicated that the addition of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) to systemic chemotherapy did not improve overall survival vs chemotherapy alone in patients receiving curative surgery for locally advanced colon cancer.
Study Details
The multicenter open-label trial included 202 patients with resectable primary clinical or pathologic T4N0-2M0 or perforated colon cancer. They were randomly assigned between April 2015 and April 2017 to receive HIPEC with standard chemotherapy (n = 100) or standard chemotherapy alone (n = 102).
HIPEC consisted of a one-time administration of oxaliplatin at 460 mg/m2 for 30 minutes at 42°C with concurrent fluorouracil/leucovorin. HIPEC was given during the initial surgical procedure in 9% of patients and at 5 to 8 weeks postoperatively in 91% of patients. Outcomes were assessed in the intention-to-treat population.
Key Findings
Median follow-up was 59 months (interquartile range [IQR] = 54.5–64.5 months). Overall survival at 5 years was 69.6% in the HIPEC group vs 70.9% in the control group (P = .692). Five-year disease-free survival was 55.7% vs 52.3% (P = .875).
A total of 49 patients developed peritoneal metastases, detected within 18 months in 42 patients (85.7%). Peritoneal metastasis–free survival at 5 years was 63.9% vs 63.2% (P = .907). An analysis performed due to crossing of the Kaplan-Meier curves at approximately 14 months showed that the hazard ratio for the HIPEC vs control group was 1.20 (P = .56) prior to 14 months and 0.84 (P = .62) after 14 months.
No differences in quality-of-life outcomes were observed between groups.
The investigators concluded, “Our findings implicate that adjuvant HIPEC should still be performed in [the] trial setting only.”
Pieter J. Tanis, MD, PhD, of the Department of Oncological and Gastrointestinal Surgery, Erasmus MC Cancer Institute, Rotterdam, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.
