KEY TAKEAWAYS
- This phase III clinical trial TRIPLETE aimed to compare the OS rate of patients with unresectable CLM who undergo liver transplantation.
- Patients who have undergone curative removal of the primary colon cancer and have liver-limited unresectable CLM with wild-type RAS and BRAF genes.
- The study’s primary outcome is to evaluate the OS rate of patients enrolled in the COLT trial compared to those in the TRIPLETE trial.
- The study includes hyper-selected patients who have liver-limited unresectable CLM, with wild-type RAS and BRAF genes, and have undergone curative removal.
- Liver transplantation may lead to a superior overall survival rate compared to patients receiving chemotherapy alone in selected patients with CLM.
Individuals diagnosed with unresectable Colorectal Liver Metastases (CLM) undergoing palliative chemotherapy exhibit an overall survival (OS) rate of less than 30% over 5 years. Liver transplantation (LT) has been shown to improve overall survival (OS) by 60%-83% based on findings from the SECA-I and SECA-II trials. This study aims to evaluate the effectiveness of liver transplantation in patients with liver-only metastatic colorectal cancer compared to a matched group of patients enrolled in a phase III clinical trial involving triplet chemotherapy and anti-EGFR therapy. The COLT trial is a clinical study conducted by investigators across multiple medical centers. It is a non-randomized, open-label, controlled, prospective, parallel trial registered under ClinicalTrials.gov identifier NCT03803436. This study includes patients who have been hyper-selected and have liver-limited unresectable colorectal liver metastases (CLM) with wild-type RAS and BRAF genes and have undergone curative removal of the primary colon cancer. The observed post-transplant outcomes will be compared prospectively in a 1:5 ratio with the results obtained from a matched cohort in the TRIPLETE trial (NCT03231722).
The primary endpoint of this study was to compare the overall survival of patients who had been enrolled in the COLT trial with those who are eligible for COLT and have been enrolled in the TRIPLETE trial over 3 and 5 years. Based on the analysis, it is predicted that the COLT population will experience an anticipated increase in overall survival of 40% over 5 years.
Specifically, the expected OS rate at 5 years for the COLT population is 70%, whereas, for the TRIPLETE population, it is 30%. The secondary objectives of this study are to evaluate the 5-year disease-free survival rate and to analyze the safety of liver transplantation using the Dindo-Clavien Classification and the Comprehensive Complication Index. In selected patients with colorectal liver metastasis (CLM), liver transplantation has been associated with the most extended overall survival reported. Enhancing the selection strategies may lead to a 5-year overall survival rate compared to other indications for liver transplantation and a superior outcome compared to patients receiving chemotherapy alone.
Source:https://pubmed.ncbi.nlm.nih.gov/36822922/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03231722
Sposito C, Pietrantonio F, Maspero M, Di Benedetto F, Vivarelli M, Tisone G, De Carlis L, Romagnoli R, Gruttadauria S, Colledan M, Agnes S, Ettorre G, Baccarani U, Torzilli G, Di Sandro S, Pinelli D, Caccamo L, Sartore Bianchi A, Spreafico C, Torri V, Mazzaferro V. Improving Outcome of Selected Patients With Non-Resectable Hepatic Metastases From Colorectal Cancer With Liver Transplantation: A Prospective Parallel Trial (COLT trial). Clin Colorectal Cancer. 2023 Feb 3:S1533-0028(23)00003-8. doi 10.1016/j.clcc.2023.01.003. Epub ahead of print. PMID: 36822922.
