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1. 5-year survival was significantly greater in the liver transplantation plus chemotherapy group compared to chemotherapy alone.

2. Serious adverse events were comparable between both groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Inoperative colorectal liver metastases remain a significant challenge for long-term survival. Existing treatments do not offer lasting benefits for many patients with advanced, unresectable liver metastases. This randomized controlled trial aimed to assess whether liver transplantation combined with chemotherapy improves survival in patients with unresectable colorectal liver metastases compared to chemotherapy alone. The primary outcome was 5-year overall survival, while key secondary outcome was safety in both treatment groups. According to study results, patients who received liver transplantation plus chemotherapy had significantly higher 5-year survival rates compared to those who received chemotherapy only. A key limitation of this study is that selected patients were prioritized for organ transplantation given their enrolment in the study. This would limit the external validity given the variability in organ donation availability in the general population relative to the study cohort.

Click to read the study in The Lancet

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In-depth [randomized-controlled trial]: Between Feb 18, 2016, and Jul 5, 2021, 157 patients were assessed for eligibility across 20 tertiary centers in Europe. Included were patients aged ≥ 18 years with unresectable colorectal liver metastases who had responded to ≥ 3 months of chemotherapy and had no extrahepatic disease. Altogether, 94 patients (47 in liver transplantation plus chemotherapy and 47 in chemotherapy alone) were included in the final analysis. The primary outcome of 5-year overall survival was significantly higher in liver transplantation plus chemotherapy compared to chemotherapy alone (56.6% vs. 12.6%, hazard rate [HR] 0.37, 95% confidence interval [CI] 0.21-0.65, p=0.0003). The secondary outcome of serious adverse events was comparable in both groups (80% vs. 83%). Findings from this study suggest that liver transplantation plus chemotherapy may improve long-term survival in patients with unresectable colorectal liver metastases compared to chemotherapy alone.

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