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TransMet

Curative Potential of Liver Transplantation in Patients With Definitively Unresectable Colorectal Liver Metastases (CLM) Treated by Chemotherapy: a Prospective Multicentric Randomized Trial

N = 94NCT02597348

Population
Permanently unresectable colorectal liver metastases from resected BRAF-non-mutated colorectal cancer, chemotherapy-responsive, no extrahepatic disease
Design
Multicentre, open-label, prospective randomised controlled trial in 20 tertiary centres in Europe: patients aged 18 to 65 years with ECOG performance score 0 to 1, permanently unresectable colorectal liver metastases from resected BRAF-non-mutated colorectal cancer responsive to systemic chemotherapy (3 months or more, up to three lines) and no extrahepatic disease were randomised (1:1, block randomisation) to liver transplantation plus chemotherapy or chemotherapy alone. Transplantation was to take place within 2 months of the last chemotherapy cycle. The primary endpoint was 5-year overall survival, analysed in the intention-to-treat and per-protocol populations. 94 patients were randomly assigned between February 2016 and July 2021 (47 per group); 11 and 9 patients did not receive the assigned treatment.
Primary endpoint
OS
Arms
  • Chemotherapy alone (control, n = 47): Continued systemic chemotherapy
  • Liver transplantation plus chemotherapy (experimental, n = 47): Liver transplantation after chemotherapy, with tailored immunosuppression and postoperative chemotherapy
People
Adam R
OSHR 0.37 (95% CI 0.21–0.65)Δ 60-month OS+44 pointsΔ 60-month OS+64 points
Show the numbers
Results reported for TransMet
EndpointAnalysisLiver transplantation plus chemotherapyChemotherapy aloneEffect
OSprimarymedian follow-up 59.3 monthsAdam 202456.6% at 5 y (43.2–74.1%)12.6% at 5 y (5.2–30.1%)HR 0.37 (95% CI 0.21–0.65)P=0.0003Primary endpoint: 5-year overall survival, intention-to-treat population. The abstract gives the median follow-up as 59.3 months (interquartile range 42.4-60.2).
OSPer-protocol population (36 in the liver transplantation plus chemotherapy group; 38 in the chemotherapy-alone group)primaryAdam 202473.3% at 5 y (59.6–90.0%)9.3% at 5 y (3.2–26.8%)The abstract also names the per-protocol population as an analysis population of the primary endpoint; no hazard ratio is given for it.
Results reported for TransMet
EndpointAnalysisLiver transplantation plus chemotherapyChemotherapy aloneEffect
OSprimarymedian follow-up 59.3 monthsAdam 202456.6% at 5 y (43.2–74.1%)12.6% at 5 y (5.2–30.1%)HR 0.37 (95% CI 0.21–0.65)P=0.0003Primary endpoint: 5-year overall survival, intention-to-treat population. The abstract gives the median follow-up as 59.3 months (interquartile range 42.4-60.2).
OSPer-protocol population (36 in the liver transplantation plus chemotherapy group; 38 in the chemotherapy-alone group)primaryAdam 202473.3% at 5 y (59.6–90.0%)9.3% at 5 y (3.2–26.8%)The abstract also names the per-protocol population as an analysis population of the primary endpoint; no hazard ratio is given for it.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.370.21–0.65
Primary publication: Adam R, Piedvache C, Chiche L, Adam JP, Salamé E, Bucur P, et al. Liver transplantation plus chemotherapy versus chemotherapy alone in patients with permanently unresectable colorectal liver metastases (TransMet): results from a multicentre, open-label, prospective, randomised controlled trial. Lancet. 2024;404(10458):1107-1118. PubMedDOI

Appears in

Sources

  1. Adam R, Piedvache C, Chiche L, Adam JP, Salamé E, Bucur P, et al. Liver transplantation plus chemotherapy versus chemotherapy alone in patients with permanently unresectable colorectal liver metastases (TransMet): results from a multicentre, open-label, prospective, randomised controlled trial. Lancet. 2024;404(10458):1107-1118.

    PubMedDOI