Attempts of liver transplantation for CRC liver metastases are registered in the European
Liver Transplant Registry (ELTR). During 1977 to 1995 survival data representing 45
patients, show a 1, 3 and 5-year survival rate of 73%, 36% and 18%, respectively(post
transplantation immunosuppression with the antiproliferative agent rapamycin was not in
regular use at that time). Historical data and have shown that more than 49% of 25 patients
transplanted in Vienna for CRC liver metastases died of non-cancer related causes.
In 2006 we acquired an ethical approval (S-05409 Regional Ethics Committee, Helse Sor-Ost)
for a clinical pilot study (SECA-study) to investigate Ltx for treatment in selected CRC
patients with non-resectable liver metastases, using the mTOR inhibitor Rapamycin as
standard immunosuppression from postoperative day 1. The ethical authorization was to
conduct an open labeled, non-randomized study for up to 25 patients. By January 1st. 2010,
16 patients have been transplanted in the study. All of the patients had advanced metastatic
disease and had received palliative chemotherapy. Patients included in the study had liver
metastasis only and was not eligible for liver resection at the time of Ltx.
Fifteen of the patients are alive at 2-37 months follow-up. One patient with massive tumor
load (4.6 kg) in the liver and overgrowth to the diaphragm (detected by explanting the
liver) developed recurrence in the transplanted liver at 2 month post transplantation and
departed 4 months later. The patients that are alive have excellent health related quality
of life (QOL) measured with EORTC QLQ-C30 (at 1, 3, 6, 12 and 18 months post transplant). As
expected, many patients have experienced recurrence of the disease, mainly to the lungs.
Preliminary data from the SECA pilot study indicate that Ltx is feasible in selected
patients with non-resectable liver metastases from CRC and the perioperative mortality is
0%. Still, it is important to recognize that Ltx is a major procedure with several potential
life threatening complications.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Norway: Regional Ethics Committee
2010/2856a (SECA II)