Combination adjuvant chemotherapy with oxaliplatin, 5-fluorouracil and leucovorin after liver transplantation for hepatocellular carcinoma: a preliminary open-label study.
Zhang Q. Chen H et al.Investigational New Drugs. 29(6): 1360-9, 2011
Aims
To determine whether or not postoperative adjuvant chemotherapy with FOLFOX regimen (oxaliplatin, 5-fluorouracil and leucovorin) could improve the outcomes of hepatocellular carcinoma (HCC) in patients following liver transplantation.
Interventions
Adjuvant chemotherapy with oxaliplatin, 5-fluorouracil and leucovorin versus without adjuvant chemotherapy.
Participants
58 liver transplant recipients.
Outcomes
Graft and patient survival, alpha-fetoprotein level, whole blood count, HCC recurrence evaluated by abdominal ultrasonography, CT scans and liver biopsy.
Follow-up
3 years
CET Conclusions
Patients with hepatocellular carcinoma that did not meet the Milan criteria and were given a liver transplant appeared to benefit from post operative adjuvant chemotherapy using the FOLFOX chemotherapy protocol (oxaliplatin, S-FU and CF). Graft and patient survival was modestly extended in the patients receiving combination chemotherapy. However the trial is not adequately powered to draw firm conclusions and a much larger trial would be required to establish the role of this advuvant chemotherapy protocol.
Data analysis
Per protocol analysis
Trial registration
ChiCTRTRC-10000961 (China Medical Ethics Committee)