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Summary of recommendations for transplantation for hepatocellular carcinoma from an International Consensus Conference

Summary of recommendations for transplantation for hepatocellular carcinoma from an International Consensus Conference
  Level of evidence Strength of recommendation
Assessment of candidates with HCC for liver transplantation
1. When considering treatment options for patients with HCC, the BCLC staging system is the preferred staging system to assess the prognosis of patients with HCC. 2b (P) Strong
2. The TNM system (7th edition), including pathological examination of the explanted liver, should be used for determining prognosis after transplantation with the addition of assessment of microvascular invasion. 2b (P) Strong
3. Either dynamic CT or dynamic MRI with the presence of arterial enhancement followed by washout on portal venous or delayed imaging is the best non-invasive test to make a diagnosis in cirrhotic patients suspected of having HCC and for preoperative staging. 1b (D) Strong
4. Extrahepatic staging should include CT of the chest and CT or MRI of the abdomen and pelvis. 3b (D) Strong
5. Tumor biopsy is not required in cirrhotic patients considered for liver transplantation who have high-quality dynamic CT or MRI findings typical for HCC and a lesion larger than 1 cm according to current AASLD guidelines. 1b (D) Weak
6. For patients with lesions smaller or equal to 10 mm, non-invasive imaging does not allow an accurate diagnosis and should not be used to make a decision for or against transplantation. 1b (D) Strong
Criteria for listing candidates with HCC in cirrhotic livers for DDLT
7. Liver transplantation should be reserved for HCC patients who have a predicted five-year survival comparable to non-HCC patients. NA Weak
8. Preoperative assessment of the size of the largest tumor or total diameter of tumors should be the main consideration in selecting patients with HCC for liver transplantation. 2a (P) Strong
9. The Milan criteria are currently the benchmark for the selection of HCC patients for liver transplantation and the basis for comparison with other suggested criteria. 2a (P) Strong
10. A modest expansion of the number of potential candidates may be considered on the basis of several studies showing comparable survival for patients outside the Milan criteria. 3b (P) Weak
11. Patients with worse prognosis may be considered for liver transplantation outside the Milan criteria if the dynamics of the waiting list allow it without undue prejudice to other recipients with a better prognosis. NA Weak
12. α-fetoprotein concentrations add prognostic information in HCC patients and may be used for making decisions regarding transplantation in combination with imaging criteria. 2b (P) Weak
13. Biomarkers other than α-fetoprotein cannot yet be used for clinical decision making regarding liver transplantation for HCC. 2b (P) Strong
14. Indication for liver transplantation in HCC should not rely on microvascular invasion because it cannot be reliably detected prior to transplantation. 2b (P) Strong
Criteria for HCC candidates with non-cirrhotic livers
15. The Milan criteria and its modifications are not applicable to patients with HCC developing in a non-cirrhotic liver. Such patients with non-resectable HCC and absence of macrovascular invasion and extrahepatic spread may be considered as appropriate candidates for liver transplantation. 4 (P) Weak
16. Patients with HCC in non-cirrhotic liver who were treated by resection, and have intrahepatic recurrence of HCC and no evidence of lymph node or macrovascular invasion, may be considered for salvage transplantation. 4 (P) Weak
Role of downstaging
17. Transplantation may be considered after successful downstaging. 5 (P) Weak
18. Liver transplantation after successful downstaging should achieve a five-year survival comparable to that of HCC patients who meet the criteria for liver transplantation without requiring downstaging. 5 (P) Strong
19. Criteria for successful downstaging should include tumor size and number of viable tumors. 4 (P) Strong
20. α-fetoprotein concentrations before and after downstaging may add additional information. 4 (P) Weak
21. Based on existing evidence, no recommendation can be made for preferring a specific locoregional therapy for downstaging over others. NA None
Managing patients on the waiting list
22. Periodic waiting-list monitoring should be performed by imaging (dynamic CT, dynamic MRI, or contrast-enhanced ultrasonography) and α-fetoprotein measurements. 5 (P) Strong
23. Based on current absence of evidence, no recommendation can be made on bridging therapy in patients with UNOS T1 (≤2 cm) HCC. NA None
24. In patients with UNOS T2 (one nodule 2 to 5 cm or three or more nodules each ≤3 cm) HCC (Milan criteria) and a likely waiting time longer than six months, locoregional therapy may be appropriate. 4 (P) Weak
25. No recommendation can be made for preferring any type of locoregional therapy to others. NA None
26. Patients found to have progressed beyond criteria acceptable for listing for liver transplantation should be placed on hold and considered for downstaging. 5 (P) Strong
27. Patients with progressive disease in whom locoregional intervention is not considered appropriate, or is ineffective, should be removed from the waiting list. 5 (P) Strong
Role of LDLT
28. LDLT is acceptable for HCC patients who have an expected five-year survival similar to comparably staged patients receiving a deceased donor liver. In LDLT, careful attention should be given to psychosocial considerations regarding both donor and recipient. NA Weak
29. LDLT must be restricted to centers of excellence in liver surgery and liver transplantation to minimize donor risk and maximize recipient outcome. NA Strong
30. In patients following LDLT for HCC within the accepted regional criteria for DDLT, retransplantation for graft failure is justified. 5 (P) Weak
31. In patients following LDLT for HCC outside the accepted regional criteria for DDLT, retransplantation for graft failure using a deceased donor organ is not recommended. 5 (P) Strong
Posttransplant management
32. Posttransplant monitoring may include 6 to 12 monthly contrast-enhanced CT or MRI imaging and α-fetoprotein measurements. 5 (P) Weak
33. There is currently insufficient evidence from clinical trials to base a recommendation for choosing the type or dose of immunosuppression therapy to influence the incidence of HCC recurrence or its prognosis. NA None
34. Based on current evidence, no recommendation can be made on the use of mTOR inhibitors solely to reduce the risk of HCC recurrence outside clinical trials. NA None
35. The current evidence does not justify the routine use of adjuvant antitumor therapy after liver transplantation for HCC outside of a controlled clinical trial. NA Weak
36. HCC recurrence after liver transplantation may be treated by surgery for resectable lesions or by locoregional therapy or systemic therapy (including sorafenib) for unresectable lesions. 4 (p) Weak
37. Liver retransplantation is not appropriate treatment for recurrent HCC. NA Strong
Level of evidence for each recommendation refers to the Oxford classification.
HCC: hepatocellular carcinoma; BCLC: Barcelona Clinic Liver Cancer; TNM: tumor, node, metastasis; P: prognosis; D: diagnosis; AASLD: American Association for the Study of Liver Diseases; NA: not applicable; OLT: orthotopic liver transplantation; UNOS: United Network for Organ Sharing; LDLT: living donor liver transplantation; DDLT: deceased donor liver transplantation; mTOR: mammalian target of rapamycin.
Reproduced from: Clavien PA, Lesurtel M, Bossuyt PM, et al. Recommendations for liver transplantation for hepatocellular carcinoma: an international consensus conference report. Lancet Oncol 2012; 13:e11. Illustration used with the permission of Elsevier Inc. All rights reserved.
Graphic 83727 Version 1.0

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