A substantial number of patients with hepatocellular carcinoma (HCC) who exceed the Milan criteria (which are currently used to select transplant candidates) could also be good candidates for successful transplantation, according to findings of a web-based survey of 1112 patients, which is published in an Article early Online and in the January edition of The Lancet Oncology.

The Milan criteria specifies that patients with a single tumour of 5 cm or less in diameter, or three or fewer tumours, each no more than 3 cm in diameter and with no macrovascular invasion, can expect an excellent outcome after liver transplantation, with a risk of recurrence of only 10%. Although these criteria are thought to be too restrictive, the survival of patients who do not meet these criteria is unpredictable and there are no evidence-based guidelines to help physicians select which of the patients whose profiles exceed the Milan criteria might benefit from transplantation.

Therefore, Dr Vincenzo Mazzaferro and colleagues used data from a web-based survey completed by liver-cancer specialists to assess the outcome of 1112 patients with HCC who exceeded the Milan criteria, but who nevertheless underwent a liver transplantation. The authors sought to develop a new prognostic model that could be used to expand the Milan criteria and that could help to identify additional patients whose chances of survival would be increased by transplantation.

The authors propose the 'Up-to-seven' criteria, where the seven refers to the maximum score based on adding the size of the largest tumour (in cm) to the total number of tumours. In this subgroup, for those without microvascular invasion, overall 5-year survival was 71% (95% CI 63-77), an outcome similar to that expected for transplant recipients who met the Milan criteria.

Vincenzo Mazzaferro (Milan, Italy) commented: "A more precise estimation of survival contouring individual tumour characteristics by use of the Up-to-seven criteria could replace the current dual (yes/no) approach to transplant candidacy based on the strict Milan criteria for patients with HCC."

The web survey, initiated at the International Liver Transplantation Society Meeting (Milan, 2006), was completed by specialists in liver cancer who entered their data online at hcc-olt-metroticket, a website built at the Clinical Trial Office of the National Cancer Institute of Milan, Italy.

Data gathered during a 10-month period were entered via the website, and described the outcome of liver transplantations done on 1556 patients from 31 centres in Europe, four centres in the USA, and one in Asia.

Of the 1556 patients, who all exceeded the Milan criteria on the basis of pre-transplant tumour staging, 444 patients did not exceed the criteria at post-transplant pathology review, leaving 1112 patients who exceeded the Milan criteria and who formed the main study group.

"Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis"
Dr Vincenzo Mazzaferro et al
The Lancet Oncology, Early Online Publication, 4 December 2008
doi:10.1016/S1470-2045(08)70284-5
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The Lancet Oncology

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