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• W2143852126 abstract "The early experiences in transplanting patients with hepatocellular carcinoma (HCC) often resulted in poor outcomes because of the inclusion of patients with advanced tumors.1, 2 In 1996, Mazzaferro et al.3 demonstrated by a prospective study that excellent outcomes could be achieved for patients with HCC undergoing transplantation if restrictive criteria, based on pre-operative imaging, were applied. The results of this study have been validated by many centers and are the basis of the current organ allocation policies affording priority to patients with HCC on the liver transplantation waiting list in the United States. HCC, hepatocellular carcinoma; TTV, total tumor volume. Are the new criteria based on preoperative imaging/biopsy or postoperative pathology? How many patients are truly beyond Milan criteria but within the new criteria? Are direct comparisons made, in terms of survival and recurrence, between those within Milan criteria and those beyond Milan criteria but within the new criteria? How will these new criteria effect dropout and the intention-to-treat survival of liver transplantation as a treatment modality for HCC? In this month's issue of Liver Transplantation, we have a study from Toso et al.4 proposing expansion of the current criteria based on total tumor volume (TTV). The authors retrospectively look at 3 separate populations of patients undergoing liver transplantation for HCC: the Alberta group is used as a training set to develop the new model, and the Toronto and Colorado groups are used as validation sets. Pathologic data are used to determine the number and size of tumors in order to determine if patients fall within or beyond Milan and University of California–San Francisco criteria and to calculate TTV. Receiver operating characteristic curve analysis of TTV determines an optimal cutoff of 115 cm3 for predicting recurrence. The authors then apply the model to their validation groups and find that TTV is an independent predictor of survival in the Colorado group but not in the Toronto group. They also find that there is a higher concordance between pathology and radiology for the TTV criteria in comparison with Milan or University of California–San Francisco criteria. However, analysis based on imaging did not demonstrate TTV as a predictor of survival on univariate analysis. The authors conclude that a new selection criteria based on TTV < 115 cm3 allows more patients to be transplanted without a concomitant decrease in survival or increase in recurrence. The major shortcoming of most studies proposing expansion of criteria is that they are performed retrospectively and are based on pathological data obtained from explants, which are not available when one is trying to determine a patient's candidacy. The tendency for preoperative imaging to underestimate the amount of tumor is well described. Unfortunately, the current study suffers from this shortcoming in that the TTV criteria were devised and tested on the basis of pathologic data. The authors also readily point out that imaging underestimated the number of tumors in roughly half of their patients in comparison with pathology. Although the authors do present data on preoperative imaging, their criteria used for noninvasive diagnosis of HCC were not well defined, and accepted criteria such as those put forward by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver were not used; this makes it difficult to interpret their analyses performed on the basis of radiological data. It is also unclear how tumors treated prior to transplantation were accounted for radiologically. The fact that the univariate analysis based on imaging data did not find TTV as a significant predictor of survival demonstrates how hard it is to extrapolate pathological data to pre-operative imaging. The receiver operating characteristic curve analysis of radiological TTV staging as a predictor of recurrence with an area under the curve of 0.6 further highlights this problem. Again, one must keep in mind that the decision to offer transplantation to a patient in real life is made on the basis of imaging. The authors do point out that their staging system had the highest concordance with imaging. Although this is true, it must be viewed with some caution. Basing eligibility on TTV places minimal importance on smaller (<2-cm) tumors because their contribution to the total volume is marginal. A staging system that is not affected by smaller tumors, which are the ones most likely to be missed by computed tomography and magnetic resonance imaging, would naturally have a high concordance between pathologic staging and preoperative staging based on imaging. Multicentricity can be viewed as a surrogate marker of vascular invasion, and vascular invasion has been repeatedly identified as a predictor of recurrence of HCC after transplantation. It seems counterintuitive that advantaging such patients would not result in higher recurrence and lower survival. Another significant shortcoming of many studies proposing expansion of criteria for HCC is that a small number of patients beyond Milan but meeting the new criteria are “diluted” into a larger pool composed mostly of patients within Milan criteria. The authors then show that adding these few “expanded” patients to the overall pool does not significantly worsen the outcome of the entire group. Direct comparisons of recurrence and survival are seldom made between patients within Milan criteria and those beyond Milan criteria but meeting the new criteria. One of the strengths of this article is that there are 94 patients beyond Milan criteria but with TTV < 115 cm3, far more cases than the majority of publications on this subject have reported. The fact that the authors have made a direct comparison between patients within Milan criteria and those beyond Milan criteria but within their new expanded criteria makes the article even more relevant. There are clear trends toward lower survival and higher recurrence when the expanded TTV group and patients within Milan criteria are compared. The fact that these trends did not reach statistical significance may be due to the small sample size and lack of statistical power. Dropout from the waiting list due to tumor progression has recently become an area of significant concern, with some centers losing 30% of their HCC patients before transplantation. Even a subset of patients within Milan criteria can be expected to have a dropout rate of 50% at 1 year on the waiting list despite treatment of their tumors.5 This phenomenon has a profound impact on the intention-to-treat survival of liver transplantation as a treatment modality, perhaps making it less advantageous than other treatment options. Any expansion of criteria and inclusion of patients with more advanced tumors on the waiting list will inevitably result in higher rates of dropout and lower intention-to-treat survival for transplantation. Our own study of transplanting patients beyond Milan criteria found that 46% of patients dropped out and that although 5-year overall survival was 44%, intention-to-treat survival at 5 years was only 26%.6 Most studies proposing expansion of criteria for HCC fail to examine this issue, often because they are conducted retrospectively. Unfortunately, Toso et al.4 also do not describe the proportion of patients that would be expected to drop out if their new criteria were to be applied. Certainly, there are certain subsets of patients beyond Milan criteria who will have good outcomes if transplanted. Unfortunately, none of the studies thus far have convincingly demonstrated that the current criteria can be expanded without a concomitant increase in dropout from the waiting list, increased recurrence, and lower survival. In our opinion, we will have more success in expanding the current criteria on the basis of the biological behavior of tumors rather than by trying to adjust the number and size of tumors allowed in the criteria." @default.
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• W2143852126 title "Expansion of criteria for transplanting patients with hepatocellular carcinoma" @default.
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• W2143852126 doi "https://doi.org/10.1002/lt.21522" @default.
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