Liver Cancer Clinical Trial
Official title:
The Intention-to-treat Effect of Bridging Therapies in the Setting of Milan-in Patients Waiting for Liver Transplantation
In patients with hepatocellular cancer (HCC) meeting the Milan Criteria (MC), the usefulness of loco-regional therapies (LRT) in the context of liver transplantation (LT) is still debated. The inconsistent literature data are the result of initial selection biases among treated and untreated patients. In order to overcome these shortcomings, an inverse probability of treatment weighting (IPTW) analysis was done in a large patient cohort. After using a competing-risk analysis, the primary end-point of the study aims at identifying the risk factors of HCC-specific LT failure, defined as pre-LT tumour-related drop-out or post-LT recurrence.
Liver transplantation (LT) is the best curative treatment of hepatocellular cancer (HCC)
developed in an underlying liver disease. LT is considered as an oncologic successful
procedure when a long-term post-transplant tumour-free survival is obtained. Conversely, a
failure is equal to pre-transplant drop-out, post-transplant tumour recurrence or death. Due
to the allograft scarcity, a HCC patient waiting for a LT is most often treated using
neo-adjuvant loco-regional therapies (LRT) in order to minimise the risk of drop-out. When
the tumour burden meets the Milan Criteria (MC) at moment of diagnosis, such an approach is
called "bridging towards LT".
Two recent international guidelines underlined the importance of the bridging strategy, due
to its potential to reduce the risk of pre-LT drop-out and post-LT recurrence. This is
especially valid in the case in which a partial/complete tumour response is achieved before
LT. Unfortunately, the quality of the evidence obtained from the currently available
literature is low due to the lack of randomized controlled trials (RCT). Actually, it is
inconceivable to realize RCT in this setting because of logistical and, even more, ethical
reasons. Consequently, the majority of reported studies just compare post-LT outcome of
treated and untreated patients, failing thereby to analyse the clinical course from an
intention-to-treat (ITT) point of view.
Even when looking at studies including the waiting list period, one should keep in mind that
substantial differences may exist among initially bridged vs untreated HCC patients regarding
tumour burden. In order to overcome these limits, a retrospective analysis of a large
European population of MC-IN HCC patients listed for LT was done. After "balancing" this
cohort with an inverse probability of treatment weighting (IPTW), we investigated the risk
factors for tumour-specific LT failure, especially focusing at the role of LRT.
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