Liver Transplant Recommendations Revised

Liver Transplant Recommendations Revised

By Nancy Walsh, Contributing Writer, MedPage Today
Published: March 08, 2010
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and
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Action Points

* Explain to interested patients that some of the recommendations for liver transplantation in patients with hepatocellular carcinoma, including the maximum size and number of lesions, are being revised to reflect current clinical experience.

The rapid evolution of clinical experience in liver transplantation during recent years has prompted several leading organizations to revisit general recommendations for patient selection and organ allocation.

A national gathering of 180 transplant experts reached a consensus that priority scores for transplantation in patients with hepatocellular carcinoma should rank candidates based on the Model for End stage Liver Disease (MELD) score, alpha-fetoprotein level, tumor size, and rate of tumor growth, according to Elizabeth A. Pomfret, MD, of the Lahey Clinic in Burlington, Mass., and colleagues.

"The current [hepatocellular carcinoma] prioritization rules are categorical, purely waiting-time based, are not based on any tumor biology variables, and do not take into account the degree of underlying liver disease. Development of a more dynamic score was highly endorsed," the authors wrote online in Liver Transplantation.

The conference was convened under the auspices of the Organ Procurement and Transplantation Network/United Network for Organ Sharing, and included representatives from the American Society of Transplant Surgeons and the International Liver Transplantation Society.

Other goals included a standardized pathology report form for assessment of diseased livers after removal, the establishment of more specific imaging criteria, and consideration of expansion of the so-called Milan criteria.

The Milan criteria for hepatocellular carcinoma (one nodule ≤5 cm or two to three nodules each <3 cm) has generally been considered an acceptable risk of recurrence after transplantation.

Recent experience, however, suggests that these criteria might safely be expanded, as is done at the University of California, San Francisco (one nodule ≤6.5 cm or two to three nodules ≤4.5 cm, and total tumor diameter ≤8 cm).

But regional variations exist in time to transplantation and risk of death, and there is a lack of national data on recurrence rates. So rather than recommending an expansion of the Milan criteria throughout the country, the working group recommended that expansion be undertaken on a regional basis with additional requirements for reporting and auditing.

Another highlight of the report was its focus on the role of locoregional treatments for hepatocellular carcinoma.

These treatments today include a number of transarterial and ablative techniques, such as bland embolization, the use of drug-eluting beads, and radio frequency ablation.

Data from a registry of transplant recipients have shown that both patient and graft survival at three years were improved when patients received locoregional treatments:

* Patient survival, 79% versus 75%, P=0.03
* Graft survival, 76% versus 71%, P=0.03

The choice among these treatments should be individualized and based on local expertise and can include repeat interventions as needed with the goal of achieving complete necrosis of the lesions, the report said.

The use of locoregional therapies also can be used for "downstaging" patients, which the working group defined as decreasing the size of liver lesions to meet current criteria for transplantation, with updated imaging studies required every three months.

Successful downstaging also requires that the alpha-fetoprotein level must be below 500 ng/mL, because multiple studies have determined that a level above 1,000 ng/mL is a strong predictor of tumor recurrence after transplantation.

The report also addressed allocation concerns for transplant recipients with conditions other than hepatocellular carcinoma, such as chronic hepatitis C infection, and stated that the allocation policy should result in similar transplant rates for hepatocellular carcinoma and other conditions.

In an editorial accompanying the report, James Neuberger, DM, of Queen Elizabeth Hospital, in Birmingham, England, argued for regional expansion of the Milan criteria.

"These local agreements should be encouraged: Only by pushing at the boundaries will we gain knowledge and improve management," he wrote.

Better predictors of outcome are needed and outcomes more clearly defined as further experience is gained, he continued.

As markers of tumor natural history are identified, new pharmacotherapies are introduced, and better immunosuppression slows the process of disease recurrence, these recommendations may be of historical interest within only a few years, Neuberger predicted.

"It is very much to be hoped that this report will not be the final word but the first in a series, refining the role of liver transplantation in the management of patients with liver cancer," he wrote.

No disclosures were provided.

Primary source: Liver Transplantation
Source reference:
Pomfret E, et al "Report of a national conference on liver allocation in patients with hepatocellular carcinomas in the United States" Liver Transplant 2010; DOI: 10.1002/lt.21999.

Additional source: Liver Transplantation
Source reference:
Neuberger J "Liver allocation for patients with hepatocellular carcinoma" Liver Transplant 2010; DOI: 10.1002/lt.22012.