In a much-needed move, liver transplantation specialists recently convened to address U.S. guidelines for allocation of organs for patients with hepatocellular carcinoma (HCC, liver cancer).
Representatives from more than 130 U.S. transplant centers were invited to the conference and participants included 180 leaders in liver transplantation (LT) from the 50 most active centers. Full details of the recommendations developed at the conference are published in the March issue of Liver Transplantation
, a journal of the American Association for the Study of Liver Diseases (AASLD).
The National Cancer Institute estimates that more than 16,000 men and over 6,000 women in the U.S. will be diagnosed with liver cancer, and over 18,000 liver cancer patients will succumb to the disease each year (2009). Furthermore, the United Network of Organ Sharing (UNOS) reports as many as 15,000 patients are waiting for liver transplantation, with living and deceased organ donation down by 1.7% and 1.2%, respectively (2008).
"Organs from deceased donors are considered a national resource, therefore their use should be equitable and fair, said James Neuberger, M.D., from Queen Elizabeth Hospital in the U.K and medical director of Organ Donation and Transplantation at NHS Blood and Transplant, in his editorial also published this month in Liver Transplantation
. U.S. transplant physicians agree and assembled six work groups at the conference to: standardize pathology reporting, develop specific imaging criteria, expand the Milan Criteria (MC, set of criteria used to measure tumor size to determine if a patient qualifies for LT), discuss locoregional therapy (LRT), define criteria for down-staging transplantation, and review current liver allocation system for HCC patients.
Elizabeth A. Pomfret, M.D., Ph.D., F.A.C.S. from the Lahey Clinic Medical Center in Burlington, MA and her team were responsible for summarizing the recommendations. Dr. Pomfret said, "Ultimately we agreed that the allocation policy should result in similar risks of removal from the waiting list and comparable transplant rates for HCC and non-HCC candidates alike."
At the end of the session, attendees agreed on 9 final recommendations for transplantation of liver cancer patients:
1. Additional priority should be maintained for candidates with HCC who meet MC. No regional adjustment in assigned priority for HCC candidates in this iteration.
2. A calculated continuous HCC priority score should be developed that incorporates calculated model end stage liver disease (MELD) score, alpha-fetoprotein (AFP), tumor size and rate of tumor growth. Only candidates with at least stage T2 tumors will receive additional HCC points.
2.1. Candidates with T1 tumors or tumors outside MC must be designated as having HCC on wait list registrations and/or updates.
2.2. A designation for HCC (yes/no) will be captured at registration for all candidates regardless of any requests for priority.
3. The candidate must be within MC for a minimum of 3 months before additional points are assigned.
3.1. Time is calculated from date of the first imaging study indicating that the MC is met if the liver tumor meets Class 5A imaging criteria.
4. Patients with a diagnosis of HCC within MC and a calculated MELD score < 15 will start with a MELD/HCC priority score of 15 until they have had the HCC diagnosis for 3 months, then they will receive the calculated MELD/HCC priority score.
5. Patients with a calculated MELD score > 15 will receive their calculated MELD until the 3 months since the diagnosis of HCC within MC have elapsed, then they will receive their calculated MELD/HCC priority score.
6. MELD/HCC priority score will be recalculated every 3 months and can increase or decrease according to changes in tumor characteristics, underlying MELD score and time within MC.
7. Allocation points will be based on candidate's calculated MELD score PLUS the following factors:
7.1. AFP < 500 ng/ml
7.2. Tumor size within MC
7.3. Time within MC, including patients down-staged to within MC
8. No points will be added if AFP > 500 ng/ml.
9. Patients with elevated AFP and no tumor by imaging will no longer receive additional MELD points.
"The recommendations set forth at the conference are warmly welcomed outside as well as within the U.S.," concluded Dr. Neuberger. "This report should not be the final word, but the first in a series of discussions that refine the role of liver transplantation in the management of patients with liver cancer."