April 13, 2015

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By Reuters Staff

April 06, 2015

NEW YORK (Reuters Health) - The Milan criteria for selecting patients with hepatocellular carcinoma (HCC) for liver transplant can be expanded safely and effectively, according to new findings from China.

While the Milan criteria are the "golden candidate selection criteria," there have been concerns that the criteria may be "too restrictive and far from satisfying the increasing candidate list, particularly in China," Dr. Shusen Zheng of Zhejiang University School of Medicine in Hangzhou and colleagues write in Gut, online March 24.

HCC is on the rise worldwide, the researchers note, but the burden is highest in China, which has 55% of all newly diagnosed cases of the disease and 45% of all deaths due to HCC. Forty percent of liver transplants are given to HCC patients.

Several expansions of the Milan criteria have been proposed, including the University of California, San Francisco (UCSF), University Clinic of Navarra (CUN), Valencia, and Hangzhou criteria, the researchers add.

To investigate safety and effectiveness of these criteria for selecting patients, the team looked at data from the China Liver Transplant Registry, the world's third-largest liver transplant database, on more than 6,000 patients with HCC treated with liver transplantation. Based on the Milan criteria, 43.8% of patients in the database would be eligible for liver transplant.

Each set of criteria would expand the number of patients eligible for transplant beyond that specified by the Milan criteria -- by 12.4% for Valencia, 16.3% for UCSF, 19.6% for CUN, and 51.5% for Hangzhou, the researchers found. Post-transplant survival with each of the expanded criteria was comparable to that seen with the Milan criteria.

Among the patients who did not meet the Milan criteria but did meet the Hangzhou criteria, five-year overall survival was 62% or higher.

The two independent prognostic factors among the 1,352 patients who did not meet the Milan criteria but did fulfill the Hangzhou criteria were alpha-fetoprotein (AFP) greater than 100 ng/mL and tumor burden above 8 cm.

The researchers classified patients with tumor burdens of 8 cm or less, or larger tumors but an AFP of 100 ng/ml or less, as type A, and patients with tumor burden greater than 8 cm and AFP between 100 and 400 ng/mL as type B. Five-year tumor-free survival was significantly better for the type A patients versus the type B patients, while survival for both was better than for patients who exceeded the Hangzhou criteria.

Survival rates were lower among patients who exceeded the Milan criteria but met the expanded criteria versus patients who fulfilled the Milan criteria, Dr. Zheng and colleagues note.

"It is a different matter whether those newly recruited patients by the expanded criteria are still good enough to be considered for liver transplant," they add. "For our part, a tumour-free survival of >80% and >55% at 1 and 5 years (in the expansion to the Milan criteria), respectively, is acceptable. Therefore, the patients exceeding Milan but fulfilling the expanded criteria may still be appropriate for liver transplant, particularly in China, which bears the greatest HCC burden worldwide."

The research did not have commercial funding.

SOURCE: http://bit.ly/19Ox2fa

Gut 2015.

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