November 7, 2007 (Boston) — More than 90% of 35 hepatocellular carcinoma (HCC) patients with down-staged tumors were alive and cancer-free 4 years after liver transplantation, according to research presented here yesterday at the American Association for the Study of Liver Diseases 58th Annual Meeting.
The data were collected between June 2002 and January 2007 as a follow-up to a smaller 2005 study of down-staging HCC to meet conventional criteria for orthotopic liver transplantation, said Francis Yao, MD, from the University of California, San Francisco. Some surgeons are very wary of the approach, for fear of cancer recurrence, and Dr. Yao acknowledged that.
"The idea of expanded criteria and as well as downsizing has generated a great deal of interest, as well as some controversy, in the past few years," he said.
For more than 10 years, the Milan protocol has limited liver transplantation to HCC patients with a single lesion smaller than 5 cm or up to 3 smaller lesions, each 2 to 3 cm.
The 61 patients enrolled in the UCSF study had (1) 1 lesion larger than 5 cm but within 8 cm; (2) 2 or 3 lesions with at least one larger than 3 cm but all within 5 cm and with total tumor diameter up to 8 centimeters; or (3) 4 to 5 nodules, but none greater than 3 cm, with total tumor diameter within 8 cm.
The researchers used transarterial chemoembolization (TACE) to down-stage tumors in 15 study subjects, laparoscopic or open radiofrequency ablation (RFA) alone in 11 patients, TACE combined with percutaneous ablation in 15 patients, laparoscopic RFA plus TACE in 14 patients, and resection in 6 patients, according to the study abstract.
Down-staging was successful in 43 patients (70.5%). Each patient was observed for at least 3 months before transplantation, and 35 patients (57.4%) had received transplants. Six patients were awaiting transplantation at the time of the study. Eighteen patients (29.5%) were considered treatment failures — 3 patients died awaiting transplant and 15 dropped out due to tumor progression.
Of 3 explanted organs of the 35 transplant patients, 13 had complete tumor necrosis, 17 met T2 criteria, and 5 exceeded T2 criteria. More than 96% of patients were alive at 1 year after transplantation, and 92.% were alive after 4 years.
Alastair MacGilchrist, MD, from the Royal Infirmary of Edinburgh, Scotland, congratulated Dr. Yao on his "excellent results." He agrees the approach will continue to be controversial. "But, the patients did very well," he said.
Dr. Yao has disclosed no relevant financial relationships.
American Association for the Study of Liver Diseases 2007 Annual Meeting: Abstract 163. Presented November 6, 2007.
Medscape Medical News © 2007 Medscape
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