By Charles Bankhead, Staff Writer, MedPage Today
Published: July 30, 2010
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Outcomes in all patients with hepatocellular carcinoma might improve with an "ablate- and-wait" strategy versus rapid transplantation, according to a group of clinicians who have regularly used the strategy.
Use of radiofrequency ablation and chemoembolization to downstage large tumors has shown that about 30% of patients do not qualify for transplantation because of disease progression. The strategy warrants consideration for all patients with hepatocellular carcinoma, regardless of whether they fall within the Milan criteria, according to authors of an article in the August issue of Liver Transplantation.
"Those patients who make it to transplantation have an excellent outcome as compared to patients transplanted with tumors beyond the Milan criteria who are not treated," John Roberts, MD, of the University of California San Francisco, and colleagues wrote in an opinion piece.
"The median time between the first ablative procedure and transplantation was 8.2 months with a range of 3 to 25 months. This approach suggests that the test of time may be the surest method to select patients with hepatocellular carcinoma who are destined to have good transplant outcomes."
The authors argue that their approach of ablating the tumor and then waiting to see whether it recurs or progresses should be expanded to all patients listed for transplantation because of hepatocellular carcinoma. Treating and waiting could help reduce the use of scarce donor organs in patients who will have recurrent disease.
"Our experience with ablative treatment and then observation suggests that the ultimate outcomes of transplantation are not dependent on the primary tumor but more on time spent waiting for transplantation," the authors wrote in their conclusion. "It would seem logical that smaller and/or fewer tumors, though more unlikely to have spread, would also benefit from a period of time if the primary tumor can be controlled."
"The waiting period may be able to decrease the 10% recurrence rate seen in patients transplanted within Milan," they added.
Published more than a decade ago, the Milan criteria for liver transplantation in patients with hepatocellular carcinoma won support because they seemed to identify patients likely to have good transplantation outcomes (N Engl J Med 1996; 334: 693-699). Based on tumor size and number, the criteria fell victim to the same fallacy as other criteria have, according to the authors.
"It has not been shown that there is any particular tumor size that represents no risk of recurrence, at least among those tumors that can be detected radiologically," Roberts and co-authors wrote in their introduction. "Furthermore, the degree of risk is not the same for all patients within the Milan criteria."
The San Francisco group's experience with a strategy of ablate and wait has indicated that patients who fall far outside the Milan criteria do quite well after transplantation, if time is added as a criterion for transplantation. A report covering their experience with 61 patients showed successful downstaging of 43, all but eight of whom had successful orthoptic liver transplants (Hepatol 2008; 48: 819-827).
Intention-to-treat analysis showed one- and four-year survival rates of 87.5% and 69.3%, respectively. One- and four-year survival after transplantation was 96.2% and 92.1%, respectively.
The authors also cited several small clinical studies that have added support to the ablate-and-wait strategy for patients outside the Milan criteria. Cumulatively, the data suggest that a waiting period of about six months after therapy might be appropriate.
Less evidence has emerged in support of ablate and wait for patients within the Milan criteria. In general, the data suggest that tumor status does not deteriorate between treatment and transplantation.
Geographic variation in the time to transplantation complicates the ablate-and-wait strategy. Roberts and co-authors cited 2007 data showing that 62% of patients underwent liver transplantation within three months after receiving exception points for hepatocellular carcinoma. A shorter waiting time might increase risk of cancer recurrence, but data on recurrence of hepatocellular carcinoma are incomplete.
"The more rapid transplantation rate in some geographic areas is going to create some issues if transplantation is delayed under an ablate-and-wait strategy," the authors acknowledged. "Fortunately, if the wait is six months long, major effects on center transplant numbers are likely to be small."
The authors reported that they had no relevant disclosures.
Primary source: Liver Transplantation
Source reference:
Roberts JP, et al "Hepatocellular carcinoma: ablate and wait versus rapid transplantation" Liver Transpl 2010; DOI: 10.1002/lt.22103.
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