In the Journals

Extended Toronto Criteria, Milan criteria provide similar 10-year survival rates

The Extended Toronto Criteria provided a 10-year survival rate similar to the currently used Milan Criteria, according to recent findings published in Hepatology. Both criteria are used to determine whether patients with hepatocellular carcinoma should receive a liver transplant by excluding those deemed to have a poor chance of survival. The Milan Criteria uses tumor size and number whereas the Extended Toronto Criteria uses tumor differentiation, cancer-related symptoms, confinement to the liver and venous or biliary tumor thrombus for patients who were previously excluded from transplant by the Milan criteria.

“Liver transplantation (LT) represents the best treatment option for patients with decompensated liver cirrhosis and hepatocellular carcinoma (HCC),” Gonzalo Sapisochin, MD, PhD, assistant professor of surgery at the University of Toronto, and colleagues wrote. “We conclude that it is possible to achieve excellent long-term survival after LT for HCC using a selection algorithm [the Extended Toronto Criteria (ETC)] that does not rely only on measurement of tumor size or number.”

In 2011, Sapisochin and colleagues showed that the ETC (M+ group) could achieve a 5-year survival rate of 70%, which was similar to the rate found using the Milan criteria (M group). In this study, the researchers aimed to validate these findings over 10 years by using an intention-to-treat analysis.

The previous study included 362 patients assessed between 1996 and 2008, of whom 294 received a transplant. The present study included an additional 243 patients assessed between 2008 and 2012, of whom 210 received a transplant. The median follow-up from listing was 59.7 months (95% CI, 26.8-103).

The researchers found that the M+ group demonstrated similar survival rates as the M group at 1 year (94% vs 95%), 3 years (76% vs 82%) and 5 years (69% vs 78%). When combining the patient populations from both studies, there was no significant difference in the 10-year survival rates (50% in M+ vs. 60% in M).

However, on an intention-to-treat basis, the dropout rate was higher in the M+ group and the 5-year and 10-year survival rates were decreased. In addition, they found that an alpha-fetoprotein (AFP) level greater than 500 ng/mL predicted poorer outcomes for both the M and M+ groups.

The researchers did not include AFP level in their criteria, but the results suggest that it should be incorporated in future selection algorithms, they wrote.

“This is the first [intention-to-treat] validation study to demonstrate that excellent outcomes can be achieved using other markers rather than tumor size and number,” the researchers wrote. “Poor tumor differentiation, cancer-related symptoms, and elevated AFP levels should be considered in future selection algorithms of LT for HCC.”

Disclosure: The researchers report no relevant financial disclosures.

The Extended Toronto Criteria provided a 10-year survival rate similar to the currently used Milan Criteria, according to recent findings published in Hepatology. Both criteria are used to determine whether patients with hepatocellular carcinoma should receive a liver transplant by excluding those deemed to have a poor chance of survival. The Milan Criteria uses tumor size and number whereas the Extended Toronto Criteria uses tumor differentiation, cancer-related symptoms, confinement to the liver and venous or biliary tumor thrombus for patients who were previously excluded from transplant by the Milan criteria.

“Liver transplantation (LT) represents the best treatment option for patients with decompensated liver cirrhosis and hepatocellular carcinoma (HCC),” Gonzalo Sapisochin, MD, PhD, assistant professor of surgery at the University of Toronto, and colleagues wrote. “We conclude that it is possible to achieve excellent long-term survival after LT for HCC using a selection algorithm [the Extended Toronto Criteria (ETC)] that does not rely only on measurement of tumor size or number.”

In 2011, Sapisochin and colleagues showed that the ETC (M+ group) could achieve a 5-year survival rate of 70%, which was similar to the rate found using the Milan criteria (M group). In this study, the researchers aimed to validate these findings over 10 years by using an intention-to-treat analysis.

The previous study included 362 patients assessed between 1996 and 2008, of whom 294 received a transplant. The present study included an additional 243 patients assessed between 2008 and 2012, of whom 210 received a transplant. The median follow-up from listing was 59.7 months (95% CI, 26.8-103).

The researchers found that the M+ group demonstrated similar survival rates as the M group at 1 year (94% vs 95%), 3 years (76% vs 82%) and 5 years (69% vs 78%). When combining the patient populations from both studies, there was no significant difference in the 10-year survival rates (50% in M+ vs. 60% in M).

However, on an intention-to-treat basis, the dropout rate was higher in the M+ group and the 5-year and 10-year survival rates were decreased. In addition, they found that an alpha-fetoprotein (AFP) level greater than 500 ng/mL predicted poorer outcomes for both the M and M+ groups.

The researchers did not include AFP level in their criteria, but the results suggest that it should be incorporated in future selection algorithms, they wrote.

“This is the first [intention-to-treat] validation study to demonstrate that excellent outcomes can be achieved using other markers rather than tumor size and number,” the researchers wrote. “Poor tumor differentiation, cancer-related symptoms, and elevated AFP levels should be considered in future selection algorithms of LT for HCC.”

Disclosure: The researchers report no relevant financial disclosures.