9/29/2016 UCSF Transplant 2016: Building Bridges to Excellence OVERVIEW • Current state of liver transplantation (LT) Liver Transplant for Hepatocellular for HCC Carcinoma (HCC): What is New? • “Let’s push past the Milan criteria” Refining selection criteria for LT Neil Mehta, MD Updates in down-staging outcomes 9/29/16 Proposed UNOS policy changes UCSF Division of Gastroenterology and Hepatology • Risk factors for post-LT HCC recurrence How often to perform surveillance? LIVER TRANSPLANTATION FOR HCC LIVER TRANSPLANTATION FOR HCC MILAN CRITERIA T1 and T2 CRITERIA 1 lesion ≤ 5 cm T2: 1 lesion 2-5 cm or 2 to 3, none > 3 cm T1: 1 lesion < 2 cm 2 to 3 lesions, none >3cm + + Absence of Macroscopic Vascular Invasion Absence of Macroscopic Vascular Invasion Absence of Extra-hepatic Spread Absence of Extra-hepatic Spread Mazzaferro, et al. N Engl J Med 1996;334:693-699 1
9/29/2016 RISING INCIDENCE OF LT FOR HCC RISING INCIDENCE OF LT FOR HCC UCSF DATA UCSF DATA 60% 60% 72 LT for HCC % of adult LT done for HCC % of adult LT done for HCC in 2015 50% 50% 47% 40% 40% 22 LT for 22 LT for 30% 30% HCC in 2006 HCC in 2006 20% 20% 15% 15% 10% 10% 0% 0% 05 06 07 08 09 10 11 12 13 14 15 05 06 07 08 09 10 11 12 13 14 15 Year Year LIVER TRANSPLANT FOR HCC: OUTCOME OF LIVER TRANSPLANT FOR HCC PROBLEMS & CHALLENGES IN THE MELD ERA (2002-2007) • HCC misdiagnosis 2002-2007 N Adjusted * Patient Survival (%) HR (95% CI) 1 yr 2 yr 3 yr 4 yr • Outcome after liver transplant for HCC still No HCC 14351 1 88.3 83.8 80.8 78.0 slightly worse than that for non-HCC HCC, no exception 592 1.58 (1.3-1.9) 83.5 72.6 67.8 67.8 indications 1 HCC, MELD 4453 1.27 (1.1-1.4) 89.0 81.4 76.5 72.7 • HCC patients receiving unfair advantage for exception donors compared to non-HCC patients 2,3 HCC, MELD 3595 1.33 (1.2-1.5) 88.3 80.4 74.8 70.7 exception (> 2 cm) *Adjusted for MELD score, underlying liver disease, age, gender, race/ethnicity, BMI and donor age (+ other donor factors) 1. Ioannou GN, et al. Gastroenterology 2008; 134:1342-1351 2. Washburn K, et al. Am J Transpl 2010;10:1652-7 3. Goldberg D, et al. Liver Transpl 2012;18:434-443 Ioannou GN, et al. Gastroenterology 2008; 134:1342-1351 2
9/29/2016 LIVER TRANSPLANT FOR HCC: WAITLIST DROPOUT OR DEATH: HCC VS NON-HCC RECENT CHANGES 25% Too sick Died • Uniform diagnostic criteria (OPTN/ LIRADS) 20% + standardized reporting Only pts w/ T2 HCC and LI-RADS 5 P<0.001 15% lesions are eligible to receive priority P<0.001 listing 10% P< 0.001 5% 0 Non-HCC Non-HCC Non-HCC HCC HCC HCC MELD 27-29 MELD 21-23 MELD 24-26 MELD 28 MELD 22 MELD 25 Goldberg D, et al. Liver Transpl 2012;18:434-443 LIVER TRANSPLANT FOR HCC: LIVER IMAGING REPORTING AND DATA SYSTEM RECENT CHANGES (LI-RADS) • Uniform diagnostic criteria (OPTN/ LIRADS) LIVER MASS + standardized reporting Diagnostic Arterial phase Arterial phase Only pts w/ T2 HCC and LI-RADS 5 Criteria hypo- or Iso- hyper- lesions are eligible to receive priority enhancement enhancement < 1 cm 1-1.9 cm ≥ 2 cm < 2 cm ≥ 2 cm listing LIRADS 3 LIRADS 3 LIRADS 3 LIRADS 3 LIRADS 4 “Washout” None LI-RADS 5: Definite HCC “Capsule” One LIRADS 3 LIRADS 4 LIRADS 4 LIRADS 4 LIRADS 5 Threshold growth ≥ Two LIRADS 4 LIRADS 4 LIRADs 4 LIRADS 5 LIRADS 5 LI-RADS 4: Probable HCC LI-RADS 3: Indeterminate 3
9/29/2016 LIVER IMAGING REPORTING AND DATA SYSTEM LIVER TRANSPLANT FOR HCC: (LI-RADS) RECENT CHANGES • Uniform diagnostic criteria (OPTN/ LIRADS) LIVER MASS + standardized reporting Diagnostic Arterial phase Arterial phase • 6-month mandatory waiting period before Criteria hypo- or Iso- hyper- MELD exception of 28 enhancement enhancement < 2 cm ≥ 2 cm < 1 cm 1-1.9 cm ≥ 2 cm • Cap at MELD of 34 None LIRADS 3 LIRADS 3 LIRADS 3 LIRADS 3 LIRADS 4 “Washout” “Capsule” LIRADS 5 One LIRADS 3 LIRADS 4 LIRADS 4 LIRADS 4 Threshold growth ≥ Two LIRADS 4 LIRADS 4 LIRADs 4 LIRADS 5 LIRADS 5 DECIDING WHO SHOULD BE TRANSPLANTED DELAYED HCC-MELD EXCEPTION SCORE IN THE NEW MELD ERA FOR HCC Delays in HCC Non-HCC HCC-MELD Transplant rates (per Transplant rates (per exception 100 person-years) 100 person-years) Within Milan Within Milan 0 108.7 30.1 Transplant would benefit 3 months 65.0 32.5 Transplant not needed Do poorly after transplant 6 months 44.2 33.9 Moving past “one-size fits all” 9 months 33.6 34.8 Mehta N, and Yao FY. Liver Transpl 2013;19:1055-1088 Heimbach J, et al. Hepatology 2015;61:1643-1650 4
9/29/2016 DECIDING WHO SHOULD BE TRANSPLANTED DECIDING WHO SHOULD BE TRANSPLANTED IN THE NEW MELD ERA FOR HCC IN THE NEW MELD ERA FOR HCC - Local regional therapy - Local regional therapy - Observation period/ - Observation period/ Within Milan Within Milan Within Milan Wait time Within Milan Wait time Transplant would benefit Transplant would benefit Transplant not needed Transplant not needed Do poorly after transplant Do poorly after transplant Tumor Down-staging DECIDING WHO SHOULD BE TRANSPLANTED DECIDING WHO SHOULD BE TRANSPLANTED IN THE NEW MELD ERA FOR HCC IN THE NEW MELD ERA FOR HCC Within Milan Within Milan Transplant would benefit Transplant would benefit Transplant not needed Transplant not needed Do poorly after transplant Do poorly after transplant 20% Transplant not needed (or less urgent) 5
9/29/2016 SUBGROUP WITH LOW DROPOUT RISK SUBGROUP WITH LOW DROPOUT RISK Criteria for low dropout risk Criteria for low dropout risk 1 lesion 2-3 cm 1 lesion 2-3 cm Complete response to 1 st treatment Complete response to 1 st treatment AFP after 1 st treatment < 20 ng/mL AFP after 1 st treatment < 20 ng/mL Cumulative dropout risks of 1.3% at 1 year, and 1.6% at 2 years. Accounts for 20% of entire cohort Mehta N, et al. Liver Transpl 2013;19:1343-1353 Mehta N, et al. Liver Transpl 2013;19:1343-1353 PROPOSED UNOS POLICY CHANGE 10 20 30 % 26.5% Single Small Lesion Criteria 21.6% All other patients (n=254) • Candidates who initially present w/ single 2-3 cm lesion Cumulative Incidence must be treated with local-regional therapy (LRT) in order to be eligible for automatic MELD exception • If the lesion is completely treated after 1+ LRTs, the candidate is not eligible for MELD exception until lesion 1 lesion 2-3 cm, complete 1 st treatment response, AFP < 20 (n= 63) recurs or develops a new lesion 1.6% 1.3% • If the lesion persists or recurs after 1+ LRTs, the candidate is eligible for MELD exception Months after listing Mehta N, et al. Liver Transpl 2013;19:1343-1353 6
9/29/2016 LIVER TRANSPLANTATION FOR HCC: LIVER TRANSPLANTATION FOR HCC: OPTIMIZING SELECTION CRITERIA OPTIMIZING SELECTION CRITERIA Scenario: Your patient with a 3.5 cm HCC is Scenario: Your patient with a 3.5 cm HCC is at the top of the wait list and is expecting a at the top of the wait list and is expecting a liver offer at any time. Today in clinic he asks liver offer at any time. Today in clinic he asks you what his expected outcomes are after you what his expected outcomes are after transplant. transplant. 5 yr post-LT survival: 75-80% 5 yr HCC recurrence: ~15% DECIDING WHO SHOULD BE TRANSPLANTED LIVER TRANSPLANTATION FOR HCC: IN THE NEW MELD ERA FOR HCC OPTIMIZING SELECTION CRITERIA Do poorly after transplant?? Within Milan Scenario: Your patient with a 3.5 cm HCC is at the top of the wait list and is expecting a 10-20% liver offer at any time. Today in clinic he asks you what his expected outcomes are after transplant. Transplant would benefit Transplant not needed Do poorly after transplant 5 yr post-LT survival: ??? 5 yr HCC recurrence: ??? 7
9/29/2016 LIVER TRANSPLANTATION FOR HCC: LIVER TRANSPLANTATION FOR HCC: OPTIMIZING SELECTION CRITERIA OPTIMIZING SELECTION CRITERIA AFP Response Response to LRT to LRT 3.5 cm 3.5 cm LIVER TRANSPLANTATION FOR HCC: LIVER TRANSPLANTATION FOR HCC: OPTIMIZING SELECTION CRITERIA OPTIMIZING SELECTION CRITERIA AFP AFP 7.5 cm 7.5 cm Response Response to LRT to LRT 3.5 cm 3.5 cm 5 yr post-LT survival: __% 5 yr HCC recurrence: __% 8
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