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WCIO 2011 – June 9 – 12 , New York




      Is RFA still the standard of treatment for patients with
                HCC awaiting liver transplantation?
     RM Lauro*, A Nicolini**

 IRCCS Cà Granda Fondation
Policlinico Hospital – Milan - Italy

 General Surgery & Liver Transplant Unit*
         Interv. Radiology Unit**
Aim of our experience

To assess the finalhistological pattern afterRFA and
DEB-TACE performed as “Bridge Treatment” for HCC
before Liver Transplantation.
HCC Bridge Treatment before Liver Transplantation
          According to BCLCA Guidelines

CurativeTreatments
• Surgery in very early (O) and early stage (A) (Laparaoscopy)
• PEI (early stage)
• Thermoablation (RFA) in early stage
• Other Ablation procedures, even though not yet approved with the
   need of further investigations (MW, CrioAbl, Laser-LITT etc..) (early
   stage)
• TACE in intermediate stage Palliative Treatment
                              Namiki Izumi, J of Gastroenterol & Hepatol 26 (2011) Suppl. 1 ; 115-122
                              J Bruix and M Sherman, Hepatology 2011; 53 N.3: 1020-1022
                              Belghiti J, Lencioni R et al., Ann Surg Oncol 2008; 15: 993-1000
                              Bharat et al, Am J Coll Surg 2006; pp. 411-420
                              Xian-Jie Shi et al.,Hepatobiliary Pancreat Dis Int. 2011; 10: 143-150
                              T Livraghi et al., Scandinavian Journal of Surgery 2011; 100: 22–29
TACE
• In recent years TACE procedures have been improved

• The recent introduction of microsphere loaded with
  Epirubicin or Doxorubicin (DEB-TACE) has improved TACE
  efficacy, extending tumor necrosis



   Varela M et al., J Hepatol 2007; 46: 474-481
   Malagari K et al., Abdom Imaging 2008; 33: 512-519
   Nicolini A et al., Dig Liver Dis 2009; 41: 143-149
   Nicolini A et al., JVIR 2010; 21: 327-332
   Mike SL Liem et al., World J Gastroenterol 2005;11(29):4465-4471
   A G Singal & J A Marrero, Current Opinion in Gastroenterology 2010,26:189–195
Methods
              January 2005 – December 2010
      Based on a Clinical Basis , we have investigated a significant
      group of patients within the “Milano Criteria”.



Patients with HCC                                     61
in BCLCA A1-A4 selected for LT

Sex                                                24M,6F

Age                                              55.6 (57±3.8)

Patients selected for the                         30 (49.2%)
“Bridge Treatment”

RFA                                                 18 pts

DEB-TACE                                            10 pts

Patients excluded                           2 pts (both treatments)
Methods
• According to BCLC guidelines all patients were considered for
  RFA.



• Only patients with at least a lesion in critical sites or more
  than 30 mm in diameter not treatable with RFA , were cured
  using DEB-TACE



• The pathological specimen of the native unhealthy liver was
  analyzed by the pathologists
Baseline Characteristics of the Patients
                     Enrolled in the Study
   Pts Characteristics       DEB-TACE                 RFA

                               10 pts                18 pts
Child-Pugh
A                                6                     12
B                                4                     6
HCC size                    30±12.2 mm           30±15.0 mm

N° of HCC Nodules                           Lap. 13 pts , Perc. 5 pts
-1 N                         7 (70%)***              1 (6%)
-2 N                           1 (10%)             11 (61%)
-3 N                           2 (20%)         6 (33%) Lap. **
Ethiology
HBV                              0                      1
HCV                              5                     10
ETH                              1                      2
Mixed                            4                      5
N. of Nodules        DEB-TACE                      RFA
                       10 pts                     18 pts

     1N            ***7 pts (70%)               1 pts (6%)

                    - Critical Sites
                -Close to main vessels
                    -Size > 30 mm
                -Less Invasive impact
                       before LT


     2N              1 pts (10%)               11 pts (61%)

     3N              2 pts (20%)               **6 pts (33%)

                                             Third nodule always
                                            detected as occasional
                                         finding >>Laparoscopic US
Results
    Treatment             RFA         DEB-TACE        p<

     N° of Pts             18              10
 N° of Treatments       1.30 (1-3)      1.5 (1-3)    n.s.
WT to LT after the    12.8 (1-24 M)   8.0 (3-18 M)   n.s.
 1st treatment
CT-scan Complete          91%            88%         0.941
Necrosis (3 months)
    Complete              82%             78%        0.963
PathologicalRespo
       nse
PartialPathological       18%            22%         n.s.
     Response
Question?

DEB-TACE :Is it only for Palliative Treatment?



           TopicofDiscussion
Conclusion
• Our results suggests that RFA and DEB-TACE have similar results
• Both RFA and DEB-TACE are good therapeutic approaches to limit HCC
    progression in stable LT candidates.
•   DEB-TACE has a better cost/benefit ratio (less invasive, lower
    costs, excellent efficacy)
• DEB-TACE in expert hands, might be also considered as “Curative
    Treatment” very soon.
• A wider comparison of the two procedures seems warranted in the light
    of Clinical Effectiveness Research
… improve is to change!
    …be perfect is to change often!
           Sir Winston Churchill (1874-1965)


Thank you very much indeed for your attention!!

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Lauro.wcio2011 ny

  • 1. WCIO 2011 – June 9 – 12 , New York Is RFA still the standard of treatment for patients with HCC awaiting liver transplantation? RM Lauro*, A Nicolini** IRCCS Cà Granda Fondation Policlinico Hospital – Milan - Italy General Surgery & Liver Transplant Unit* Interv. Radiology Unit**
  • 2. Aim of our experience To assess the finalhistological pattern afterRFA and DEB-TACE performed as “Bridge Treatment” for HCC before Liver Transplantation.
  • 3. HCC Bridge Treatment before Liver Transplantation According to BCLCA Guidelines CurativeTreatments • Surgery in very early (O) and early stage (A) (Laparaoscopy) • PEI (early stage) • Thermoablation (RFA) in early stage • Other Ablation procedures, even though not yet approved with the need of further investigations (MW, CrioAbl, Laser-LITT etc..) (early stage) • TACE in intermediate stage Palliative Treatment Namiki Izumi, J of Gastroenterol & Hepatol 26 (2011) Suppl. 1 ; 115-122 J Bruix and M Sherman, Hepatology 2011; 53 N.3: 1020-1022 Belghiti J, Lencioni R et al., Ann Surg Oncol 2008; 15: 993-1000 Bharat et al, Am J Coll Surg 2006; pp. 411-420 Xian-Jie Shi et al.,Hepatobiliary Pancreat Dis Int. 2011; 10: 143-150 T Livraghi et al., Scandinavian Journal of Surgery 2011; 100: 22–29
  • 4. TACE • In recent years TACE procedures have been improved • The recent introduction of microsphere loaded with Epirubicin or Doxorubicin (DEB-TACE) has improved TACE efficacy, extending tumor necrosis Varela M et al., J Hepatol 2007; 46: 474-481 Malagari K et al., Abdom Imaging 2008; 33: 512-519 Nicolini A et al., Dig Liver Dis 2009; 41: 143-149 Nicolini A et al., JVIR 2010; 21: 327-332 Mike SL Liem et al., World J Gastroenterol 2005;11(29):4465-4471 A G Singal & J A Marrero, Current Opinion in Gastroenterology 2010,26:189–195
  • 5. Methods January 2005 – December 2010 Based on a Clinical Basis , we have investigated a significant group of patients within the “Milano Criteria”. Patients with HCC 61 in BCLCA A1-A4 selected for LT Sex 24M,6F Age 55.6 (57±3.8) Patients selected for the 30 (49.2%) “Bridge Treatment” RFA 18 pts DEB-TACE 10 pts Patients excluded 2 pts (both treatments)
  • 6. Methods • According to BCLC guidelines all patients were considered for RFA. • Only patients with at least a lesion in critical sites or more than 30 mm in diameter not treatable with RFA , were cured using DEB-TACE • The pathological specimen of the native unhealthy liver was analyzed by the pathologists
  • 7. Baseline Characteristics of the Patients Enrolled in the Study Pts Characteristics DEB-TACE RFA 10 pts 18 pts Child-Pugh A 6 12 B 4 6 HCC size 30±12.2 mm 30±15.0 mm N° of HCC Nodules Lap. 13 pts , Perc. 5 pts -1 N 7 (70%)*** 1 (6%) -2 N 1 (10%) 11 (61%) -3 N 2 (20%) 6 (33%) Lap. ** Ethiology HBV 0 1 HCV 5 10 ETH 1 2 Mixed 4 5
  • 8. N. of Nodules DEB-TACE RFA 10 pts 18 pts 1N ***7 pts (70%) 1 pts (6%) - Critical Sites -Close to main vessels -Size > 30 mm -Less Invasive impact before LT 2N 1 pts (10%) 11 pts (61%) 3N 2 pts (20%) **6 pts (33%) Third nodule always detected as occasional finding >>Laparoscopic US
  • 9. Results Treatment RFA DEB-TACE p< N° of Pts 18 10 N° of Treatments 1.30 (1-3) 1.5 (1-3) n.s. WT to LT after the 12.8 (1-24 M) 8.0 (3-18 M) n.s. 1st treatment CT-scan Complete 91% 88% 0.941 Necrosis (3 months) Complete 82% 78% 0.963 PathologicalRespo nse PartialPathological 18% 22% n.s. Response
  • 10. Question? DEB-TACE :Is it only for Palliative Treatment? TopicofDiscussion
  • 11. Conclusion • Our results suggests that RFA and DEB-TACE have similar results • Both RFA and DEB-TACE are good therapeutic approaches to limit HCC progression in stable LT candidates. • DEB-TACE has a better cost/benefit ratio (less invasive, lower costs, excellent efficacy) • DEB-TACE in expert hands, might be also considered as “Curative Treatment” very soon. • A wider comparison of the two procedures seems warranted in the light of Clinical Effectiveness Research
  • 12. … improve is to change! …be perfect is to change often! Sir Winston Churchill (1874-1965) Thank you very much indeed for your attention!!