transarterial therapy: how to choose ctace vs. deb-tace ...transarterial therapy: how to choose...
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Transarterial therapy:
how to choose
cTACE vs. DEB-TACE vs.Y90-SIRT
台大醫院影醫部 梁博欽
TLAC 2015.12.27
TLCA Guideline 2015
TLCA Guideline 2015
Precision V Design
• Randomised phase II study
• Control arm of conventional transarterial chemoembolisation
(cTACE) with doxorubicin
• 200 patients (100 per arm)
• 23 European centres in Austria, France, Germany, Greece, and
Switzerland
• Patients receive up to 3 treatments (baseline, 2 and 4 months)
• Follow-up period: 6 months
Patients
randomised
1:1
(n=212)
TACE with DC BeadDoxorubicin dose = 150mg
Conventional TACE Doxorubicin dose = 50–75mg/m2
(maximum 150mg)
TACE repeated at 2 and 4 months
• Primary endpoint: tumor response at 6 months (by blinded independent
review of MR images)
• Secondary endpoints included safety
TACE repeated at 2 and 4 months
International multicentre, randomised phase II study of DC Bead uploaded
with doxorubicin versus conventional Lipiodol TACE with doxorubicin
Lencioni R et al. ASCO 2009; Lammer J et al. Cardiovasc Intervent Radiol 2010 (e-pub)
TACE with DC Bead vs conventional TACE:
a randomized trial (“PRECISION V”)
Main Exclusion Criteria
• Severe liver dysfunction
- Child C
- Bilirubin level >3mg/dl
• Advanced tumour stage
- tumor involvement > 50%
of the whole liver
- Portal vein invasion
- extrahepatic spread
• Patient previously treated with
chemo- or radiotherapy
Main Inclusion Criteria
• Patient with large / multinodular
HCC without vascular invasion or
extrahepatic spread
• Patient not suitable for curative
resection / ablation
• ECOG performance status 0 or 1
• Child Pugh A or B
• Recurrent tumor after resection or
ablation
• Patients on the transplant list who
may not receive a transplant within
6 months
TACE with DC Bead vs conventional TACE:
enrolment criteria
Lencioni R et al. ASCO 2009; Lammer J et al. Cardiovasc Intervent Radiol 2010 (e-pub)
PRECISION TACE with DC Bead
• 2 x 2 ml vials of DC Bead (total 4ml) for total doxorubicin dose of 150mg
• 1 vial 300-500µm plus 1 vial 500-700µm
Conventional TACE
• Doxorubicin dose of 50-75mg/m2 to maximum of 150mg, lipiodol, embolic
Technique (both groups)
• Unifocal tumours: segmental approach
• Bilobar disease: both lobes treated within a 3-week period
• Embolisation to stasis in 2nd or 3rd order branches, additional unloaded
beads (Bead Block, Biocompatibles) if needed
TACE with DC Bead vs conventional TACE: treatment
Lencioni R et al. ASCO 2009; Lammer J et al. Cardiovasc Intervent Radiol 2010 (e-pub)
CharacteristicsDC Bead (n=102) cTACE (n=110)
n % n %
Child Pugh A 83 81.4 91 82.7
B 19 18.6 19 17.3
ECOG0 78 76.5 81 73.6
1 24 23.5 29 26.4
Bilobar DiseaseNo 54 52.9 63 57.3
Yes 48 47.1 47 42.7
Recurrent
Disease
No 91 89.2 97 88.2
Yes 11 10.8 13 11.8
TACE with DC Bead vs conventional TACE: baseline
stratification allows for balanced statistical evaluation
Lencioni R et al. ASCO 2009; Lammer J et al. Cardiovasc Intervent Radiol 2010 (e-pub)
6-Month Response in More Advanced Patients
DC BeadTM Demonstrated Statistically Significant Advantage in Advanced Patients
Objective Response (p=0.038) and Disease Control (p=0.026)
DC Bead shows a significant (p<0.05)
response benefit in More Advanced patients
Serious Adverse Events – Advanced Disease
*per 100 patients, events within 30 days of treatment
The significant (p<0.05) response benefit in More Advanced patients
with DC Bead is delivered with an improved safety profile
Summary
Overall, DC BeadTM has
• Greater objective response (p=0.11)
• Lower related SAEs and AEs
DC Bead has a significant (p<0.05) advantage in
• Objective response in more advanced patients (p=0.038)
• Disease control in more advanced patients (p=0.026)
DC Bead has a highly significant (p<0.01) advantage in the
• Reduction of doxorubicin associated side effects (p=0.0001) in all
patients
• Reduction of disturbance in liver enzymes, AST and ALT (p<0.01)
TLCA Guideline 2015
Transarterial therapy: how to choose cTACE vs. DEB-TACE vs.Y90-SIRT
TLCA Guideline 2015
NCI level of evidence
GRADE System(Grading of Recommendations, Assessment, Development and Evaluation)
GRADE system(Grading of Recommendations, Assessment, Development and Evaluation)
5th APPLE 2014 Recommendation for SIRT
• In early stage HCC, SIRT can be considered for bridging treatment for cadaveric liver transplantation (evidence level B1).
• In intermediate stage HCC, SIRT can be considered for bilobar, multinodular or large tumour burden HCC, and also for HCC after conventional TACE has failed. There is limited data that SIRT may be used as neoadjuvant treatment (evidence level B1).
• In advanced stage HCC, SIRT can be used for patients with vascular invasion and liver-dominant metastatic HCC (evidence level B1).
5th APPLE 2014 Recommendation for SIRT
• In early stage HCC, SIRT can be considered for bridging treatment for cadaveric liver transplantation (evidence level B1).
• In intermediate stage HCC, SIRT can be considered for bilobar, multinodular or large tumour burden HCC, and also for HCC after conventional TACE has failed. There is limited data that SIRT may be used as neoadjuvant treatment (evidence level B1).
• In advanced stage HCC, SIRT can be used for patients with vascular invasion and liver-dominant metastatic HCC (evidence level B1).
5th APPLE 2014 Recommendation for SIRT
• In early stage HCC, SIRT can be considered for bridging treatment for cadaveric liver transplantation (evidence level B1).
• In intermediate stage HCC, SIRT can be considered for bilobar, multinodular or large tumour burden HCC, and also for HCC after conventional TACE has failed. There is limited data that SIRT may be used as neoadjuvant treatment (evidence level B1).
• In advanced stage HCC, SIRT can be used for patients with vascular invasion and liver-dominant metastatic HCC (evidence level B1).
SIRTEX ongoing clinical studyTitle Setting Sponsor Study ID Treatment Arm(s) Location
SIRveNIBhttp://www.sirvenib.com/Study to compare selective internal radiation therapy (SIRT) versus sorafenib in locally advanced hepatocellular carcinoma
HCC
Collaborative Group Study
NCT01135056Sorafenib versus SIR-Spheres microspheres
Asia-Pacific
SARAHSorafenib versus radioembolizationin advanced hepatocellular carcinoma
HCC
Collaborative Group Study
NCT01482442Sorafenib versus SIR-Spheres microspheres
France
SORAMICwww.soramic.de Sorafenib and micro-therapy guided by primovist-enhanced MRI in patients with inoperable liver cancer
HCC
Investigator-Initiated Research Study
NCT01126645Sorafenib versus SIR-Spheres microspheres > Sorafenib
Europe
TRYPHON -- terminatedY90 radioembolization prior to surgical resection or radiofrequency for hepatocellular carcinoma in cirrhotic liver
HCC
Investigator-Initiated Research Study
NCT01686880 SIR Spheres microspheres Belgium
Selective internal radiation therapy (SIRT) versus transarterial chemoembolisation (TACE) for the treatment of cholangiocellular carcinoma (CCC)
CCC
Investigator-Initiated Research Study
NCT01798147SIR Spheres microspheres versus transarterial chemoembolisation (TACE)
Germany
Guidelines for management of HCC
Peipei Song, Liver International 2012;32(7): 1053-1063
Guidelines for management of HCC
Peipei Song, Liver International 2012;32(7): 1053-1063
AASLD/BCLC staging and treatment strategy 2010
Hepatology 2011(53;3): 1020-1022 Lancet 2012; 379: 1245-1255
Substaging of BCLC stage B
Luigi Bolondi et al. Semin Liver Dis 2012; 32: 348-359
Milan criteria for Liver Txp
• A solitary lesion of < 5 cm, or 2 to 3 nodules, all < 3 cm and without microscopic vascular invasion or extrahepatic disease.
• 5-year post-transplant survival exceeding 70%
• 5-year tumor recurrence rate below 15%
Mazzaferro et al. N Engl J Med 1996; 334: 693-699
UCSF criteria for Liver Txp
University of California San Francisco criteria
• 1 lesion ≤ 6.5cm in diameter or 2 to 3 lesions, each ≤ 4.5 cm in diameter, with a total diameter of ≤ 8 cm.
• 2-year survival of 86%
Yao et al. Hepatology 2001; 33: 1394-1403
New Milan criteria(Up-to-seven criteria, Ut-7 criteria) • hepatocellular carcinomas with seven as the sum of
the size of the largest tumor (in cm) and the number of tumors.
• 5-year overall survival rate 71.2%.
Mazzaferro et al. Lancet Oncol 2009; 10: 35-43
NCCN Guidelines Version2.2014
• All arterial directed therapies are relatively contraindicated in patients bilirubin > 3 mg/dL unless segmental injection can be performed.
• Radioembolization with Yttrium-90 microspheres has an increased risk of radiation induced liver disease in patients with bilirubin over 2 mg/dL
• Arterial directed therapies are relatively contraindicated in patients with main portal vein thrombosis and Child C
NCCN Guidelines Version2.2015
ESMO Strategy for staging and treatment 2012
Annals of Oncology 23 (Supplement 7): vii41–vii48, 2012
EASL-EORTC recommendation for treatment 2012
Journal of Hepatology 2012(56): 908-943
NCI level of evidence
GRADE System(Grading of Recommendations, Assessment, Development and Evaluation)
APASL treatment algorithm 2010
Omata M, et.al Hepatol Int 2010 4:439–474
Kudo 2010 APASL
J-HCC 2009 Evidence-based treatment guideline
J Gastroenterol. 2009;44 Suppl 19:119-21.
JSH-LCSGJ 2011Consensus-Based Treatment Algorithm
Dig Dis 2011;29:339–364
TLCA Guideline 2015
National Cancer Center Singapore Consensus Guideline 2014
TPVGH Guideline 3rd Version
NTUH Guideline 2015
APASL treatment algorithm 2010
Omata M, et.al Hepatol Int 2010 4:439–474
Transarterial therapy: how to choose cTACE vs. DEB-TACE vs.Y90-SIRT
Conclusion
•Transarterial therapy: how to choose cTACE vs. DEB-TACE vs.Y90-SIRT
TLCA Guideline 2015
DEB-TACE
Thanks for your attention !!
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