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Radiologieinterventionnellechctdebaere

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Radiologie interventionnelle du CHC. Pr Thierry de Baere

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Radiologieinterventionnellechctdebaere

  1. 1. Radiologie Interventionnelle & CHC Thierry de Baère Imagerie thérapeutique - Gustave Roussy - Villejuif Journée d’Hépatologie du Centre Hépato-Biliaire 12 juin 2015 - Paris
  2. 2. J Hepatol 2012. 56; 908–943. JM. Llovet; R Lencioni; AM. Di Bisceglie; PR. Galle; JF Dufour; TF. Greten; E Raymond; T Roskams; T de Baere; Michel Ducreux; and Vincenzo Mazzaferro.
  3. 3. J Hepatol 2012. 56; 908–943. JM. Llovet; R Lencioni; AM. Di Bisceglie; PR. Galle; JF Dufour; TF. Greten; E Raymond; T Roskams; T De Baere; Michel Ducreux; and Vincenzo Mazzaferro.
  4. 4. % AP n=928 EU n=1113 LA n=90 USA n=563 Japan n=508 Overall N=3202 All LRTs 67.2 43.5 27.8 49.4 84.4 57.5 TACE 60.3 33.1 13.3 37.1 71.3 47.2 Conventional Lipiodol TACE * 90.2 59.2 83.3 40.7 82.3 73.9 DEB-TACE * 2.9 36.1 16.7 39.7 1.7 15.9 Ablation 15.5 20.2 17.8 12.6 50.0 22.2 Surgery 24.2 15.5 5.6 9.4 43.3 21.1 * For patients who received TACE: n=1511; AP=560, EU=368, LA=12, USA=209, Japan=362; AP, Asia-Pacific; LA, Latin America; LRTs, Loco-Regional Therapies Lencioni R et al. Int J Clin Pract 2014;68:609-617 GIDEON Pre-Sorafenib therapy in 3202 HCC (observation)
  5. 5. Breen DJ,. Nat Rev Clin Oncol 2015;12:175-186 Ablation for Early-Stage HCC: Italy Japan Corea France
  6. 6. Feng K et al. J Hepatol 2012;57:794-802Huang J et al. Ann Surg 2010;252:903-912 ● 230 patients, 94% Child A ● Single ≤ 5 cm, up to 3 ≤ 3 cm ● 168 patients, 49% Child A ● Up to 2 HCC tumors ≤ 4 cm Overall Survival Overall Survival months months p = 0.001 (log-rank test) p = 0.342 (log-rank test) Ablation vs. Resection : Randomized Trials
  7. 7. Feng K et al. J Hepatol 2012;57:794-802Huang J et al. Ann Surg 2010;252:903-912 ● 230 patients, 94% Child A ● Single ≤ 5 cm, up to 3 ≤ 3 cm ● 168 patients, 49% Child A ● Up to 2 HCC tumors ≤ 4 cm Overall Survival Overall Survival months months p = 0.001 (log-rank test) p = 0.342 (log-rank test) Ablation vs. Resection : Randomized Trials
  8. 8. "Very Early” (stage 0) vs "Early" (stage A) VS “Milan” Sasaki A et al. Cancer 2005;103:299-306 46% of patients with single HCC < 5 cm show microsatellites on histology Radiofrequency ablation is recommended in most instances as the main ablative therapy in tumours less than 5 cm due to a significantly better control of the disease (evidence 1iD; recommendation 1A) J Hepatol 2012. 56; 908–943. JM. Llovet; R Lencioni; AM. Di Bisceglie; PR. Galle; JF Dufour; TF. Greten; E Raymond; T Roskams; T de Baere; Michel Ducreux; and Vincenzo Mazzaferro. Milan criteria : X3 <3cm ; >5cm
  9. 9. Pompili M et al. J Hepatol 2013;59:89-97 Tumor Recurrence Overall Survival
  10. 10. Ablation in HCC : APASL Consensus Omata M et al. Hepatol Int 2010;4:439-474 LOCATION! T
  11. 11. Omata M et al. Hepatol Int 2010;4:439-474 Ablation in HCC : APASL Consensus
  12. 12. Forner et al. Lancet 2012;379:1245-1255 Ablation Ablation The Two Roles of Ablation in HCC Treatment: Updated BCLC Treatment Algorithm
  13. 13. Focused Ultrasound Cryoablation Radiofrequency Ablation Irreversible Electroporation Laser AblationMicrowave Ablation
  14. 14. Mazzaferro V, Lencioni R, Majno P. Semin Liver Dis 2014;34:415-426 Image-Guided Ablation of HCC: Evolving Methods and Technologies
  15. 15. • Resection et ablation sont probablement équivalente pour les stade 0 et A (very early; early)  Complémentaire plus que compétitive : localisation • Pour les HCC < 5cm si candidat chirurgicaux limites  Rôle des nouvelles techniques d’ablation à définir , outil par outil  Traitement combiné (TACE+RF) • La difficultés est plus celle de la récidive à distance que de la récidive locale  Traitement préventif ! (STORM study) Ablation for Early-Stage HCC
  16. 16. BCLC Staging and Treatment Strategy: Critical Considerations EASL-EORTC. J Hepatol 2012;56:908-943 - Eur J Cancer 2012;48:599-641
  17. 17. BCLC Staging and Treatment Strategy: Critical Considerations EASL-EORTC. J Hepatol 2012;56:908-943 - Eur J Cancer 2012;48:599-641 ADVANCED STAGE: - ECOG PS 1-2 - Portal Vein Invasion - Extrahepatic Disease
  18. 18. (Yau T. Gastroenterology 2014;146:1691–1700 )EVM : extrahe-patic or vascular invasion/metastasis 0 / 1 / 2 negative factor Tumor size: ≥ 5 cm Tumor number: ≥ 3 Intrahepatic vascular invasion
  19. 19. (Yau T. Gastroenterology 2014;146:1691–1700 )
  20. 20. • HKC identified subsets of BCLC B & 50% of BCLCC C more aggressive treatments than recommended by BCLC Such aggressive treatments Improved survival outcomes  hypothetical median OS: HKLC 16.6 months, BCLC 8.9 months) “The benefits of the HKLC system are clearly apparent when dealing with patients who have intermediate to advanced stage disease according to the BCLC”. “In a European cohort of HCC patients, the newly developed HKLC staging system does not seem to allow a better predictive value than the BCLC”. (Adhoute X. J Hepatol 2014) (Chapiro J. Nat Rev Gastroenterol Hepatol 2014;11:334-336)
  21. 21. 177 patients randomized to DEB-TACE or c-TACE (med number of TACE = 2) • 89 DEB-TACE • 88 cTACE (Golfieri R. 2014 BJC; 111 : 255–264)
  22. 22. CR OR DC Targeted Overall (Golfieri R. 2014 BJC; 111 : 255–264)
  23. 23. (Golfieri R. 2014 BJC; 111 : 255–264)
  24. 24. • Median TTP = 9 months in both arms • 1- and 2-year survival  86.2% and 56.8% after DEB-TACE  83.5% and 55.4% after cTACE (p=0.949). No difference in AE incidence and severity except post-TACE pain, more frequent and severe after cTACE (p=0.001). Pain did not affected the length of hospital stay and patient acceptance of additional TACEs (Golfieri R. 2014 BJC; 111 : 255–264)
  25. 25. 67 DEB-TACE (53 patients) 100-300 μm (Group 1) lobar in 42 and selective in 7 cases 65 DEB-TACE (54 patients) 70-150 μm (Group 2) lobar in 60 and selective in 11 m-RECIST 1-2 months CR (%) PR (%) SD (%) PD (%) Group 1 19 2 67 12 Group 2 16 8 69 7 (Deipolyi AR, J Vasc Interv Radiol 2015; 26:516–522)
  26. 26. BCLC Staging and Treatment Strategy: Critical Considerations EASL-EORTC. J Hepatol 2012;56:908-943 - Eur J Cancer 2012;48:599-641 Radioembolization - Sarra - Soramic - STOPP HCC
  27. 27. A single-centre prospective study of 291 patients with HCC looked at long-term clinical outcomes with TheraSphere® Overall response rate according to WHO criteria was 42% TheraSphere® & HCC 29 Treatment response predicts survival benefit for BCLC A, B &C patients Salem R, Lewandowski RJ, Mulcahy MF, et al. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology 2010;138(1):52–64.
  28. 28. (Garlipp B, de Baere T, Seidensticker M. Hepatology 2014.59:1864-1873) 26 matched pairs PVE : 61.5 ± 39 % after 33 [24-56] days RE : 29 ± 28 % after 46 [27-79] days (p<0.001)
  29. 29. Traitements combinés
  30. 30. (Peng ZW; JCO 2013. 31 426-432) HCC less than 7 cm (single), or X3 & <3cm TACE-RFA Vs RFA OS : (HR=0.525; 95% CI = 0.335-0.822; P = .002 ) DFS : (HR=0.575; 95% CI = 0.374-0.897; P = .009) OS : treatment allocation (HR=1.87), tum. Size 3cm (HR=1.73), and tum. number (HR=2.49) DFS : Treatment allocation (HR=1.67) and tum. Number (HR=1.97)
  31. 31. HR: 0.797 95% Cl: 0.588, 1.08 P = 0.072 Sorafenib Median: 169 days 95% Cl: 166, 219 days Placebo Median: 166 days 95% Cl: 113, 168 days PrimaryEndpoint Sorafenib 400mg bid Matching Placebo R A N D O M I Z E 1 3 5 7 9 11 13 15 17 19 TACE (optional) Cycle no (=4 weeks) n=154 n=153 SPACE Trial
  32. 32. PRODIGE 16 - ESSAI FFCD 0905 ESSAI RANDOMISE EN DOUBLE AVEUGLE DE PHASE II-III EVALUANT LA CHIMIOEMBOLISATION COMBINEE AU SUNITINIB OU A UN PLACEBO CHEZ DES PATIENTS ATTEINTS DE CARCINOME HEPATOCELLULAIRE (SATURNE) DEB - TACE with sunitinib 37.5 mg/d orally 4 weeks out of 6 started 7-15 days before TACE for one year vs placebo. Primary end-point : specific safety of the TACE-sunitinib combination (severe bleeding, liver failure , …) Secondary end-points : general safety, progression-free survival (PFS), Overall Survival (OS), quality of life. May 2011 to May 2014 : 78 patients were randomized (39 in each arm) median age 66 years [IQR (60-70)]. Bilobar HCC : 41 / 70 patients The median number of cycles was 3 [IQR : 2 :5 ] in arm A and 5 [IQR : 4 :7 ] in arm B .No bleeding complication; 1liver failure (PT = 40%) armA, & 2 liver failure in arm B (PT=42%, ,encephalopathy). Sunitinib dose was reduced to 25 mg/d as a result of toxicity for 19 pts (48.7%) in arm A. 6 patients are still under treatment (3 in each arm). The main grades 3-4 toxicities were: thrombocytopenia (28.2% vs. 2.6% in placebo arm), neutropenia (28.2% vs. none), asthenia (20.5% vs. 5.3%), diarrhea (5.1% vs. none) respectively in arm A and B. The median PFS in arm A was 8.8 [95%CI 5.8 -12] months, and 6.3 [95%CI 4.2 - 9.0 ] months in arm B. Conclusion This study indicated a modest and manageable toxicity of sunitinib when combined with TACE. Regarding efficacy endpoints (PFS and OS) we are waiting for more mature data as 6 patients are still under treatment.
  33. 33. RFA plus Sorafenib vs RFA Alone in RCC Hakimé et al, Radiology 2007 4-time increase in ablation volume
  34. 34. 125 HCC received TACE group A (n = 61) : TACE + As2O3 at 10 mg/d for 4 courses (21 days per course) group B (n = 64) : TACE alone
  35. 35. 125 HCC received TACE group A (n = 61) : TACE + As2O3 at 10 mg/d for 4 courses (21 days per course) group B (n = 64) : TACE alone
  36. 36. J Vasc Interv Radiol 2014; 25:379–387
  37. 37. % EU n=1113 Overall N=3202 All LRTs 43.5 57.5 TACE 33.1 47.2 Conventional Lipiodol TACE * 59.2 73.9 DEB-TACE * 36.1 15.9 Ablation 20.2 22.2 Surgery 15.5 21.1 Conclusion DOSISPHERES-01 Y-90 GLASS MICROSPHERES FOR HCC :OPTIMIZED DOSIMETRY vs STANDARD DOSIMETRY STOPP HCC Y-90 GLASS MICROSPHERES FOR HCC PRIOR TO SORAFENIB THERAPY vs STANDARD DOSIMETRY Sunitinib loaded beads Lipiodol ready to inject emulsion

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