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Eva Gallardo, MD Medical Manager, Biocompatibles UK

Drug Eluting Bead: Clinical Updates and Histological Data. Eva Gallardo, MD Medical Manager, Biocompatibles UK. DC Bead: Clinical Programme. Primary Liver Cancer. Colorectal Metastases. Very Early/Early Stage Prior to resection Bridge to transplant RFA + PRECISION TACE

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Eva Gallardo, MD Medical Manager, Biocompatibles UK

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  1. Drug Eluting Bead: Clinical Updates and Histological Data Eva Gallardo, MD Medical Manager, Biocompatibles UK

  2. DC Bead: Clinical Programme Primary Liver Cancer Colorectal Metastases Very Early/Early Stage Prior to resection Bridge to transplant RFA + PRECISION TACE Intermediate Stage Precision I Precision II Precision V Advanced Stage Sorafenib + PRECISION TACE EarlyCT Lines Late Stage Doxorubicin Bead Irinotecan Bead Other Primary Cancers Secondary Liver Cancer Renal Breast Cholangiocarcinoma Melanoma Gastric Neuroendocrine Sarcoma

  3. PRECISION TACE in treatment of Colorectal Metastases Investigators: Camillo Aliberti, MD Giammaria Fiorentini, MD Department of Diagnostic and Interventional Radiology, Delta Hospital AUSL Ferrara, Ferrara Italy Department of Oncology, General Hospital San Giuseppe, Empoli, Florence, Italy

  4. Irinotecan Bead in Advanced Colorectal Cancer: Patient Selection • 62 patients (M/F = 42/20), median aged 64.6 (range 42-85) • Not operable and pretreated at least two lines of chemo (range 2-6) • Maximum dose 4 ml (2ml of 100-300mm and 2ml of 300-500mm) with 200mg of Irinotecan • 2-3 TACE 4 weeks

  5. Irinotecan Bead in Advanced Colorectal Cancer: Toxicity Postembolization-syndrome

  6. Irinotecan Bead in Advanced Colorectal Cancer: Response to Treatment • The median follow-up was 15.4 months • 1 month CT scan showed reduction of metastatic CE 85%, range 75-100% in all patients • RECIST at 3 months: 78% • 55/62 pts (90%) declared a general improvement of QoL lasting 6.5 months, range 3-12 

  7. Irinotecan Bead in Advanced Colorectal Cancer: Survival • Median survival not reached at 22 months • Median Free Time from symptoms 5.3 (5-20 months) • Median Time to further chemoteraphy 6.3 (5-22 months )

  8. Irinotecan Bead in Advanced Colorectal Cancer: Cases 18 months after TACE

  9. Irinotecan Bead in Advanced Colorectal Cancer: Cases 09.2005 02.2005 6 months after TACE

  10. Neuroendocrine Metastasis Principal Investigator: Thierry De Baere, MD Chief of Interventional Radiology Department Institut de Cancérologie Gustave Roussy - Villejuif - France

  11. Doxorubicin Bead in NET:Materials and Methods • 20 patients with liver metastases from low-grade GEP tumour • Progressive liver disease on two subsequent imaging studies according to RECIST criteria • Disease predominant to the liver • Up to 4ml DC Bead 500-700mm loaded with up to 100mg doxorubicin • Concomitant treatment with long-acting ST analog

  12. Doxorubicin Bead in NET:Results • 34 sessions (6 unilobar, 14 bilobar) • RECIST 3M: • 16/20 (80%) partial response • 3/20 (10%) stable disease • 1/20 (15%) progressive disease • After a median follow-up of 15 months (6-24), disease remained controlled without tumour progression in 45% • 1 patient become resectable Median Time to Progression: 15 months

  13. Doxorubicin Bead in NET:Toxicity • Post-embolisation syndrome: • < 7 days in 67% sessions • > 7 days in 22% sessions • No symptoms in 11% sessions • Hypodense subsegmental peripheral areas (TACE-induced necrotic liver tissue?) in 5 patients at 1 month CTscan • 1 death: resected patient due to postoperative septic complications

  14. Doxorubicin Bead in NET:Cases

  15. Doxorubicin Bead in NET:Cases

  16. Combined PRECISION TACE/RFA: Results and Outcome Principal Investigator: Riccardo Lencioni, MD Associate Professor of Diagnostic and Interventional Radiology Department of Oncology, Transplants, and Advanced Technologies in Medicine – Pisa University, Italy

  17. Sub-lethal heating(45-50 °C) Vessel RFA: Inherent Limitations 50 °C

  18. 20 pts (mean age, 70 ± 6 ) with residual viable tumour at CT / MRI 1-2 hrs after RFA • Tumour diameter 3.3-7.0 cm (mean, 5.0 cm ± 1.4) • - Child-Pugh class A, ECOG 0 • PT ratio > 50%, platelets > 50,000/mm3 • Excl: - Eligibility for liver resection or transplantation • - Vascular invasion / extrahepatic disease • - Any previous treatment for HCC DEB-Enhanced RFA of HCC: A Pilot Study Design / Enrollment Criteria

  19. Follow-up period 6-20 months (mean, 12 months ± 5) • DC Bead (Biocompatibles) injection < 24 hrs of RFA • - 50 mg doxorubicin in 2 ml of 100-300 μm beads • - Additional loads (100-300 / 300-500 µm) if needed • Tumour response: RECIST criteria - EASL amendment • - CR: absence of enhancement at 1-month CT / MRI • - Confirmed CR: CR lasting no less than 6 months • - OR: confirmed CR target lesion, no new lesions DEB-Enhanced RFA of HCC: A Pilot Study Materials and Methods

  20. DEB-Enhanced RFA of HCC: A Pilot Study Results – Change in Ablation Volume 180,000 160,000 140,000 61% + 120,000 100,000 Ablation Volume (mm3) 80,000 60,000 40,000 20,000 0,000 Standard RFA DEB-Enhanced RFA

  21. DEB-Enhanced RFA of HCC: A Pilot Study Results – Clinical Case # 2 6 cm Pre-treatment CT Post-RFA Post-TACE

  22. DEB-Enhanced RFA of HCC: A Pilot Study Results – Overall Response Table. Overall Response at the End of Follow-Up New lesions No. (%) Overall response Target lesions NoNoYesYes / No CRPRCR / PRPD 10 (50%)5 (25%) 3 (15%) 2 (10%) CRPRPD Note: Numbers are numbers of patients. Overall number of patients: 20.

  23. 30 24 DEB-Enhanced RFA of HCC: A Pilot Study Results – Overall Survival 100% 92% 100 80 60 40 20 DEB-enhanced RFA (n = 20) 0 0 6 12 18 months

  24. Doxorubicin Bead prior to liver transplant

  25. TACE Prior to Transplant • Major issue = Dropout rate (30-40%) • Role of TACE: • Patients within Milan criteria (maintain in waiting list) • Patients outside Milan criteria (for downstaging to fullfil Milan criteria) • Induce high hystological tumour response rate • Decrease recurrence rates?

  26. Dr Citron –Atlanta, US • Retrospective study • 9 listed patients (>Child A-B, single nodules, mean tumour size 2cm (0.3-5.1) • 1-3 treatments prior to transplant • 100-300 and/or 300-500mm DC Bead with up 150mg doxorubicin • Liver transplant (1-281 days post-treatment)

  27. Results • CTscan: • Complete necrosis 88% patients • Histology: • Complete necrosis 77% patients • 2 non-complete necrosis: • Patient transplanted 8 hours after TACE with no necrosis • Patient with residual 0.5cm viable tumour within 7.5cm necrotic tumour

  28. Dr Nicolini - Italy • Retrospective study Doxorubicin Bead vs TAE • 16 patients (15 waiting list/ 1 outside Milan) • 1-4 treatments until complete RX response • DC Bead arm: 100-300mm DC Bead with 50mg epirubicin • TAE:100-300mm Embosphere

  29. Tumour Response * % Tumour response by tumours • 62.5% DC Bead achieved complete RX response after one treatment vs 12.5% in TAE • 15 patients alive with no recurrence

  30. Prof Goffette - Belgium • 16 patients: • 9 within the Milan criteria for LT • 7 outside the Milan criteria for LT • Diameter > 5 cm 4 • More than 3 tumours 3 • Mean tumour size 5.4 cm (2.3-7.8) , 2 portal vein thrombosis • Standardized DC Beads doses and sizes: • 4ml (2 vials) of 300-500 µm particles loaded with 25mg/ml doxorubicin:100 mg Doxo/session • Additional unloaded particles (300-500,500-700µ) if persitent flow • Sequential treatment every 3 months (Max 4) • Alternate treatment if bi-lobar lesions

  31. Procedural Results • Mean number of sessions 2.7 4pts:1, 6pts:2, 7pts:3, 1pt:4 • Serious adverse event Cholecystitis 1 • 30-day mortality 0 • Post-embol syndrome 15 • Transient impaired liver function 12

  32. Clinical Results • Transplanted patients 10 • Delay: 6.5 months (2-15) • Biliary complications:3 • Follow-up: 7.5 months • 1 recurrence at 5 m (40% necrosis) • Patients on waiting list 4 • Deaths 2 • Pneumonia • Terminal liver failure • Significant downstaging in 6/7 patients

  33. Results Imaging (EASL) • Complete 4(25%) • Partial 11(69%) • Residual peripheral enhancement 9 • Persistent enhanced nodules 4 • Stable Disease 1 • Progressive Disease 0 • Objective Response 15(94%)

  34. Histological Response

  35. Surgical Complications • Complicated arterial anastomosis 7 • Co/proper Hep. Art. occlusion 4 • Pedicular inflammation 3 • Early arterial occlusion…redo-OLT in 1 • Difficult biliary anastomosis 3 • Severe chronic cholecystitis 4

  36. First TACE session left lobe 46 yr old male: Bilobar HCC ( >7cm seg IV) Downstaging before LT

  37. Second TACE (right lobe) and control CT……waiting list 46 yr old male: Bilobar HCC ( >7cm seg IV) Downstaging before LT Repeated controls CT after first session

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