DC BeadM1 TM in hepatocellular carcinoma and metastatic colorectal cancer

Transkript

1 Krankenhaus Barmherzige Brüder DC BeadM1 TM in hepatocellular carcinoma and metastatic colorectal cancer PD Dr. med. Tobias F. Jakobs Department of Diagnostic and Interventional Radiology Hospital Barmherzige Brueder - Munich tobias.jakobs@barmherzige-muenchen.de consultant to Biocompatibles UK Ltd, A BTG International group company Krankenhaus Barmherzige Brüder PD Dr. med. Tobias F Jakobs tobias.jakobs@barmherzige-muenchen.de

2 peak for DC Bead in day 3 DC Bead and DC BeadM1 are manufactured by Biocompatibles UK Ltd, Chapman House, Farnham Business Park, Weydon Lane, Farnham, Surrey GU9 8QL, UK. DC Bead and DC BeadM1 are trademarks and/or registered trademarks of Biocompatibles UK Ltd. Biocompatibles UK Ltd is a BTG International group company

3 DC Bead TACE

4 Krankenhaus Barmherzige Brüder PRECISION V

5 DC Bead TACE: Response after 6 months - all patients Krankenhaus Barmherzige Brüder Cave: relatively big beads ( / ) Lammer et al., Cardiovasc Intervent Radiol 2010

6 DC Bead TACE: response after 6m - advanced disease Krankenhaus Barmherzige Brüder Lammer et al., Cardiovasc Intervent Radiol 2010

7 beads and microspheres Krankenhaus Barmherzige Brüder tumor vessels: μm

8 biliary sequela Krankenhaus Barmherzige Brüder tumor bile duct artery vein theory: bigger beads get stuck in the pretumoral arteries - elute their drug in high concentration directly to the bile duct - potential reason for biliary complications!?!

9 indications Krankenhaus Barmherzige Brüder DC Bead M1 is primarily intended as an embolic agent to treat vessels supplying malignant colorectal cancer metastasised to the liver (mcrc). DC Bead M1 is compatible with irinotecan, which can be loaded prior to embolisation and then, as a secondary action, elute a local, controlled and sustained dose to the mcrc after embolisation. DC Bead M1 is primarily intended as an embolic agent for the treatment of malignant hypervascularised tumour(s). DC Bead M1 is compatible with doxorubicin, which can be loaded prior to embolisation and then, as a secondary action, elute a local, controlled and sustained dose to the tumour after embolisation.

10 Frequency size distribution Krankenhaus Barmherzige Brüder DC Bead um DC Bead M1 DC Bead M1 with dox DC Bead M1 with iri Range (µm) DC Bead M1 has a narrower distribution than DC Bead um DC Bead M1 reduces in size by 20-30% when loaded with irinotecan and doxorubicin

11 kidney model Krankenhaus Barmherzige Brüder µm beads penetrate more distally in the vasculature may allow delivery of greater volume of beads and drug intratumourally and lead to greater intratumoural devascularisation pulmonary shunting? absesses? and µm beads are displayed with consistent scaling Dreher MR et al. Radiopaque Drug-Eluting Beads for Transcatheter Embolotherapy: Experimental Study of Drug Penetration and Coverage in Swine. J Vasc Interv Radiol 23 (2012):

12 doxorubicin concentration (VX2) Krankenhaus Barmherzige Brüder more drug delivered to the tumour core and around the tumour periphery with DC Bead M1 may lead to increased efficacy p=0.1 DC Bead M1 DC Bead p=0.05 Tumour Core Tumour Periphery p=0.005 Overall, mean tumour doxorubicin concentration in the DC Bead M1 (70-150µm) group was significantly higher than in the DC Bead µm group (p=0.005) Geschwind J et al. Doxorbicin Eluting Bead Sizes µm and µm in the VX2 Model. Presented at ECIO 2012 (Terumo Symposium)

13 Krankenhaus Barmherzige Brüder defining endpoints

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15 Krankenhaus Barmherzige Brüder Case - HCC

16 Krankenhaus Barmherzige Brüder Case - CRC

17 Krankenhaus Barmherzige Brüder Case - HCC

18 Krankenhaus Barmherzige Brüder DC Beads M1 and iflow

19 Case - CRC Krankenhaus Barmherzige Brüder 4 months

20 Summary M1 Krankenhaus Barmherzige Brüder DC Bead M1 has similar loading and elution characteristics to DC Bead Animal models confirmed DC Bead M1 ability to deliver beads more distally (Kidney model) 1 with more drug delivered to the core and periphery of the tumour (VX2) 2 these results may allow the following: more concentrated drug delivery with in the tumor and greater tumoral devascularization may allow to be more selective and target only the vessels feeding the tumor and therefore protect the healthy liver and reduce stress to cirrhotic/previously treated liver and / or bile ducts effective at penetrating metastatic tumors and avoiding premature proximal occlusion of tumor-feeding vessels. 1 Drug-eluting beads for transcatheter embolotherapy: experimental study of drug penetration and coverage in swine. J Vasc Interv Radiol Feb; 23(2): Eluting Bead Sizes μm and μm in the VX2 Model. Presented at ECIO 2012 (Terumo symposium)

21 Thank You!