Delcath Systems, Inc. · NASDAQ:DCTH
Delcath Systems — Technical Presentation (2012)
20 slides from Delcath Systems's technical presentation, 2012
Slide 1: Chemosaturation Using Percutaneous Hepatic Perfusion: Pre-Embolization of GI Branches
Chemosaturation Using Percutaneous Hepatic Perfusion: Pre-Embolization of GI Branches in a Phase 3 Clinical Trial Fred M. Moeslein, MD, PhD1 & Charles Nutting, MD2 1. University of Maryland School of Medicine Baltimore, MD 2. Swedish Medical Center, Englewood, CO
Slide 2: Disclosures
DISCLOSURES Chemosaturation is not FDA approved. It is currently performed only under IDE/HDE. FDA approval is currently pending. FM & CN — Delcath Consultants and prior Honorariums
Slide 3: Chemosaturation – The Concept
Chemosaturation – The Concept
Slide 4: Chemosaturation Using the PHP System
Chemosaturation Using the PHP System Isolation Saturation Filtration
Slide 5: Chemosaturation
Chemosaturation • IVC venogram • Back filling of hepatic veins • Left usually does not fill • No leak around cranial balloon into right atrium
Slide 6: Melphalan Dosing
Melphalan Dosing Multiple myeloma 0.25 mg/kg1 Chemoembolization 0.62 mg/kg (25 mg/m2)2 Isolated hepatic perfusion 1.5 mg/kg3 Percutaneous hepatic 3.0 mg/kg perfusion Myeloablation 2.5-3.5 mg/kg (100-140 mg/m2)1
Slide 7: Pingpank et al., ASCO 2010
Authors: JF Pingpank, MS Hughes, HR Alexander, MB Faries, JS Zager, RE Royal, ED Whitman, CW Nutting, GP Siskin, SS Agarwala June 5, 2010 ASCO Chicago, Illinois
Slide 8: Phase III Random-Assignment PHP vs. BAC
Phase III Random-Assignment PHP vs. BAC Accrual goal: 92 patients (Cross-over at Hepatic progression) 10 Institutions Melphalan dose: 3.0 mg/kg Primary endpoint: Hepatic PFS Secondary endpoints: Response rates, DFS with best available therapy Response rates for patients treated with PHP
Slide 9: Treatment Schema
Treatment Schema On Study Evaluation/Randomization Post Treatment Follow-up Interval Evaluation (Baseline, 6-weeks, 12 weeks, 20 weeks, 28 weeks, 36 weeks) Treatments 1 through 6 - Melphalan - Angiogram (Celiac, SMA) - GDA assessment (Treatment #1) 4-5 Weeks 4-5 Weeks 4-5 Weeks 4-5 Weeks 4-5 Weeks 4
Slide 10: Melphalan GI Toxicity
Melphalan GI Toxicity • The GI tract is extremely sensitive to melphalan • Exposure results: • Ulceration/perforation • Gastritis • Diarrhea
Slide 11: Arterial Isolation
Arterial Isolation • Pre-treatment Collateral Vessel assessment and embolization • Goals • Protect Extrahepatic GI structures • Simplify CS administration
Slide 12: Results: Vessels Embolized
Results: Vessels Embolized (18) (2) (5) (11) (8) (70) Patients (%)
Slide 13: Results: Number of Embolizations
Results: Number of Embolizations (66) Patients (%) (18) (16)
Slide 14: Results: Embolization Cycle
Results: Embolization Cycle Patients (%)
Slide 15: Hepatic Arterial Redistribution
Hepatic Arterial Redistribution Left Hepatic? GDA Right Gastric
Slide 16: Hepatic Arterial Redistribution
Hepatic Arterial Redistribution Left Hepatic GDA Right Gastric
Slide 17: Treatment Associated Toxicities
Treatment Associated Toxicities Angiographic Complications Coil migration 1 pt (1.5%) GI Toxicities Gastric Ulcer/Perforation 1 pt (1.5%)
Slide 18: Conclusions
Conclusions • Hepatic arterial mapping with collateral arterial embolization is essential prior to CS-PHP • The most commonly embolized vessels are the GDA, RGA, and LGA branches • Dedicated pre-treatment angiography essential to locate and eliminate “new” collateral vessels if they arise prior to r
Slide 19: Recommendations
Recommendations • Pre-CS Hepatic Mapping should be performed 1-2 weeks prior to planned initial CS treatment • Hepatic Arterial Redistribution simplifies CS treatment and should be utilized when feasible • *Highly recommend complete extrahepatic collateral embolization* • GDA • RGA Y90 Experience •
Slide 20: Thank You!
Thank You! Contact Info: Fred M. Moeslein, MD, PhD Assistant Professor of Radiology University of Maryland School of Medicine Department of Radiology Baltimore, MD 21231 [email protected]