COMPARING Y90 DEVICES William S Rilling MD, FSIR Professor of Radiology and Surgery Director, Vascular and Interventional Radiology Medical College of Wisconsin
DISCLOSURES Research support : Siemens, Biocompatibles Consultant B Braun Vascular, Bayer, Nordion, Cook Advisory board : Navilyst, DBO innovations Will be discussing off label use
Y90 RADIOEMBOLIZATION Critical differences from TACE Requires more advanced case planning Even more critical to identify anatomic variants Less flexibility in technique No or little visual feedback during administration Effects of day of treatment ( number of spheres/dose )
BILOBAR DISEASE : TYPICAL TREATMENT ALGORITHM Clinic visit Hepatic angiogram, MAA shunt study, possible embolization of extrahepatic vessels 3D lobar liver volume calculations Dose calculation, device ordered Y90 administration to lobe with dominant disease Clinic, labs @ 1 month Dose calculation other lobe Y90 administration to remaining lobe 1 month post imaging, clinic, labs
LOGISTICS: Y90 VS TACE Y90 Consult, clinic visit Determine device and HDE,IDE,CU status Obtain IRB/FDA approval for CU Liver volumes Shunt study/embo Shunt analysis and calculations Dose calculations Procedure scheduling Dose ordering Insurance pre- authorization Dose calibration pre-and post Treatment Ave delay from consult to treat: 14-21 days TACE Consult, clinic visit Insurance pre-certification Treatment Ave delay from consult to treatment: 7 days
Y90 DEVICES TheraSphere MDS Nordion, Canada Glass Yttrium-90 Size = 25 microns doses = 3-20 GBq # spheres/tx = 1.2-8 mil Specific grav = >2 US FDA HCC approved Dec 1999 SIR-Spheres Sydney, Australia Resin Yttrium-90 Size = 35 microns dose = 3 GBq # spheres/tx = 40-80 million Specific grav = < 1.8 US FDA colorectal approved March 2002
Implantation Procedure: Start IR works B line, AU Works D line Spheres delivered in multiple small aliquots over 20 minutes B line - IR D line - AU
TheraSphere System Ready for Assembly
IDEAL Y90 DEVICE Reproducible, patient specific dosimetry Easy to order, schedule cases Customize particle load Simple dose calibration Easy to divide doses Safe for personnel handling Simple, complete administration Visual feedback during administration Simple disposal
Dis/advantages TheraSphere/Sirspheres TheraSphere Pros: Not embolic, minimal toxicity Can use in portal vein thrombosis or compression Simple dosimetry Shelf-life 14 days Can retreat Independent of tumor burden SIR-Spheres Pros: X-ray guidance Can fractionate dose better suspension, coverage Dependent on tumor burden Lower dose, allows fractionation Courtesy R Salem
Yttruim-90 Radioembolization: Is Routine Prophylactic Embolization of Extrahepatic Vessels Necessary? William S. Rilling, MD; Melissa J. Neisen, MD; Robert A. Heib, MD; Eric J. Hohenwalter, MD; Sean M. Tutton, MD Medical College of Wisconsin Affiliated Hospitals March 5, 2007
Falciform Artery Embolization HCC Segment 4 Coil embolization of falciform artery
GDA Embolization Ocular melanoma Segment 4 Coil embolization GDA
CHOOSING A DEVICE Availability Operator Familiarity Data Approval status Reimbursement Institutional politics Clinical trial availability Tumor burden Tumor vascularity Arterial anatomy Previous therapy Hepatic reserve
REGULATORY AND REIMBURSEMENT STATUS Reimbursement status variable Both companies have resources to help Institutional response to regulatory staus is variable Medicare patients sign ABN for TS at MCW
CUSTOMIZING THERAPY Tumor coverage : treatment day, device selection Segmental or subsegmental treatment Divided doses : avoiding non target vessels, forcing distribution into target segments Fewer particles in higher risk patients ( PVT, hepatofugal flow, biliary colonization,etc )
PRE Y90 CASE 3 Define ROI #1 in normal liver tissue Define ROI #2 & #3 to be in tumors Filled ROIs to examine the ROI curves Rilling W et al SIR 2010
Decay Graph ~8 million microspheres/dose ~6 million microspheres/dose ~4 million microspheres/dose ~2.8 million microspheres/dose ~2 million microspheres/dose ~1.2 million microspheres/dose 64.2 hrs
LIVER DAMAGE FROM CHEMOTHERAPY 406 patients with CRC mets resected 158 no chemo 248 neoadjuvant chemo 16 week median duration Irinotecan based 23% Oxaliplatin based 20% 8% steatohepatits, significantly associated with irinotecan exposure (OR 5.4) 90 d mortality 14.7% with steatohepatitis vs 1.6% overall (OR 10.5) Vauthey et al J Clin Oncol 2006
HIGH RISK ANATOMY
61 y.o, salvage Rx for CRC mets
SUMMARY The ideal RE device does not exist TS and SS have important differences Choice of device is complex With two devices and companies working in this field, IO physicians and patients have benefitted