Pancreatic Cancer: ChemoembolizationUsing A Double Balloon CatheterJacob Cynamon, MDMontefiore Medical Center/ AECOMDivision of VIR2016

Disclosures Post Market Registry Investigator

Adenocarcinoma of the Pancreas 54, 000 cases of pancreatic adenocarcinoma per year in US Only potential cure: resectionPancreatic Cancer Stages:Stage 2Stage 3Stage 4Not spread to vessels or lymph nodes)(Spread to vessels and/or lymph nodes, but notother parts of body)Spread to other parts of the body15% - “Resectable”35% LAPC50% Metastatic Primary reason Locally Advanced Pancreatic Cancer (LAPC) not resectable:tumor involvement of celiac axis and SMA; can not get clean margin with resection Systemic gemcitabine is only guideline driven treatment with Class 1 evidence benefit; other treatmentregimen extrapolated from studies of patients with stage 4 disease Therefore, LAPC patients undergo a potpourri of treatment options: systemic gemcitabine, combinationchemo, chemo-radiation, research protocol, etc.

Can TACE Benefit these patients?Several studies, including meta analysis withthe use of gemcitabine, have shown promiseOpportunities:Familiar AnatomyChallenges: can not identify orengage tumor feeder vessels

04:000:04:150:04:300:04:450:05:00Pressure (mmHG)Potential Solution:Pressure over Time70605040 catheter insplenic artery302010first balloon up0start infusionsecond balloon upTime

Tumor HeadCommon Hepatic ArterySMACommon Hepatic ArterySMARenovoCath BalloonsRenovoCath Balloons

66 y/o MPancreatic CAPost Systemic ChemoContinued growth

4 Treatments: Hepatic, SMA, Hepatic, SMA

Infuse 100-120 cc at 6cc/Min

Technical Considerations when using RenovoCath 6 Fr Guiding Sheath must be advanced into Celiac or SMA RenovoRx Catheter is compatible with 0.014 wire Acute angled SMA may be difficult to access with routine techniques Working length 76-86 cm. (RA access is not feasible) Morph Catheter can be extremely helpful

Use of a Morph Catheter

Clinical Response with RenovoCath TACE vs. Historical ControlAdenocarcinoma of the Pancreas10.90.865% survival0.7Survival (%)0.651% survival0.50.437% Survival*0.30.2RenovoCath completing 8 treatments – Average 5.75g/m2 of Gemcitabine (n 9)RenovoCath greater than 2 treatments – Average 4.4g/m2 of Gemcitabine (n 15)0.1Systemic Intravenous Gemcitabine – Average 6.8g/m2 (n 44) *0050100150200250300350400450Days post Initial Diagnosis† Jiang X, Galettix P, Links M et al. Population pharmacokinetics of gemcitabine and its metabolite in patients withcancer: effect of oxaliplatin and infusion rate. British Journal of Clinical Pharmacology; 65:326-333*Chauffert B, Mornex F, Bonnetain F et al. Phase III trial comparing intensive induction chemoradiotherapy. AnnOncol 2008; 19:1592-9

Post-Market RegistryA Multi-Center, Post-Marketing, Prospective, Observational StudyFollowing Treatment with Intra-Arterial Delivery ofChemotherapeutic Agents Using the RenovoCath Catheter Up to 10 US centers Up to 100 patients Launched January 2016 5 centers recruiting Additional centers in process16

Conclusions Intra-arterial gemcitabine can be given to patients with pancreaticcancer using localized delivery via RenovoCath Catheter withacceptable safety profile There is less Systemic side effects of gemcitabine as assessed byhematologic markers, using RenovoCath localized delivery There appears to be survival benefits in patients receiving localizedgemcitabine especially if they complete a full course of therapy Post Market registry data will be extremely important for theadaptation of this mode of therapy