Interventional Oncology: Current Status and Future Directions

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1 Interventional Oncology: Current Status and Future Directions Ripal T. Gandhi, MD, FSIR, FSVM Miami Cardiac & Vascular Institute Miami Cancer Institute Associate Clinical Professor, FIU Herbert Wertheim College of Medicine Associate Clinical Professor, USF School of Medicine 1

2 Objectives History of Interventional Oncology at MCVI Development of Miami Cancer Institute Procedure Volumes Research Future Directions Miami Cancer Institute Grand Opening: January 16,

3 Miami Cancer Institute Statistics MCI is a free standing, state-of-the art facility which provides all outpatient cancer services under one room $430 million center 440,000 square feet Clinical care wing: 305,000 square feet Research wing: 140,000 square feet 113 patient friendly exam rooms Currently seeing up to 1000 patients per day Currently 1200 FTE s Miami Cancer Institute Info MCI is not a consolidation of cancer services, but a massive expansion of personnel, facilities, and capabilities MCI is one of the 4 members of the Memorial-Sloan Kettering Cancer Alliance Combined Tumor Board/DMT Meetings Access to Sloan-Kettering Clinical Trials Combining best of academics with best of community oncology practice 60 infusion rooms / 8 infusion beds Multi-media conference and meeting rooms 3

4 4 Pillars of the Miami Cancer Institute Medical Oncology Statistics Patient Statistics - Oncology 5200 unique cancer patients in FY patients on schedule for FY 2018 Patient Statistics Hematology 4200 benign hematology consults 4000 benign other than hematology consults 4

5 Medical Oncology Medical (sub-specialized) and Pediatric Oncology, including a state of the art adult infusion suite and pediatric infusionarium Autologous and allogeneic stem cell transplantation Clinical Trials, including a Phase I unit Genomic Medicine Breast Center Symptom Management and Palliative Medicine Center Integrative Medicine Herbal therapy and dietary supplement consultations Acupuncture, massage therapy, art/music therapy, yoga, tai chi Navigation, Survivorship Cardio-Oncology, Onco-Fertility Radiation Oncology Aruably most technologically advanced radiation oncology department in the US Only proton therapy center in south Florida 2 nd center in the United States to treat with MRIdian Linac (MR is acquired continuously during treatment) 7 state-of-the-art photon therapy machines Team 11 Radiation Oncologists 19 Physicists, 12 Dosimetrists, >40 Therapists Daily Operations ~ pt. treatments per day (external beam/protons) 2-5 treatments per day (High dose rate brachytherapy) 5

6 Comprehensive technology under one roof.. Comprehensive Technology Under One Roof Varian TrueBeam CyberKnife M6 Radixact GammaKnife Icon ViewRay MRIdian Linac Prostate Seed Brachytherapy High Dose Rate Brachytherapy Zevalin, Xofigo, I-131, TBI, TSET, SpaceOAR rectal spacer, GRID, hyperthermia (coming soon) IBA Proton Therapy Comprehensive technology FY 2018 Total Radiotherapy Treatments under one roof.. 6

7 Surgical Oncology Multiple surgical centers of excellence, staffed by sub-specialty cancer surgeons only Recruitment of Renowned Surgeons Horacio Asbun Chief of Pancreatic and Hepatobiliary Surgery (from Mayo Clinic) Murugesan Manoharan Chief of Urologic Oncologic Surgery (from Univ of Miami) Geoffrey Young Chief of Head and Neck Surgery (from Mayo Clinic) Robert Udelsman - Chief of Endocrine Surgery (from Yale) Surgical Volumes rapidly increasing Interventional Oncology - VISION GOAL: Building a world class all encompassing comprehensive IO program at Baptist health 7

8 Interventional Oncology Chemoembolization Conventional TACE Drug Eluting Bead TACE Yttrium-90 Radioembolization Resin radiomicrospheres (SIR-spheres) Glass radiomicrospheres (Theraspheres) Ablation Technology Radiofrequency Ablation (Angiodynamics) Microwave (Neuwave, Medtronic, Angiodynamics) Cryoablation (Galil, Endocare) IRE Nanoknife (Angiodynamics) Govindarajan ( Raj ) Narayanan Chief of Interventional Oncology Previously founding chair of interventional radiology at University of Miami Pioneer and world authority on irreversible electroporation Founder and course director for Synergy and Spectrum meetings His published work on Percutaneous IRE of the pancreas was honored as a distinguished study of the year at the 2018 SIR Annual meeting Has published numerous articles and speaks regularly at national and international conferences 8

9 Interventional Oncology - VISION Looking Inside & Out IO Looking Inside Increased IO education curriculum Expansion of IO treatment options offered Outpatient vs Inpatient Outreach within the institution and satellites Education courses Funded Research Publications and basic sciences research 9

10 IO Looking Out Community outreach Baptist International team Marketing Practice building Philanthropy IO Patient Volumes 10

11 Increasing Y90 Treatment Volumes Annual Y90 Volumes Projected Monthly Y90 Volume

12 Irreversible Electroporation (IRE) Obtained IRE Nanoknife Device in June 2018 Technique that increases the permeability of cell membranes by changing the transmembrane potential resulting in disruption of the cell membrane Electroporation Intact Cell Membrane Application of short pulse high voltage DC current Disruption of Cell Membrane IRE Treatment Volumes IRE Volumes June August September 12

13 HCC 2.8cm Near Portal Vein Irreversible Electroporation (IRE) 13

14 Irreversible Electroporation (IRE) PRE TREATMENT 1MONTH POST 14

15 Current IO Clinical Trials Radiation-Emitting Selective Internal Radiation-Spheres in Non-Resectable (RESIN) Liver Tumor Study Trans (Intra)-arterial Gemcitabine vs. Continuation of IV Gemcitabine and Nab-Paclitaxel following Radiotherapy for Locally Advanced Pancreatic Cancer (TIGeR-PaC Randomized Clinical Trial) Accuracy of Simple Visual Estimation in Assessment of Hepatic Volumes and Tumor Infiltration in Dose Calculation for Yttrium-90 Radioembolization A Clinical Study to Survey the Experience and Acceptability by Physicians using BTG (LC Beam LUMI) for Embolization Procedures Multicenter Study Evaluating the Safety of Yttrium-90 Radioembolization in Patients with Previous Biliary Intervention: Analysis of Hepatobiliary Infections RESIN Study Radiation-Emitting Selective Internal Radiation-Spheres in Non-Resectable (RESIN) Liver Tumor Study RESiN is a national, multicenter study that is enrolling patients with primary or secondary liver cancer receiving Y90 It is a real world evidence study with the goal is to collect real-world data, including rare tumors which are difficult to study in a randomized clinical trial Goal is to enroll 3,000 patients (over 1100 patients enrolled nationwide thus far) We are the 3 rd leading enrolling site of over 50 sites 15

16 TIGeR-PaC Randomized Clinical Trial Trans (Intra)-arterial Gemcitabine vs. Continuation of IV Gemcitabine and Nab- Paclitaxel following Radiotherapy for Locally Advanced Pancreatic Cancer (TIGeR-PaC Randomized Clinical Trial) Prospective multicenter randomized clinical Trial evaluating systemic therapy versus intraarterial gemcitabine for pancreatic cancer Primary Objective: Overall Survival from time of randomization Secondary Objectives: PFS, objective response rate, duration of response, HR-QOL, degree of peripheral neuropathy, incidence of neutropenia, tolerability, and safety Inclusion Criteria: 1. Histologically confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent 2. Locally advanced, unresectable disease, as defined by NCCN Guidelines TIGeR-PaC Randomized Clinical Trial 32 16

17 Future IO Clinical Trials Investigation of a Novel Imaging Approach for Selective Internal Radiation Therapy (SIRT) to Improve Dose Calculation Accuracy and Evaluate Dosimetric Correlation with Clinical Outcomes Irreversible Electroporation (IRE) in the Management of Locally Advanced Pancreatic Cancer Irreversible Electroporation(IRE) versus Radiotherapy for Locally Advanced Pancreatic Cancer Safety and Efficacy of Combined Radioembolization and Immunotherapy in Patients with Metastatic Colorectal Cancer IO Related Training Programs at MCVI Yttrium-90 Radioembolization Training Course Proctor led preceptorship with live case observation Didactic lectures Case Reviews TransRadial Access Course Cadaver lab Didactic lectures Live case/pre-recorded case observation Coming Soon: Irreversible Electroporation (Nanoknife) Training Course Live case observation Didactic lectures 17

18 CIO Symposium on Clinical Interventional Oncology Founded at MCVI, now in it s 11 th year Practical program renowned for its originality, patient-care focus, and dynamic learning format CIO highlights the most viable and sought-after treatments in clinical interventional oncology, delivers a preview of new developments, and provides practical pearls in this rapidly growing practice area Moving as a stand alone meeting separate from ISET in 2019 October Eden Roc Hotel in Miami Beach, FL Conclusions Interventional Oncology has developed into one of the 4 pillars of cancer care With the development of the Miami Cancer Institute, we are at the infancy of potential significant growth in the IO Space The vision and goal is to become a world class center of excellence in interventional oncology though clinical care, state of the art technology, research, and education 18

19 Thank You! Thank You! 19

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