The Economic Club of Florida Tallahassee August 13, 2018 Nancy P Mendenhall, MD. The Promise of Protons

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1 The Economic Club of Florida Tallahassee August 13, 2018 Nancy P Mendenhall, MD The Promise of Protons

2 The Promise of Protons Cancer and radiation therapy The promise of protons UFHPTI: missions and operation The economic impact The future.

3 The Promise of Protons Cancer and Radiation

4 The Promise of Protons: Cancer & Radiation Cancer affects 1 in every 3 Americans Cancer is 2nd most common cause of death in the US

5 The Promise of Protons: Cancer & Radiation Standard Cancer Therapy Local Systemic Surgery Radiation Chemotherapy Hormonal & Targeted therapy Immunotherapy Cryosurgery, laser, & HIFU are local therapies used in certain settings. Radiation may be delivered with an external source (external beam therapy), an implanted or intracavitary source (brachytherapy), or an isotope (systemic)

6 The Promise of Protons: Cancer & Radiation Radiation used in ~50% of cancer patients Most is External Beam Radiation Therapy using a radiation source external to patient s body Most EBRT uses X rays (Photons) aka conventional radiation therapy Including cancers of the prostate, breast, lung, colorectum, brain, head & neck, female organs, male organs, urinary tract, lymphatic system, and children

7 The Promise of Protons The Promise of Protons

8 First Principles of Radiation Therapy Radiation Therapy is a nonspecific treatment Damages normal tissue as well as cancer Damage is dose-related and volume-related Dose distribution is key determinant of the patient s outcome

9 Percent Depth Dose Dose Distribution: Depth dose for X rays & Protons Depth dose comparison of 18 MV X-rays & Protons MV Photon (X ray) Proton Water-Equivalent Depth (g/cm 2 ) 18 MV Photon (X ray)

10 The Promise of Protons: Photons (X rays) X rays leave a track of damage like a bullet The dose decreases with depth of penetration There is a higher dose (red) along the entrance path than in the target, and more dose along the exit path Protons are particles with mass; they only penetrate the body according to the energy they are given They can be programmed to stop in the target (tumor) The entrance dose is much less and there is no exit dose

11 WHAT IS THE IMPACT OF RADIATION DOSE TO NORMAL TISSUE? Modeling Radiation Dosimetry to Predict Cognitive Outcomes in Pediatric Patients with CNS Embryonal Tumors Including Medulloblastoma Merchant et al, IJROBP Each Gy increased IQ decline THERE WAS NO DOSE THRESHOLD Merchant. Cancer J 15: Merchant et al. J Neurosurg 104: Merchant et al. Pediatr Blood Cancer 51: Merchant et al. J Clin Oncol 27:

12 Craniopharyngioma-Comparative Craniopharyngioma: IMRT Dose vs Distribution SRT vs PT IMRT:photons SBRT: photons Protons Mean Dose cgye IMRT STR PT % dec with PT body % brain % LTL % LH % Target Dose of 54 GyE CLINICAL DATA: ~850 pediatric brain tumors treated, including >100 craniopharyngiomas, pc Dr. Daniel Indelicato.. Collaboration with St. Jude Research Hospital, NHS, PPCR

13 Medulloblastoma: Craniospinal Axis Irradiation: Photons & 3DCRT Protons vs PT RATIONALE: Increased risk of 2 nd malignancy with dose 4 Gy (Travis et al, 2002, 2003, Tukenova, 2010) Increased risk of cardiac disease with doses 1Gy (Mulrooney 2009, Darby 2013). Dosimetry: courtesy of Z Li PhD, D Louis CMD. 36 Gy/CGE Mean Dose Cardiac IMRT Proton Mean Dose 20 1 CLINICAL DATA: Giantsoudi et al, IJROBP 95: 2016: 111 children, 5 y, similar disease control and acute toxicity to historical controls. anticipating less late effects.

14 Impact of Radiation on Ischemic Heart Disease in Breast Cancer DESPITE A SURVIVAL ADVANTAGE WITH with RADIATION in breast cancer. The rate of major cardiac events increased by 7.4% for each increase of 1 Gy in the mean RT dose to the heart Patients Darby S et al. Risk of Ischemic Heart Disease in Women after Radiotherapy for Breast Cancer. New England Journal of Medicine 2013; 368(11):987-98

15 Breast Cancer: IMRT and PT IMRT 3DPT Mean heart dose 5 Gy 1Gy Xu et al Can proton therapy improve the therapeutic ratio in breast cancer patients at risk for nodal disease? Am J Clin Oncol Bradley et al. Early Clinical Results

16 The Promise of Protons UFHPTI: The University of Florida Proton Therapy Institute Mission and Operation

17 University of Florida Proton Therapy Institute Mission With the compelling rationale for protons, UF decided to create a proton facility Missions Provide best patient care possible Conduct research into best indications and techniques for proton therapy Fiscal stewardship* Education *Funded by state grants, city loans, bonds, philanthropy

18 University of Florida Proton Therapy Institute: Operations 1st proton facility in Southeast US, opened in c3, Affiliated with University of Florida Mission of Patient Care and Proton Therapy Research >255K treatments to >7500 patients, >1500 children ~40 Prospective Clinical Trials and Studies ~98% of patients involved in outcome studies 150 staff including 11 subspecialty MDs, 11 PhD Physicists, and 12 engineers

19 Gainesville: University of Florida and College of Medicine (COM) Jacksonville: second UF COM campus and site of the UF Proton Therapy Institute Population ~ 1.3 m International air and sea ports Excellent interstate highways

20 UFHPTI Treatment Floor Eye Treatment Room Proton Area PET-CT Simulation Large Bore CT MR 230 MeV Cyclotron Photon Area

21 The Promise of Protons: Facility 440,000 lbs Cyclotron

22 The Promise of Protons: Facility

23 The Promise of Protons: Facility 3 Story - 200,000 lbs Gantry

24 The Promise of Protons: Facility Proton Treatment Room and Nozzle

25 The Promise of Protons: Clinical Operation Clinical Mission Daily >90 patients operating hours Prostate Breast Pediatrics Lung Lymphoma Pancreas Head & Neck Sarcoma Bone Eye

26

27 Current Expansion Project

28 The Promise of Protons: Expansion Expansion Fun Facts: ~11,000 Sq. Ft. project 172 tons (344K pounds) of steel rebar 210 trucks of high density concrete 8.8 million pounds of concrete

29 The Promise of Protons: Research Operation UFHPTI Research Mission 98% patient participation in in-house IRB approved Outcomes Tracking Protocol ~40% also in bench mark, optimization, comparative IRB approved studies ~40 clinical research trials/studies conducted Currently 18 open >130 publications to date in peer reviewed medical journals dealing with technical issues and clinical outcomes treatment

30 The Promise of Protons: Research Operation UFHPTI Research Mission Collaborations with St. Jude Pediatric Proton Cooperative Registry Proton Cooperative Group Mayo Clinic University of Pennsylvania PROSTQA Prostate Study Group Radiation Therapy Oncology Group/NRG Aarhus University Netherlands University of Groningen COMPPARE consortium First UFHPTI/UF federal funded research grant 2018

31 The Promise of Protons UFHPTI: The Economic Impact of UFHPTI

32 The Promise of Protons: Economic Impact Covered by Medicare and most major insurers The actual proton treatment takes 1-10 minutes Each treatment visit takes minutes Patients receive proton therapy daily for 6-8 weeks after a 1-2 week planning interval ~900 patients are evaluated for protons each year ~3000 physical followup visits annually

33 The Promise of Protons: Economic Impact Initial capital investment = $125 million* Current expansion / equipment upgrade project = $44 million Total employees = 193 FTEs [152 (UFHPTI) + 26(UF) +15(IBA)] Total annual operating budget = ~$46.1 million *State grants, city loans, bonds, philanthropy

34 The Promise of Protons: Economic Impact ~60% of patients travel >60 miles All US states & 32 countries including: U.K. Canada Australia Norway Peru Saudi Arabia Hong Kong Mainland China

35 The Promise of Protons: Economic Impact Patients typically in JAX for 2-3 months >100 short-term housing options are currently offered on our web site Estimated average ~$5,500/person spent by non-local patients for food, housing, transportation and entertainment Estimated non-medical expenditures >$25 million since 2006

36 The Promise of Protons: Research Economics Research Mission is critically important to patients, institution, society Answers questions of best indications and techniques for proton therapy UFHPTI is not only a clinical, but also a research leader in proton therapy UFHPTI Research to date has been funded by operating revenue, philanthropy, state and regional grants ($2m per year)

37 PCa: IMRT and PT Dose Distribution Obvious difference in radiation dose distribution between IMRT and Protons in Prostate Cancer: Does it make a difference?

38 Observations from UFHPTI published prostate cancer trials/studies & published IMRT results on disease control (PSA) Mind the Gap!!!

39 The Promise of Protons: Research Economics Results from UFHPT prostate cancer trials provided the basis for a federally funded national clinical trial, COMPPARE, which will compare outcomes of 3000 men treated for prostate cancer with IMRT vs Protons 44 institutions, UF leadership, funding by PCORI ($11.9m over 5 years)

40 The Promise of Protons The Future..

41 The Promise of Protons: The Future With the compelling rationale and first decade of clinical, research, and operational results, we believe the future is bright More clinical expansion, enhanced technology, more research to probe the limits of the Promise of Protons.

42 University of Florida Health Proton Therapy Institute

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