Proton Beam Radiation Therapy. Disclosures. Equity Holder - Procure Proton Therapy Center of Oklahoma

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1 Proton Beam Radiation Therapy Disclosures Equity Holder - Procure Proton Therapy Center of Oklahoma

4 2D Treatment Planning

8 Therapeutic Ratio: TCP/NTCP Tumor control probability (TCP) Higher radiation dose to the target volume means greater likelihood of tumor control Normal tissue complications probability (NTCP) Less dose to normal tissue means fewer acute and long term side effects Opportunity for radiation or chemotherapy dose intensification

12 Evolution of Radiation Therapy Improvements in radiation dose distribution 6x Parallel opposed fields 3D 5 fields IMRT 9 fields Protons 4 field x-rays x-rays x-rays proton s tumor

13 What is Proton Radiation? How is it different from X-rays and IMRT?

14 Tumor

15 High End Image Guidance with Linear Accelerators

16 High End Image Guidance with Linear Accelerators These are all the same they have 6 MV X-Rays

19 Relative Dose (%) The Physics of Protons In order to deliver the same dose to the tumor, x-rays must deliver a greater dose outside the target than protons do 300 Depth dose curves for protons and x-rays 250 X-rays Additional dose outside the target delivered with x-rays Protons Tumor Depth in Body (mm)

The Value of Protons Protons are physically superior to X-rays Protons behave differently than x-rays: Protons X-Rays do not Protons improve the therapeutic ratio maximizing tumor control while

20 The Value of Protons Protons are physically superior to X-rays Protons behave differently than x-rays: Protons X-Rays do not Protons improve the therapeutic ratio maximizing tumor control while minimizing side effects At a given radiation dose to a tumor protons deliver, on average, less than half the radiation dose to normal tissues than do x-rays 1 20 (1) Jay Loeffler, Massachusetts General Hospital, Proton Therapy 2009

21 Cranio-Spinal Irradiation

22 Decreased Heart Dose with P+

23 Decreased GI Dose with P+

24 Decreased Ovarian Dose with P+

25 CSI Therpeutic Ratio Same Dose = Same TCP Decreased Normal Tissue Complication Probability Increased TR Less dose to critical structures Heart, GI tract, ovaries/testes Less need for antiemetics Less need for blood transfusions

26 Evidence of Distal Range Stopping Before treatment Treatment plan After treatment

28 Relative Dose SOBPs for different Energies/Ranges 100 R50=70 R50=96 R50 =146 R50=193 R50= Depth in water (mm)

29 The Most Advanced Proton Therapy Center

33 April 10, OKC Group

34 Gantry Construction of the

38 Replacing some Gantries with Dual fixed beam (Inclined + Horizontal) Beam Delivery The ProCure Systems. Dual Beam System April 10, OKC Group

40 Spot Scanning Principle Single Spot Pictures - With compliments from PSI Few Spots Total Picture

Protons are Most Beneficial When Critical Structures Must Be Spared High Radiation X-ray Protons

(colored area indicates radiation exposure) With proton therapy, less healthy tissue is exposed

treated to 60 Gy. Assumes dental x-ray is 0.

45 Protons are Most Beneficial When Critical Structures Must Be Spared High Radiation X-ray Protons Tumor Tumor Low Radiation With x-ray radiation, more healthy tissues is exposed to radiation (colored area indicates radiation exposure) With proton therapy, less healthy tissue is exposed to radiation (grey/white area indicates no radiation exposure) Note: Glioma (Brain tumor) treated to 60 Gy. Assumes dental x-ray is Gy Source of treatment plans: ProCure Training and Development Center and Dr. S Keole (1) Jay Loeffler, Massachusetts General Hospital, Proton Therapy 2009

46 Normal Tissue Dose Constraints Optic Pathway: D < 62 Gy(RBE) Brain stem: surface: D < 67 Gy(RBE) chiasm center: D < 55 Gy(RBE) brainst em

48 Why Protons for Paraspinal Sites? Increased TCP Increased dose No reductions Decreased NTCP Decreased dose to critical structures Kidneys Lungs Heart Blood vessels GI tract More dose and better tolerance of therapy

49 Paraspinal Ewing s Sarcoma: A Case Comparison A teenage football player ignoring a right back bruise for 4 months Diagnosis: Paraspinal Ewing s Sarcoma Treatment per COG protocol: 42 weeks of 5 drug chemotherapy RT to primary site for local control

50 Diagnosis Nearly Identical Location and GTV

51 10% 50% Larger PTV needed for IMRT R Kidney

52 18 months post-rt

53 Renal Function of Patient Treated with IMRT Date BUN Creatinine 12/ /06 4/06: RT (1.2 Gy BID 55.2 Gy) 7/ / / / Patient is currently being followed by nephrology service

54 Questions

55 So What About Prostate Cancer? (The elephant in the room)

56 Executive Summary Prostate cancer in over-treated in the United States

57 Executive Summary Prostate cancer in over-treated in the United States Prostate cancer in over-treated in the United States

58 Executive Summary Prostate cancer in over-treated in the United States Prostate cancer in over-treated in the United States Prostate cancer in over-treated in the United States

59 Executive Summary Radiation therapy options include brachytherapy (BT) external beam radiation therapy (EBRT) Brachytherapy is vastly underutilized Effective Safe (in the appropriately selected patients) Convenient (1 to 2 day procedure) Proton beam is superior to IMRT Higher cure rates Lower complication rates

60 Where do protons fit in?

61 Definitive Therapy Surgery Brachytherapy External- Beam Radiation Open Laparoscopic (Da Vinci) Low-Dose Rate High-Dose Rate X-Ray (IMRT) Proton Beam But, don t forget about active surveillance!

62 Misconceptions About Proton Therapy Just because someone keeps saying it doesn t make it true. The typical quote: There is no data showing protons have better control rates FACT: Protons do have better control By definition, protons will never have worse control rates than x-rays The typical quote: There is no data showing that side effects and complications ( toxicity ) are lower with protons FACT: At a similar treatment dose, the toxicity is lower with protons The typical quote: Protons are 2x to 5x times more expensive than IMRT FACT: Protons are at most 40% 60% more than IMRT, based on Medicare, and offer a much better value The lifetime costs of protons are much less than IMRT 62 Patient access must not be based on misconceptions. We must rely on science and data to drive these decisions.

63 Why Protons for Prostate Cancer? Increase Dose TCP CGE in 2 CGE fractions 70 CGE in 2.5 CGE fractions Decrease NTCP Rectum 59% less dose Bladder 35% less dose Pelvis - ~ 60% less dose

2-field DS Higher dose bath to healthy tissue with IMRT: Pelvis, rectum and bladder Tumor Less healthy tissue exposed to radiation compared to

64 Radiation Therapy Plans for Prostate Cancer Direct Radiation Complications Never Occur In Unirridiated Tissues Dr. Herman Suit 1 IMRT irradiates more healthy tissue IMRT - 7-field co-planer Blue 13% Green 51% Purple 63% Yellow 76% Red 95% Proton Therapy - 2-field DS Higher dose bath to healthy tissue with IMRT: Pelvis, rectum and bladder Tumor Less healthy tissue exposed to radiation compared to IMRT (1) Herman Suit, The Grey Lecture 2001: Coming Technological Advances in Radiation Oncology, International Journal of Radiation Oncology Biology Physics 53 No. 4 (2002):

65 Protons decrease Rectal Dose in Prostate Cancer

66 Volume Rectum Rectum IMRT - MSK 3D CRT - MSK The limit of the photon modality IMRT - UFPTI Proton - UFPTI Dose Adapted from Zelefsky 2000 and Vargas 2008

68 PROG: Proton-photon trial PSA-Failure free survival corrected calculation (JAMA 299, 2008) 92% PSA- FFS 68

69 Dose Escalation Trials Support Protons for Prostate Cancer Protons offer better control and lower toxicity than X-Rays Randomized Boost Planning High 5-year GI toxicity trial 1-4 Modality Technique dose arm control G2 G3 MD Anderson X-rays 2-D/3-D 78.0 Gy 78% 28% 10% CKVO96-10 X-rays 3-D 78.0 Gy 64% 32% 5% MRC RT01 X-rays 3-D 74.0 Gy 71% 33% 10% PROG Protons 3-D 79.2 Gy 92% 17% 1% The best outcome for control AND toxicity was achieved using protons (1) DA Kuban, SL Tucker, L Dong et al., Long-term results of the M.D. Anderson randomized dose-escalation trial for prostate cancer, International Journal of Radiation Oncology Biology Physics 70 (2008): (Note: toxicity updated from Viani et al, ref 6) (2) ST Peters, WD Heemsbergen, PC Koper et al., Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy, 24 (2006): (3) DP Dearnaley, MR Sydes, JD Graham et al, Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT101 randomized controlled trial, Lancet Oncology 8 (2007): (4) Anthony L. Zietman, Correction: Inaccurate analysis and results in a Study of Radiation Therapy in Adenocarcinoma of the Prostate, JAMA 299 No. 8 (2008): Anthony L. Zietman et al., Comparison of Conventional-Dose vs. High-Dose Conformal Radiation Therapy in Clinically Localized Adenocarcinoma of the Prostate. A Randomized Controlled Trial, JAMA 294 No. 10 (2005): (5) Beckendorf V, Guerif S, Le Prise E, et al. The GETUG 70 Gy vs. 80 Gy randomized trial for localized prostate cancer: Feasibility and acute toxicity. Int J Radiat Oncol Biol Phys 2004;60: (Note: no 5-year control rates given) (6) Viani GA et al. Higher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized, controlled trials. Int J Radiat Oncol Biol Phys Aug 1;74(5):

71 Retrospective Single Institution Studies Usually Show Results Superior To Prospective Studies Study Radiation Planning Dose Control PROG Protons 3-D 79.2 Gy 94% (10 year) MSK IMRT 3-D 81.0 Gy 85% (8 year) (1) Zietman, JCO 2010 (2) Zelefsky, J Urol

Protons are Safer and More Effective A 2008 MGH study determined that protons decreases the risk of patients developing a secondary cancer by 50% (1) Protons significantly decrease the risk of

72 Protons are Safer and More Effective A 2008 MGH study determined that protons decreases the risk of patients developing a secondary cancer by 50% (1) Protons significantly decrease the risk of secondary malignancies in prostate cancer treatment over 5 year period According to the study, 6.4 percent of patients who underwent proton therapy developed a secondary cancer while 12.8 percent of patients who had photon treatment [x-rays] developed another type of cancer. Modality Risk of Induced Tumor Baseline risk 2 4% Conventional 3 10% IMRT % Protons 5 6% (1) Comparative Analysis of Second Malignancy Risk in Patients Treated with Proton Therapy versus Conventional Photon Therapy, presented by Nancy Tarbell, M.D. at ASTRO 2008 (Chung et al. study) (2) SEER data (3) McGee et al., Comparison of Second Cancer Risk in Prostate Cancer Patients Treated with Neutron/Photon Irradiation, Photon Irradiation, or Prostatectomy, International Journal Radiation Oncology Biology Physics 66 (2006): S318-S319 (4) Fontenot et al., Risk of secondary malignant neoplasms from proton therapy and intensity-modulated x-ray therapy for early-stage prostate cancer, International Journal Radiation Oncology Biology Physics 74 (2009): (5) Chung et al., Comparative Analysis of Second Malignancy Risk in Patients Treated with Proton Therapy versus Conventional Photon Therapy, International Journal Radiation Oncology Biology Physics 72 (2008) :S8

73 QUESTIONS YOU NEED TO ASK BEFORE STARTING TREATMENT FOR PROSTATE CANCER

74 If you are being referred for radiation therapy by a urologist, then ask him/her: Do you have a financial interest in the radiation center you are referring me to? The Urorad Model In IMRT, the professional component (doctor s fees) are less than 25% of the total charges The technical component comprises the balance (this goes to the owners of the machine) A growing trend across the nation is for urologists to purchase (or lease from a hospital) the radiation therapy equipment and then to refer their patients to the centers they have a financial interest in. The urologists will then hire a radiation oncologist to work for them. The urologists will split the technical fees generated from the treatments. A $1 million dollar investment can return $3+ million a year Elrod (atty for a group opposing the construction of a Urorad center) said the urologists, under the "complicated financial arrangement" proposed, would basically be investing $1.2 million while making a $3 million net profit the first year of operation and $4.1 million in the second year. "These numbers, frankly, are astounding," he said. Urologists are not required to share with the patient that they have a financial interest in the center they are referring the patient to

75 Profit and Questions on Prostate Cancer Therapy By STEPHANIE SAUL Published: December 1, 2006 Profit and Questions on Prostate Cancer Therapy NY Times Jan 1,

76 The 277 New Y 1http%3a% %20Sales %20The% By%20ST The%20N %20Busin www%2en Box1%2c 9w0aCXq default STEPH Decembe Sales Pitch for a Treatment By STEPHANIE SAUL Published: December 1, 2006 For Urorad Healthcare, a company that helps urologists set up radiation technology called I.M.R.T., making money is a highly desired side effect of prostate cancer treatment. One analysis that Urorad performed for a urology group calculated the ''break even'' point at four patients a month. If the doctors could achieve the level of 21 I.M.R.T. patients a month, according to the analysis, the annual revenue per doctor would amount to $425,000.

77 Summary Protons are AN option for prostate cancer treatment Protons are superior to IMRT Protons are different from surgery and brachytherapy Active surveillance is perfectly acceptable for many men with prostate cancer Tell your patients about ALL the options

78 No form of x-ray radiation can treat a tumor and give less radiation dose to healthy tissue than proton beam therapy can!

79 I can t change the laws of physics, captain!!!!!

80 ASTRO Supports Protons ASTRO believes that proton beam radiation therapy is deemed medically necessary 80

81 President Obama Supports Protons Proton therapy is a preferred treatment in many adult and pediatric cancers, and is a highly effective treatment for tumors in the head, brain, neck, lung and prostate 81

82 Senator Kennedy Received The Cause of My Life Inside the fight for universal health care. Published July 18, 2009 Proton Therapy In 1964, I was flying with several companions to the Massachusetts Democratic Convention when our small plane crashed and burned short of the runway. My friend and colleague in the Senate, Birch Bayh, risked his life to pull me from the wreckage. Our pilot, Edwin Zimny, and my administrative assistant, Ed Moss, didn't survive. With crushed vertebrae, broken ribs, and a collapsed lung, I spent months in New England Baptist Hospital in Boston. To prevent paralysis, I was strapped into a special bed that immobilizes a patient between two canvas slings. Nurses would regularly turn me over so my lungs didn't fill with fluid. I knew the care was expensive, but I didn't have to worry about that. I needed the care and I got it. Now I face another medical challenge. Last year, I was diagnosed with a malignant brain tumor. Surgeons at Duke University Medical Center removed part of the tumor, and I had proton-beam radiation at Massachusetts General Hospital. I've undergone many rounds of chemotherapy and continue to receive treatment. Again, I have enjoyed the best medical care money (and a good insurance policy) can buy. I had proton beam radiation at Massachusetts General Hospital I have enjoyed the best medical care money can buy Every American should be able to get the same treatment that U.S. Senators are entitled to. But quality care shouldn't depend on your financial resources, or the type of job you have, or the medical condition you face. Every American should be able to get the same treatment that U.S. senators are entitled to. This is the cause of my life. Source: Newsweek Magazine < 82

83 We want to learn something from everyone we treat. Every patient is asked to sign a consent form (and most do) allowing retrospective review of their clinical information with the intent of publication

91 All data is tracked using EMR database.

92 INTEGRIS Cancer Institute of Oklahoma

93 Comprehensive Cancer Care with Proton Therapy The INTEGRIS Cancer Institute of Oklahoma at the Proton Campus was established to provide comprehensive, world class cancer treatment for patients, as well as support for ProCure Proton Therapy Center patients. The Proton Campus is the only communitybased proton therapy center in the United States

94 The Integris Cancer Institute of Oklahoma (The ICIO) was literally designed from the ground up (starting with a grassy field) using everything we know that works best when caring for patients with cancer.

95 The ICIO includes: - A 40,000 square foot state of the art photon radiation therapy department designed by radiation oncologists

96 A state of the art imaging center designed by radiologists

97 A patient friendly chemotherapy infusion center designed by oncology nurses and medical oncologists

98 A chemotherapy mixing lab and an out patient pharmacy designed by pharmacists

99 A medical laboratory designed by laboratory technicians and pathologists

100 Lobby, waiting areas and floor plan designed with input from our receptionists, front office staff and administrative assistants.

101 A wellness center offering - -Counseling -Patient support groups - Social services - Art therapy - Nutritional counseling by a registered dietician - Massage therapy

102 Ensuring Exceptional Patient Care Innovative technology to ensure exceptional clinical benefit and convenience for patient Experienced care team to provide patient care 24/7 nurse support Dedicated concierge service Seamless continuum of cancer care for patients

103 The ICIO has meeting rooms and a large conference room (The first meeting of the international Proton Cooperative Group (PCG) was held in this conference room)

104 The ICIO, IBMC, ISMC and Procure all share an electronic medical record system (MOSAIC) for both Radiation Oncology and Medical Oncology.

105 Continuum of Comprehensive Cancer Care Infusion Therapy Chemo Suites Lab/ Pathology Education, Research & Conference Minor Procedures Photon Center Integrated Wellness Center Patient Resource Center Retail, Information Pharmacy Retail & Compounding Multi-specialty Clinic Exam/Consult Rooms Urgent Care MOB Public Lobby Registration, Financial Svcs, Lounge Areas Imaging Diagnostic and Evaluation Proton Therapy Procure

106

Radiation Therapy 2013 The Role of Protons. Bob Gaston, D.O.

Radiation Therapy 2013 The Role of Protons Bob Gaston, D.O. Disclosures Oklahoma ProCure Treatment Center Radiation Medicine Associates Goal of Radiation Therapy Increase the Therapeutic Ratio Therapeutic