The Maastricht Protontherapy Project : ZON-PTC. Daniëlle Eekers Radiation Oncologist Maastro Clinic, Maastricht
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1 The Maastricht Protontherapy Project : ZON-PTC Daniëlle Eekers Radiation Oncologist Maastro Clinic, Maastricht
2 Contents presentation Clinical benefit of Proton Therapy Indications Proton Therapy The Dutch Model Research Maastro Protontherapy Project
3 Contents presentation Clinical benefit of Proton Therapy Indications Proton Therapy The Dutch Model Research Maastro Protontherapy Project
4 Clinical benefit protons 1. Improve local tumor control 2. Prevention or reduction of radiation induced side effects
5 Clinical benefit of Proton Therapy 1. Improve local control Dose insufficient to cure the tumor Tumor located near to OAR With protons: optimize dose deposited in the tumor without increasing dose to OAR Dose escalation
6 Clinical benefit of Proton Therapy 2. Prevention or reduction of radiationinduced site effects
7 Clinical benefit of Proton Therapy Reduction of acute toxicity
8 Clinical benefit of Proton Therapy and reduction of late toxicity
9 Clinical benefit of Proton Therapy Randomised controlled trials (RCT) Better local control? Without increasing toxicity? BUT: Some late effects have long latency time RCT would take years (example: cardiovascular complications)
10 Clinical benefit of Proton Therapy AND: Techniques are rapidly evolving RCT on outdated technology Data not applicable to clinical practice RCT not realistic
11 Clinical benefit of Proton Therapy RCT Toxicity reducing trials Randomize 2 technologies Same dose to tumor Less dose to OAR not ethical, principle of equipose
12 Solution Treat everybody with protons? Literature
13 Contents presentation Clinical benefit of Proton Therapy Indications Proton Therapy The Dutch Model Research Maastro Protontherapy Project
14 Prostate cancer Vargas C, et al. Int J Radiat Oncol Biol Phys. 2008;70(3):
15 Prostate cancer Vargas C, et al. Int J Radiat Oncol Biol Phys. 2008;70(3):
16 Prostate cancer Roelofs, et al. J. Thorac. Onc., Jan 2012
17 Prostate cancer
18 Pediatric tumors Lee Int J Radiat Oncol Biol Phys. 2005;63(2):
19 Pediatric tumors Lee Int J Radiat Oncol Biol Phys. 2005;63(2):
20 Pediatric tumors Miralbell, et al. IJROBP 2002
21 Pediatric tumors Miralbell, et al. IJROBP 2002
22 Head and Neck Van der Laan, et al. Acta Oncol. Apr 2013
23 Head and Neck Taheri-Kadkhoda, et al. Radiat Oncol. 2008
24 Base of Skull
25 Chordoma and Chondrosarcoma Ares C, Hug EB, Lomax AJ, et al.ijrobp 2009;75(4):
26 Lung Roelofs, et al. J. Thorac. Onc., Jan 2012
27 Lung Chang JY, et al. IJROBP 2006
28 Ocular Melanoma PSI, Villingen, Ch
29 Ocular Melanoma Gragoudas ES Arch Ophthalmol.2002
30 Standard Indications Pediatric tumors Base of Skull, paraspinal tumors Ocular melanoma
31 Contents presentation Clinical benefit of Proton Therapy Indications Proton Therapy The Dutch Model Research Maastro Protontherapy Project
32
33 Proton Therapy in The Netherlands Maximum of 4 permits: all granted Treatment capacity of 2200 patients/year Amsterdam, Groningen, R dam/delft/leiden: 600 Maastricht: 400 pat/jr Intra-ocular and pediatric tumors in max 2 PTC
34 Model based approach 2 questions: 1. How to select the patients who are likely to benefit from proton therapy (prevention of side effects)? 2. How to clinically validate the predicted benefits when RCT is inappropriate? The Health Council of the Netherlands adopted this approach.
35 2 Phases in the model based approach A. The selection of patients who might benefit B. The clinical validation: sequential prospective observational cohort (SPOC) studies
36 Phase A: Selection 3 steps: 1. Develop en validate NTCP models in patients treated with state of the arts RT 2. Individual in silico plannings comparative studies (ISPS) 3. Estimate the potential benefit from protons compared to photons
37 Step 1. NTCP models Dose OAR and side effect DVH parameters vary between side effects Obtained from prospective cohort studies Optimize planning Multivariable NTCPmodels Langendijk Radiother & Oncol. 2013
38 Step 2. in silico planning comparative studies Langendijk Radiother & Oncol. 2013
39 Step 2. in silico planning comparative studies Langendijk Radiother & Oncol. 2013
40 Step 3. Estimation of clinical benefit
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47 Phase B. Clinical validation
48 Proton therapy reimbursement decision tree for the Netherlands Yes Is this disease a standard indication? No Is this a model based indication? Create state of the art PHOTON and PROTON treatment plans Compare both plans according to protocol No Yes Evident dosimetric benefit with protons? No Integrate complication probability modelling Yes Clinically relevant benefit expected? No Treatment with PROTONS Treatment with PHOTONS
49 Model based indications Breast cancer Lung cancer Head and Neck cancer Prostate cancer
50 DUPROTON DUPROTON nationaal PTC consortium Amsterdam PTC Groningen PTC Holland PTC ZON-PTC Purpose: Sound introduction and application of protontherapy in The Netherlands
51 DUPROTON ( Communication (expl Health Insurrance) Financial structure (DOT) Coordination permit demands: Database Validation model-based approach Uniform follow up Need for Education Refer to PTC abroad Alignement (clinical) research
52 Contents presentation Clinical benefit of Proton Therapy Indications Proton Therapy The Dutch Model Research Maastro Protontherapy Project
53 MISTIR framework : Data centre Multicenter In Silico Trials In Radiotherapy ROCOCO: Photon, Proton, C-ion Comparison project Principal Investigators Initialisation MTA Protocol Collaboration Reporting Preparation DICOM datasets* CT/PET Calibration Database (DB) QA Grid spacing Orientation, offsets Contour names Limited nr. of slices Secure DB Participants TP Dummy Run** Institute n Institute 1 Roelofs, et al. Radiother. Oncol. Dec 2010 Analysis Reporters Generate DVH Derive parameters Biological modelling Perform statistics
54
55 ROCOCO network Europe (13 partners): Aken Amsterdam (NKI) Vienna Darmstadt Gent Groningen Hasselt Heidelberg Luik Lyon Maastricht (PI) Paris Villigen Switserland United States (3 partners): Boston Pennsylvania Madison Wisconstin Japan: Chiba
56 Computer Aided Theragnostics ( ) eurocat, americat, ducat, chinacat 5 2 Active or funded CAT partners (10) Prospective centers (4)
57 Rapid Learning In [..] rapid-learning [..] data routinely generated through patient care and clinical research feed into an evergrowing [..] set of coordinated databases. Abernethy, J Clin Oncol 2010;28:4268 [..] rapid learning [..] where we can learn from each patient to guide practice, is [..] crucial to guide rational health policy and to contain costs [..]. Lancet Oncol 2011;12:933
58 Models built & validated : PredictCancer Lung cancer Survival Lung dyspnea Lung dysphagia Rectal cancer Tumor response Local recurrences Distant metastases Overall survival Larynx cancer Local recurrences Overall survival
59 Cost-effectiveness at The increased effectiveness of IMPT does not seem to outweigh the higher costs for all head-andneck cancer patients. However, when assuming equal survival among both modalities, there seems to be value in identifying those patients for whom IMPT is cost-effective.
60 PRODECIS : clinical grade decision support system
61 Contents presentation Clinical benefit of Proton Therapy Indications Proton Therapy The Dutch Model Research Maastro Protontherapy Project
62 The Maastro Project Efficient and Lean: One Gantry compact system Maximal use of shared resources met azm and MAASTRO Only PBS (Pencil Beam Scanning) All-Round staff Treatment from Maintenance during night and weekends Building possibilities for a second compact system in the future.
63 Why ZON PTC in Maastricht? Maastricht central in de Euregio Travel distance for patients in the South limited Building attached to Maastricht UMC+ completely equipped MAASTRO CLINIC: state of the art radiotherapy Active research program Comprehensive Cancer Center UMC+
64 Location and building ZON- PTC A 2
65
66 Patiënts ZON-PTC 14 letters of intent of Radiotherapy Centers in Belgium and en Luxemburg
67 Thank you for your attention!
68
69 Het erkennen van patiënt heterogeniteit in Health Technology Assessment Richting gepersonaliseerde besluiten voor innovatieve radiotherapeutische behandelingen Bram Ramaekers
70 Zorgkosten Promotie Bram Ramaekers 70
71 Health Technology Assessment Health Technology Assessment Economische evaluatie QALY Promotie Bram Ramaekers 71
72 Goedkoper Duurder Economische evaluatie Minder effectief Effectiever (QALYs) Promotie Bram Ramaekers 72
73 Goedkoper Duurder Economische evaluatie Minder effectief Effectiever Promotie Bram Ramaekers 73
74 Economische evaluatie (voorbeeld) Promotie Bram Ramaekers 74
75 Economische evaluatie (voorbeeld) Promotie Bram Ramaekers 75
76 Casus zonder individuele patiënten data: Protonentherapie voor hoofd-halskanker patiënten Promotie Bram Ramaekers 76
77 Casus zonder individuele patiënten data: Protonentherapie voor hoofd-halskanker patiënten Dosimetrische voordelen (theoretisch) Geen overtuigend klinisch bewijs om dit te bevestigen Hogere kosten Investeringskosten ± 100 miljoen Weinig gegevens omtrent de kosteneffectiviteit Promotie Bram Ramaekers 77
78 Kans op bijwerkingen Casus zonder individuele patiënten data: Protonentherapie voor hoofd-halskanker patiënten Modelmatige economische evaluatie Fotonen Protonen Dosimetrische data 70% 60% 50% 40% Kans op bijwerkingen 30% 20% 10% 0% Dosis response modellen Dosis Promotie Bram Ramaekers 78
79 Casus zonder individuele patiënten data: Protonentherapie voor hoofd-halskanker patiënten Proton radiotherapie kosteneffectief voor geselecteerde hoofd-halskanker patiënten Promotie Bram Ramaekers 79
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