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La Protonterapia nel paziente adulto U.O. Protonterapia-APSS Marco Cianchetti Protontherapie: eine Chance zur Cooperation in der Europaregion Protonterapia:

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Presentazione sul tema: "La Protonterapia nel paziente adulto U.O. Protonterapia-APSS Marco Cianchetti Protontherapie: eine Chance zur Cooperation in der Europaregion Protonterapia:"— Transcript della presentazione:

1 La Protonterapia nel paziente adulto U.O. Protonterapia-APSS Marco Cianchetti Protontherapie: eine Chance zur Cooperation in der Europaregion Protonterapia: un’opportunità di cooperazione nell’Euregio

2 Minor dose ai tessuti normali Minore tossicità ai tessuti normali Migliore radiotolleranza (< interruzioni) Migliore integrazione con terapia sistemica Riduzione effetti tardivi Possibile dose-escalation Maggior controllo tumorale Vantaggi della protonterapia

3 Vantaggio dosimetrico dimostrato dagli studi in-silico dei protoni rispetto ai fotoni per diverse patologie Studi prospettici randomizzati: spesso non fattibili, eticamente ingiustificati (?) Studi prospettici osservazionali più indicati per gli studi con protoni Vantaggio clinico su cui ancora non c’è completo accordo tra i ricercatori

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6 Approved May, 20, 2014

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8 Category A: number of patients treatable with protons in Italy (strongly indicated) Tumor typesPatients / yearTreatable with protons Uveal Melanoma % Skull base Chordoma % Skull base Chondrosarcoma % Skull base Meningioma % Paraspinal Tumors % Cranial nerves Schwannoma % Hypophysis Adenoma % TOTAL %

9 Category B: number of patients treatable with protons in Italy with potential gain Tumor types patients / year treatable with protons Brain neuroepithelial tumors % Brain Metastases % Head neck tumors % Thyroid tumors % NSCLC % Tymomas % Esophageal tumors % Biliary tract tumors % Hepatocellular tumors % Pancreatic tumors % Rectal tumors % Cervix tumors % Bladder tumors % Prostate tumors % Pelvic recurrences after surgery >500 >25050% Pediatric solid tumors % Non-neoplastic lesions- - - AVMs % Macular degeneration ? ? ? TOTAL > > %

10 ReferencePtsRT regimenOS (%)LC (%)FU (months) Serious side effects Hug ‘9933Frac PT+/-P (64-79 GyE)5y 795y % Munzenrider ‘99290Frac PT+P (66-83 GyE)10y % Igaki ‘0413Frac PT+/-P (63-95 GyE)5y 675y % Noel ‘05100Frac PT+P (60-71 GyE)5y 804y % Ares ‘0942Frac PT (67-74 GyE)86 (Abs.)5y % Deraniyagala ‘1433Frac PT (70-79 GyE)2 y 92%2 y 86%3-5818% (G2) No>G2 Grosshans ‘1410SIB, Frac (2) (68-70 GyE)2 y 80 (Abs) (FFS) 2 y 90 (Abs.) (LFFS) 13-42No>G2 Cordomi della base del cranio Frac PT: fractionated proton therapy SIB: simoultaneous integrated boost P: fractionated photon RT: radiotherapy GyE: GyEquivalent y: years Abs.: absolute FFS: Failure Free Survival LFFS: Local Failure Free Survival

11 Condrosarcomi della base del cranio ReferencePtsRT regimenOS (%)LC (%)FU (months) Serious side effects Hug ‘9925Frac PT+/-P (64-79 GyE)5y 1005y % Rosenberg ‘99200Frac PT+P (64-80 GyE)10y 9910y NR Noel ‘0426Frac PT+P (60-70 GyE)4y 863y % Ares ‘0922Frac PT (63-74 GyE)95 (Abs)5y % Grosshans ‘145SIB PT (66-70 GyE)2 y 100 FFS(Abs) 2 y LFFS (Abs) 13-42No>G2 Frac PT: fractionated proton therapy SIB: simoultaneous integrated boost P: fractionated photon RT: radiotherapy GyE: Gy Equivalent y: years Abs.: absolute FFS: Failure Free Survival LFFS: Local Failure Free Survival

12 De Laney, JSO 2014;110:115–122

13 Erogati 19,8-50,4 Gy(RBE) pre- operativamente per ridurre il rischio di disseminazione chirurgica Massima resezione chirurgica possibile, evitando di posizionare barre metalliche (Ti) Boost di brachiterapia di Gy su dura, se chirurgia at MGH Follow up mediano 7.3 anni (2,8-14,5) De Laney, JSO 2014;110:115–122

14 Complicanze di Grado 3-4: a 5 anni 10%; a 8 anni 13%

15 ReferencePtsRT regimenOS (%)LC (%)FU (months) Serious side effects DeLaney Frac PT+/-P ( GyE) (pre-post-operatoria) 5y 84 8y 65 5y 81 8y y 10% (G3-4) 8 y 13% (G3-4) Staab Frac PT (59.4–75.2 GyE)5y 805y G3: 2 G5: 1 Mina PT/C (70.4/16-32fr GyE)3y 943y G3-4: 39% Cordomi extracranici Frac PT: fractionated proton therapy P: fractionated photon C: Carbon Ion RT: radiotherapy GyE: Gy Equivalent y: years

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17 McDonald, IJROBP, 87,5,2013 PtsSedeChirurgiaDose erogataRisultatiTossicitàFU in mesi 16Clivale: 8 Cervicale: 2 Toraco/lombare: 3 Sacrale: 3 8 eseguita 8 non resecabili 75.6 GyE ( ) Acuta: G3- G4: 2 Cronica: G3-G4: 2 23 (6-63)

18 ReferencePtsRT regimenOS (%)LC (%)FU (months)Serious side effects Tokuye Frac PT+/-P 72 GyE (42-98) 5/11 (Abs.)9/11 (Abs)23 (6-58)G3: 1 Resto Frac PT +/- P 71.6 GyE (55.4–79.4) 5y CR: 90% PR: 53% Bx: 49% (P = 0.02) 5y CR: 95% PR: 82% Bx: 87% (P = 0.32) 43.2 ( ) - Zenda PT 65 GyE (60-70)5y 551y ( ) G3: 4 G5: 1 Frac PT: fractionated proton therapy P: fractionated photon RT: radiotherapy GyE: Gy Equivalent Abs: absolute y: years Protonterapia per le neoplasie testa-collo: seni paranasali

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20 Carcinoma adenoideo cistico del distretto testa collo ReferencePtsRT regimenSurgery (%)OS (%)LC (%)FU (months)Serious side effects Takagi EQD 10/ GyE (67.7–74.3) Chirurgia: 30 N. chirurgia: 70 5y 63.35y (38)G3: 36 G4: 9 G5: 3 Linton GyEChirurgia: 77 N. chirurgia: 33 2y 822y (25)G3: 2 G4: 1 G5: 1 EQD: Equivalent Dose GyE: Gy Equivalent y: years

21 Nasofaringe re-irradiazione Lin R. et al, Radiology, 1999, 213: pazienti trattati per recidiva di carcinoma del rinofaringe 9 pazienti hanno sviluppato una recidiva loco-regionale ad una media di 9.6 mesi dalla fine del trattamento (range: 0-26 mesi) 2 year - Overall Survival: 50% (6 pazienti morti per malattia, 1 per cause intercorrenti) 2 year - Local Control: 50% 2 year - Disease Free-Survival: 50% Tossicità G3: 3 pazienti

22 Nasofaringe re-irradiazione Lin R. et al, Radiology, 1999, 213: Fattori prognostici Qualità del piano Significativo per OS anche all ’ analisi multivariata (p=0.028)

23 Nasofaringe-Ghiandole lacrimali Nasofaringe 17 pazienti, 1990 – 2002, tecnica mista fotoni/protoni Stadio T4 N0-4, 12 pazienti (71%) con WHO II-III Dose media prescritta al GTV 73.6 Gy(RBE), range Gy(RBE) Ghiandole lacrimali 11 pazienti con ACC trattati a Boston con chirurgia conservativa (MEEI) e protonterapia (MGH) per ACC. 3 recidive A. W. Chan et al, JCO, 22, 14S, 2004:5574; Ahmad et al., Opht, 116 (6), 2009

24 ReferencePts #RT regimenTV (cc)LC (Absolute) Hormone normalization Serious side effects Ronson ‘06 24 NON-func. 4 ACTH-secr. 11 GH-secr. 6 Prolactine-secr. Frac PT (50- 56GyE) 1-9 cm (Ø) 100% - 25% (CR) 45% (CR) 39% (CR) 4.6% RION Wattson ‘14 79 ACTH-secr. 61 GH-secr. 12 Prolactine-secr. 3 TSH 10 NS SRS PT (15- 24GyE) Frac PT ( GyE) %67% (CR) 49% (CR) 38% (CR) 50% (CR) 75% (CR) 2.5% Seizure Frac PT: fractionated proton therapy SRS PT: proton radiosurgery #: number RT: radiotherapy TV: target volume NS: Nelson syndrome CR: complete response RION: radiation-induced optic neuropathy Class III evidence Same as photons Cortesia Dr. Dante Amelio Adenomi Pituitari

25 ReferencePts #WHORT regimenTV (cc)LC (%)Serious side effects Gudjonsson ‘9919I(Hypo)Frac PT (24GyE) (Absolute)None Wenkel ‘0046IFrac PT+P (53-74GyE)9-2875y 10017% Noel ’0551IFrac PT+P (54-61GyE)1-1204y 984% Halasz ‘1150ISRS PT (10-15GyE) y 946% Vernimmen ‘0123NRFrac PT (54-62GyE) (Hypo) Frac PT (17-24GyE) (Absolute)13% Slater ‘1272I-IIFrac PT (50-72GyE)5-2295y 99 WHO I 50 WHO II 8% Weber ’1239I-II-IIIFrac PT (52-67GyE)1-5465y 100 WHO I 49 WHO II- III 13% Combs ‘1370I-II-IIIFrac PT/I+P (52-68GyE)(Absolute) 100 WHO I 81 WHO II-III None Hug ’0016II-IIIFrac PT+P (50-72GyE)NR5y 38 WHO II 52 WHO III 9% Boskos ‘0924II-IIIIFrac PT+P (64GyE - Median) y 478% #: number; RT: radiotherapy; Frac PT: fractionated proton therapy; P: fractionated photon; SRS PT: proton radiosurgery; I: fractionated ion therapy; TV: target volume; y: years; NR: not reported Class III evidence Same as photons Meningiomi Cortesia Dr. Dante Amelio

26 ReferencePts #RT regimenTV (cc)LCHearing preservation Serious side effects Bush ’0231Frac PT (54-60GyE) (Absolute) 31%None Weber ’0388SRS PT (10-18GyE)1-165y 9433%9% FND 10% TND Vernimmen ‘0951(Hypo)Frac PT (20- 42GyE) 1-465y 9842%4% FND Frac PT: fractionated proton therapy SRS PT: proton radiosurgery #: number RT: radiotherapy TV: target volume FND: facial nerve dysfunction TND: trigeminal nerve dysfunction Class III evidence Same as photons Schwannoma vestibolare Cortesia Dr. Dante Amelio

27 ReferencePts #RT regimenOutcomesComplianceFU in mts Fitzek ’01 (Boston) GyRBE (1.8 GyRBE/fr)5-yrs OS 71%100% (Mild Tox) Hauswald ‘12 (Heidelberg) GyRBE (1.8-2 GyRBE/fr) 15 SD, 2 PR, 1 CR, 1 P 100% * (Mild Tox) 0-22 Maquilian ‘13 (Philadelphia) 2354 GyRBE (1.8 GyRBE/fr)23 SD100% * (Mild Tox) 1-9 Shih ‘15 (Boston) 2054 GyRBE (1.8 GyRBE/fr)5-yrs PFS 40% 5-yrs OS 84% 100% ** (Mild Tox) Med 5.1 yrs Neurocognitive and QoL evaluationin on going. ** No neurocognitive and QoL decline Gliomi di basso grado Cortesia Dr. Dante Amelio

28 ReferencePts #RT regimenOutcomesToxicityFU in mts Fitzek ’99 (Boston) 23 (GBM) 90 GyRBE (Hyperfr.) NO CONC. CHT in most pts Med OS 20 mts 30% Radio- necrosis NA Mizumoto ‘10 (Tokio) 21 (GBM) 96 GyRBE (Hyperfr.) CONC. CHT: ACNU Med OS 21.6 mts NO RT G3-4 5% Radio- necrosis NA Gliomi di alto grado Cortesia Dr. Dante Amelio

29 Gastroenterol. Hepatol. Res. accepted October 2013 Clinical experience with proton therapy for GI cancers: a review F. Dionisi, D. Amelio, M. Cianchetti, E Iannacone, D. Ravanelli, B. Rombi, S. Vennarini, L. Vinante, M. Amichetti Gastroenterol. Hepatol. Res. accepted October 2013 ……. Thus, the clinical experience is still scarce. Most of the studies regarding the use of PT in GI cancer treatment focused on HCC and reported good outcomes. A survival benefit could also be achieved in pancreatic cancer. A potential benefit can be presumed in all other malignancies by the reduction of treatment-related toxicity with a possible improvement in cancer survivors’quality of life. Several trials are currently ongoing such as ……

30 Cortesia Dr. Francesco Dionisi

31 Inoltre, negli Stati Uniti l’HCC è inserito dall’ASTRO tra le patologie elettive per protonterapia (https://www.astro.org/uploadedFiles/Main_Site/Practice_Management/Reimb ursement/ASTRO%20PBT%20Model%20Policy%20FINAL.pdf) sulla base di dati di letteratura favorevoli e consistenti:https://www.astro.org/uploadedFiles/Main_Site/Practice_Management/Reimb ursement/ASTRO%20PBT%20Model%20Policy%20FINAL.pdf Qi WX et al. Charged particle therapy versus photon therapy for patients with hepatocellular carcinoma: A systematic review and meta-analysis. Radiother Oncol Dec 9. pii: S (14) doi: /j.radonc ; Dionisi F, Ben-Josef E The use of proton therapy in the treatment of gastrointestinal cancers: liver. Cancer J (6):371-7.; Klein J, Dawson LA Hepatocellular carcinoma radiation therapy: review of evidence and future opportunities. Int J Radiat Oncol Biol Phys Sep 1;87(1): D.A. Bush et al., The safety and efficacy of high-dose proton beam radiotherapy for hepatocellular carcinoma: a phase 2 prospective trial, Cancer. 117 (2011) 3053–3059.

32 Sarcomi retroperitoneali Yoon et al. Ann Surg Oncol (2010) 17:1515–1529 Esperienza del MGH nel trattamento di 28 pazienti con sarcomi retroperitoneali. Chirurgia radicale più radioterapia(Protoni e/o fotoni) Sopravvivenza libera da malattia locale a 3 anni: 90%-30% (Primitivi –Recidive)

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35 The use of proton-beam therapy in the treatment of non-small-cell lung cancer. Oshiro Y, Sakurai H. Expert Rev Med Devices Mar;10(2): doi: /erd Review.

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37 ASTRO’s five recommendations 2013: Don’t initiate whole breast radiotherapy as a part of breast conservation therapy in women age ≥50 with early stage invasive breast cancer without considering shorter treatment schedules. Don’t initiate management of low-risk prostate cancer without discussing active surveillance. Don’t routinely use extended fractionation schemes (>10 fractions) for palliation of bone metastases. Don’t routinely recommend proton beam therapy for prostate cancer outside of a prospective clinical trial or registry. Don’t routinely use intensity modulated radiation therapy (IMRT) to deliver whole breast radiotherapy as part of breast conservation therapy.

38 Melanoma della coroide

39 Risultati: Protonterapia 2,435 melanomi oculari, Marzo 1984 e Dicembre 1998; PSI Villigen/University Eye Clinic Lausanne Follow up mediano: 40 mesi Dose 60 Gy(RBE)/4 frazioni/4giorni consecutivi Gy(RBE)/4 frazioni/4giorni consecutivi Controllo Locale: 95.8% a 5 anni; 94.8% a 10 anni 90.6% ( ) 96.3% ( ) 98.9% ( ) Sopravvivenza a 10 anni: 72.6% (senza recidiva) 47.5% (con recidiva) Sopravvivenza per periodo di trattamento: : 81.8% : 83.3% : 87.9% (p=0.003) Int J Rad Onc Biol Phys, 2001,51,

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41 Attività U.O. Protonterapia-Trento Pazienti trattati

42 Accelerated partial breast irradiation with Protons Kozak KR et al. IJROBP, 66: , 2006

43 …thank you for your attention… October 22 nd, 2014 – Trattamento del primo paziente

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