The Quest for Evidence for Proton Therapy: Model-Based Approach and Precision Medicine

International Journal of Radiation Oncology Biology Physics

Volumn 95, Issue 1, 2016, Pages 30-36

  Widder, Joachim ^a   Van Der Schaaf, Arjen ^a   Lambin, Philippe ^b   Marijnen, Corrie A M ^c   Pignol, Jean Philippe ^d   Rasch, Coen R ^e   Slotman, Ben J ^f   Verheij, Marcel ^g   Langendijk, Johannes A ^a  

^a UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^b MAASTRICHT UNIVERSITY   (Netherlands)

^c LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^d ERASMUS MC CANCER INSTITUTE   (Netherlands)

^e ACADEMIC MEDICAL CENTER   (Netherlands)

^f VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^g NETHERLANDS CANCER INSTITUTE   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

HEALTH CARE; PHOTONS; PROTON BEAMS; TISSUE;

ADVERSE EVENTS; METHODS AND MATERIALS; MODEL BASED APPROACH; NORMAL-TISSUE COMPLICATION PROBABILITY MODELS; PROTON TREATMENT; RESEARCH AGENDA; STATE OF THE ART; TREATMENT PLANS;

PATIENT TREATMENT;

DIHYDROPYRIMIDINE DEHYDROGENASE; HOMOCYSTEINE; BIOLOGICAL MARKER;

ARTICLE; CANCER PROGNOSIS; CANCER RADIOTHERAPY; CARDIOTOXICITY; COHORT ANALYSIS; DIHYDROPYRIMIDINE DEHYDROGENASE DEFICIENCY; DNA POLYMORPHISM; DOSIMETRY; HUMAN; HUMAN CELL; INTENSITY MODULATED RADIATION THERAPY; MODEL; NORMAL TISSUE COMPLICATION PROBABILITY MODEL; PERSONALIZED MEDICINE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTON THERAPY; RADIATION DOSE ESCALATION; RADIATION INJURY; TOXICITY; ADVERSE EFFECTS; CONFORMAL RADIOTHERAPY; CONSERVATIVE TREATMENT; EVIDENCE BASED MEDICINE; NEOPLASMS; NETHERLANDS; ORGANS AT RISK; PATIENT SELECTION; PHOTON; PROBABILITY; PROCEDURES; RADIATION DOSE; RADIATION INJURIES; RADIATION RESPONSE; RANDOMIZED CONTROLLED TRIAL (TOPIC); THEORETICAL MODEL; THERAPEUTIC USE;

BIOMARKERS; EVIDENCE-BASED MEDICINE; HUMANS; MODELS, THEORETICAL; NEOPLASMS; NETHERLANDS; ORGAN SPARING TREATMENTS; ORGANS AT RISK; PATIENT SELECTION; PHOTONS; PRECISION MEDICINE; PROBABILITY; PROTON THERAPY; RADIATION DOSAGE; RADIATION INJURIES; RADIOTHERAPY, CONFORMAL; RADIOTHERAPY, INTENSITY-MODULATED; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84977913842     PISSN: 03603016     EISSN: 1879355X     Source Type: Journal    
DOI: 10.1016/j.ijrobp.2015.10.004     Document Type: Article

References (56)

1. J.A. Langendijk, P. Lambin, D. De Ruysscher, J. Widder, M. Bos, and M. Verheij Selection of patients for radiotherapy with protons aiming at reduction of side effects: The model-based approach Radiother Oncol 107 2013 267 273
2. Y. Lievens, and M. Pijls-Johannesma Health economic controversy and cost-effectiveness of proton therapy Semin Radiat Oncol 23 2013 134 141
3. D. De Ruysscher, M. Mark Lodge, B. Jones, and et al. Charged particles in radiation therapy: A 5-year update of a systematic review Radiother Oncol 103 2012 5 7
4. J.E. Bekelman, D.A. Asch, Z. Tochner, and et al. Principles and reality of proton therapy treatment allocation Int J Radiat Oncol Biol Phys 89 2014 499 508
5. T. Mitin, and A.L. Zietman Promise and pitfalls of heavy-particle therapy J Clin Oncol 32 2014 2855 2863
6. Leroy R, Benahmed N, Hulstaert F, et al. Hadron therapy in children - An update of the scientific evidence for 15 paediatric cancers. KCE Reports 235. D/2015/10.273/04 ed. Brussels: Health Technology Assessment Brussels: 2015.
7. M. Brada, M. Pijls-Johannesma, and D. De Ruysscher Current clinical evidence for proton therapy Cancer J 15 2009 319 324
8. H. Paganetti Relative biological effectiveness (RBE) values for proton beam therapy. Variations as a function of biological endpoint, dose, and linear energy transfer Phys Med Biol 59 2014 R419 R472
9. F. Tommasino, and M. Durante Proton radiobiology Cancers (Basel) 7 2015 353 381
10. F. Guan, L. Bronk, U. Titt, and et al. Spatial mapping of the biologic effectiveness of scanned particle beams: Towards biologically optimized particle therapy Sci Rep 5 2015 9850
11. F.S. Collins, and H. Varmus A new initiative on precision medicine N Engl J Med 372 2015 793 795
12. D.L. Sackett, W.M. Rosenberg, J.A. Gray, and et al. Evidence based medicine: What it is and what it isn't BMJ 312 1996 71 72
13. J. Howick, P. Glasziou, and J.K. Aronson The evolution of evidence hierarchies: What can Bradford Hill's 'guidelines for causation' contribute? J R Soc Med 102 2009 186 194
14. Royal Dutch Academy of Sciences Evaluation of new technology in health care. In need of guidance for relevant evidence 2014 Available at: https://www.knaw.nl/en/news/publications/evaluation-of-new-technology-in-health-care-1?set-language=en Accessed November 1, 2015
15. P. Lambin, E. Roelofs, B. Reymen, and et al. Rapid learning health care in oncology - An approach towards decision support systems enabling customised radiotherapy Radiother Oncol 109 2013 159 164
16. P. Lambin, J. Zindler, B. Vanneste, and et al. Modern clinical research: How rapid learning health care and cohort multiple randomised clinical trials complement traditional evidence based medicine Acta Oncol 54 2015 1289 1300
17. Beoordeling stand van de wetenschap en praktijk 2015 Zorginstituut Nederland Rapporten en standpunten The Hague Available at: https://www.zorginstituutnederland.nl/zoeken?query=stand+wetenschap+praktijk
18. Indicaties voor protonentherapie (deel 2): Model-based indicaties 2011 College voor zorgverzekeringen The Hague Available at: https://www.zorginstituutnederland.nl/zoeken?query=protonentherapie Accessed November 1, 2015
19. Health Council of the Netherlands Proton radiotherapy. Horizon scanning report 2009 Health Council of the Netherlands The Hague Available at: http://www.gezondheidsraad.nl/en/publications/optimale-gezondheidszorg/proton-radiotherapy Accessed November 1, 2015
20. P. Lambin, R.G. van Stiphout, M.H. Starmans, and et al. Predicting outcomes in radiation oncology-multifactorial decision support systems Nat Rev Clin Oncol 10 2013 27 40
21. S. Marnitz, W. Wlodarczyk, O. Neumann, and et al. Which technique for radiation is most beneficial for patients with locally advanced cervical cancer? Intensity modulated proton therapy versus intensity modulated photon treatment, helical tomotherapy and volumetric arc therapy for primary radiation - An intraindividual comparison Radiat Oncol 10 2015 91
22. H.P. van der Laan, T.A. van de Water, H.E. van Herpt, and et al. The potential of intensity-modulated proton radiotherapy to reduce swallowing dysfunction in the treatment of head and neck cancer: A planning comparative study Acta Oncol 52 2013 561 569
23. A.B. Milby, S. Both, M. Ingram, and et al. Dosimetric comparison of combined intensity-modulated radiotherapy (IMRT) and proton therapy versus IMRT alone for pelvic and para-aortic radiotherapy in gynecologic malignancies Int J Radiat Oncol Biol Phys 82 2012 e477 e484
24. J.Y. Chang, H. Li, X.R. Zhu, and et al. Clinical implementation of intensity modulated proton therapy for thoracic malignancies Int J Radiat Oncol Biol Phys 90 2014 809 818
25. J.B. Petersen, Y. Lassen, A.T. Hansen, and et al. Normal liver tissue sparing by intensity-modulated proton stereotactic body radiotherapy for solitary liver tumours Acta Oncol 50 2011 823 828
26. R. Kienböck Über die einwirkung des röntgen-lichtes auf die haut Wien Klin Wochenschr 13 1900 1153 1166
27. J. Widder The origins of radiotherapy: Discovery of biological effects of X-rays by Freund in 1897, Kienböck's crucial experiments in 1900, and still it is the dose Radiother Oncol 112 2014 150 152
28. J.P. Pignol, and C. Janus The evaluation of innovation in radiation oncology - What can we do and what should we do? Acta Oncol 54 2015 1251 1253
29. L. Zhang, S. Ma, X. Song, and et al. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): A multicentre, double-blind randomised phase 3 trial Lancet Oncol 13 2012 466 475
30. K.V. Ballman Biomarker: Predictive or prognostic? [published online October 5, 2015] J Clin Oncol 2015 10.1200/JCO.2015.63.3651
31. A. Italiano Prognostic or predictive? It's time to get back to definitions! J Clin Oncol 29 2011 4718 author reply 4718-4719
32. C.K. Lee, C. Brown, R.J. Gralla, and et al. Impact of EGFR inhibitor in non-small cell lung cancer on progression-free and overall survival: A meta-analysis J Natl Cancer Inst 105 2013 595 605
33. C. Boeckx, C. Weyn, I. Vanden Bempt, and et al. Mutation analysis of genes in the EGFR pathway in head and neck cancer patients: Implications for anti-EGFR treatment response BMC Res Notes 7 2014 337
34. R. Simon Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology Per Med 7 2010 33 47
35. S.M. Offer, C.C. Fossum, N.J. Wegner, and et al. Comparative functional analysis of DPYD variants of potential clinical relevance to dihydropyrimidine dehydrogenase activity Cancer Res 74 2014 2545 2554
36. G. Toffoli, L. Giodini, A. Buonadonna, and et al. Clinical validity of a DPYD-based pharmacogenetic test to predict severe toxicity to fluoropyrimidines Int J Cancer 137 2015 2971 2980
37. G. Gentile, A. Botticelli, L. Lionetto, and et al. Genotype-phenotype correlations in 5-fluorouracil metabolism: A candidate DPYD haplotype to improve toxicity prediction [published online July 28, 2015] Pharmacogenomics J 2015 10.1038/tpj.2015.56 [Epub ahead of print]
38. F. Innocenti DPYD variants to predict 5-FU toxicity: The ultimate proof J Natl Cancer Inst 106 2014
39. A. Seidman, C. Hudis, M.K. Pierri, and et al. Cardiac dysfunction in the trastuzumab clinical trials experience J Clin Oncol 20 2002 1215 1221
40. E.A. Perez, V.J. Suman, N.E. Davidson, and et al. Cardiac safety analysis of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in the North Central Cancer Treatment Group N9831 adjuvant breast cancer trial J Clin Oncol 26 2008 1231 1238
41. S.C. Kao, V.H. Phan, and S.J. Clarke Predictive markers for haematological toxicity of pemetrexed Curr Drug Targets 11 2010 48 57
42. K. Wopken, H.P. Bijl, A. van der Schaaf, and et al. Development of a multifactorial normal tissue complication probability (NTCP) model for tube feeding dependence after curative radiotherapy/chemo-radiotherapy in head and neck cancer Radiother Oncol 113 2014 95 101
43. A. van der Schaaf, J.A. Langendijk, C. Fiorino, and et al. Embracing phenomenological approaches to normal tissue complication probability modeling: A question of method Int J Radiat Oncol Biol Phys 91 2015 468 471
44. R.G. Kierkels, E.W. Korevaar, R.J. Steenbakkers, and et al. Direct use of multifactorial normal tissue complication probability models in treatment plan optimisation for individualised head and neck cancer radiotherapy produces clinically acceptable treatment plans Radiother Oncol 112 2014 430 436
45. P. van Luijk, S. Pringle, J.O. Deasy, and et al. Sparing the region of the salivary gland containing stem cells preserves saliva production after radiotherapy for head and neck cancer Sci Transl Med 7 2015 305ra147
46. P.J. Brouwers, T. Lustberg, J.H. Borger, and et al. Set-up verification and 2-dimensional electronic portal imaging device dosimetry during breath hold compared with free breathing in breast cancer radiation therapy Pract Radiat Oncol 5 2015 e135 e141
47. B.G. Vanneste, M. Pijls-Johannesma, L. Van De Voorde, and et al. Spacers in radiotherapy treatment of prostate cancer: Is reduction of toxicity cost-effective? Radiother Oncol 114 2015 276 281
48. B.L. Ramaekers, J.P. Grutters, M. Pijls-Johannesma, and et al. Protons in head and neck cancer: Bridging the gap of evidence Int J Radiat Oncol Biol Phys 85 2013 1282 1288
49. B.L. Ramaekers, M.A. Joore, J.P. Grutters, and et al. The impact of late treatment-toxicity on generic health-related quality of life in head and neck cancer patients after radiotherapy Oral Oncol 47 2011 768 774
50. N.C. Sheets, G.H. Goldin, A.M. Meyer, and et al. Intensity-modulated radiation therapy, proton therapy, or conformal radiation therapy and morbidity and disease control in localized prostate cancer JAMA 307 2012 1611 1620
51. R. Mirnezami, J. Nicholson, and A. Darzi Preparing for precision medicine N Engl J Med 366 2012 489 491
52. D. Church, R. Kerr, E. Domingo, and et al. 'Toxgnostics': An unmet need in cancer medicine Nat Rev Cancer 14 2014 440 445
53. E.W. Steyerberg, A.J. Vickers, N.R. Cook, and et al. Assessing the performance of prediction models: A framework for traditional and novel measures Epidemiology 21 2010 128 138
54. A.G. Niezink, N.J. Dollekamp, H.J. Elzinga, and et al. An instrument dedicated for modelling of pulmonary radiotherapy Radiother Oncol 115 2015 3 8
55. J.D. Bradley, R. Paulus, R. Komaki, and et al. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): A randomised, two-by-two factorial phase 3 study Lancet Oncol 16 2015 187 199
56. World Medical Association World Medical Association Declaration of Helsinki: Ethical principles for medical research involving human subjects JAMA 310 2013 2191 2194