title: Testing the Assessment of New Radiation Oncology Technology and Treatments framework using the evaluation of post-prostatectomy radiotherapy techniques.
abstract: BACKGROUND
  We tested the ability of the Assessment of New Radiation Oncology Technology and Treatments framework to determine the clinical efficacy and safety of intensity-modulated radiation therapy (IMRT) compared with 3-dimensional radiation therapy (3DCRT) for post-prostatectomy radiation therapy (PPRT) to support its timely health economic evaluation.
  
  
  METHODS
  Treatment plans produced using FROGG guidelines provided dosimetry parameters for both techniques at 64 Gy and 70 Gy and were also used to model early and late outcome probabilities. Clinical parameters were derived from early toxicity and quality of life patient data, systematic literature review and expert opinion. Dosimetry parameters were correlated with the measures of clinical efficacy and safety.
  
  
  RESULTS
  Data from two patient cohorts (29 and 27 respectively) were collected within the project timeframe, providing evidence for acute toxicity and quality of life, and dosimetric comparisons. Relative rates of tumour control probability (TCP) and normal tissue control probability (NTCP) modelling were readily derived from the planning exercise and demonstrated advantages in uncomplicated TCP for IMRT over 3DCRT, predominantly due to normal tissue sparing. The safety of IMRT delivery was demonstrated with TCP uncompromised by IMRT protocol violations, which achieved rectal sparing only by reducing minimum target dose and coverage.
  
  
  CONCLUSIONS
  Sources of desk-top and patient-based evidence were successfully used to demonstrate potential improved clinical efficacy and safety of applying dose escalation using IMRT instead of 3DCRT in PPRT.
authors.affiliation: Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Gillian M
authors.initials: GM
authors.lastname: Duchesne
authors.affiliation: Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Annette
authors.initials: A
authors.lastname: Haworth
authors.affiliation: TROG, Consumer Representative, Newcastle, New South Wales, Australia.
authors.forename: Eric
authors.initials: E
authors.lastname: Bone
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Hannah
authors.initials: H
authors.lastname: Carter
authors.affiliation: Radiation Oncology, Sir Charles Gairdner Hospital, Perth, Western Australia, Australia.|School of Physics, University of Western Australia, Perth, Western Australia, Australia.
authors.forename: Martin A
authors.initials: MA
authors.lastname: Ebert
authors.affiliation: William Buckland Radiotherapy Centre, The Alfred Hospital, Melbourne, Victoria, Australia.
authors.forename: Frank
authors.initials: F
authors.lastname: Gagliardi
authors.affiliation: Radiation Oncology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.
authors.forename: Adrian
authors.initials: A
authors.lastname: Gibbs
authors.affiliation: Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Colin
authors.initials: C
authors.lastname: Hornby
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Martin
authors.affiliation: Liverpool Cancer Therapy Centre, University of New South Wales, Sydney, New South Wales, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Sidhom
authors.affiliation: Coffs Harbour Health Campus, North Coast Cancer Institute, Coffs Harbour, New South Wales, Australia.
authors.forename: Maree
authors.initials: M
authors.lastname: Wood
authors.affiliation: Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Jackson
mesh_terms: D001315:Australia / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D009520:New Zealand / Q000453:epidemiology; D011468:Prostatectomy / Q000191:economics / Q000401:mortality*; D011471:Prostatic Neoplasms / Q000191:economics / Q000401:mortality* / Q000628:therapy*; D011788:Quality of Life; D011832:Radiation Injuries / Q000401:mortality* / Q000517:prevention & control; D011879:Radiotherapy Dosage; D018714:Radiotherapy, Adjuvant / Q000191:economics / Q000401:mortality* / Q000706:statistics & numerical data*; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome
keywords: IMRT versus 3DCRT; framework evaluation; modelled outcomes; post-prostatectomy radiotherapy; safety