ESTRO 38 Abstract book

S126 ESTRO 38

Radiation Oncology, A Coruña, Spain ; 4 Hospital Universitari Son Espases, Department of Radiation Oncology, Palma de Mallorca, Spain ; 5 Hospital Universitario de Salamanca, Department of Radiation Oncology, Salamanca, Spain ; 6 Hospital Ramon y Cajal, Department of Radiation Oncology, Madrid, Spain ; 7 El Hospital Infanta Cristina de Badajoz, Department of Radiation Oncology, Badajoz, Spain ; 8 Hospital Universitario Reina Sofía, Department of Radiation Oncology, Córdoba, Spain ; 9 Astellas Pharma Inc., Head of Medical Affairs Hospitals - Oncology, Madrid, Spain ; 10 Astellas Pharma Inc., Oncology, Madrid, Spain; 11 ERESA- Hospital General Universitario de València, Department of Radiation Oncology, València, Spain Purpose or Objective Prostate cancer (PCa) is the third most prevalent type of cancer in Spain, with various treatment options, including radiotherapy (RT), depending on disease stage. Health- related quality of life (HRQoL) is greatly affected by functional alterations specific to PCa and its treatment. The Expanded Prostate Cancer Index Composite (EPIC-16), a shorter version of EPIC-50, was designed to be administered in routine clinical practice in patients (pts) with clinically localised prostate cancer, evaluating aspects of therapy that are most bothersome to pts. The objectives of this study were to measure the impact of RT on quality of life and to validate the Spanish version of EPIC-16 in routine clinical practice in Spain. Material and Methods An observational, non-interventional, multicentre study was conducted in Spain with pts >40 years (yrs) of age with localised PCa, initiating treatment with external RT (eRT) or brachytherapy (BQT). Changes from baseline in EPIC-16 and UCLA Prostate Cancer Index (PCI) and patient- perceived state of health were measured at two follow-up visits. Psychometric evaluations of the Spanish version of EPIC-16 were conducted to assess its validity. Results Of the 516 pts enrolled this study, 495 were included in the analysis (eRT, n=361; BQT, n=134). Mean (standard deviation [SD]) age was 71.7 (6.4) yrs [eRT] and 66.7 (7.5) yrs [BQT]. At baseline, 264 (73.1%) eRT and 21 (15.7%) BQT pts had a Gleason score ≥7; mean (SD) EPIC-16 global score (range 0–60, 60 being the worst) was 11.9 (7.5) in eRT pts and 10.3 (7.7) in BQT pts. For eRT pts, the total EPIC-16 score increased from baseline by a mean (SD) of 6.8 (7.6) for visit (V) 2 and 2.4 (7.4) at V3 (Figure). For BQT pts, total scores increased from baseline by a mean (SD) of 4.2 (7.6) and 3.9 (8.2) at end of treatment and 3 months after RT, respectively (Figure). Changes from baseline in individual domains (range 0–12, 12 being worse HRQoL) are shown in the table. Changes in the Spanish EPIC-16 domains correlated well with those of the UCLA-PCI for urinary, bowel and sexual domains. Patients perceived no change in their HRQoL status compared to baseline. EPIC- 16 showed good internal consistency (Cronbach’s alpha=0.84) and reliability, with a moderate intraclass correlation coefficient in all domains, with the exception of the bowel domain. Construct validity was shown with a 5-factor analysis indicating that EPIC-16 domains are conceptually distinct and merit an independent measure. Longitudinal validity was not evident in all HRQoL domains.

Conclusion A high demand for ePRO could be concluded from the survey. An app to assess PROs for RT-related AEs was successfully created and its design will be adapted to results of the survey. PV-0257 Radiotherapy impact on quality of life in localised prostate cancer: validation of EPIC-16 in Spain A. Zapatero Laborda 1 , X. Maldonado Pijoan 2 , A. Gómez- Caamaño 3 , J. Pardo Masferrer 4 , V. Macias Hernández 5 , A. Hervás Morón 6 , J.L. Muñoz García 7 , A. Palacios Eito 8 , P. Anguita-Alonso 9 , C. González-Junco 10 , J. López Torrecilla 11 1 Hospital Universitario La Princesa, Department of Radiation Oncology, Madrid, Spain ; 2 Hospital Universitari Vall d’Hebron, Department of Radiation Oncology, Barcelona, Spain ; 3 Hospital Clínico Universitario de Santiago de Compostela, Department of