Health-Related Quality of Life in Men with Localized Prostate Cancer Treated with Radiotherapy: Validation of an Abbreviated Version of the Expanded Prostate Cancer Index Composite for Clinical Practice in Spain - Beyond the Abstract

Treatment options for localized prostate cancer (PCa) include radical prostatectomy and radiotherapy (external beam radiotherapy [EBRT] and brachytherapy [BQT]). However, these therapeutic interventions can negatively impact patients in terms of physical and emotional symptoms. It is also true that the effect on the health-related quality of life (HRQoL) strongly depends on the treatment being given, as well as the temporary HRQoL changes. Patient-reported outcome measures are increasingly being used to assess long-term HRQoL in patients with PCa providing and helpful information in the treatment decision process.

A well-established instrument that is frequently used to assess a patient’s post-intervention-related HRQoL is the 50-item Expanded Prostate Cancer Index Composite for clinical practice (EPIC) questionnaire, which was developed based on the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI). There are two shorter versions of the EPIC-50 questionnaire, the 26-item (EPIC-26) and the 16-item (EPIC-CP) questionnaires. The EPIC-CP, specifically designed to be administered in routine clinical practice, is a one-page questionnaire constructed to measure urinary incontinence, urinary irritation, and bowel, sexual, and hormonal HRQOL domains to evaluate aspects of therapy that are most bothersome.

Our study aimed to measure the impact of radiotherapy on HRQoL and to further validate the Spanish version of the 16-item Expanded Prostate Cancer Index Composite (EPIC-16) in routine clinical practice. For this purpose, we conducted an observational, non-interventional, multicenter study in 41 Spanish radiation oncology departments that enrolled 516 patients initiating treatment with external beam radiotherapy (EBRT) or brachytherapy (BQT). Patients had three study visits where clinical variables were collected at baseline, i.e. before the beginning of treatment (EBRT or BQT) [visit 1, V1], at the first follow-up visit, i.e. the final EBRT session, or 1 month after the first BQT session or seed implantation (visit 2, V2), and a final follow-up visit approximately 3 months after the end of treatment (visit 3, V3). Changes from baseline (V1) in EPIC-16, UCLA-PCI, and patient-perceived health status were longitudinally assessed in the 3 visits. Of 516 patients enrolled, 495 were included in the analysis (EBRT, n = 361; BQT, n = 134). For EBRT pts, the total EPIC-16 score increased from baseline by a mean (SD) of 6.8 (7.6) at V2 and 2.4 (7.4) at V3. 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.. Patients perceived no change in their HRQoL status compared to baseline.

Overall, our results showed that the EPIC-16 scores worsened after radiotherapy in different HRQoL domains, regardless of patients’ perceptions of their health status, suggesting that patients did not perceive the change in functional domains as a global change in their health status. Similarly, the UCLA-PCI scores decreased with radiotherapy in both treatment groups (EBRT or BQT). However, 3 months after the end of radiotherapy, EBRT patients recovered their scores in the urinary function, urinary bother, and bowel function domains, and BQT patients showed a strong tendency towards the baseline recuperation.

The results of the current study further highlight the importance of using appropriate PRO instruments to aid physicians treating patients newly diagnosed with localized PCa, enabling them to decide appropriate treatment strategies, to consider their potential adverse effects, and to incorporate individual patient preferences.
Figure 1. Evolution of overall urinary quality of life in the EPIC-16 questionnaire according to type of radiotherapy
BL Baseline, V2 Visit 2 (end of radiotherapy), V3 Visit 3 (90 days after the end of radiotherapy)

Written by: Almudena Zapatero, Xavier Maldonado Pijoan, Antonio Gómez-Caamaño, José Pardo Masferrer, Víctor Macías Hernández, Asunción Hervás Morón, Julia Luisa Muñoz García, Amalia Palacios Eito, Paloma Anguita-Alonso, Cristina González-Junco, José López Torrecilla

Department of Radiation Oncology, Hospital Universitario de La Princesa, Madrid, Spain., Department of Radiation Oncology, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Department of Radiation Oncology, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, Spain., Department of Radiation Oncology, Hospital Universitari Son Espases, Palma de Mallorca, Spain., Hospital Universitario Y Politecnico La Fe, Valencia, Spain., Department of Radiation Oncology, Hospital Ramon Y Cajal, Madrid, Spain., Department of Radiation Oncology, Hospital Infanta Cristina de Badajoz, Badajoz, Spain., Department of Radiation Oncology, Hospital Universitario Reina Sofía, Córdoba, Spain., Astellas Pharma Inc., Madrid, Spain., Department of Radiation Oncology, ERESA, Hospital General Universitario de València, València, Spain.

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