Early and late CTCAE and patient-reported outcomes following prostate radiotherapy in the REQUITE cohort.
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Heumann Philipp, Romero Juan Camilo Rosas, Aguado Barrera Miguel E, Aguado Flor Ester, Avuzzi Barbara, Azria David, Briers Erik, Carballo-Castro Ana, Chang-Claude Jenny, Choudhury Ananya, Dunning Alison, Elliott Rebecca M, Fachal Laura, Farcy-Jacquet Marie-Pierre, Gómez-Caamaño Antonio, Gutiérrez-Enríquez Sara, Herskind Carsten, Kaaks Rudolf, Kerns Sarah L, Lambrecht Maarten, Maldonado Xavier, Michalet Morgan, Chiorda Barbara Noris, Peleteiro-Higueiro Paula, Rattay Tim, Rosenstein Barry S, De Ruysscher Dirk, Sperk Elena, Stobart Hilary, Symonds R Paul, Talbot Christopher J, Tubío-Abuín María Aránzazu, Vega Ana, Veldeman Liv, Veldwijk Marlon R, Ward Tim, Webb Adam, West Catharine M L, REQUITE/REQUITEplus/RADprecise consortia, Seibold Petra, Rancati Tiziana
Аннотация
METHODS: Longitudinal data on pre-radiotherapy, acute and late symptoms up to eight years after radiotherapy were available from 1760 non-metastatic prostate cancer patients recruited in seven European countries and the USA. External beam radiotherapy (EBRT) and/or brachytherapy were given with curative intent between 2014 and 2016 according to local regimens. Gastrointestinal (GI) and genitourinary (GU) symptoms including sexual dysfunction were prospectively assessed by healthcare professionals according to CTCAE v4.0. Patient-reported outcomes were collected.
RESULTS: The highest incidence of clinician-reported grade ≥ 2 long-term GI and GU symptoms were for proctitis (12.1%) and haematuria (12.9%) among the EBRT-only treated patients, and proctitis (6.4%) and urinary incontinence (32.4%) among the post-prostatectomy/EBRT patients. Incidence of grade 3 adverse events was below 1.5%, with the only exception of late urinary incontinence in post-prostatectomy patients (10.2%).
CONCLUSION: The frequency and distribution of GI and GU symptoms in a real-world multicentre cohort of patients following prostate radiotherapy were comparable to those reported in large interventional trials. Our finding highlights the value of standardised data farming approaches like the REQUITE project. Most patients consented to provide their data for future cancer research which is available on request.