Early and late CTCAE and patient-reported outcomes following prostate radiotherapy in the REQUITE cohort.

BACKGROUND

Prospectively collected long-term adverse event data with pre-radiotherapy assessment and regular follow-up reflecting 'real world settings' are still limited. Here, we present the available data on early and long-term outcomes up to eight years after radiotherapy in men with prostate cancer who participated in the international REQUITE cohort study, stratified by treatment modalities and patient characteristics.

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.