Patients
urothelial carcinoma of the bladder, Cancers, muscle-invasive bladder cancer
ADVERSE EVENT, CANCERS
From 15th of January 2019 all patients with urothelial carcinoma of the bladder initiating chemo- or immunotherapy (cisplatin/gemcitabine, carboplatin/gemcitabine, pembrolizumab or vinflunin) as neoadjuvant treatment for muscle-invasive or locally advanced BC (from here on referred to as locally advanced BC) or palliative treatment for metastatic BC at the oncological department of four university hospitals (Copenhagen University Hospitals Rigshospitalet and Herlev Hospital, Aalborg University Hospital and Odense University Hospital) were asked to participate, please see Fig. Study overview. Abbreviations: PRO-CTCAE: Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events. QLQ-C30: European Organisation for Research and Treatment of Cancers global quality of life core questionnaire. QLQ-BLM30: European Organisation for Research and Treatment of Cancers questionnaire for muscle-invasive bladder cancer. Randomization allocation was provided by the Ambuflex softwareTreatments (chemo- or immunotherapy) were for all patients given every three weeks in an out-patient setting. As part of enrollment into the study patients were asked to complete questionnaires (see below) for a maximum of six cycles of treatment [18 weeks]. Irrespective of allocated arm of randomization all patients could at any time contact their treatment department from home with troublesome symptoms.The co-primary clinical endpoints were hospital admissions and treatment completion rate. Secondary endpoints were OS, quality of life (QoL) (EORTC’s QLQ-C30 and QLQ-BLM30) and dose reductions.