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Patient-reported Outcomes from JAVELIN Bladder 100: Avelumab First-line Maintenance Plus Best Supportive Care Versus Best Supportive Care Alone for Advanced Urothelial Carcinoma by Petros Grivas; Evgeny Kopyltsov; Po-Jung Su; Francis X. Parnis; Se Hoon Park; Yoshiaki Yamamoto; Peter C. Fong; Christophe Tournigand; Miguel A. Climent Duran; Aristotelis Bamias; Claudia Caserta; Jane Chang; Paul Cislo; Alessandra di Pietro; Jing Wang; Thomas Powles is a Medicine article available to read on EtoBox.

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## Background: In javelin bladder 100, avelumab first-line maintenance plus best supportive care (bsc) significantly prolonged overall survival (os; primary endpoint) versus bsc alone in patients with advanced urothelial carcinoma (auc) without disease progression with first-line platinum-containing chemotherapy. ## Objective: To evaluate patient-reported outcomes (pros) with avelumab plus bsc versus bsc alone. ## Design, setting, and participants: A randomized phase 3 trial (nct02603432) was conducted in 700 patients with locally advanced or metastatic urothelial carcinoma that had not progressed with first-line gemcitabine plus cisplatin or carboplatin. pros were a secondary endpoint. ## Intervention: Avelumab plus bsc (n = 350) or bsc alone (n = 350). ## Outcome measurements and statistical analysis: National comprehensive cancer network/functional assessment of cancer therapy bladder symptom index-18 (fblsi-18) and euroqol five-level eq-5d (eq-5d-5l) assessments were analyzed using descriptive statistics and mixed-effect models. time to deterioration (ttd; prespecified definition: a ≥3-point decrease from baseline in the fblsi-18 disease-related symptoms-physical subscale for t

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Author

Petros Grivas; Evgeny Kopyltsov; Po-Jung Su; Francis X. Parnis; Se Hoon Park; Yoshiaki Yamamoto; Peter C. Fong; Christophe Tournigand; Miguel A. Climent Duran; Aristotelis Bamias; Claudia Caserta; Jane Chang; Paul Cislo; Alessandra di Pietro; Jing Wang; Thomas Powles

Publisher

Elsevier BV

Published

2022

Language

EN

Field

Medicine (Health Sciences)