Meiyan Li, Lihua Pei
Exploring challenges in academic language-related skills of EFL learners in Chinese EMI settings
Acta psychologica
keynote057 trial evaluated activity safety pembrolizumab patients bcgunresponsive highrisk nonmuscleinvasive bladder cancer ineligible declined radical cystectomy cohort patients carcinoma situ without papillary tumours keynote057 study pembrolizumab monotherapy led complete response rate 41 3 months 46 responders maintained response lasting least 12 months evaluate pembrolizumab monotherapy cohort b patients papillary tumours without carcinoma situ keynote057 singlearm phase 2 study 54 sites hospitals cancer centres 14 countries cohort b eligible patients aged 18 years older eastern cooperative oncology group performance status 02 bcgunresponsive highrisk nonmuscleinvasive bladder cancer papillary tumours highgrade ta anygrade t1 without carcinoma situ transurethral resection bladder tumour within 12 weeks first pembrolizumab dose required patients received pembrolizumab 200 mg intravenously every 3 weeks maximum 35 cycles primary endpoint 12month diseasefree survival highrisk nonmuscleinvasive bladder cancer progressive disease assessed cystoscopy cytology central pathology radiology review activity assessed patients received least one dose study drug baseline evaluation safety assessed patients received least one dose study drug trial registered clinicaltrialsgov number nct02625961 ongoing april 12 2016 june 17 2021 132 patients 104 79 men 28 21 women received median ten iqr 915 previous bcg instillations enrolled cohort b study patients received median 10 cycles iqr 627 pembrolizumab data cutoff date oct 20 2022 median followup 454 months iqr 364593 five 4 132 patients remained treatment 12month diseasefree survival 435 95 ci 349519 treatmentrelated adverse events occurred 97 73 132 patients 19 14 grade 3 4 treatmentrelated adverse event common grade 3 4 treatmentrelated adverse events colitis three 2 patients diarrhoea two 2 17 13 132 patients experienced serious treatmentrelated adverse events colitis three patients 2 common treatmentrelated deaths occurred pembrolizumab monotherapy showed antitumour activity manageable toxicity patients bcgunresponsive highrisk ta t1 bladder cancer without carcinoma situ could potentially suitable treatment option patients decline ineligible radical cystectomy findings need confirmed randomised controlled trial merck sharp dohme