Albert Alan, Michelle Ennabe, Muath Alsarafandi, Noor Malik, Edward R Laws, Martin Weinand
Redefining cerebellar assessment: A comprehensive review of the cerebellum's cognitive and affective roles and the efficacy of CCAS scales
Surgical neurology international
ongoing randomised doubleblind phase 3 topaz1 study durvalumab pdl1 inhibitor plus gemcitabine cisplatin associated significant improvements overall survival compared placebo gemcitabine cisplatin people advanced biliary tract cancer preplanned intermin analysis paper present patientreported outcomes topaz1 topaz1 nct03875235 participants aged 18 years older previously untreated unresectable locally advanced metastatic biliary tract cancer eastern cooperative oncology group performance status 0 1 one measurable lesions per response evaluation criteria solid tumors recist version 11 randomly assigned 11 durvalumab group placebo group using computergenerated randomisation scheme participants received 1500 mg durvalumab matched placebo intravenously every 3 weeks day 1 cycle eight cycles combination 1000 mgm2 gemcitabine 25 mgm2 cisplatin intravenously days 1 8 every 3 weeks eight cycles thereafter participants received either durvalumab 1500 mg placebo monotherapy intravenously every 4 weeks disease progression discontinuation criteria met randomisation stratified disease status initially unresectable vs recurrent primary tumour location intrahepatic cholangiocarcinoma vs extrahepatic cholangiocarcinoma vs gallbladder cancer patientreported outcomes assessed secondary outcome participants completed european organisation research treatment cancers 30item quality life cancer patients questionnaire qlqc30 21item cholangiocarcinoma gallbladder cancer quality life module qlqbil21 calculated time deteriorationie time randomisation absolute decrease least 10 points patientreported outcome confirmed subsequent visit date death cause absence deteriorationand adjusted mean change baseline patientreported outcomes april 16 2019 dec 11 2020 685 participants enrolled randomly assigned 341 durvalumab group 344 placebo group overall 345 50 participants male 340 50 female data qlqc30 available 318 participants durvalumab group 328 placebo group median followup 99 months iqr 67 141 data qlqbil21 available 305 participants durvalumab group 322 placebo group median followup 102 months iqr 67 143 proportions participants groups completed questionnaires high baseline scores mostly similar across treatment groups global health status quality life functioning symptoms noted difference time deterioration adjusted mean changes baseline observed groups median time deterioration global health status quality life 74 months 95 ci 56 89 durvalumab group 67 months 56 79 placebo group hazard ratio 087 95 ci 069 112 adjusted mean change baseline 123 95 ci 071 316 durvalumab group 035 163 232 placebo group addition durvalumab gemcitabine cisplatin detrimental effect patientreported outcomes results suggest durvalumab gemcitabine cisplatin tolerable treatment regimen patients advanced biliary tract cancer astrazeneca