Characteristics of patients with lung cancer in clinical practice and their potential eligibility for clinical trials evaluating tyrosine kinase inhibitors or immune checkpoint inhibitors.
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アブストラクト INTRODUCTION:In- and exclusion criteria of randomized clinical trials (RCTs) aim to include a homogeneous study-population. This study compared characteristics of lung cancer patients from phase III RCTs evaluating tyrosine kinase inhibitors (TKIs) or immune checkpoint inhibitors (ICIs) with characteristics of lung cancer patients in a real world setting in the United Kingdom.METHODS:A retrospective study was conducted using the Clinical Practice Research Datalink GOLD. Patients (N = 9239) with a first ever lung cancer registration between 2014 and 2018 were identified. Eligibility for inclusion was assessed for twelve RCTs (evaluating TKIs or ICIs). Reasons for potential exclusion and the number of unmet criteria were assessed for each RCT independently. OS was assessed using Kaplan-Meier and Cox proportional hazards analyses.RESULTS:The proportion of potentially eligible patients was 74.3% and 51.9% for TKI and ICI RCTs, respectively. History of another malignancy, renal insufficiency or concomitant drug-use were main reasons for exclusion. OS was considerably longer for potentially eligible patients. Hazards ratios varied from 1.17 (95% confidence interval, 1.11-1.24) to 1.35 (1.20-1.42) across the RCTs.CONCLUSION:This study showed that a considerable proportion of lung cancer patients in a real-world setting would have been ineligible for participation in phase III RCTs and that potentially ineligible patients experienced a shorter OS.ジャーナル名 Cancer epidemiology 投稿日 2022/4/17 投稿者 van Veelen, Ard; Abtahi, Shahab; Souverein, Patrick; Driessen, Johanna H M; Klungel, Olaf H; Dingemans, Anne-Marie C; van Geel, Robin; de Vries, Frank; Croes, Sander 組織名 Department of Clinical Pharmacy & Toxicology, Maastricht University Medical;Centre+, Maastricht, The Netherlands; CARIM School of Cardiovascular Disease,;Maastricht University Medical Centre+, Maastricht, The Netherlands; Division of;Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for;Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.;Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for;Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands; NUTRIM,;Maastricht University Medical Centre+, Maastricht, The Netherlands.;Department of Pulmonology, Erasmus MC, Rotterdam, The Netherlands.;Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands; MRC;Lifecourse Epidemiology Unit, Southampton General Hospital, University of;Southampton, SO16 6YD, UK.;Maastricht University Medical Centre+, Maastricht, The Netherlands. Electronic;address: s.croes@mumc.nl. Pubmed リンク https://www.ncbi.nlm.nih.gov/pubmed/35429893/ -
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