LBA02-01 PERSISTENT DEFICIENCIES IN THE MEASUREMENT AND REPORTING OF TOBACCO USE IN CONTEMPORARY GENITOURINARY ONCOLOGY CLINICAL TRIALS

Abstract

You have accessJournal of UrologyLate-breaking Abstract II - Malignant1 Sep 2021LBA02-01 PERSISTENT DEFICIENCIES IN THE MEASUREMENT AND REPORTING OF TOBACCO USE IN CONTEMPORARY GENITOURINARY ONCOLOGY CLINICAL TRIALS Richard Matulewicz, Calvin Zhao, Akya Myrie, Zach Feuer, Timothy Roberts, and Marc Bjurlin Richard MatulewiczRichard Matulewicz More articles by this author , Calvin ZhaoCalvin Zhao More articles by this author , Akya MyrieAkya Myrie More articles by this author , Zach FeuerZach Feuer More articles by this author , Timothy RobertsTimothy Roberts More articles by this author , and Marc BjurlinMarc Bjurlin More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002149.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Smoking is a causal or contributory factor for nearly all genitourinary cancers and exerts significant influence on treatment, quality of life, and survival outcomes. In order to understand the influence smoking has on the outcomes of contemporary therapies, pertinent smoking-related data must be systematically collected and report. We sought to determine how often and how rigorously smoking status is collected and reported in publications of clinical trials in genitourinary cancers. METHODS: We conducted a systematic review according to PRISMA guidelines of high impact urology, general medicine, and oncology journals to identify manuscripts that reported the results of phase II-IV randomized clinical trials in prostate, urothelial, or kidney cancer. Manuscripts were screened in three phases by two independent reviewers; any conflict was resolved by a third reviewer with content expertise. Studies were included if they were published between May 2010-May 2020, reported results of a Phase II-IV randomized trial with a therapeutic intervention, and reported planned analysis of primary data. Pilot or Phase I studies, reports of unplanned secondary analyses, and studies with diagnostic/screening interventions were excluded. Our primary outcome of interest was whether a study collected and reported data on participant smoking status. Secondary outcomes included details about how smoking status was reported, whether the trial arms were balanced with respect to smoking status, and if smoking status was included in analysis. RESULTS: Our initial search yielded 622 articles, 354 of which met criteria. Outcomes of trials in prostate cancer (59.3%) and those studying systemic therapies (46.9%) were most common. Most were Phase III studies (69.8%) and included patients with either localized (33.9%) or metastatic (33.9%) disease. The vast majority of included studies (91.8%) did not report any details about trial participants’ smoking status. When included, 96.3% of studies reported baseline status qualitatively. No studies used a validated measurement instrument or reported change in participants’ smoking status over the study period. When included in final analysis, smoking had a significant association with the primary outcome in two of three studies. CONCLUSIONS: Clinical trial participants’ smoking status is rarely collected and reported in publications of genitourinary cancer trials. Absence of these data precludes further study of how smoking impacts outcomes and highlights an important deficiency in GU oncology clinical trial design. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1175-e1175 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Richard Matulewicz More articles by this author Calvin Zhao More articles by this author Akya Myrie More articles by this author Zach Feuer More articles by this author Timothy Roberts More articles by this author Marc Bjurlin More articles by this author Expand All Advertisement Loading ...