Reference : Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy

	Document type :	Scientific journals : Article
	Discipline(s) :	Human health sciences : Surgery
	To cite this reference:	http://hdl.handle.net/10993/45781

Title :	Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy
Language :	English
Author, co-author :	Iseli, Thomas [Kantonsspital St Gallen, St Gallen, Switzerland > Dept of Radiation Oncology]
	Berghmans, Thierry [Thoracic Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium]
	Glatzer, Markus [Kantonsspital St Gallen, St Gallen, Switzerland > Dept of Radiation Oncology]
	Rittmeyer, Achim [Lungenfachklinik Immenhausen, Immenhausen, Germany > Dept of Thoracic Oncology]
	Massard, Gilbert [University of Luxembourg > Faculty of Science, Technology and Medicine (FSTM) > Department of Life Sciences and Medicine (DLSM) >]
	Durieux, Valérie [Université Libre de Bruxelles, Brussels, Belgium > Dept of Libraries and Information Science]
	Buchsbaum, Thomas [Stadtspital Triemli, Zurich, Switzerland > Dept of Radiation Oncology]
	Putora, Paul Martin [Kantonsspital St Gallen, St Gallen, Switzerland > Dept of Radiation Oncology]
Publication date :	14-Sep-2020
Journal title :	ERJ Open Research
Publisher :	European Respiratory Society
Peer reviewed :	Yes (verified by ORBilu)
Audience :	International
e-ISSN :	2312-0541
City :	Sheffield
Country :	United Kingdom
Keywords :	[en] Non-small cell lung cancer ; Surgery ; Radiotherapy
Abstract :	[en] Background: Current treatment options for stage III non-small cell lung cancer (NSCLC) consist of different combinations of chemotherapy, surgery, radiotherapy and immunotherapy. Treatment choices are highly individual decisions, in which adverse events (AEs) are relevant for decision-making. This study aims to analyse reporting of AEs in prospective stage III NSCLC trials, focussing on trials including radiotherapy and/or surgery. Methods: PubMed was searched for prospective studies dealing with stage III NSCLC from January 1987 to April 2019. Meta-analyses were screened as a positive control. Pearson’s Chi-squared test and smooth kernel distribution were used to estimate distributions. Data was resampled using bootstrapping. Results: Out of 1193 initially identified studies, 119 met the inclusion criteria. Of these, 31 had a surgical procedure in any study arm. Grade 3 and 4 AEs were reported in 94.12% and 92.44% of the included studies, respectively. Reporting of grade 5 AEs was provided in 87.39% of cases. Grade 1 and 2 AEs were less commonly reported at 53.78% and 63.03%, respectively. One study did not mention any AEs. Of the 31 treatment arms including any form of surgery, AEs were not reported in 10. Overall, 231 different AE items were reported, only 18 of them were included in at least 20% of the analysed studies. Conclusion: Overall, AE reporting in stage III NSCLC was inconsistent and inhomogeneous. Studies including surgical study arms often reported only treatment-related deaths in regards of surgical AEs. Underreporting of AEs prohibits the extraction of patient-relevant information for decision-making and represents a suboptimal use of invested resources.
Target :	Researchers ; Professionals
Permalink :	http://hdl.handle.net/10993/45781
DOI :	10.1183/23120541.00010-2020

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