Reference : Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy
Scientific journals : Article
Human health sciences : Surgery
http://hdl.handle.net/10993/45781
Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy
English
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 mailto [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]
14-Sep-2020
ERJ Open Research
European Respiratory Society
Yes (verified by ORBilu)
International
2312-0541
Sheffield
United Kingdom
[en] Non-small cell lung cancer ; Surgery ; Radiotherapy
[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.
Researchers ; Professionals
http://hdl.handle.net/10993/45781
10.1183/23120541.00010-2020

File(s) associated to this reference

Fulltext file(s):

FileCommentaryVersionSizeAccess
Open access
Iseli et al., 2020.pdfPublisher postprint560.75 kBView/Open

Bookmark and Share SFX Query

All documents in ORBilu are protected by a user license.