Publication

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

Journal Paper/Review - Sep 14, 2020

Units
Keywords
PubMed
Doi
Link
Contact

Citation
Iseli T, Berghmans T, Glatzer M, Rittmeyer A, Massard G, Durieux V, Buchsbaum T, Putora P. Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy. ERJ Open Res 2020; 6
Project
Type
Journal Paper/Review (English)
Journal
ERJ Open Res 2020; 6
Publication Date
Sep 14, 2020
Issn Print
2312-0541
Issn Electronic
Pages
Publisher
Brief description/objective

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.