PMID- 32963993
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220417
IS  - 2312-0541 (Print)
IS  - 2312-0541 (Electronic)
IS  - 2312-0541 (Linking)
VI  - 6
IP  - 3
DP  - 2020 Jul
TI  - Adverse events reporting in stage III NSCLC trials investigating surgery and 
      radiotherapy.
LID - 00010-2020 [pii]
LID - 10.1183/23120541.00010-2020 [doi]
AB  - 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.
CI  - Copyright (c)ERS 2020.
FAU - Iseli, Thomas
AU  - Iseli T
AUID- ORCID: 0000-0002-5007-2294
AD  - Dept of Radiation Oncology, Kantonsspital St Gallen, St Gallen, Switzerland.
FAU - Berghmans, Thierry
AU  - Berghmans T
AD  - Thoracic Oncology Clinic, Institut Jules Bordet, Universite Libre de Bruxelles, 
      Brussels, Belgium.
FAU - Glatzer, Markus
AU  - Glatzer M
AD  - Dept of Radiation Oncology, Kantonsspital St Gallen, St Gallen, Switzerland.
FAU - Rittmeyer, Achim
AU  - Rittmeyer A
AD  - Dept of Thoracic Oncology, Lungenfachklinik Immenhausen, Immenhausen, Germany.
FAU - Massard, Gilbert
AU  - Massard G
AD  - Lung Transplantation Group, University Hospital Strasbourg, Strasbourg, France.
FAU - Durieux, Valerie
AU  - Durieux V
AUID- ORCID: 0000-0002-8975-6562
AD  - Dept of Libraries and Information Science, Universite Libre de Bruxelles, 
      Brussels, Belgium.
FAU - Buchsbaum, Thomas
AU  - Buchsbaum T
AD  - Dept of Radiation Oncology, Stadtspital Triemli, Zurich, Switzerland.
FAU - Putora, Paul Martin
AU  - Putora PM
AD  - Dept of Radiation Oncology, Kantonsspital St Gallen, St Gallen, Switzerland.
AD  - Dept of Radiation Oncology, Inselspital, University of Bern, Bern, Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20200914
PL  - England
TA  - ERJ Open Res
JT  - ERJ open research
JID - 101671641
PMC - PMC7487347
COIS- Conflict of interest: I. Iseli has nothing to disclose. Conflict of interest: T. 
      Berghmans has nothing to disclose. Conflict of interest: M. Glatzer has nothing 
      to disclose. Conflict of interest: A. Rittmeyer reports grants from AbbVie, 
      AstraZeneca, BMS, Eli Lilly, Boehringer Ingelheim, MSD, Pfizer and Roche, outside 
      the submitted work. Conflict of interest: G. Massard has nothing to disclose. 
      Conflict of interest: V. Durieux has nothing to disclose. Conflict of interest: 
      T. Buchsbaum has nothing to disclose. Conflict of interest: P.M. Putora has 
      nothing to disclose.
EDAT- 2020/09/24 06:00
MHDA- 2020/09/24 06:01
PMCR- 2020/09/14
CRDT- 2020/09/23 06:36
PHST- 2020/01/08 00:00 [received]
PHST- 2020/05/26 00:00 [accepted]
PHST- 2020/09/23 06:36 [entrez]
PHST- 2020/09/24 06:00 [pubmed]
PHST- 2020/09/24 06:01 [medline]
PHST- 2020/09/14 00:00 [pmc-release]
AID - 00010-2020 [pii]
AID - 10.1183/23120541.00010-2020 [doi]
PST - epublish
SO  - ERJ Open Res. 2020 Sep 14;6(3):00010-2020. doi: 10.1183/23120541.00010-2020. 
      eCollection 2020 Jul.