PMID- 33260049
OWN - NLM
STAT- MEDLINE
DCOM- 20210122
LR  - 20220531
IS  - 1879-0461 (Electronic)
IS  - 1040-8428 (Linking)
VI  - 157
DP  - 2021 Jan
TI  - Adverse events reporting in phase 3 oncology clinical trials of checkpoint 
      inhibitors: A systematic review.
PG  - 103162
LID - S1040-8428(20)30298-5 [pii]
LID - 10.1016/j.critrevonc.2020.103162 [doi]
AB  - INTRODUCTION: This study aimed at exploring adverse events (AEs) reporting in 
      cancer trials involving immune checkpoint inhibitors (ICIs). METHOD: A systematic 
      review on how ICIs phase 3 trials follow TRIO and 2004 CONSORT harms extension 
      recommendations referring to toxicity was performed by two independent reviewers. 
      RESULTS: Among 46 trials included, 74 % did not present separately grade 3 and 
      grade 4 AEs. Timing of onset and duration were reported in 30 % and 28 %, 
      respectively. AEs occurring in <10 % of patients were only reported in 35 % of 
      studies. Patient-related outcomes (PROs) were analyzed in only 17 % of reports. 
      Eight articles qualified the toxicity profile as "manageable", "tolerable", "well 
      tolerated" or "favorable" despite reporting a rate of grade 3-4 greater than 33 
      %. CONCLUSION: Reporting toxicity results is crucial. However, toxicity reporting 
      is highly incomplete in clinical trials. Guidelines, new metrics and 
      incorporation of PROs are needed for a comprehensive knowledge of toxicity 
      profile.
CI  - Copyright (c) 2020 Elsevier B.V. All rights reserved.
FAU - Barhli, Aline
AU  - Barhli A
AD  - AP-HP, Hopital Henri Mondor, Service d'oncologie medicale, 52 avenue du Marechal 
      de Lattre de Tassigny, 94000 Creteil, France. Electronic address: 
      aline.barhli@hotmail.com.
FAU - Joulia, Marie-Liesse
AU  - Joulia ML
AD  - AP-HP, Hopital Henri Mondor, Service d'oncologie medicale, 52 avenue du Marechal 
      de Lattre de Tassigny, 94000 Creteil, France. Electronic address: 
      joulia.marie@gmail.com.
FAU - Tournigand, Christophe
AU  - Tournigand C
AD  - AP-HP, Hopital Henri Mondor, Service d'oncologie medicale, 52 avenue du Marechal 
      de Lattre de Tassigny, 94000 Creteil, France; Univ Paris Est Creteil, INSERM, 
      IMRB, F-94010 Creteil, France. Electronic address: christophe.tournigand@aphp.fr.
FAU - Kempf, Emmanuelle
AU  - Kempf E
AD  - AP-HP, Hopital Henri Mondor, Service d'oncologie medicale, 52 avenue du Marechal 
      de Lattre de Tassigny, 94000 Creteil, France; Univ Paris Est Creteil, INSERM, 
      IMRB, F-94010 Creteil, France. Electronic address: emmanuelle.kempf@aphp.fr.
LA  - eng
PT  - Journal Article
PT  - Systematic Review
DEP - 20201111
PL  - Netherlands
TA  - Crit Rev Oncol Hematol
JT  - Critical reviews in oncology/hematology
JID - 8916049
SB  - IM
MH  - Clinical Trials, Phase III as Topic
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - Humans
MH  - Medical Oncology
MH  - *Neoplasms/drug therapy
OTO - NOTNLM
OT  - Adverse event
OT  - Immune checkpoint inhibitors
OT  - Immune toxicity
OT  - Quality reporting
OT  - Systematic review
EDAT- 2020/12/02 06:00
MHDA- 2021/01/23 06:00
CRDT- 2020/12/01 20:11
PHST- 2020/06/25 00:00 [received]
PHST- 2020/10/27 00:00 [revised]
PHST- 2020/11/05 00:00 [accepted]
PHST- 2020/12/02 06:00 [pubmed]
PHST- 2021/01/23 06:00 [medline]
PHST- 2020/12/01 20:11 [entrez]
AID - S1040-8428(20)30298-5 [pii]
AID - 10.1016/j.critrevonc.2020.103162 [doi]
PST - ppublish
SO  - Crit Rev Oncol Hematol. 2021 Jan;157:103162. doi: 
      10.1016/j.critrevonc.2020.103162. Epub 2020 Nov 11.