PMID- 38026965
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231201
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 14
DP  - 2023
TI  - Hematologic and lymphatic system toxicities associated with immune checkpoint 
      inhibitors: a real-world study.
PG  - 1213608
LID - 10.3389/fphar.2023.1213608 [doi]
LID - 1213608
AB  - Introduction: Immune checkpoint inhibitors (ICIs) exert antitumor responses in 
      many types of cancer but may also induce serious or fatal toxicities that affect 
      all organ systems, including the hematologic and lymphatic systems. However, the 
      risk of hematologic and lymphatic system toxicities following different ICI 
      treatments remains unknown. This study aimed to describe the hematologic and 
      lymphatic system toxicities associated with different ICI regimens and the impact 
      of combining ICIs with anti-vascular endothelial growth factor drugs using the 
      United States Food and Drug Administration Adverse Event Reporting System 
      pharmacovigilance database. Methods: The reporting odds ratio (ROR) and 
      information component (IC) indices were used to identify disproportionate 
      reporting of ICI-associated hematologic and lymphatic adverse events (AEs). 
      Results: We extracted 10,971 ICI-associated hematologic and lymphatic AEs from 
      35,417,155 reports. These AEs were more frequently reported in female patients 
      (ROR: 1.04 95% confidence interval [CI]: 1.01-1.07) and younger patients (ROR: 
      1.05 95% CI: 1.01-1.09). The disseminated intravascular coagulation fatality rate 
      (63.97%) was the highest among the reported preferred terms, despite its low 
      incidence (3.32%). The time to onset of ICI-related hematologic and lymphatic AEs 
      was relatively short, with 77.44% reported within 3 months. Disproportionate 
      analysis showed that most ICIs were associated with significant overreporting of 
      hematologic and lymphatic AEs (IC(025): 0.34 and ROR(025): 2.10). Hematologic and 
      lymphatic system AEs were more frequently reported in patients treated with 
      anti-programmed cell death protein 1/programmed cell death ligand 1 monotherapy 
      than in those treated with anti-cytotoxic T-lymphocyte-associated protein 4 
      monotherapy (ROR: 1.54, 95% CI: 1.38-1.71), with atezolizumab showing the 
      strongest signal (ROR(025): 4.19, IC(025): 1.00). In patients receiving combined 
      treatment, ICIs plus bevacizumab exerted a higher disproportion signal than 
      monotherapy (ROR: 161, 95% CI: 1.75-1.88). Discussion: The spectrum of 
      hematologic and lymphatic AEs differed according to the ICI regimen. Early 
      recognition and management of ICI-related hematologic and lymphatic AEs are vital 
      in clinical practice.
CI  - Copyright (c) 2023 Li, Feng, Chen, Li, Zhang and Yin.
FAU - Li, Na
AU  - Li N
AD  - Department of Central Laboratory, Shenyang Tenth People's Hospital, Shenyang 
      Chest Hospital, Shenyang, China.
FAU - Feng, Yong
AU  - Feng Y
AD  - Department of Thoracic Surgery, Shenyang Tenth People's Hospital, Shenyang Chest 
      Hospital, Shenyang, China.
FAU - Chen, XiaoLing
AU  - Chen X
AD  - Department of Pathology, Shenyang Tenth People's Hospital, Shenyang Chest 
      Hospital, Shenyang, China.
FAU - Li, Ye
AU  - Li Y
AD  - Department of Central Laboratory, Shenyang Tenth People's Hospital, Shenyang 
      Chest Hospital, Shenyang, China.
FAU - Zhang, Chengmiao
AU  - Zhang C
AD  - Department of Central Laboratory, Shenyang Tenth People's Hospital, Shenyang 
      Chest Hospital, Shenyang, China.
FAU - Yin, Yin
AU  - Yin Y
AD  - Department of Central Laboratory, Shenyang Tenth People's Hospital, Shenyang 
      Chest Hospital, Shenyang, China.
LA  - eng
PT  - Journal Article
DEP - 20231031
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC10644043
OTO - NOTNLM
OT  - FDA adverse event reporting system
OT  - bevacizumab
OT  - combination therapy
OT  - cytotoxic T-lymphocyte-associated protein
OT  - hematologic and lymphatic toxicities
OT  - immune checkpoint inhibitors
OT  - monotherapy
OT  - programmed cell death protein 1/programmed cell death ligand 1
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2023/11/29 18:42
MHDA- 2023/11/29 18:43
PMCR- 2023/10/31
CRDT- 2023/11/29 16:59
PHST- 2023/04/28 00:00 [received]
PHST- 2023/10/17 00:00 [accepted]
PHST- 2023/11/29 18:43 [medline]
PHST- 2023/11/29 18:42 [pubmed]
PHST- 2023/11/29 16:59 [entrez]
PHST- 2023/10/31 00:00 [pmc-release]
AID - 1213608 [pii]
AID - 10.3389/fphar.2023.1213608 [doi]
PST - epublish
SO  - Front Pharmacol. 2023 Oct 31;14:1213608. doi: 10.3389/fphar.2023.1213608. 
      eCollection 2023.