Abstract 1071P
Background
The utilization of immune checkpoint inhibitors (ICIs) has become increasingly prevalent in cancer treatment. However, ICIs may also precipitate a spectrum of immune-related adverse events, which can target various organ systems. Among these, pulmonary immune-related adverse events (pirAEs) are the leading cause of ICI cessation and mortality.
Methods
Individual Case Safety Reports (ICSRs) were obtained from FAERS and VigiBase. We identified reports pertaining to eight ICIs for the purposes of this study, namely nivolumab, pembrolizumab, cemiplimab, atezolizumab, avelumab, durvalumab, ipilimumab, and tremelimumab. Subsequently, we utilized expert consensus to select 52 significant pirAEs with high incidence or of clinical significance and then evaluated the incidence and mortality of pirAEs across varying time periods following the initiation of ICIs therapy.
Results
16,372 and 7,943 ICSRs were collected using FAERS and VigiBase, respectively. More than 50% of pirAEs occurred within 60 days after treatment with ICIs (FAERS:70.0%,VigiBase:55.7%), and their mortality was higher than that after 60 days (15% vs 12%, 12% vs 7%). In each period after the use of ICIs, pirAEs with the highest incidence were interstitial lung disease (14.6%,26.4%), dyspnoea (18.4%,17.0%)and pneumonitis (13.0%,17.0%). The all-cause mortality of respiratory failure (30%, 58%), pulmonary hemorrhage (28%,57%), acute interstitial pneumonitis (75%, 27%), and stridor (31%, 30%)was over 25%. The mortality of respiratory failure remained stable at a high level in each period after initiation of immune therapy (24-40%, 42-69%).
Conclusions
Using data from the FAERS and VigiBase, we conducted an analysis of the frequency and incidence of pirAEs during varied periods after the onset of ICIs therapy. We offer a groundbreaking revelation, identifying the occurrence of pirAEs which manifest early on, within the initial 60 days of treatment, and exhibit a high incidence and mortality rate. Among pirAEs, interstitial lung disease, dyspnea, and pneumonitis were most frequently reported with respiratory failure being a consistently fatal adverse event highlighting the necessity of heightened physician vigilance.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1057P - Long-term follow-up of a phase II study of tislelizumab (TIS) monotherapy in patients (pts) with previously treated, locally advanced, unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) solid tumors
Presenter: Jian Li
Session: Poster session 19
1058P - Intraperitoneal nivolumab for malignant ascites in patients with advanced gastrointestinal or pancreaticobiliary tract cancer
Presenter: Hsiu-Tzu Wang
Session: Poster session 19
1059P - Tertiary lymphoid structures localization and maturation heterogeneities correlate with divergent clinical outcomes and immune responses of clear cell renal cell carcinoma
Presenter: Dingwei Ye
Session: Poster session 19
1061P - Association of transcriptomic mapping of tumors with high expression of Tregs to identify surfaceome gene signatures with efficacy to check point inhibitors
Presenter: María Del Mar Noblejas Lopez
Session: Poster session 19
1062P - Anti-PD1 efficacy in European patients with advanced MSI-H/MMRd non-colorectal cancers
Presenter: Christophe Tournigand
Session: Poster session 19
1063P - Differential tumor responses are a poor prognostic factor in patients receiving immune checkpoint inhibitors
Presenter: Caterina Tozzi
Session: Poster session 19
1065P - Prospective assessment of nutritional status in patients with advanced non-small cell lung cancer and renal cell carcinoma treated with immune checkpoint inhibitors
Presenter: Federica Pecci
Session: Poster session 19
1066P - Negative impact of steroids on the efficacy of immunotherapy in a multi-tumor cohort of patients: time and dose-dependent
Presenter: Víctor Albarrán
Session: Poster session 19
1067P - The interchangeability of Immune checkpoint inhibitors
Presenter: Lonneke Timmers
Session: Poster session 19