Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Mar 5:11:607531.
doi: 10.3389/fonc.2021.607531. eCollection 2021.

Immune-Related Adverse Events and Their Association With the Effectiveness of PD-1/PD-L1 Inhibitors in Non-Small Cell Lung Cancer: A Real-World Study From China

Xiaoling Chen  1 , Jun Nie  1 , Ling Dai  1 , Weiheng Hu  1 , Jie Zhang  1 , Jindi Han  1 , Xiangjuan Ma  1 , Guangming Tian  1 , Sen Han  1 , Di Wu  1 , Yang Wang  1 , Jieran Long  1 , Ziran Zhang  1 , Jian Fang  1
Affiliations

Immune-Related Adverse Events and Their Association With the Effectiveness of PD-1/PD-L1 Inhibitors in Non-Small Cell Lung Cancer: A Real-World Study From China

Xiaoling Chen et al. Front Oncol. .

Abstract

Background: Programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) inhibitors are increasingly used in China, but no real-world data are available about the immune-related adverse events (irAEs). This real-world retrospective study aimed to assess the safety and effectiveness of PD-1/PD-L1 inhibitors in patients with non-small cell lung cancer (NSCLC) and to analyze the association between irAEs and effectiveness.

Methods: This was a retrospective study of the clinical data of patients with NSCLC treated with PD-1/PD-L1 inhibitors from August 2016 to November 2019 at Beijing Cancer Hospital. The patients were divided into the irAE or non-irAE groups. Overall adverse events, the impact of irAE on tumor response, and the association of irAEs with effectiveness were evaluated.

Results: One hundred and ninety-one patients were included, including 70 (36.6%) patients in the irAE group and 121 (63.4%) patients in the non-irAE group. AE, grades 3-5 AEs, and irAE occurred in 107 (56.0%), 24 (12.6%), and 70 (36.6%) of the patients, respectively. The objective response rate (ORR) and disease control rate (DCR) were higher in the irAE group compared with the non-irAE group (42.0% vs. 25.8%, P=0.038; 91.9% vs. 70.8%, P=0.002). Multivariable analyses identified that irAE were associated with progression-free survival (HR=0.62, 95%CI: 0.43-0.91; P=0.015), but not with overall survival (HR=0.76, 95%CI: 0.44-1.28; P=0.299).

Conclusion: In NSCLC treated with PD-1/PD-L1 inhibitors, patients with irAEs showed improved effectiveness over patients without irAEs. Future studies of anti-PD-1/PD-L1 immunotherapy should explore this association and the underlying biological mechanisms of efficacy.

Keywords: adverse events; immunotherapy; non-small cell lung cancer; objective response; real-world evidence; survival.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Impact of immune-related adverse events (irAEs) on progression-free survival (PFS). PFS, progression-free survival; CI, confidence interval; irAE, immune-related adverse events; P-values <0.05 were considered statistically significant.
Figure 2
Figure 2
Impact of immune-related adverse events (irAEs) on overall survival (OS). OS, overall survival; CI, confidence interval; irAE, immune-related adverse events; P-values <0.05 were considered statistically significant.
See this image and copyright information in PMC

References

    1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin (2016) 66(1):7–30. 10.3322/caac.21332 - DOI - PubMed
    1. Feng RM, Zong YN, Cao SM, Xu RH. Current cancer situation in China: good or bad news from the 2018 Global Cancer Statistics? Cancer Commun (Lond) (2019) 39(1):22. 10.1186/s40880-019-0368-6 - DOI - PMC - PubMed
    1. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin (2018) 68(6):394–424. 10.3322/caac.21492 - DOI - PubMed
    1. Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest (2013) 143(5 Suppl):e142S–e65S. 10.1378/chest.12-2353 - DOI - PubMed
    1. Aguiar PN Jr, De Mello RA, Barreto CMN, Perry LA, Penny-Dimri J, Tadokoro H, et al. . Immune checkpoint inhibitors for advanced non-small cell lung cancer: emerging sequencing for new treatment targets. ESMO Open (2017) 2(3):e000200. 10.1136/esmoopen-2017-000200 - DOI - PMC - PubMed