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
Meta-Analysis
. 2019 Dec 4;7(1):341.
doi: 10.1186/s40425-019-0779-6.

Incidence rates of immune-related adverse events and their correlation with response in advanced solid tumours treated with NIVO or NIVO+IPI: a systematic review and meta-analysis

Puyuan Xing  1 , Fan Zhang  2 , Guoqiang Wang  3 , Yu Xu  3 , Chengcheng Li  3 , Shouzheng Wang  1 , Yiying Guo  1 , Shangli Cai  3 , Yan Wang  1 , Junling Li  4
Affiliations
Meta-Analysis

Incidence rates of immune-related adverse events and their correlation with response in advanced solid tumours treated with NIVO or NIVO+IPI: a systematic review and meta-analysis

Puyuan Xing et al. J Immunother Cancer. .

Erratum in

Abstract

Background: Deciphering the correlation between immune-related adverse events (irAEs) categorized by organ system class and clinical benefit of immunotherapy is critical for clinical practice. The aim of this study is to investigate the incidence rates of irAEs and their correlations with objective response rate (ORR) in patients with advanced solid tumours treated with nivolumab (NIVO) or nivolumab plus ipilimumab (NIVO+IPI).

Methods: PubMed, Embase and Cochrane library were searched for eligible studies from January 1st, 2000 to May 1st 2019. Published clinical trials on NIVO or NIVO+IPI with reported irAEs were included. Logit transformation of the irAE incidences was applied for the generation of pooled estimate and Pearson correlation coefficient was calculated to evaluate the correlation between irAE and ORR.

Results: 48 clinical trials involving 7936 patients treated with NIVO or NIVO+IPI were included. Compared to NIVO, NIVO+IPI led to more all-grade and grade 3 or higher irAEs categorized by system organ class (P < 0.05). The ORR of NIVO was positively correlated with the incidence rate of skin (r = 0.79, P < 0.001), gastrointestinal (r = 0.56, P = 0.006) and endocrine irAEs (r = 0.44, P = 0.05), but not hepatic, pulmonary and renal irAEs. The ORR of NIVO+IPI was positively correlated with the incidence rate of skin (r = 0.54, P = 0.04), and gastrointestinal irAEs (r = 0.60, P = 0.02), but not endocrine, hepatic, pulmonary and renal irAEs.

Conclusion: This meta-analysis summarizes the incidence rates of irAEs in patients with advanced solid tumours treated with NIVO or NIVO+IPI, and uncovers their correlations with ORR across multiple neoplasms. These findings highlight the potential of irAE to reflect response to NIVO or NIVO+IPI.

Keywords: Immune-related adverse events; Ipilimumab; Meta-analysis; Nivolumab.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram of the study selection
Fig. 2
Fig. 2
Incidence rates of the select immune-related adverse events of nivolumab. TSH, thyroid stimulating hormone; AST, aspartate aminotransferase; ALT, alanine aminotransferase; AP, alkaline phosphatase; GGT, γ-glutamyltransferase
Fig. 3
Fig. 3
Incidence rates of the select immune-related adverse events of nivolumab plus ipilimumab. AST, aspartate aminotransferase; ALT, alanine aminotransferase; AP, alkaline phosphatase; GGT, γ-glutamyltransferase
Fig. 4
Fig. 4
Correlation between response and immune-related adverse events by system organ class in nivolumab
Fig. 5
Fig. 5
Correlation between response and immune-related adverse events by system organ class in nivolumab plus ipilimumab
See this image and copyright information in PMC

References

    1. Pauken Kristen E., Dougan Michael, Rose Noel R., Lichtman Andrew H., Sharpe Arlene H. Adverse Events Following Cancer Immunotherapy: Obstacles and Opportunities. Trends in Immunology. 2019;40(6):511–523. doi: 10.1016/j.it.2019.04.002. - DOI - PMC - PubMed
    1. Haanen J, Carbonnel F, Robert C, Kerr KM, Peters S, Larkin J, et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017;28(suppl_4):iv119–iiv42. doi: 10.1093/annonc/mdx225. - DOI - PubMed
    1. Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, et al. Nivolumab versus Docetaxel in advanced squamous-cell non-small-cell lung Cancer. N Engl J Med. 2015;373(2):123–135. doi: 10.1056/NEJMoa1504627. - DOI - PMC - PubMed
    1. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, et al. Nivolumab versus Docetaxel in advanced nonsquamous non-small-cell lung Cancer. N Engl J Med. 2015;373(17):1627–1639. doi: 10.1056/NEJMoa1507643. - DOI - PMC - PubMed
    1. Overman MJ, McDermott R, Leach JL, Lonardi S, Lenz HJ, Morse MA, et al. Nivolumab in patients with metastatic DNA mismatch repair-deficient or microsatellite instability-high colorectal cancer (CheckMate 142): an open-label, multicentre, phase 2 study. Lancet Oncol. 2017;18(9):1182–1191. doi: 10.1016/S1470-2045(17)30422-9. - DOI - PMC - PubMed

Publication types

MeSH terms

Substances