The effect of age, sex, and eastern cooperative oncology group performance status on the efficacy and safety of immune checkpoint inhibitors in patients with hepatocellular carcinoma: a systematic review and meta-analysis

ABSTRACT

Background

The effect of age, sex, and eastern cooperative oncology group performance status (ECOG PS) on the efficacy and safety of immune checkpoint inhibitor (ICI) therapy among hepatocellular carcinoma (HCC) patients remains elusive. Thus, a meta-analysis was conducted to evaluate whether such effects exist.

Research design and methods

Eligible studies in PubMed, Embase, and Cochrane Library databases were retrieved.

Results

One-hundred-and-eleven studies involving 14,768 HCC patients were included. The findings indicated that the ECOG PS didn’t have a significant effect on the ORR and PFS in ICI-treated HCC patients (higher ECOG PS vs. lower ECOG PS: ORR: OR = 0.78, 95%CI = 0.55–1.10; PFS: HR = 1.15, 95%CI = 0.97–1.35), while those patients with a higher ECOG PS may have a worse OS (HR = 1.52, 95% CI = 1.26–1.84). There is no significant evidence of the effect of age (older vs. younger) or sex (males vs. females) on the efficacy of ICI therapy in HCC.

Conclusion

ICI therapy in HCC should not be restricted strictly to certain patients in age or sex categories, while HCC patients with higher ECOG PS may require closer medication or follow-up strategy during ICI therapy.

PROSPERO Registration

CRD42024518407

KEYWORDS:

• Immune checkpoint inhibitor
• hepatocellular carcinoma
• age
• sex
• eastern cooperative oncology group performance status

Abbreviations

ECOG PS, eastern cooperative oncology group performance status; ICI, immune checkpoint inhibitor; HCC, hepatocellular carcinoma; ORR, objective response rate; PFS, progression-free survival; OS, overall survival; AEs, adverse events; HR, hazard ratios; OR, odds ratio; CI, confidence interval; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analysis; NOS, Newcastle-Ottawa Scale; RoB2, risk of bias tool 2.0; trAE: treatment-related adverse event; irAE, immune-related adverse event.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14737140.2024.2341723

Author contributions

CL Han, BW Tian, LJ Yan and T Li designed the protocol of this meta-analysis. CL Han, BW Tian, LJ Yan and T Li performed the literature search of relevant studies. CL Han, BW Tian, LJ Yan, ZN Ding, H Liu, GQ Pan, X Zhang, and T Li identified relevant studies and assessed study quality. CL Han, BW Tian, LJ Yan, XC Mao, SY Tan, RZ Li, and T Li extracted eligible data from the involved articles. CL Han, BW Tian, LJ Yan, DX Wang, ZR Dong, YC Yan, and T Li analyzed, interpreted the data. CL Han, BW Tian, LJ Yan and T Li drafted the original manuscript. CL Han, BW Tian, LJ Yan and T Li revised the manuscript. The final version of the manuscript was assessed and approved by all authors.

Availability of data material

The authors confirm that the data supporting the finding of this study are available within the article.

Additional information

Funding

This manuscript was funded by the Taishan Scholars Program for Experts of Shandong Province [Grant No. tstp20221158], National Natural Science Foundation of China [82172647, 82073200, 81874178], Funds for Independent Cultivation of Innovative Team from Universities in Jinan [2020GXRC023], Shandong Provincial Natural Science Foundation [ZR2021ZD26, ZR2021MH194] and China Postdoctoral Science Foundation [2020M682192, 2022T150385].