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
. 2025 Apr 28:18:2319-2331.
doi: 10.2147/IJGM.S521360. eCollection 2025.

Feasibility and Safety of Anlotinib Plus Docetaxel versus Docetaxel Monotherapy in Patients with Previously Immunotherapy-Treated NSCLC: A Retrospective Exploratory Study

Da-Wei Li #  1 , Ying-Dong Li #  2 , Hong Jin  3
Affiliations

Feasibility and Safety of Anlotinib Plus Docetaxel versus Docetaxel Monotherapy in Patients with Previously Immunotherapy-Treated NSCLC: A Retrospective Exploratory Study

Da-Wei Li et al. Int J Gen Med. .

Abstract

Objective: This study aims to evaluate the efficacy and safety of anlotinib plus docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have previously treated with immunotherapy.

Methods: This retrospective analysis was conducted on 86 previously immunotherapy-treated patients with advanced NSCLC from December 2018 to October 2024 in clinical practice. Those who received anlotinib plus docetaxel were assigned to experimental group (EG, N=43), while those who were treated with docetaxel monotherapy were deemed as control group (CG, N=43) in clinical practice. Efficacy and safety of both regimens were compared with regular follow-up for survival data collection. The primary endpoints included overall survival (OS) and secondary endpoints were progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR).

Results: ORR in the experimental and control groups was 30.2% (95% CI: 17.2-46.1%) and 13.9% (95% CI: 5.3-27.9%), respectively, showing a trend towards significance (P=0.069). DCR was significantly higher in the EG at 79.1% (95% CI: 63.9-89.9%) compared to 51.2% (95% CI: 35.5-66.7%) in the CG (P=0.007). After a median follow-up of 12.8 and 8.5 months, respectively, the median PFS was 6.5 months (95% CI: 4.08-8.92) in the EG, compared to 2.9 months (95% CI: 2.53-3.27) in the CG (P=0.019). The median OS was 13.5 months (95% CI: 10.49-16.51) in the EG, compared to 9.2 months (95% CI: 5.73-12.67) in the CG (P=0.007). Adverse events of all grades occurred in 93.0% of patients in the EG and 83.7% in the CG. Grade 3 or above adverse events were detected in 51.2% and 44.2%, respectively, with similar safety profiles between the groups.

Conclusion: Anlotinib plus docetaxel demonstrated preliminary efficacy and a tolerable safety profile in patients with previously immunotherapy-treated advanced NSCLC, providing a potential therapeutic option in the post-immunotherapy setting. The conclusion should be confirmed in prospective clinical trials subsequently.

Keywords: NSCLC; anlotinib; docetaxel; efficacy; previously immunotherapy-treated; safety.

PubMed Disclaimer

Conflict of interest statement

The authors declare that there are no conflicts of interest.

Figures

Figure 1
Figure 1
Flowchart of this retrospective study (NSCLC: non-small cell lung cancer).
Figure 2
Figure 2
Waterfall plots of the best changes in target lesions of patients with previously immunotherapy-treated advanced non-small cell lung cancer (NSCLC) in experimental group (EG) and control group (CG).
Figure 3
Figure 3
Comparison of objective response rate (ORR) and disease control rate (DCR) between experimental group (EG) and control group (CG).
Figure 4
Figure 4
Comparison of progression free survival (PFS) between experimental group (EG) and control group (CG).
Figure 5
Figure 5
Comparison of overall survival (OS) between experimental group (EG) and control group (CG).
See this image and copyright information in PMC

Similar articles

See all similar articles

References

    1. Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. doi:10.3322/caac.21660 - DOI - PubMed
    1. Luo XC, Tang P, Zhong PX. Analysis of the effects of bevacizumab combined with chemoradiotherapy on VEGF, bFGF, and Let-7 levels in non-small cell lung cancer and the factors influencing therapeutic efficacy: a retrospective cohort study. Int J Gen Med. 2024;17:5727–5735. doi:10.2147/ijgm.s488849 - DOI - PMC - PubMed
    1. Saad MB, Hong L, Aminu M, et al. Predicting benefit from immune checkpoint inhibitors in patients with non-small-cell lung cancer by CT-based ensemble deep learning: a retrospective study. Lancet Digit Health. 2023;5(7):e404–e420. doi:10.1016/s2589-7500(23)00082-1 - DOI - PMC - PubMed
    1. Jiang X, Wang J, Deng X, et al. Role of the tumor microenvironment in PD-L1/PD-1-mediated tumor immune escape. Mol Cancer. 2019;18(1):10. doi:10.1186/s12943-018-0928-4 - DOI - PMC - PubMed
    1. Zhou C, Huang D, Fan Y, et al. Tislelizumab versus docetaxel in patients with previously treated advanced NSCLC (RATIONALE-303): a phase 3, open-label, randomized controlled trial. J Thorac Oncol. 2023;18(1):93–105. doi:10.1016/j.jtho.2022.09.217 - DOI - PubMed

LinkOut - more resources