Safety and efficacy of anlotinib hydrochloride capsules in advanced non-small-cell lung cancer: a multicenter, real-world study

Abstract

Objective: To investigate the safety and efficacy of anlotinib hydrochloride capsules in stage III–IV non-small-cell lung cancer (NSCLC). Methods: NSCLC patients received anlotinib monotherapy or combination therapy. The primary end point was adverse reactions during anlotinib treatment and the secondary end point was progression-free survival. Results: During anlotinib treatement, 41.85% (167/399) of patients experienced adverse reactions, and the monotherapy group had a lower incidence than the combination group (36.89 vs 49.68%; p = 0.012). The median progression-free survival of patients in the monotherapy group was significantly lower than that in the combination group (5 vs 6 months; p = 0.0119). Conclusion: Compared with anlotinib monotherapy, combination therapy resulted in longer PFS and a higher incidence of adverse reactions in patients with NSCLC.

Keywords::

• anlotinib
• efficacy
• non-small-cell lung cancer
• real-world
• safety

Author contributions

Conceptualization: J Cai and Q Ye; data curation: M Wang and M Mao; formal analysis: Y Yang and Z Cai; investigation: Y Li; methodology: Y Chen; writing – original draft: M Wang and M Mao; writing – review and editing: J Cai and Q Ye.

Financial & competing interests disclosure

This research was supported by the Hubei Provincial Science and Technology Plan Key Project (Special Project on Big Health; No. 2022BCE038) and the Yangtze University Joint Fund (No. WJ2019-25). The authors have no other 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 apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Additional information

Funding

This research was supported by the Hubei Provincial Science and Technology Plan Key Project (Special Project on Big Health; No. 2022BCE038) and the Yangtze University Joint Fund (No. WJ2019-25). The authors have no other 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 apart from those disclosed.