Efficacy and Safety of Anlotinib-Containing Regimens in Advanced Non-Small Cell Lung Cancer: A Real-World Study

Lei Sun; Qi Zhao; Yanning Wang; Yongsheng Wang; Ming Zheng; Xuansheng Ding; Liyun Miao

doi:10.2147/IJGM.S424777

Efficacy and Safety of Anlotinib-Containing Regimens in Advanced Non-Small Cell Lung Cancer: A Real-World Study

Int J Gen Med. 2023 Sep 12:16:4165-4179. doi: 10.2147/IJGM.S424777. eCollection 2023.

Authors

Lei Sun^#¹, Qi Zhao^#², Yanning Wang^#³, Yongsheng Wang², Ming Zheng², Xuansheng Ding⁴, Liyun Miao²

Affiliations

¹ School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University Nanjing Drum Tower Hospital, Nanjing, People's Republic of China.
² Department of Respiratory and Critical Care Medicine, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.
³ Clinical Stem Cell Center, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, People's Republic of China.
⁴ School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, People's Republic of China.

^# Contributed equally.

Abstract

Purpose: Anlotinib is widely used in the clinical treatment of non-small cell lung cancer (NSCLC), alone or in combination with other anticancer drugs. The aim of this study was to investigate the real-world efficacy and safety of anlotinib-containing regimens.

Patients and methods: Confirmed advanced NSCLC patients who had received anlotinib alone or in combination were enrolled. An overall analysis of the efficacy and safety of anlotinib was performed in all patients, and then subgroup analysis was used to further compare the efficacy between anlotinib monotherapy and combination therapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were ADR, ORR, and DCR.

Results: A total of 240 patients were included. The overall median PFS was 8.5 months (95% confidence interval [CI]: 7.1-9.9 months). Anlotinib treatment regimens (monotherapy or combination therapy) and whether they received previous antiangiogenesis were associated with PFS. Anlotinib plus immunotherapy achieved longer PFS than anlotinib monotherapy (median PFS: 10.5 vs 6.5 months, p=0.007). Stratification analysis showed the PFS of anlotinib plus immunotherapy was significantly longer in male, adenocarcinoma, <=65 years old, patients stage IV, EGFR wild type, with extrathoracic metastasis, performance status scores ≥2, the first-line treatment, patients with a history of hypertension and no previous antiangiogenesis than anlotinib monotherapy. The median PFS of anlotinib plus chemotherapy, targeted therapy was slightly longer than anlotinib alone (respectively, 10.5 vs 6.5 months, p=0.095; 9.5 vs 6.5 months, p=0.177). Adverse reactions were mostly mild and acceptable, with hypertension being the most common.

Conclusion: Anlotinib is effective and tolerable in advanced NSCLC patients. Immunotherapy combination with anlotinib significantly improved PFS. The efficacy of anlotinib may be impaired by previous antiangiogenic therapy, which can be investigated in further studies.

Keywords: anlotinib; combination therapy; efficacy; immunotherapy; non-small cell lung cancer; safety.