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 Jin3 1Department of Prescription Teaching and Research, Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, 150006, People’s Republic of China; 2Department of Intensive Care Rehabilitation, The Fourth Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, 150070, People’s Republic of China; 3Department of Acupuncture, The First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang, 150040, People’s Republic of China*These authors contributed equally to this workCorrespondence: Hong Jin, Department of Acupuncture, The First Affiliated Hospital of Heilongjiang University of Chinese Medicine, No. 26, He Ping Street, Xiang Fang District, Harbin, Heilongjiang, 150040, People’s Republic of China, Tel +86 13836129681, Email [email protected]: 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, previously immunotherapy-treated, anlotinib, docetaxel, efficacy, safety