Efficacy and safety of anlotinib plus docetaxel versus docetaxel monotherapy in advanced non–small cell lung cancer: A systematic review and meta-analysis.

Abstract

e20734 Background: Docetaxel monotherapy remains a standard second-line treatment for patients with advanced non–small cell lung cancer (NSCLC) who experience disease progression following first-line chemoimmunotherapy. However, its clinical benefit is limited by modest efficacy and the development of treatment resistance. Given the paucity of robust evidence evaluating combination strategies, we conducted this meta-analysis to assess whether anlotinib plus docetaxel provides superior therapeutic efficacy with an acceptable safety profile compared with docetaxel alone. Methods: We systematically searched PubMed, the Cochrane Central Register of Controlled Trials, Scopus, and Web of Science for randomized controlled trials (RCTs) and retrospective studies. Continuous outcomes were pooled as mean differences, and dichotomous outcomes as risk ratios, using a random-effects model. Results: Six studies comprising 609 patients were included, with a mean age of 55 years. Anlotinib plus docetaxel significantly improved progression-free survival (PFS; p < 0.00001), objective response rate (ORR; p = 0.001), and disease control rate (DCR; p < 0.00001), with median overall survival ranging from 12.0 to 16.82 months in the combination group compared with 9.2 to 10.9 months in the docetaxel monotherapy group. Combination therapy was associated with higher rates of hand–foot syndrome (p < 0.0001), hypertension (p < 0.0001), hypertriglyceridemia (p = 0.05), and fatigue (p = 0.05). No significant differences were observed in thrombocytopenia (p = 0.72), proteinuria (p = 0.37), abnormal liver function (p = 0.07), oral mucositis (p = 0.23), or diarrhea (p = 0.25). Conclusions: In this systematic review and meta-analysis, anlotinib combined with docetaxel demonstrated significantly improved therapeutic efficacy and survival outcomes compared with docetaxel monotherapy in patients with advanced NSCLC who progressed after prior treatment. These benefits were achieved without a meaningful increase in hematologic toxicities. Although combination therapy was associated with higher rates of hand–foot syndrome and hypertension, these adverse events were largely manageable with standard supportive measures. Collectively, these findings suggest that anlotinib plus docetaxel represents a promising, clinically meaningful second-line treatment option for advanced NSCLC, with improved efficacy and manageable toxicity, and warrants prospective randomized validation.