BACKGROUND: Anlotinib has shown remarkable efficacy in later-line treatment of advanced non-small cell lung cancer (NSCLC). This prospective real-world study evaluated its efficacy and safety in routine clinical practice. METHODS: Patients from 13 centers in China received anlotinib (8-12 mg) once daily on days 1-14 of a 21-day cycle until disease progression, death, or unacceptable toxicity. Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. RESULTS: From July 2019 to October 2021, 352 of 373 enrolled patients received ≥ 2 cycles of anlotinib. Median follow-up was 35.5 months. Median PFS and OS were 5.8 months (95% CI, 5.0-6.4) and 11.3 months (95% CI, 9.9-13.1), respectively. ORR and DCR were 19.3% and 84.4%. Multivariable analysis indicated that age ≥ 70 years was independently associated with poorer OS, though a clinically meaningful benefit remained (PFS, 5.9 months; OS, 9.6 months). Efficacy appeared generally similar regardless of baseline brain metastases. Median PFS and OS were 6.3 and 12.7 months in the second-line setting, and 5.5 and 11.3 months in the≥ third-line setting. Treatment-related adverse events occurred in 10.5%, with grade ≥ 3 events in 1.4%; no treatment-related deaths were observed. CONCLUSION: In this real-world cohort, anlotinib demonstrated effectiveness and acceptable tolerability in advanced NSCLC. Given the observational design, exploratory analyses-including age, treatment line, and baseline brain metastases-should be interpreted with caution. These findings complement limited existing real-world data and may inform future clinical research and decision-making. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04871997.
Wang et al. (Mon,) studied this question.
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