The real-world efficacy and safety of anlotinib in advanced non-small cell lung cancer

PURPOSE: Anlotinib is an anti-angiogenetic multi-targeted tyrosine kinase inhibitor. This study aimed to evaluate the efficacy and safety of anlotinib in advanced non-small cell lung cancer (aNSCLC) in the real world. METHODS: Patients with aNSCLC receiving anlotinib were enrolled in two cohorts (treatment naive and previously treated). The endpoints included progression-free survival (PFS), overall survival (OS) and anlotinib-related adverse events (ar-AEs). RESULTS: 203 patients accrued in the study. In the treatment-naïve cohort (n = 80), the PFS was 7.4 (95% confidence interval [CI] 4.1–10.7) and OS was 10.8 (95% CI 5.8–15.8) months of monotherapy group (immature survival for combination group). In previously treated cohort (n = 123), the PFS was 8.0 months (95% CI 6.1–9.9) in the combination group and 4.3 months (95% CI 2.1–6.6) in the monotherapy group (hazard ratio [HR] 0.49; 95% CI 0.29–0.83; p = 0.007), respectively. The OS was 18.5 months (95% CI 10.5–26.6) in the combination group and 7.8 months (95% CI 7.1–8.4) in the monotherapy group (HR 0.38; 95% CI 0.22–0.66; p = 0.001), respectively. The ar-AEs of grade ≥ 3 in the monotherapy and the combination groups were hypertension (9.0 and 8.7%), fatigue (8.1 and 7.6%), hand-foot syndrome (8.1 and 6.5%), diarrhea (5.4 and 8.7%), proteinuria (5.4 and 5.4%), and mucositis oral (6.3 and 8.7%). CONCLUSION: In aNSCLC, anlotinib monotherapy has a promising efficacy in the first-line setting. It may be an option for those who are ineligible for chemotherapy; anlotinib combination therapy in a ≥ second-line setting showed manageable toxicities and encouraging efficacy, indicating a good application prospect. TRIAL REGISTRATION: This study was retrospectively registered with ISRCTN Registry (ID ISRCTN35543977) on January 26th, 2021 and Chinese Clinical Trial Register (ChiCTR2000032265) on April 4th, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00432-021-03752-x.