Discussion
NSCLC, ANL, fatigue, HCC, hypertension, hemoptysis, hand and foot syndrome
ADVERSE REACTIONS, ADVERSE REACTIONS, LOSS OF APPETITE, NSCLC, HYPERTENSION
In this phase II prospective clinical trial, we observed the efficacy and safety of ANL alone or in combination with S-1 in patients with advanced HCC. To the best of our knowledge, this is the first controlled study to evaluate ANL alone or in combination with S-1 in patients with advanced HCC. The results showed that ANL had certain antitumor activity in the treatment of advanced HCC and that adverse reactions could be controlled. However, it would be necessary to compare ANL with standard treatment in a randomized trial with more patients included before this drug appears in standard practice for HCC.Anlotinib is a novel multitarget tyrosine kinase inhibitor that mainly inhibits vascular endothelial growth factor receptor 2 and 3 (VEGFR2/3), fibroblast growth factor 1–4 (FGFR1-4), platelet-derived growth factor receptor α and β (PDGFR α/β), C-Kit and Ret.The mechanism of action of ANL is similar to that of apatinib.In this study, the main adverse reactions included hypertension, loss of appetite, fatigue, increased liver transaminase and hand and foot skin reactions, most of which were grade 1–2, and only a few patients with grade 3–4 adverse reactions needed to reduce the dose of ANL, indicating that the side effects of ANL were tolerable. Adverse reactions in NSCLC patients treated with ANL included hypertension (67.4%), hand and foot syndrome (43.9%), hemoptysis (14.0%), elevated thyroid stimulating hormone (TSH) (46.6%) and corrected QT interval (26.2%).The study has some limitations. First, this was a single-center study. Second, the study had a small sample size, with only 22 patients per cohort. The study is not powered enough to compare the ANL and ANL+S1 groups and to conclude that S1 does not add to efficacy.