The therapeutic response was evaluated according to RECIST version 1.1 criteria by investigator assessment using the chest computed tomography (CT) scans or nuclear magnetic resonance imaging (MRI) at baseline and during anlotinib treatment. Change of target lesions was assessed every two cycles or based on the actual situation when the clinical symptoms of patients worsened. The best overall response of each enrolled patient was recorded during anlotinib treatment. Furthermore, adverse reactions during treatment were documented using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 criteria to describe toxicity profile that might be drug-related.23 (link) The prognostic significance of common adverse reactions was performed and analyzed. For this analysis, hypertension was defined as either new-onset hypertension or worsening grade (CTCAE v4.03) from baseline in patients with a history of hypertension using AE data and actual blood pressure measurements. For preexisting hypertension, any increase in drug dosage or initiation of a new antihypertensive agent was denoted as grade 3.24 (link)
Initial follow-up was performed in the hospital, where baseline characteristics and adverse reactions and the date of disease progression of each patient could be clearly obtained through the electronic medical record system. The subsequent follow-up was performed through mobile phone and progression or death status was mainly obtained. The last follow-up date of this study was June 25, 2020.