Efficacy and Safety of Anlotinib for Patients with Advanced NSCLC Who Progressed After Standard Regimens and the Preliminary Analysis of an Efficacy Predictor.

Background: The aim of this study was to investigate the efficacy and safety of anlotinib for patients with advanced non-small cell lung cancer (NSCLC) who progressed after standard regimens in real world situations and the preliminary analysis of an efficacy predictor.

Methods: A total of 118 patients with advanced NSCLC who progressed after standard regimens were included in this retrospective study. Efficacy was evaluated and toxicity profile was recorded. Progression-free survival (PFS) and overall survival (OS) were assessed using Kaplan-Meier survival curve and multivariate analysis was adjusted using Cox regression analysis.

Results: All of the 118 patients with NSCLC were available for evaluation of efficacy. Complete response (CR, 0 case), partial response (PR, 10 cases), stable disease (SD, 79 cases) and progressive disease (PD, 29 cases) were evaluated according to RECIST version 1.1. In consequence, objective response rate (ORR) was 8.47% and disease control rate (DCR) was 75.42%. The median PFS of the 118 patients with NSCLC was 4.3 months and the median OS was 10.3 months. The results of Cox regression analysis suggested that ECOG score was an independent factor for PFS. The toxicity profile indicated that hypertension and hand-foot syndrome were the most common adverse reactions. Additionally, the preliminary analysis of an efficacy predictor suggested that the PFS of patients with hypertension was superior to those without hypertension.

Conclusion: Anlotinib is effective and safe for patients with advanced NSCLC who progressed after standard regimens in real world situations. Hypertension may be a biomarker for efficacy prediction.