Efficacy and Safety of Anlotinib for Elderly Patients with Previously Treated Extensive-Stage SCLC and the Prognostic Significance of Common Adverse Reactions

Background: This study was to investigate the efficacy and safety of anlotinib for elderly patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) and the prognostic significance of common adverse reactions.

Patients and methods: A total of 79 elderly patients (≥60 years) with ES-SCLC who failed after at least two lines of previous systemic therapy were included. Baseline characteristics of the patients were collected. Follow-up was conducted regularly. Adverse reactions were documented. Survival curves were drawn using Kaplan-Meier method. Univariate analysis was assessed using log rank test, and multivariate analysis was adjusted by Cox regression analysis. Additionally, the prognostic significance of common adverse reactions was performed.

Results: All of the 79 patients were available for evaluation of efficacy. Partial response (PR) was observed in 7 patients, stable disease (SD) was noted in 48 patients and progressive disease (PD) was confirmed in 24 patients. Consequently, the objective response rate (ORR) was 8.9% and disease control rate (DCR) was 69.6%. The median progression-free survival (PFS) of the 79 elderly patients with ES-SCLC was 3.0 months [95% confidence interval (CI): 2.02-3.98]. The median overall survival (OS) was 7.1 months (95% CI: 5.07-9.13). Safety profile demonstrated that the relatively common adverse reactions of the elderly patients with ES-SCLC receiving anlotinib treatment were hypertension (40.5%), hand-foot syndrome (HFS, 31.6%), diarrhea (27.8%), decreased appetite (20.3%), fatigue (17.7%) and weight loss (17.7%). Interestingly, the prognostic significance of common adverse reactions indicated that the median PFS of patients with hypertension and without hypertension was 4.35 and 2.95 months, respectively (P=0.01), and the median PFS of patients with HFS and without HFS was 4.20 and 2.95 months, respectively (P=0.03).

Conclusion: The preliminary efficacy and safety of anlotinib in the treatment for elderly patients with previously treated ES-SCLC was satisfactory, and patients with hypertension and hand-foot syndrome might confer superior prognosis.