No abstract

Background: ALTER1202 trial, the phase II study has demonstrated that anlotinib significantly prolonged progress-free survival (PFS) in relapsed SCLC patients as 3 rd or further line treatment. Here, we performed a comparative analysis for patients with liver metastases in the placebo and anlotinib group.Methods: Eligible either limited-or extensive-stage SCLC patients who failed 2 lines of chemotherapy were randomized 2:1 to receive anlotinib or placebo (12 mg QD from day 1 to 14 of a 21-day cycle) till progression or intolerable toxicity. The primary endpoint was PFS. This subgroup analysis was based on patients with liver metastases at baseline.Results: There are 39 patients with liver metastases in anlotinib and placebo groups (27 vs 12). Anlotinib significantly improved median PFS (1.84 vs 0.71 months; HR ¼0.37; 95% CI, 0.17e0.81; P¼0.0039) but not median overall survial (3.29 vs 1.91 months; HR ¼ 0.54; 95% CI, 0.23e1.26; P ¼0.1042) comparing to placebo in patients with liver metastases at baseline. The objective response rate was 3.7% in the anlotinib group and 0% in the placebo group (P ¼0.9999). 11(40.74%) patients in the anlotinib group and 1 (8.33%) patients in the placebo group had stable disease. The disease control rate was significantly higher in the anlotinib group (44.4%) than in the placebo group (8.33%, P < 0.0173). There was no complete response in either group.The most common adverse events in anlotinib group were hypertension(40.74%), fatigue(29.63%), loss of appetite(22.22%) and loss of weight (22.22 %) while in placebo group were ALT elevation (33.33%) , AST elevation (33.33%) and fatigue(25.00%).Conclusions: Anlotinib, administrate as 3 rd or further line treatment, was welltolerated and significantly prolonged PFS of relapsed SCLC patients with liver metastases.Clinical trial identification: NCT03059797.