1791P - Effect of anlotinib in advanced small cell lung cancer (SCLC) patients with liver metastases: A subgroup analysis from a randomized, double-blind phase II trial (ALTER 1202)

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 =0.37; 95% CI, 0.17–0.81; P=0.0039) but not median overall survial (3.29 vs 1.91 months; HR = 0.54; 95% CI, 0.23–1.26; P =0.1042) 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 =0.9999). 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 well-tolerated and significantly prolonged PFS of relapsed SCLC patients with liver metastases.

Clinical trial identification

NCT03059797.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Chia Tai Tianqing Pharm co., Ltd.

Disclosure

All authors have declared no conflicts of interest.