Abstract 1787P
Background
ALTER1202 trial,the phase II study has demonstrated that anlotinib significantly prolonged progress-free survival (PFS) in relapsed small cell lung cancer(SCLC) patients as 3rd or further line treatment. Here, we performed a comparative analysis for patients with pleural metastases/pleural effusion in the placebo and anlotinib group.
Methods
Eligible either limited- or extensive-stage SCLC pts 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 pleural metastases/pleural effusion at baseline.
Results
There are 42 patients with pleural metastases/pleural effusion in anlotinib and placebo groups (27 vs. 15). Anlotinib significantly improved PFS (2.83 vs. 0.69 months; HR =0.10; 95% CI, 0.03–0.28; P＜0.0001) compared to placebo and prolonged the overall suirval of 3.75 months without statistical significance (6.51 vs. 2.76 months; HR = 0.52; 95% CI, 0.22–1.23; P =0.1285) compared to placebo. The objective response rate was 3.85% in the anlotinib group and 0% in the placebo group (P =0.442). 16(61.54%) patients in the anlotinib group and no patient in the placebo group had stable disease. The disease control rate was significantly higher in the anlotinib group (65.38%) than in the placebo group (0, P =0.000043). There was no complete response in either group. The most common adverse events in anlotinib group were hypertension (37.04%), fatigue (29.63%) and loss of appetite (29.63%) while in placebo group were γ- glutamyl transferase elevation (20.00%) and loss of appetite (20.00 %).
Conclusions
Anlotinib, administrate as 3rd or further line treatment, was well-tolerated and significantly prolonged PFS of relapsed SCLC patients with pleural metastases/pleural effusion.
Clinical trial identification
NCT03059797.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.