Open AccessEffectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study
Author(s) -
Liu Ying,
Cheng Ying,
Wang Qiming,
Li Kai,
Shi Jianhua,
Wu Lin,
Han Baohui,
Chen Gongyan,
He Jianxing,
Wang Jie,
Qin Haifeng,
Li Xiaoling
Publication year - 2021
Publication title -
thoracic cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.823
H-Index - 28
eISSN - 1759-7714
pISSN - 1759-7706
DOI - 10.1111/1759-7714.14176
Subject(s) - medicine , placebo , pleural effusion , gastroenterology , lung cancer , adverse effect , chemotherapy , surgery , pathology , alternative medicine
Background The presence of pleural effusion is an independent predictor for poor survival in patients with small‐cell lung cancer (SCLC). The aim of this study was to assess the efficacy and safety of anlotinib in patients with SCLC and pleural effusion. Methods This was a randomized, double‐blind, multicenter, phase II trial. Patients histologically diagnosed with SCLC and pleural effusion and had received at least two lines of chemotherapy were enrolled into the study. The patients received anlotinib 12 mg/day or a placebo. Results The overall response rate (ORR) was 3.7% for anlotinib ( n = 27) and 0% in the placebo group ( n = 15) ( p = 1.000). The disease control rate (DCR) of the anlotinib group (63.0%) was higher than that of the placebo group (0%, p < 0.0001). The median progression‐free survival (PFS) increased in the anlotinib group (2.8 months) compared to the placebo group (0.7 months, HR = 0.10, 95% CI: 0.03–0.28, p < 0.001). The median overall survival of the anlotinib group (6.5 months) was higher than that of the placebo group (2.8 months, HR = 0.52, 95% CI: 0.22–1.23, p = 0.1285). The incidence of any grade adverse events was 100% in both groups. The percentage of grade 3–4 adverse events in the anlotinib group was 44.4% (12/27) compared to 40.0% (6/15) in the placebo group. Hypertension (37.0%), fatigue (29.6%), and loss of appetite (29.6%) typically appeared in the anlotinib group. Conclusions In this post hoc analysis, anlotinib was associated with improved PFS in patients with SCLC and baseline pleural effusion. However, additional studies with a large sample size are necessary to substantiate the current findings.