Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study

Abstract 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, doubl...

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Autores principales:	Ying Liu, Ying Cheng, Qiming Wang, Kai Li, Jianhua Shi, Lin Wu, Baohui Han, Gongyan Chen, Jianxing He, Jie Wang, Haifeng Qin, Xiaoling Li
Formato:	article
Lenguaje:	EN
Publicado:	Wiley 2021
Materias:	anlotinib objective response pleural effusion small‐cell lung cancer survival Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/ab2994bcd8054ec189ff9236a03df8b0
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spelling	oai:doaj.org-article:ab2994bcd8054ec189ff9236a03df8b02021-11-14T23:28:25ZEffectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study1759-77141759-770610.1111/1759-7714.14176https://doaj.org/article/ab2994bcd8054ec189ff9236a03df8b02021-11-01T00:00:00Zhttps://doi.org/10.1111/1759-7714.14176https://doaj.org/toc/1759-7706https://doaj.org/toc/1759-7714Abstract 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.Ying LiuYing ChengQiming WangKai LiJianhua ShiLin WuBaohui HanGongyan ChenJianxing HeJie WangHaifeng QinXiaoling LiWileyarticleanlotinibobjective responsepleural effusionsmall‐cell lung cancersurvivalNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENThoracic Cancer, Vol 12, Iss 22, Pp 3039-3045 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	anlotinib objective response pleural effusion small‐cell lung cancer survival Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	anlotinib objective response pleural effusion small‐cell lung cancer survival Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Ying Liu Ying Cheng Qiming Wang Kai Li Jianhua Shi Lin Wu Baohui Han Gongyan Chen Jianxing He Jie Wang Haifeng Qin Xiaoling Li Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study
description	Abstract 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.
format	article
author	Ying Liu Ying Cheng Qiming Wang Kai Li Jianhua Shi Lin Wu Baohui Han Gongyan Chen Jianxing He Jie Wang Haifeng Qin Xiaoling Li
author_facet	Ying Liu Ying Cheng Qiming Wang Kai Li Jianhua Shi Lin Wu Baohui Han Gongyan Chen Jianxing He Jie Wang Haifeng Qin Xiaoling Li
author_sort	Ying Liu
title	Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study
title_short	Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study
title_full	Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study
title_fullStr	Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study
title_full_unstemmed	Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study
title_sort	effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: subgroup analysis from a randomized, multicenter, phase ii study
publisher	Wiley
publishDate	2021
url	https://doaj.org/article/ab2994bcd8054ec189ff9236a03df8b0
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Effectiveness of anlotinib in patients with small‐cell lung cancer and pleural effusion: Subgroup analysis from a randomized, multicenter, phase II study

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