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Clinical Trial
. 2020 Dec 15;147(12):3453-3460.
doi: 10.1002/ijc.33161. Epub 2020 Jun 26.

A phase II study of anlotinib in 45 patients with relapsed small cell lung cancer

Di Wu  1 , Jun Nie  1 , Weiheng Hu  1 , Ling Dai  1 , Jie Zhang  1 , Xiaoling Chen  1 , Xiangjuan Ma  1 , Guangming Tian  1 , Jindi Han  1 , Sen Han  1 , Jieran Long  1 , Yang Wang  1 , Ziran Zhang  1 , Jian Fang  1
Affiliations
Clinical Trial

A phase II study of anlotinib in 45 patients with relapsed small cell lung cancer

Di Wu et al. Int J Cancer. .

Abstract

The purpose of this prospective phase II clinical trial was to investigate the efficacy and safety of anlotinib in patients with relapsed small cell lung cancer (SCLC). Forty-five patients with relapsed SCLC were enrolled and treated with anlotinib (one cycle of 12 mg daily for 14 days, discontinued for 7 days, and repeated every 21 days) until disease progression or intolerance of treatment. The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), disease control rate (DCR), objective control rate (ORR) and toxicity. The median PFS was 4.1 months (95% confidence interval [CI] 2.4-5.8) and the median OS was 6.1 months (95% CI 2.2-10.0). The OS for the limited-stage subgroup was significantly longer than that of the extensive-stage subgroup (P = .02). The DCR was 67%, and the ORR was 11%. The most common adverse event was hypertension (13%), which was controlled well with antihypertensive drugs. In conclusion, anlotinib has likely efficacy in patients with relapsed SCLC, and the side effects can be well tolerated. A longer OS was observed in limited-stage SCLC patients treated with anlotinib.

Keywords: anlotinib; phase II; small cell lung cancer.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

FIGURE 1
FIGURE 1
Efficacy of anlotinib. A, Progression‐free survival for all 45 patients. B, OS for all 45 patients. C, Overall survival stratified by clinical stage
FIGURE 2
FIGURE 2
Measurable changes in lesions from baseline. Among the 36 patients for whom changes in lesion size could be determined, 5 patients were PR, 23 patients were SD and 8 patients were PD. According to the RECIST standard, measurable lesions increased more than 20% were evaluated as PD, and reduced more than 30% as PR
See this image and copyright information in PMC

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