Kong Fanming, Wang Ziwei, Wang Na, Zhang Dou, Liao Dongying, Zhang Jing, Sun Yidan, Zhang Haojian, Jia Yingjie
Department of Oncology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Anshanxi Road, Nankai District, Tianjin 300193, China.
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion Tianjin 300193, China.
Am J Cancer Res. 2023 Aug 15;13(8):3679-3685. eCollection 2023.
The extent to which anlotinib provides survival benefits in the maintenance therapy of extensive-stage small cell lung cancer (ES-SCLC) remains unclear. Thus, this study aimed to assess the efficacy and safety of anlotinib monotherapy as maintenance therapy following induction chemotherapy in ES-SCLC patients. 27 ES-SCLC patients registered at the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine were screened from February 2022 to October 2022, of which 3 were not eligible. Eligible patients in stable status after first-line chemotherapy would subsequently accept oral anlotinib (12 mg, p.o., qd. on d1-d14, every 21 days). The maintenance method was continued until disease progression or unmanageable toxicity occurred. The primary endpoint is median progression-free survival (mPFS). The second endpoints include median duration of response (mDOR), median overall survival (mOS) and safety. The mPFS and mDOR have been determined (mPFS: 252 days, 95% CI: 217.782-286.218 days; mDOR: 126 days, 95% CI: 98.899-153.101 days). The mOS was not reached; only 7 patients were reached while 20 patients survived. The primary treatment-related adverse events included hypertension (n=7, 25.9%), fatigue (n=5, 18.5%), poor appetite (n=5, 18.5%), and others. Notably, no patients required a dose reduction due to the severity of adverse events. Patients were generally able to tolerate treatment with anlotinib and exhibited a favorable prognosis. Anlotinib achieved prospective efficacy and manageable safety in the maintenance treatment of ES-SCLC.
安罗替尼在广泛期小细胞肺癌（ES-SCLC）维持治疗中提供生存获益的程度尚不清楚。因此，本研究旨在评估安罗替尼单药作为ES-SCLC患者诱导化疗后维持治疗的疗效和安全性。2022年2月至2022年10月，对天津中医药大学第一附属医院登记的27例ES-SCLC患者进行筛选，其中3例不符合条件。一线化疗后病情稳定的合格患者随后接受口服安罗替尼（12 mg，口服，第1 - 14天每天一次，每21天重复）。维持治疗方法持续至疾病进展或出现无法耐受的毒性。主要终点是中位无进展生存期（mPFS）。次要终点包括中位缓解持续时间（mDOR）、中位总生存期（mOS）和安全性。已确定mPFS和mDOR（mPFS：252天，95%CI：217.782 - 286.218天；mDOR：126天，95%CI：98.899 - 153.101天）。mOS未达到；仅7例患者达到终点，20例患者存活。主要的治疗相关不良事件包括高血压（n = 7，25.9%）、疲劳（n = 5，18.5%）、食欲减退（n = 5，18.5%）等。值得注意的是，没有患者因不良事件严重程度而需要减量。患者总体上能够耐受安罗替尼治疗，预后良好。安罗替尼在ES-SCLC维持治疗中取得了预期疗效且安全性可控。
