| Heng Cao,Kai Liang,Peng Liu,Yonggui Hong,Jing Wang,Yuanyuan Ji,Lujuan Xu,Weilong Wu,Shengnan Guo,Xuekun Song. Efficacy and safety of anlotinib plus S-1 as thirdly-line or later-line treatment in advanced non-small cell lung cancer. Oncol Transl Med, 2020, 6: 10-15. |
| 安罗替尼联合替吉奥治疗三线及以上晚期非小细胞肺癌的疗效及安全性观察 |
| Efficacy and safety of anlotinib plus S-1 as thirdly-line or later-line treatment in advanced non-small cell lung cancer |
| Received:July 23, 2019 Revised:March 11, 2020 |
| DOI：10.1007/s10330-019-0370-0 |
| 中文关键词: 非小细胞肺癌；安罗替尼；替吉奥胶囊；晚期 |
| 英文关键词: non-small cell lung cancer (NSCLC); anlotinib; tegafur gimerac; advanced stage |
| 基金项目:国家自然科学基金项目（青年科学基金项目61702164） |
| Author Name | Affiliation | E-mail | | Heng Cao | Department of Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of | caoheng123jun@126.com | | Kai Liang | Department of Surgical Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University | | | Peng Liu | Department of Surgical Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University | | | Yonggui Hong* | Department of Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of | hygsir168@126.com | | Jing Wang | Department of Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of | | | Yuanyuan Ji | Department of Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of | | | Lujuan Xu | Department of Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of | | | Weilong Wu | Department of Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of | | | Shengnan Guo | Department of Oncology, Anyang Tumor Hospital, The Fourth Affiliated Hospital of Henan University of | | | Xuekun Song | Henan University of Chinese Medicine, Zhengzhou 450000, China | |
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| 中文摘要: |
| 【摘要】背景与目的 安罗替尼在体内和体外试验中证实对肺癌具有抗肿瘤活性，被推荐为晚期非小细胞肺癌患者的三线治疗方案。本研究前瞻性探讨三线及以上应用安罗替尼联合替吉奥治疗晚期非小细胞肺癌的临床疗效及安全性。方法 均经组织病理或细胞学明确诊断晚期非小细胞肺癌，二线化疗和（或）EGFR-TKI治疗后疾病进展。口服安罗替尼胶囊8mg/日，D1-14联合替吉奥胶囊60mg/m2 D1-14，21天为一周期。治疗终止时间为疾病进展或出现不可接受的毒副反应。结果 41例患者均可评价疗效，客观缓解率（overall response rate,ORR）为26.8%，疾病控制率（disease control rate, DCR）为80.5%。中位无进展生存期（progression-free survival, PFS）为5.2个月（95%CI:3.9个月－6.6个月）。单因素分析，脑转移患者和无脑转移患者的中位PFS差异具有统计学意义（4.8个月vs 5.9个月，p=0.039）。多变量回归分析显示，ECOG评分(P=0.002)、治疗线数（P=0.015）和疗效评价(P=0.014)是PFS的独立影响因素。最常见不良反应为高血压、蛋白尿、骨髓抑制、胃肠道反应、疲乏和口腔黏膜炎。结论 安罗替尼联合替吉奥胶囊三线及以上治疗晚期非小细胞肺癌疗效显著且安全性良好。 |
| 英文摘要: |
| Objective Anlotinib, an oral vascular endothelial growth factor receptor 2 (VEGFR2) inhibitor, has
confirmed antitumor activity in lung cancer in both in vitro and in vivo assays, and has been recommended
as third-line treatment agent in non-oncogene driven non-small cell lung cancer (NSCLC). This prospective
study aimed to investigate the efficacy and safety of anlotinib plus S-1 for third- or later-line treatment in
patients with advanced NSCLC.
Methods Patients with histologically or cytologically confirmed NSCLC, and documented disease
progression following second-line chemotherapy, and/or epidermal growth factor receptor-tyrosine kinase
inhibitor (EGFR-TKI) treatment were enrolled in this study. The patients were treated anlotinib (8 mg
daily d 1–14) and S-1 (60 mg/m2 d 1–14) and the treatment was repeated every 3 weeks. Treatment was
continued until disease progression or unacceptable toxicity occurred. The objective response rate (ORR),
disease control rate (DCR), progression-free survival (PFS), and adverse events (AEs) were reviewed and
evaluated.
Results Forty-one patients were enrolled in the study between June 2018 and December 2018. The total
ORR and DCR were 26.8% and 80.5%, respectively. The median PFS was 5.2 months [95% confidence
interval (CI), 3.9 to 6.6 months]. In the univariate analysis, there was a significant difference in the median
PFS between patients with brain metastases and those without brain metastases (4.8 months vs 5.9
months, respectively; P = 0.039). The Eastern Cooperative Oncology Group (ECOG) performance status (P
= 0.002), lines of therapy (P = 0.015), and therapeutic evaluation (P = 0.014) were independent factors that
influenced PFS. The most common AEs were hypertension, proteinuria, myelosuppression, gastrointestinal
reactions, fatigue, and mucositis.
Conclusion Anlotinib plus S-1 is an effective and safe regimen for advanced NSCLC as third- or later-line
therapy. |
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