国际肿瘤学杂志

国际肿瘤学杂志 ›› 2023, Vol. 50 ›› Issue (12): 705-710.doi: 10.3760/cma.j.cn371439-20230715-00133

• 论著 • 上一篇    下一篇

安罗替尼单药在PS评分差的广泛期小细胞肺癌二线治疗中的临床疗效

黄锐, 张允清()   

  1. 安徽省阜阳市人民医院放疗科，阜阳 236000
  • 收稿日期:2023-07-15 修回日期:2023-09-13 出版日期:2023-12-08 发布日期:2024-01-16
  • 通讯作者: 张允清 E-mail:973289704@qq.com

Clinical efficacy of anlotinib monotherapy in second-line treatment of extensive stage small cell lung cancer with poor PS score

Huang Rui, Zhang Yunqing()   

  1. Department of Radiation Oncology， Fuyang People's Hospital of Anhui Province， Fuyang 236000， China
  • Received:2023-07-15 Revised:2023-09-13 Online:2023-12-08 Published:2024-01-16
  • Contact: Zhang Yunqing E-mail:973289704@qq.com

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摘要：

目的 探究安罗替尼单药在一线标准方案治疗失败且体力状况（PS）评分差的广泛期小细胞肺癌（ES-SCLC）二线治疗中的临床疗效和安全性。方法 选取2021年1月至2022年12月安徽省阜阳市人民医院经一线标准方案治疗失败且PS评分差的ES-SCLC患者33例，所有患者二线治疗均口服安罗替尼10 mg，服用2周停1周，21 d为1周期，直至疾病进展或患者不可耐受。观察客观缓解率（ORR）、疾病控制率（DCR）和不良反应，采用Kaplan-Meier法估算患者无进展生存期（PFS），Cox回归模型分析PFS的影响因素。结果 安罗替尼单药治疗至少2个周期后，33例患者中无完全缓解，部分缓解5例，病情稳定17例，疾病进展11例，ORR为15.2%（5/33），DCR为66.7%（22/33）。患者中位PFS为3.7个月（95%CI为2.9~4.5个月）。单因素分析显示，一线复发时间（χ2=4.90，P=0.027）、脑转移（χ2=12.42，P<0.001）、肝转移（χ2=11.05，P=0.001）和控制营养状况（CONUT）评分（χ2=12.43，P<0.001）均是安罗替尼单药治疗经一线治疗失败且PS评分差的ES-SCLC患者PFS的影响因素；多因素分析显示，脑转移（HR=3.21，95%CI为1.24~8.29，P=0.016）、肝转移（HR=2.80，95%CI为1.03~7.61，P=0.044）和CONUT评分（HR=2.72，95%CI为1.16~6.38，P=0.021）均是安罗替尼单药治疗经一线治疗失败且PS评分差的ES-SCLC患者PFS的独立影响因素。常见不良反应为乏力、高血压、食欲减退等，大部分不良反应为1~2级，3级不良反应发生率为9.1%（3/33），无4~5级不良反应。结论 安罗替尼单药在一线标准方案治疗失败且PS评分差的ES-SCLC二线治疗中的临床疗效较好，不良反应可控。

关键词: 小细胞肺癌, 治疗学, 安罗替尼

Abstract:

Objective To investigate the clinical efficacy and safety of anlotinib monotherapy in second-line treatment of extensive stage small cell lung cancer （ES-SCLC） with poor performance status （PS） score after treatment failure with first-line standard regimen. Methods Thirty-three patients with ES-SCLC who failed to receive first-line standard treatment and had poor PS score were selected from Fuyang People's Hospital of Anhui Province from January 2021 to December 2022. All patients were given anrotinib 10 mg orally for second-line treatment， which was taken for 2 weeks and stopped for 1 week， with every 21 days being a cycle period， until the disease progressed or the patient became intolerable. Objective response rate （ORR）， disease control rate （DCR） and adverse reactions were observed. Progression-free survival （PFS） was estimated by Kaplan-Meier method， and the influencing factors of PFS were analyzed by Cox regression model. Results After at least 2 cycles of anlotinib monotherapy， there were no complete remission， 5 cases of partial remission， 17 cases of stable disease， 11 cases of progressive disease. ORR was 15.2% （5/33）， DCR was 66.7% （22/33）. The median PFS was 3.7 months （95%CI： 2.9-4.5 months）. Univariate analysis showed that first-line recurrence time （χ2=4.90， P=0.027）， brain metastases （χ2=12.42， P<0.001）， liver metastases （χ2=11.05， P=0.001） and controlling nutritional status （CONUT） score （χ2=12.43， P<0.001） were the influential factors of PFS in ES-SCLC patients with poor PS score and first-line treatment failure of anlotinib monotherapy. Multivariate analysis showed that brain metastases （HR=3.21， 95%CI： 1.24-8.29， P=0.016）， liver metastases （HR=2.80， 95%CI： 1.03-7.61， P=0.044） and CONUT score （HR=2.72， 95%CI： 1.16-6.38， P=0.021） were independent influencing factors of PFS in ES-SCLC patients with first-line treatment failure of anlotinib monotherapy and poor PS score. Common adverse reactions were fatigue， hypertension， anorexia， etc. Most of the adverse reactions were grade 1-2， with the incidence of grade 3 adverse reactions being 9.1% （3/33）， and no grade 4-5 adverse reactions occurred. Conclusion The clinical efficacy of anlotinib monotherapy in second-line treatment of ES-SCLC with poor PS score and failure of first-line standard regimen is good， and the adverse reactions are controllable.

Key words: Small cell lung carcinoma, Therapeutics, Anlotinib