安罗替尼联合放疗三线治疗广泛期小细胞肺癌真实世界研究

Real world analysis of third-line treatment with anlotinib in combination with radiotherapy for extensive-stage small-cell lung cancer

目的探索真实世界中安罗替尼联合放疗三线治疗广泛期小细胞肺癌(ES-SCLC)的临床疗效和安全性。方法收集2018年11月—2021年7月新疆医科大学附属肿瘤医院收治的采用三线治疗(安罗替尼靶向治疗)联合放疗的ES-SCLC患者40例,所有患者的治疗方案均为在口服安罗替尼胶囊的基础上针对部分病灶行放疗。分析总生存(OS)期、无进展生存(PFS)期、安全性、生活质量。采用Kaplan-Meier法进行生存情况的统计分析。结果 40例患者中,部分缓解7例,疾病稳定24例,疾病进展9例,客观缓解率为18%,疾病控制率为78%。中位PFS期为4.5个月,中位OS期为9个月。常见的不良反应包括乏力(28%)、各类出血(合计20%)、食欲减退(13%)、手足综合征(8%)。多数不良反应为1-2级,≥3级不良反应为4例,未记录到5级不良反应。结论在真实世界中,安罗替尼联合放疗可延长ES-SCLC患者的PFS、OS期,不良反应可耐受,是一种值得进一步探索的联合治疗方案。

Objective To investigate the clinical efficacy and safety of anlotinib combined with radiotherapy as a third-line treatment regimen for extensive stage small-cell lung cancer(ES-SCLC)in a real-world background.Methods Forty ES-SCLC patients enrolled in a single center of Affiliated Cancer Hospital of Xinjiang Medical University in China between November 2018 and July 2021 were treated with radiotherapy added on anlotinib as a third-line treatment regimen.Overall survival(OS),progression-free survival(PFS),safety,and quality of life were analyzed,and the survival status was statistically analyzed using Kaplan-Meier method.Results Among the 40 patients,partial remission,stable disease,and progressive disease was confirmed in 7,24 and 9 patients,respectively.The obtained objective remission rate(ORR)was 18%,the disease control rate(DCR)was 78%,and median PFS and median OS were 4.5 months and 9 months,respectively.The most common adverse reactions included fatigue(28%),bleeding(20%),anorexia(13%),and hand-foot syndrome(8%).Most of them were grade 1-2 in severity,4 cases were documented as≥grade 3,and no grade 5 toxicity was recorded.Conclusions In the real world,radiotherapy added on anlotinib as a third-line regimen can prolong PFS and OS of the ES-SCLC patients,and the adverse reactions are generally tolerated.This combination treatment regimen is worthy of further investigation.