安罗替尼联合放疗三线治疗广泛期小细胞肺癌的Ⅱ期临床研究  

Clinical study of antinib combined with radiotherapy in the treatment of third-line extensive small cell lung cancer

作　　者：宗玉峰 谭遥[1] 巴尔夏古丽·扎比胡拉[1] 王海峰[1] Zong Yufeng;Tan Yao;Baerxiaguli·Zhabihula;Wang Haifeng(Department of Radiotherapy of the Chest and Abdomen,Afiliated Cancer Hospital of Xinjiang Medical University,Urumqi 83001l,China)

机构地区：[1]新疆医科大学附属肿瘤医院胸腹放疗科,乌鲁木齐830011

出　　处：《中华肿瘤杂志》2023年第10期892-897,共6页Chinese Journal of Oncology

基　　金：北京康盟慈善基金会(TB202002)。

摘　　要：目的探讨安罗替尼联合放疗三线治疗广泛期小细胞肺癌(ES-SCLC)的疗效并评价治疗的安全性。方法研究为前瞻性单臂Ⅱ期临床研究,选取2018年11月至2021年7月于新疆医科大学附属肿瘤医院接受三线治疗且转移器官≤3个的ES-SCLC患者,全组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。生存分析采用Kaplan-Meier法,根据欧洲癌症研究治疗组织生命质量核心量表评价生活质量。结果研究随访截止时间为2021年7月1日,随访时间为4.8~31.0个月,中位随访时间为10.2个月。全组27例患者中,部分缓解4例,疾病稳定17例,疾病进展6例,客观有效率为14.8%,疾病控制率为77.8%。中位无进展生存时间、中位总生存时间分别为5和11个月。全组患者的常见不良反应包括乏力(33.3%,9/27)、食欲减退(14.8%,4/27)、出血(14.8%,4/27)、手足综合征(11.1%,3/27)。多数不良反应为1~2级,≥3级不良反应3例,未发生5级不良反应。放疗联合安罗替尼治疗后,患者总体健康状况、躯体功能、社会功能、情绪功能等方面均有改善(均P<0.05)。结论对于三线ES-SCLC患者,在安罗替尼治疗的基础上联合放疗能延长患者的无进展生存时间和总生存时间,不良反应可耐受。ObjectiveTo explore whether the survival benefit of the third-line extensive small-cell lung cancer(ES-SCLC)will be obtained by the combination of anlotinib and radiotherapy,and evaluate the safety of this treatment regimen.MethodsTwenty-seven patients with ES-SCLC who received third-line treatment with less than three metastatic organs at the Cancer Hospital of Xinjiang Medical University from November 2018 to July 2021 were collected and treated with radiotherapy based on anlotinib.Kaplan-Meier curve was used to estimate the overall survival(OS)and progression-free survival(PFS),descriptive statistical analysis was used to evaluate the safety,and European organisation for research and treatment of cancer quality of life questionnaire-core 30(EORTC QLQ-C30)was used to evaluate the quality of life.ResultsThe follow-up cut-off date was July 1,2021,and the follow-up time ranged from 4.8 to 31.0 months,with a median follow-up time of 10.2 months for the entire group.Among the 27 patients,4 achieved partial remission,17 had stable disease and 6 had progression of disease.The objective remission rate(ORR)was 14.8%,and the disease control rate(DCR)was 77.8%.Median PFS and the median OS were 5 months and 11 months,respectively.The most common adverse reactions included fatigue(33.3%,9/27),anorexia(14.8%,4/27),bleeding(14.8%,4/27)and hand-foot syndrome(11.1%,3/27).Most of them were grade 1 to grade 2,3 cases were more than grade 3,and there was no grade 5 toxicity recorded.After radiotherapy combined with amlotinib treatment,patients showed improvement in general health,somatic functioning,social functioning,and emotional functioning(all P<0.05).ConclusionFor the third-line ES-SCLC patients,radiotherapy based on the anlotinib can significantly prolong their PFS and OS,and the adverse reactions can be tolerated.

关 键 词：肺肿瘤 小细胞癌 安罗替尼 放射治疗 安全性 

分 类 号：R734.2[医药卫生—肿瘤]