首页|安罗替尼联合信迪利单抗同步放化疗治疗驱动基因阴性非小细胞肺癌临床研究

安罗替尼联合信迪利单抗同步放化疗治疗驱动基因阴性非小细胞肺癌临床研究

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目的 探讨安罗替尼联合信迪利单抗同步放化疗一线治疗驱动基因阴性非小细胞肺癌(NSCLC)的临床疗效和安全性。方法 选取苏州大学附属张家港医院 2021 年 3 月至 2022 年 3 月收治的驱动基因阴性NSCLC患者 80 例,按随机数字表法分为观察组和对照组,各 40 例。对照组患者给予NP化疗方案(顺铂 30 mg/m2 +长春瑞滨 25 mg/m2)+肺内原发灶和区域淋巴结放射治疗,观察组患者在对照组基础上加用安罗替尼联合信迪利单抗 200 mg/m2(第 1 天)。两组患者均以 21d为 1 个周期,共治疗 4 个周期。结果 观察组客观缓解率和疾病控制率分别为 72。50%和 85。00%,均显著高于对照组的 37。50%和 52。50%(P<0。05)。治疗后,两组患者血清癌胚抗原(CEA)、糖类抗原 125(CA125)、细胞角质蛋白 19 片段抗原 21-1(CYFRA21-1)水平均显著降低(P<0。05),生活质量调查核心问卷(QLQ-C30)和肺癌专用问卷(QLQ-LC13)评分均显著升高(P<0。05),且观察组均显著优于对照组(P<0。05)。观察组和对照组患者Ⅲ级及以上不良反应发生率相当(62。50%比 52。50%,P>0。05)。所有患者的中位随访时间为 15 个月(12~24 个月),失访 3 例。观察组中位无进展生存期(PFS)和中位总生存期(OS)分别为 6。9 个月和 12。6 个月,均显著长于对照组的 4。3 个月和 8。9 个月(Log-rank χ2 = 13。760,31。830,P<0。05)。结论 安罗替尼联合信迪利单抗同步放化疗可提高驱动基因阴性NSCLC患者的临床疗效,改善生活质量,降低血清肿瘤标志物水平,延长生存时间,且安全性高。
Clinical Study of Concurrent Chemoradiotherapy with Anlotinib Combined with Sintilimab in the Treatment of Driver-Gene Negative Non-Small Cell Lung Cancer
Objective To investigate the efficacy and safety of first-line concurrent chemoradiotherapy with anlotinib combined with sintilimab in the treatment of driver-gene negative non-small cell lung cancer(NSCLC).Methods A total of 80 patients with driver-gene negative NSCLC admitted to the Zhangjiagang Hospital Affiliated to Soochow University from March 2021 to March 2022 were selected and divided into two groups by the random number table method,with 40 cases in each group.The patients in the control group received NP chemotherapy regimen(30 mg/m2 of cisplatin + 25 mg/m2 of vinorelbine)and radiation therapy for primary lung lesions and regional lymph nodes.On this basis,the patients in the observation group received anlotinib + 200 mg/m2 of sintilimab on the first day.Both groups were treated four cycles of treatment with 21 d as a cycle.Results The objective response rate(ORR)and disease control rate(DCR)in the observation group were 72.50%and 85.00%,which were significantly higher than 37.50%and 52.50%in the control group(P<0.05).After treatment,the levels of serum carcinoembryonic antigen(CEA),carbohydrate antigen 125(CA125),and cytokeratin 19 fragment antigen 21-1(CYFRA21-1)in the two groups significantly reduced(P<0.05),while the scores of the Quality of Life Core Questionnaire(QLQ-C30)and the Quality of Life Questionnaire-Lung Cancer Module(QLQ-LC13)significantly increased(P<0.05),and those in the observation group were significantly better than those in the control group(P<0.05).The incidence of grade Ⅲ and above adverse reactions in the observation group was comparable to that in the control group(62.50%vs.52.50%,P>0.05).The median follow-up time for all patients was 15 months(12-24 months),with three cases lost to follow-up.The median progression-free survival(PFS)and median overall survival(OS)in the observation group were 6.9 months and 12.6 months,which were significantly longer than 4.3 months and 8.9 months in the control group(Log-rank χ2 = 13.760,31.830,P<0.05).Conclusion Concurrent chemoradiotherapy with anlotinib combined with sintilimab in the treatment of patients with driver-gene negative NSCLC can improve the clinical efficacy,improve the quality of life,reduce serum tumor marker levels,prolong survival time,and have high safety.

anlotinibsintilimabnon-small cell lung cancerconcurrent chemoradiotherapydriver-gene

吴春锋、蒋健、朱惠平、柳燕冬

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苏州大学附属张家港医院,江苏 张家港 215600

苏州大学附属第一医院,江苏 苏州 215004

安罗替尼 信迪利单抗 非小细胞肺癌 同步放化疗 驱动基因

江苏省苏州市科技计划项目

SKJY2021004

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(3)
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