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桓兴医讯 对既往治疗过的晚期非小细胞肺癌进行纳武单抗治疗的5年
文章来源:北京市朝阳区桓兴肿瘤医院 点击数: 发布时间:2019-09-02 13:59
美国《临床肿瘤学杂志》2018年3月2日在线先发:
对既往治疗过的晚期非小细胞肺癌进行纳武单抗治疗的5年随访:来自CA209-003研究结果
背景
纳武单抗(Nivolumab)是一种PD-1抑制剂抗体,在两项Ⅲ期研究中发现,纳武单抗与多西他赛相比,可以改善既往治疗过的晚期非小细胞肺癌的总生存(OS)。在此,我们报告了一项早前的对这类患者的I期研究的5年随访结果,并对5年幸存者的特征进行了总结。
患者与方法
既往治疗过的晚期非小细胞肺癌患者,每2周接受一次1、3或10mg/kg的纳武单抗治疗,8周一疗程,长达96周。通过生存曲线Kaplan-Meier方法,估算自首次剂量起算的总生存。
结果
对于所有治疗患者(N=129),5年总生存率为16%。鳞状细胞(16%)和非鳞状细胞(15%)非小细胞肺癌患者的5年总生存率相似。16名5年生存者中,大部分(88%)为目前吸烟或以前吸烟,可以定量分析PD-1配体1(PD-L1)表达的5年生存患者中,70%的患者在入组时PD-L1表达≥1%。按照实体瘤疗效评价标准1.0版评价,最佳缓解情况是,纳武单抗治疗后12名5年生存者(75%)获得了部分缓解,2名病情稳定、2名疾病进展。9名5年生存患者(56%)完成了最高96个星期的纳武单抗治疗,4名(25%)由于不良反应中断治疗,3名(19%)由于疾病进展中断治疗。2016年11月数据库锁定时,12名5年生存患者以后未接受治疗,最后一次随访无疾病进展的证据。
结论
纳武单抗治疗使得一定比例的既往治疗过的晚期非小细胞肺癌患者持续缓解、长期生存。长期生存患者入组时情况各异、治疗过程中的特征差异很大。
北京市朝阳区桓兴肿瘤医院 桓兴医讯编译组 田朋飞
2018年9月2日 星期一
Five-Year Follow-Up of Nivolumab in Previously Treated Advanced Non–Small-Cell Lung Cancer: Results From the CA209-003 Study
http://ascopubs.org/doi/full/10.1200/JCO.2017.77.0412
Purpose
In two phase III studies, nivolumab, a programmed death-1 (PD-1) inhibitor antibody, improved overall survival (OS) versus docetaxel in pretreated advanced non–small-cell lung cancer (NSCLC). We report 5-year follow-up results from an early phase I study of nivolumab in this patient population and describe characteristics of 5-year survivors.
Patients and Methods
Patients with pretreated, advanced NSCLC received nivolumab 1, 3, or 10 mg/kg every 2 weeks in 8-week cycles for up to 96 weeks. OS from the time of first dose was estimated by the Kaplan-Meier method.
Results
The estimated 5-year OS rate was 16% for all treated patients (N = 129); 5-year OS rates were similar for squamous (16%) and nonsquamous (15%) NSCLC. Of 16 5-year survivors, most (88%) were known current or former smokers. Of 10 5-year survivors with quantifiable PD-1 ligand 1 expression, 70% had ≥ 1% PD-1 ligand 1 expression at baseline. Twelve 5-year survivors (75%) achieved a partial response to nivolumab per Response Evaluation Criteria in Solid Tumors, version 1.0, and two each (12%) had stable disease and progressive disease as best response. Nine 5-year survivors (56%) completed the maximum 96 weeks of nivolumab; four (25%) discontinued owing to adverse events and three (19%) owing to disease progression. As of a November 2016 database lock, 12 5-year survivors (75%) received no subsequent therapy and were without evidence of progressive disease at last follow-up.
Conclusions
Nivolumab treatment resulted in long-term OS and durable responses in a proportion of patients with pretreated advanced NSCLC. Long-term survivors had diverse baseline and on-treatment characteristics.

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