Nivolumab safety and efficacy in advanced, platinum-resistant, non-small cell lung cancer, radical radiotherapy-ineligible patients: A phase II study in Taiwan
Nivolumab safety and efficacy in advanced, platinum-resistant, non-small cell lung cancer, radical radiotherapy-ineligible patients: A phase II study in Taiwan
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DOI：
10.1016/j.jfma.2020.01.004
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发表时间：
2020-12-01
影响因子：
3.2
通讯作者：
Yu, Chong-Jen
中科院分区：
文献类型：
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作者：
Chen, Yuh-Min;Yang, James Chih-Hsin;Yu, Chong-Jen
背景/目的：目前缺乏关于台湾晚期或复发性非小细胞肺癌（NSCLC）患者的nivolumab治疗结果的数据，这些患者不适合进行根治性放疗，并且对铂类化疗耐药。我们调查了nivolumab在该population.Methods中的安全性和有效性：在这项正在进行的多中心、开放标签、单臂、II期研究中，年龄>= 20岁、体能状态为0-1、IIIB/IV期或复发性NSCLC的患者每2周接受nivolumab 3 mg/kg，6周为一个周期。分析了2016年1月27日至2017年5月21日期间获得的中期数据。基于不良事件（AE）报告的安全性是主要终点。疗效评估参数包括总缓解率（ORR），总生存期（OS），无进展生存期（PFS）。结果：在53例接受治疗的晚期NSCLC患者（中位年龄61.0岁; 62.3%男性）中，平均治疗持续时间为99.7天。分别有92.5%和47.2%的患者报告了AE（任何级别）和严重AE。58.5%的患者发生药物不良反应（ADR;任何）; 13.2%的患者发生≥ 3级ADR。发生5例死亡; 2例病例（肿瘤进展和脓毒性休克）被认为是治疗后出现的。常见不良反应为疲乏（17.0%）和皮疹（13.2%）。常见的免疫相关治疗后出现的AE为皮疹（17.0%）和瘙痒（13.2%）。中心评估的ORR为9.4%（5/53）。中位OS和中位PFS分别为11.5个月和1.4个月。这些中期结果表明，nivolumab是该人群的合适治疗选择。版权所有（C）2020，台湾医学会.出版社：Elsevier Taiwan LLC
Background/Purpose: There is a lack of data on nivolumab treatment outcomes in Taiwanese patients with advanced or recurrent non-small cell lung cancer (NSCLC) ineligible for radical radiotherapy and resistant to platinum-based chemotherapy. We investigated the safety and efficacy of nivolumab in this population.Methods: In this ongoing, multicenter, open-label, single-arm, phase II study, patients aged >= 20 years with a performance status of 0-1 and stage IIIB/IV or recurrent NSCLC received nivolumab 3 mg/kg every 2 weeks in 6-week cycles. Interim data obtained between 27 January 2016 and 21 May 2017 were analyzed. Safety, based on adverse event (AE) reporting, was the primary endpoint. Efficacy assessment parameters included overall response rate (ORR), overall survival (OS), and progression-free survival (PFS).Results: Among 53 treated patients with advanced NSCLC (median age 61.0 years; 62.3% male), mean treatment duration was 99.7 days. AEs (any grade) and serious AEs were reported by 92.5% and 47.2% of patients, respectively. Adverse drug reactions (ADRs; any) occurred in 58.5% of patients; grade >= 3 ADRs occurred in 13.2% of patients. Five deaths occurred; two cases (neoplasm progression and septic shock) were considered treatment-emergent. Common ADRs were fatigue (17.0%) and rash (13.2%). Common immune-related treatment-emergent AEs were rash (17.0%) and pruritus (13.2%). The centrally assessed ORR was 9.4% (5/53). The median OS and median PFS were 11.5 months and 1.4 months, respectively.Conclusion: Nivolumab appeared to be safe and effective in Taiwanese patients. These interim results suggest that nivolumab is a suitable treatment option for this population. Copyright (C) 2020, Formosan Medical Association. Published by Elsevier Taiwan LLC.