Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Taiwan; Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
J Formos Med Assoc. 2020 Dec;119(12):1817-1826. doi: 10.1016/j.jfma.2020.01.004. Epub 2020 Feb 22.
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.
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).
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.
Nivolumab appeared to be safe and effective in Taiwanese patients. These interim results suggest that nivolumab is a suitable treatment option for this population.
NCT02582125.
背景/目的：在台湾，由于无法进行根治性放疗且对铂类化疗耐药，晚期或复发性非小细胞肺癌（NSCLC）患者缺乏纳武单抗治疗的数据。我们调查了纳武单抗在这一人群中的安全性和疗效。
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、表现状态为 0-1 级、ⅢB/Ⅳ期或复发性 NSCLC 的患者接受纳武单抗 3mg/kg，每 2 周一次，每 6 周为一个周期。分析了 2016 年 1 月 27 日至 2017 年 5 月 21 日之间获得的中期数据。根据不良事件（AE）报告，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）和无进展生存期（PFS）。
在 53 例晚期 NSCLC 患者（中位年龄 61.0 岁；62.3%为男性）中，中位治疗持续时间为 99.7 天。92.5%和 47.2%的患者分别报告了任何级别的 AE 和严重 AE。58.5%的患者发生药物不良反应（ADR）；13.2%的患者发生≥3 级 ADR。有 5 例死亡，其中 2 例（肿瘤进展和感染性休克）被认为是治疗突发。常见 ADR 为疲劳（17.0%）和皮疹（13.2%）。常见的免疫相关治疗突发的 AEs 是皮疹（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。
纳武单抗在台湾患者中似乎是安全有效的。这些中期结果表明，纳武单抗是该人群的一种合适的治疗选择。
NCT02582125。
