Osaka International Cancer Institute, Osaka, Japan.
National Hospital Organization Kinki-chuo Chest Medical Center, Osaka, Japan.
Clin Lung Cancer. 2018 Mar;19(2):e171-e176. doi: 10.1016/j.cllc.2017.09.002. Epub 2017 Oct 13.
The increased risk for early death owing to anti-programmed cell death 1 inhibitors is a major disadvantage that requires special management. We evaluated the frequency, causes, and risk factors of early death during nivolumab treatment for non-small cell lung cancer (NSCLC) in a Japanese clinical setting.
The medical records of patients with NSCLC who started receiving nivolumab between December 17, 2015 and July 31, 2016 in 3 Japanese institutes were collected. Early death was defined as any death within 3 months from the start of nivolumab treatment, irrespective of its cause. Treatment response was evaluated using the Response Evaluation Criteria In Solid Tumors criteria, version 1.1.
A total of 201 patients with NSCLC were enrolled, and 38 (18.9%) died within the first 3 months. Thirty-one (81.6%) patients who experienced early death developed progressive disease, whereas 14 (36.8%) patients who experienced early death demonstrated nivolumab-induced immune-related adverse events, which required corticosteroid intervention, including interstitial lung disease in 7 (18.4%) patients. Multivariate logistic regression demonstrated that an Eastern Cooperative Oncology Group performance status score ≥ 2 (odds ratio [OR], 5.66; 95% confidence interval [CI], 2.01-15.61; P < .001), C-reactive protein-to-albumin ratio > 0.3 (OR, 10.56; 95% CI, 3.61-30.86; P < .001), and the response to prior treatment (OR, 2.07; 95% CI, 1.03-4.14; P = .041) were independent predictors for early death.
Disease progression and immune-related adverse events are 2 major causes of early death with nivolumab in patients with NSCLC. An Eastern Cooperative Oncology Group performance status score ≥ 2, pretreatment C-reactive protein-to-albumin ratio > 0.3, and poor response to prior treatment were associated with early death.
抗程序性死亡 1 抑制剂导致的早期死亡风险增加是一个主要的缺点，需要特殊管理。我们在日本临床环境中评估了纳武利尤单抗治疗非小细胞肺癌（NSCLC）患者的早期死亡频率、原因和危险因素。
收集了 2015 年 12 月 17 日至 2016 年 7 月 31 日期间在日本 3 家机构开始接受纳武利尤单抗治疗的 NSCLC 患者的病历。早期死亡定义为纳武利尤单抗治疗开始后 3 个月内任何原因导致的死亡。使用实体瘤反应评估标准 1.1 评估治疗反应。
共纳入 201 例 NSCLC 患者，其中 38 例（18.9%）在头 3 个月内死亡。31 例（81.6%）早期死亡患者发生疾病进展，而 14 例（36.8%）早期死亡患者出现纳武利尤单抗诱导的免疫相关不良事件，需要皮质类固醇干预，包括 7 例（18.4%）患者发生间质性肺病。多变量逻辑回归表明，东部肿瘤协作组（ECOG）表现状态评分≥2（比值比[OR]，5.66；95%置信区间[CI]，2.01-15.61；P<.001）、C 反应蛋白与白蛋白比值>0.3（OR，10.56；95%CI，3.61-30.86；P<.001）和既往治疗的反应（OR，2.07；95%CI，1.03-4.14；P=0.041）是早期死亡的独立预测因素。
疾病进展和免疫相关不良事件是纳武利尤单抗治疗 NSCLC 患者早期死亡的两个主要原因。ECOG 表现状态评分≥2、治疗前 C 反应蛋白与白蛋白比值>0.3、以及对既往治疗反应差与早期死亡相关。
