Onze-Lieve-Vrouw Ziekenhuis Aalst, Belgium; Faculty of Medicine and Life Sciences, Ghent University, Ghent, Belgium.
Ziekenhuis Oost Limburg, Limburg and Faculty of Medicine and Life Sciences, Hasselt University, Hasselt, Belgium.
Lung Cancer. 2018 Jan;115:49-55. doi: 10.1016/j.lungcan.2017.11.008. Epub 2017 Nov 16.
In patients with refractory or recurrent non-small-cell lung cancer (NSCLC) after first line chemotherapy, phase III trials showed superiority of nivolumab, an IgG4 programmed death-1 immune-checkpoint-inhibitor antibody, over docetaxel. We evaluated case mix, effectiveness and safety of nivolumab upon implementation in general practice.
In 20 general hospitals, all consecutive NSCLC patients treated with nivolumab within the medical need program (inclusion period 12 months) in Flanders - Belgium were evaluated.
There were 267 patients, Eastern Cooperative Oncology Group (ECOG) score was 2 in 24% and 0-1 in 76%. In 48%, two or more systemic regimens were given before nivolumab. The median overall survival was 7.8 months (95% confidence interval (CI) 6.3-9.3). At one year, the overall survival rate was 36.5±0.34%. Median progression-free survival was 3.7 months (95% CI 2.9-4.5). An objective response was obtained in 23.2%. ECOG score 2 and presence of liver metastasis strongly correlated with worse survival (p<0.00001). Treatment related adverse events grade 3 or 4 were reported in 21%, colitis (4%) and pneumonitis (7%) were most frequent.
Upon implementation of nivolumab therapy in general hospitals, the case mix was characterized by a more heavily pretreated population with a substantial fraction of patients with ECOG score 2. The median overall survival is slightly inferior to what was published in the randomized phase III trials. An ECOG score 2 and the presence of liver metastasis correlated strongly with a worse survival. We report a high prevalence of serious adverse events.
在一线化疗后出现难治性或复发性非小细胞肺癌（NSCLC）的患者中，III 期试验表明 nivolumab（一种 IgG4 程序性死亡-1 免疫检查点抑制剂抗体）优于多西他赛。我们评估了 nivolumab 在一般实践中的病例组合、疗效和安全性。
在 20 家综合医院中，评估了在佛兰德斯-比利时的医疗需求计划中使用 nivolumab 治疗的所有连续 NSCLC 患者（纳入期为 12 个月）。
共有 267 例患者，ECOG 评分为 2 的占 24%，0-1 的占 76%。48%的患者在使用 nivolumab 之前接受了两种或更多种全身治疗方案。中位总生存期为 7.8 个月（95%置信区间[CI]为 6.3-9.3）。一年时，总生存率为 36.5±0.34%。中位无进展生存期为 3.7 个月（95%CI 为 2.9-4.5）。客观缓解率为 23.2%。ECOG 评分 2 和肝转移的存在与较差的生存密切相关（p<0.00001）。报告了 21%的 3 级或 4 级治疗相关不良事件，结肠炎（4%）和肺炎（7%）最常见。
在综合医院实施 nivolumab 治疗后，病例组合的特点是接受过更多治疗的人群，其中相当一部分患者的 ECOG 评分为 2。中位总生存期略低于随机 III 期试验的结果。ECOG 评分 2 和肝转移的存在与生存较差密切相关。我们报告了严重不良事件的高发率。
