Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
Center for Clinical Oncology, Okayama University Hospital, Okayama, Japan.
Jpn J Clin Oncol. 2019 Aug 1;49(8):762-765. doi: 10.1093/jjco/hyz066.
Immune checkpoint inhibitors (ICIs) have demonstrated long survival for the treatment of advanced non-small cell lung cancer (NSCLC). However, the effect and safety of ICI rechallenge have not been fully evaluated. The aim of this study was to investigate the efficacy and safety of ICI rechallenge in NSCLC patients.
We defined 'rechallenge' as re-administration of ICIs for patients who were previously treated with ICIs and discontinued treatment for any reason, and received subsequent chemotherapy. We retrospectively analyzed the histories of 434 patients with advanced NSCLC who received ICIs from December 2015 to December 2017 at seven centers.
A total of 317 patients discontinued the ICI treatment, and 14 patients (4.4%) received ICI rechallenge. All 14 patients discontinued the first ICI due to disease progression. Eight patients received the same kind of ICIs, and six patients received different ICIs. Median progression-free survival and overall survival were 1.5 months [95% confidence interval (CI): 0.8-2.6] and 6.5 months [95% CI: 1.4-19.0], respectively. The objective response rate was 7.1%, and the disease control rate was 21.4%. Two of three patients who achieved at least a stable disease, received radiotherapy between the first and second ICIs. Adverse events were not significantly different compared with the first ICIs.
In this study, the effect of ICI rechallenge was limited. Careful consideration of the administration of ICI rechallenge is necessary. This report involved a small number of cases, so further large prospective studies are warranted to confirm the efficacy of ICI rechallenge and to investigate predictive markers to identify a patient population in which ICI rechallenge is effective.
免疫检查点抑制剂（ICI）在治疗晚期非小细胞肺癌（NSCLC）方面显示出了较长的生存获益。然而，ICI 再挑战的效果和安全性尚未得到充分评估。本研究旨在探讨 NSCLC 患者接受 ICI 再挑战的疗效和安全性。
我们将“再挑战”定义为先前接受过 ICI 治疗并因任何原因停止治疗而接受后续化疗的患者重新使用 ICI。我们回顾性分析了 2015 年 12 月至 2017 年 12 月在 7 个中心接受 ICI 治疗的 434 例晚期 NSCLC 患者的病史。
共有 317 例患者停止了 ICI 治疗，14 例（4.4%）接受了 ICI 再挑战。所有 14 例患者因疾病进展而停止了首次 ICI 治疗。8 例患者接受了同种 ICI，6 例患者接受了不同的 ICI。中位无进展生存期和总生存期分别为 1.5 个月（95%CI：0.8-2.6）和 6.5 个月（95%CI：1.4-19.0）。客观缓解率为 7.1%，疾病控制率为 21.4%。在首次和第二次 ICI 之间接受放疗的 3 例患者中，有 2 例至少达到了稳定疾病。与首次 ICI 相比，不良反应无显著差异。
在本研究中，ICI 再挑战的效果有限。在考虑实施 ICI 再挑战时需要谨慎。本报告涉及的病例数较少，因此需要进一步开展大样本前瞻性研究，以证实 ICI 再挑战的疗效，并探讨预测标志物，以确定有效的 ICI 再挑战患者人群。
