The Prognostic Significance of the Continuous Administration of Anti-PD-1 Antibody via Continuation or Rechallenge After the Occurrence of Immune-Related Adverse Events.
The Prognostic Significance of the Continuous Administration of Anti-PD-1 Antibody via Continuation or Rechallenge After the Occurrence of Immune-Related Adverse Events.
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DOI：
10.3389/fonc.2021.704475
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发表时间：
2021
影响因子：
4.7
通讯作者：
Kikuchi T
中科院分区：
文献类型：
--
作者：
Fujisaki T;Watanabe S;Ota T;Kushiro K;Sato Y;Takahashi M;Ohtsubo A;Shoji S;Nozaki K;Ichikawa K;Hokari S;Kondo R;Miyabayashi T;Abe T;Miura S;Tanaka H;Okajima M;Terada M;Matsumoto N;Ishida T;Iwashima A;Sato K;Yoshizawa H;Aoki N;Hayashi M;Ohshima Y;Koya T;Kikuchi T
尽管免疫检查点抑制剂（ICI）已被证明可改善晚期非小细胞肺癌（NSCLC）患者的总生存期（OS），但ICI有时会引起各种类型的免疫相关不良事件（irAE），导致ICI治疗中断。本研究旨在评价在发生irAE的NSCLC患者中继续使用ICI的临床意义，并评估因irAE停药后再次使用ICI的安全性和疗效。我们回顾性确定了2016年1月至2017年10月在新泻肺癌治疗组的多家机构接受一线至三线抗程序性细胞死亡-1（PD-1）治疗的晚期NSCLC患者。在有和无irAE、有和无ICI中断、有和无ICI再给药的患者中分析了自ICI治疗开始后的无进展生存期（PFS）和OS。对PFS和OS进行了6周里程碑分析，以尽量减少与时间依赖性因素相关的提前期偏倚。在接受抗PD-1抗体治疗的231例患者中，93例患者（40%）发生irAE。在84例发生irAE的合格患者中，32例患者（14%）继续接受ICI，继续接受ICI的患者的OS显著长于中止ICI的患者[未达到（95% CI：NE-NE）vs.未达到（95% CI：22. 4-NE）; p = 0. 025]。在52例中止ICI的患者中，14例患者（6.1%）再次给予ICI，再次给予ICI的患者的OS显著长于未给予ICI的患者[未达到（95% CI：NE-NE）vs.未达到（95% CI：8.4-NE）; p = 0.031]。本研究证明，在发生ICI相关irAE的NSCLC患者中，与永久中断ICI相比，在irAE发生后继续和重新给予ICI均改善了OS。
Although immune checkpoint inhibitors (ICIs) have been shown to improve overall survival (OS) in advanced non-small-cell lung cancer (NSCLC) patients, ICIs sometimes cause various types of immune-related adverse events (irAEs), which lead to the interruption of ICI treatment. This study aims to evaluate the clinical significance of the continuation of ICIs in NSCLC patients with irAEs and to assess the safety and efficacy of the readministration of ICIs after their discontinuation due to irAEs. We retrospectively identified patients with advanced NSCLC who were treated with first- to third-line anti-programmed cell death-1 (PD-1) therapy from January 2016 through October 2017 at multiple institutions belonging to the Niigata Lung Cancer Treatment Group. Progression-free survival (PFS) and OS from the initiation of ICI treatment were analyzed in patients with and without irAEs, with and without ICI interruption, and with and without ICI readministration. A 6-week landmark analysis of PFS and OS was performed to minimize the lead-time bias associated with time-dependent factors. Of 231 patients who received anti-PD-1 antibodies, 93 patients (40%) developed irAEs. Of 84 eligible patients with irAEs, 32 patients (14%) continued ICIs, and OS was significantly longer in patients who continued ICIs than that in patients who discontinued ICIs [not reached (95% CI: NE-NE) vs. not reached (95% CI: 22.4–NE); p = 0.025]. Of 52 patients who discontinued ICIs, 14 patients (6.1%) readministered ICIs, and OS in patients with ICI readministration was significantly longer than that in patients without ICI readministration [not reached (95% CI: NE-NE) vs. not reached (95% CI: 8.4–NE); p = 0.031]. The current study demonstrated that both the continuation and readministration of ICIs after irAE occurrence improved OS compared to the permanent interruption of ICIs in NSCLC patients with ICI-related irAEs.
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影响因子：
3.8
作者：
Tachihara M;Negoro S;Inoue T;Tamiya M;Akazawa Y;Uenami T;Urata Y;Hattori Y;Hata A;Katakami N;Yokota S
通讯作者：
Yokota S
影响因子：
3.6
作者：
Ksienski, Doran;Wai, Elaine S.;Lesperance, Mary
通讯作者：
Lesperance, Mary
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作者：
Teraoka, Shunsuke;Fujimoto, Daichi;Tomii, Keisuke
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Tomii, Keisuke
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28.4
作者：
Simonaggio, Audrey;Michot, Jean Marie;Lambotte, Olivier
通讯作者：
Lambotte, Olivier
影响因子：
10.9
作者：
Abou Alaiwi, Sarah;Xie, Wanling;Harshman, Lauren C.
通讯作者：
Harshman, Lauren C.