Pharmaceutical Division, 73964Sapporo Minami-Sanjo Hospital (Hokkaido Keiaikai), Sapporo, Hokkaido, Japan.
Division of Clinical Pharmacy, Department of Pharmacy, Faculty of Pharmaceutical Sciences, 88281Hokkaido University of Science, Sapporo, Hokkaido, Japan.
Cancer Control. 2021 Jan-Dec;28:1073274820985790. doi: 10.1177/1073274820985790.
Corticosteroids are used to treat immune-related adverse events (irAEs) associated with nivolumab. However, patients with non-small-cell lung cancer who are administered corticosteroids before the initiation of nivolumab treatment are commonly excluded from clinical trials. The appropriate timing for corticosteroid administration in relation to nivolumab treatment, effects of corticosteroids on the efficacy of nivolumab, and resulting adverse events are not clearly understood. In this study, the effects of differences in the timing of corticosteroid administration on nivolumab efficacy and the resulting adverse events were examined.
A retrospective study was conducted with 109 patients who were treated with nivolumab at Sapporo Minami-Sanjo Hospital between December 2015 and March 2018.
Of the 109 patients treated with nivolumab, 12 patients were administered corticosteroids before the first cycle of nivolumab (pre-CS), and 33 patients were administered corticosteroids after the first cycle of nivolumab (post-CS). These 2 groups were compared with the control group comprising 64 patients who were not administered corticosteroids (non-CS). The objective response rate in the post-CS group was significantly higher than that in the non-CS group, and the disease control rate in the pre-CS group was significantly lower than that in the non-CS group. The overall survival time and progression-free survival time in the pre-CS group were significantly shorter than those observed in the non-CS group; however, these did not differ from those in the post-CS group.
These results suggest that corticosteroids administered to patients with non-small-cell lung cancer after initiation of nivolumab treatment did not affect the disease prognosis. Thus, corticosteroids can be administered immediately for rapid treatment of irAEs.
皮质类固醇被用于治疗与纳武利尤单抗相关的免疫相关不良事件(irAEs)。然而,在开始纳武利尤单抗治疗前接受皮质类固醇治疗的非小细胞肺癌患者通常被排除在临床试验之外。皮质类固醇与纳武利尤单抗治疗的时间关系、皮质类固醇对纳武利尤单抗疗效的影响以及由此产生的不良事件尚不清楚。在这项研究中,研究了皮质类固醇给药时间的差异对纳武利尤单抗疗效和由此产生的不良事件的影响。
对 2015 年 12 月至 2018 年 3 月在札幌南三条医院接受纳武利尤单抗治疗的 109 例患者进行了回顾性研究。
在接受纳武利尤单抗治疗的 109 例患者中,12 例患者在纳武利尤单抗第一周期前(预 CS)接受了皮质类固醇治疗,33 例患者在纳武利尤单抗第一周期后(后 CS)接受了皮质类固醇治疗。将这两组与未接受皮质类固醇治疗的对照组(非 CS 组)进行比较,后 CS 组的客观缓解率明显高于非 CS 组,预 CS 组的疾病控制率明显低于非 CS 组。预 CS 组的总生存时间和无进展生存时间明显短于非 CS 组;然而,这些与后 CS 组并无差异。
这些结果表明,在开始纳武利尤单抗治疗后给予非小细胞肺癌患者皮质类固醇治疗不会影响疾病预后。因此,可以立即给予皮质类固醇以快速治疗 irAEs。