Survival Impact of Glucocorticoid Administration for Adverse Events During Immune Checkpoint Inhibitor Combination Therapy in Patients with Previously Untreated Advanced Renal Cell Carcinoma.

IF 4.4 3区医学 Q2 ONCOLOGY Targeted Oncology Pub Date : 2024-07-01 Epub Date: 2024-05-31 DOI:10.1007/s11523-024-01069-6

Maki Yoshino, Hiroki Ishihara, Yuki Nemoto, Shinsuke Mizoguchi, Takashi Ikeda, Takayuki Nakayama, Hironori Fukuda, Kazuhiko Yoshida, Junpei Iizuka, Hiroaki Shimmura, Yasunobu Hashimoto, Tsunenori Kondo, Toshio Takagi

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Abstract

Background: The impact of glucocorticoid administration for adverse events (AEs), including immune-related AEs, on the effectiveness of immune checkpoint inhibitor (ICI) combination therapy for advanced renal cell carcinoma (RCC) remains unknown.

Objectives: To clarify the prognostic impact of glucocorticoid use for AEs during first-line ICI combination therapy for advanced RCC.

Patients and methods: We retrospectively evaluated data from 194 patients who received dual ICI combination therapy [i.e., immunotherapy (IO)-IO] or combinations of ICIs with tyrosine kinase inhibitors (TKIs) as first-line therapy. The patients were divided into two groups according to the history of glucocorticoid administration in each treatment group. Survival based on glucocorticoid administration was assessed.

Results: A total of 101 (52.0%) and 93 (48.0%) patients received IO-IO and IO-TKI combination therapy, respectively. Glucocorticoids were administered to 46 (46%) and 22 (24%) patients in the IO-IO and IO-TKI groups, respectively. In the IO-IO group, progression-free survival (PFS) and overall survival (OS) were significantly longer in patients with glucocorticoid administration than in those without administration (median PFS: 14.4 versus 3.45 months, p = 0.0005; median OS: 77.6 versus 33.9 months, p = 0.0025). Multivariable analysis showed that glucocorticoid administration was an independent predictor of longer PFS (hazard ratio: 0.43, p = 0.0005) and OS (hazard ratio: 0.35, p = 0.0067) after adjustment for covariates. In the IO-TKI group, neither PFS nor OS significantly differed between patients treated with and without glucocorticoid administration (PFS: p = 0.0872, OS: p = 0.216).

Conclusions: Glucocorticoid administration did not negatively impact the effectiveness of ICI combination therapy for RCC, prompting glucocorticoid treatment use when AEs develop.

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免疫检查点抑制剂联合疗法期间糖皮质激素对既往未治疗过的晚期肾细胞癌患者不良事件的生存影响

背景：使用糖皮质激素治疗不良事件（AEs），包括免疫相关AEs，对免疫检查点抑制剂（ICI）联合治疗晚期肾细胞癌（RCC）疗效的影响尚不清楚：明确在一线 ICI 联合疗法治疗晚期 RCC 期间使用糖皮质激素对 AEs 的预后影响：我们回顾性评估了194例接受双ICI联合疗法[即免疫疗法（IO）-IO]或ICIs与酪氨酸激酶抑制剂（TKIs）联合疗法作为一线疗法的患者的数据。根据糖皮质激素用药史将各治疗组患者分为两组。根据糖皮质激素的使用情况评估患者的生存率：共有 101 例（52.0%）和 93 例（48.0%）患者分别接受了 IO-IO 和 IO-TKI 联合治疗。IO-IO组和IO-TKI组分别有46例（46%）和22例（24%）患者使用糖皮质激素。在IO-IO组中，使用糖皮质激素的患者的无进展生存期（PFS）和总生存期（OS）明显长于未使用糖皮质激素的患者（中位PFS：14.4个月对3.45个月，P = 0.0005；中位OS：77.6个月对33.9个月，P = 0.0005）：77.6个月对33.9个月，P = 0.0025）。多变量分析显示，在调整协变量后，使用糖皮质激素是延长PFS（危险比：0.43，p = 0.0005）和OS（危险比：0.35，p = 0.0067）的独立预测因素。在IO-TKI组，使用和不使用糖皮质激素治疗的患者的PFS和OS均无显著差异（PFS：P = 0.0872，OS：P = 0.216）：结论：使用糖皮质激素不会对ICI联合疗法治疗RCC的疗效产生负面影响，当出现AE时应及时使用糖皮质激素治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Targeted Oncology 医学-肿瘤学

CiteScore

8.40

自引率

3.70%

发文量

审稿时长

>12 weeks

期刊介绍： Targeted Oncology addresses physicians and scientists committed to oncology and cancer research by providing a programme of articles on molecularly targeted pharmacotherapy in oncology. The journal includes: Original Research Articles on all aspects of molecularly targeted agents for the treatment of cancer, including immune checkpoint inhibitors and related approaches. Comprehensive narrative Review Articles and shorter Leading Articles discussing relevant clinically established as well as emerging agents and pathways. Current Opinion articles that place interesting areas in perspective. Therapy in Practice articles that provide a guide to the optimum management of a condition and highlight practical, clinically relevant considerations and recommendations. Systematic Reviews that use explicit, systematic methods as outlined by the PRISMA statement. Adis Drug Reviews of the properties and place in therapy of both newer and established targeted drugs in oncology.