THOR 3 期日本亚组分析:厄达非替尼治疗晚期或转移性尿路上皮癌及成纤维细胞生长因子受体改变。

IF 2.4 3区 医学 Q3 ONCOLOGY
Nobuaki Matsubara, Yuji Miura, Hiroyuki Nishiyama, Rikiya Taoka, Takahiro Kojima, Nobuaki Shimizu, Jason Hwang, Tatsuya Ote, Ryo Oyama, Kiichiro Toyoizumi, Sutapa Mukhopadhyay, Spyros Triantos, Kris Deprince, Yohann Loriot
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引用次数: 0

摘要

研究背景在THOR试验(NCT03390504)队列1中,与化疗相比,厄达非替尼明显延长了FGFR改变的转移性尿路上皮癌(mUC)患者的总生存期(OS)(中位12.1个月对7.8个月),并将死亡风险降低了36%(危险比0.64,P = 0.005),这些患者在既往接受过≥1次治疗(包括抗PD-(L)1)后病情出现进展。目前还没有关于日本亚组结果的报告:THOR 队列 1 将患者随机分为每天一次的厄达菲替尼或每 3 周一次的多西他赛/文氟宁。主要终点为OS。次要终点包括无进展生存期(PFS)和客观反应率(ORR)。此次日本亚组分析未设定特定的统计能力:在266名随机患者中,有27名日本人(14名厄达非替尼患者;13名化疗患者)。除了日本患者中男性较多、体重较轻、上呼吸道原发肿瘤较多之外,不同治疗方法的基线特征与总体人群基本相似。与化疗相比,厄达非尼的OS(中位25.4个月对12.4个月)、PFS(中位8.4个月对2.9个月)和ORR(57.1%对15.4%)均有所改善。两组所有患者均发生了任何级别的治疗相关不良事件(AEs),但厄达菲尼治疗组的3/4级AEs和导致停药的AEs较少。在日本亚组中没有观察到新的安全性信号:结论:在日本亚组中,与化疗相比,厄达非替尼的生存率和反应均有所改善,且未出现新的安全性问题。这些结果支持将厄达菲尼作为FGFR改变的日本mUC患者的治疗选择,并应考虑在确诊mUC后尽早进行FGFR检测。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Phase 3 THOR Japanese subgroup analysis: erdafitinib in advanced or metastatic urothelial cancer and fibroblast growth factor receptor alterations.

Phase 3 THOR Japanese subgroup analysis: erdafitinib in advanced or metastatic urothelial cancer and fibroblast growth factor receptor alterations.

Background: In the THOR trial (NCT03390504) Cohort 1, erdafitinib demonstrated significantly prolonged overall survival (OS) (median 12.1 versus 7.8 months) and reduced risk of death by 36% (hazard ratio 0.64, P = 0.005) compared with chemotherapy in metastatic urothelial carcinoma (mUC) patients with FGFR alterations who progressed after ≥ 1 prior treatments, including anti-PD-(L)1. There have been no reports of the Japanese subgroup results yet.

Methods: THOR Cohort 1 randomized patients to erdafitinib once daily or docetaxel/vinflunine once every 3 weeks. Primary endpoint was OS. Secondary endpoints included progression-free survival (PFS) and objective response rate (ORR). No specific statistical power was set for this Japanese subgroup analysis.

Results: Of 266 patients randomized, 27 (14 erdafitinib; 13 chemotherapy) were Japanese. Baseline characteristics were generally similar between treatments and to the overall population, except for more males, lower body weight, and more upper tract primary tumors among Japanese patients. Compared with chemotherapy, erdafitinib showed improved OS (median 25.4 versus 12.4 months), PFS (median 8.4 versus 2.9 months) and ORR (57.1% versus 15.4%). Any grade treatment-related adverse events (AEs) occurred in all patients from both arms but Grade 3/4 AEs and AEs leading to discontinuation were lower in the erdafitinib arm. No new safety signals were observed in the Japanese subgroup.

Conclusion: In the Japanese subgroup, erdafitinib showed improved survival and response compared to chemotherapy, with no new safety concerns. These results support erdafitinib as a treatment option for Japanese mUC patients with FGFR alterations, and early FGFR testing after diagnosis of mUC should be considered.

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来源期刊
CiteScore
6.80
自引率
3.00%
发文量
175
审稿时长
2 months
期刊介绍: The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.
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