恩福单抗维多汀治疗晚期尿路上皮癌的良好疗效与身体(而非实验室)治疗相关不良事件有关:一项具有里程碑意义的分析。

IF 1.8 3区 医学 Q3 UROLOGY & NEPHROLOGY International Journal of Urology Pub Date : 2024-11-22 DOI:10.1111/iju.15640
Satoru Taguchi, Taketo Kawai, Yoshiki Ambe, Kenjiro Kishitani, Michio Noda, Tomoyuki Kaneko, Jimpei Miyakawa, Yu Nakamura, Hayato Hoshina, Daisuke Obinata, Kenya Yamaguchi, Shigenori Kakutani, Yoshitsune Furuya, Yujiro Sato, Yume Adachi, Kazuma Sugimoto, Keigo Sato, Mariko Tabata, Takehiro Tanaka, Katsuhiko Nara, Yukari Uemura, Jun Kamei, Yoshiyuki Akiyama, Yusuke Sato, Yuta Yamada, Aya Niimi, Daisuke Yamada, Tappei Takada, Sayuri Takahashi, Yukio Yamada, Hideyo Miyazaki, Yutaka Enomoto, Hiroaki Nishimatsu, Tetsuya Fujimura, Hiroshi Fukuhara, Tohru Nakagawa, Satoru Takahashi, Haruki Kume
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引用次数: 0

摘要

背景:虽然免疫相关不良事件的发生已被认为是接受免疫检查点抑制剂治疗的患者的预后标志,但治疗相关不良事件(trAEs)对接受恩福单抗维多汀(EV)等抗体药物共轭物治疗的患者的预后意义却存在争议:我们回顾了2021年至2023年间在10家机构接受EV治疗的106例晚期尿路上皮癌患者。采用Cox比例危险模型评估了临床参数与总生存期和无进展生存期的关系。为评估trAEs,进行了地标分析,以尽量减少不死时间偏差:106名患者中,55人(51.9%)在随访期间疾病进展,44人(41.5%)死亡。94例(88.7%)和44例(41.5%)患者分别出现了任何等级和等级≥3的trAEs。常见的 trAE 包括皮肤病(74.5%)、胃肠道疾病(62.3%)、疲劳(50.0%)、周围神经病变(36.8%)和血液病(37.7%)。一名患者死于间质性肺炎(5 级)。根据对存活 2 个月或以上的 88 名患者进行的地标分析,trAEs 与患者存活时间的延长有显著相关性。此外,如果将trAEs分为 "物理性trAEs"(如皮肤病)和 "实验室性trAEs"(如血液病),前者与较长的存活期相关,而后者与较短的存活期相关:结论:身体上的 trAEs 与晚期尿路上皮癌 EV 治疗的良好疗效有关,但与实验室的 trAEs 无关。管理trAEs并将其作为预后指标是使用EV等抗体药物共轭物的关键点。
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Physical, but not laboratory, treatment-related adverse events are associated with favorable outcomes of enfortumab vedotin for advanced urothelial carcinoma: A landmark analysis.

Background: While the occurrence of immune-related adverse events has been recognized as a prognostic marker in patients receiving immune checkpoint inhibitors, the prognostic significance of treatment-related adverse events (trAEs) in patients undergoing antibody-drug conjugates such as enfortumab vedotin (EV) is controversial.

Methods: We reviewed 106 patients with advanced urothelial carcinoma who were treated with EV therapy at 10 institutions between 2021 and 2023. Associations of clinical parameters with overall survival and progression-free survival were assessed using the Cox proportional hazards model. For the assessment of trAEs, landmark analysis was conducted to minimize immortal time bias.

Results: Of 106 patients, 55 (51.9%) experienced disease progression and 44 (41.5%) died during the follow-up period. Any grade and grade ≥3 trAEs occurred in 94 (88.7%) and 44 (41.5%) patients, respectively. Common trAEs included skin disorders (74.5%), gastrointestinal disorders (62.3%), fatigue (50.0%), peripheral neuropathy (36.8%), and hematological disorders (37.7%). One patient died of interstitial pneumonia (grade 5). According to landmark analysis using 88 patients who survived for 2 months or more, trAEs were significantly associated with longer survival. Furthermore, when trAEs were classified into "physical trAEs" such as skin disorders and "laboratory trAEs" such as hematological disorders, the former were associated with longer survival while the latter were associated with shorter survival.

Conclusions: Physical, but not laboratory, trAEs are associated with favorable outcomes of EV therapy for advanced urothelial carcinoma. Both managing trAEs and utilizing them as prognostic markers are key points in the use of antibody-drug conjugates such as EV.

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来源期刊
International Journal of Urology
International Journal of Urology 医学-泌尿学与肾脏学
CiteScore
4.70
自引率
11.50%
发文量
340
审稿时长
3 months
期刊介绍: International Journal of Urology is the official English language journal of the Japanese Urological Association, publishing articles of scientific excellence in urology. Submissions of papers from all countries are considered for publication. All manuscripts are subject to peer review and are judged on the basis of their contribution of original data and ideas or interpretation.
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