Effects of Avelumab Maintenance on Advanced Urothelial Carcinoma: A Real-World Multicenter Study

IF 3.1 2区医学 Q2 ONCOLOGY

Cancer Medicine Pub Date : 2025-09-12 DOI:10.1002/cam4.71241

Noritaka Ishii, Yuya Sekine, Masanao Shinohara, Yohei Kawashima, Kanami Mori, Mizuki Kobayashi, Kazuyuki Numakura, Jotaro Mikami, Naoki Fujita, Teppei Okamoto, Takahiro Yoneyama, Ryuji Tabata, Satoshi Sato, Tomonori Habuchi, Chikara Ohyama, Shingo Hatakeyama

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Abstract

Objectives

Oncological outcomes in patients with urothelial carcinoma treated with avelumab maintenance therapy or conventional platinum-based first-line chemotherapy were compared in real-world practice.

Methods

Outcomes in patients with advanced urothelial carcinoma treated with platinum-based first-line chemotherapy without avelumab (chemo group, n = 300) or avelumab maintenance therapy (avelumab group, n = 85) between March 2004 and September 2024 were retrospectively evaluated. Overall survival (OS) in the chemo and avelumab groups was stratified by the number of cycles of first-line chemotherapy. The primary outcome was OS among patients without progressive disease (non-PD) at the cycle-4 assessment (the standard-switch cohort). The secondary outcome was OS among patients with non-PD at the cycles-2 to 3 assessment (the early-switch cohort).

Results

In the standard-switch cohort (non-PD at cycle 4), the chemo and avelumab groups comprised 122 and 47 patients, respectively; median OS was significantly longer with avelumab than with chemo (70 vs. 26 months; p = 0.015). In the early-switch cohort (non-PD at cycles 2–3), the chemo and avelumab groups comprised 104 and 35 patients, respectively; median OS was significantly longer with avelumab than with chemo (33 vs. 13 months; p = 0.002). A multivariable Cox regression analysis revealed that avelumab administration was significantly associated with a reduced risk of OS (hazard ratio, 0.37; p < 0.001). The retrospective design is a limitation of this study.

Conclusion

Avelumab maintenance appeared to improve outcomes across cycles 2–3 and ≥ 4, though residual confounding cannot be excluded.

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Avelumab维持对晚期尿路上皮癌的影响：一项真实世界的多中心研究

目的在现实世界的实践中比较尿路上皮癌患者接受avelumab维持治疗或传统铂类一线化疗的肿瘤预后。方法回顾性分析2004年3月至2024年9月期间接受铂基一线化疗（化疗组，n = 300）或维单抗维持治疗（维单抗组，n = 85）的晚期尿路上皮癌患者的预后。化疗组和avelumab组的总生存期（OS）按一线化疗周期数分层。在第4周期评估（标准切换队列）中，主要结局为无进展性疾病（非pd）患者的OS。次要结果是非pd患者在第2 - 3周期评估时的OS（早期切换队列）。在标准切换队列（第4周期非pd）中，化疗组和avelumab组分别有122例和47例患者；avelumab组的中位生存期明显长于化疗组（70个月vs 26个月；p = 0.015）。在早期切换队列（第2-3周期非pd）中，化疗组和avelumab组分别有104例和35例患者；avelumab组的中位生存期明显长于化疗组（33个月vs 13个月；p = 0.002）。多变量Cox回归分析显示，给药avelumab与OS风险降低显著相关（风险比，0.37;p < 0.001）。回顾性设计是本研究的一个局限性。结论维持Avelumab似乎改善了2-3和≥4个周期的结局，但不能排除残留的混杂因素。

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

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.