Ishii Noritaka, Sekine Yuya, Shinohara Masanao, Kawashima Yohei, Mori Kanami, Kobayashi Mizuki, Numakura Kazuyuki, Mikami Jotaro, Fujita Naoki, Okamoto Teppei, Yoneyama Takahiro, Tabata Ryuji, Sato Satoshi, Habuchi Tomonori, Ohyama Chikara, Hatakeyama Shingo
Department of Urology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Department of Urology, Aomori Rosai Hospital, Hachinohe, Japan.
Cancer Med. 2025 Sep;14(18):e71241. doi: 10.1002/cam4.71241.
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.
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).
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.
Avelumab maintenance appeared to improve outcomes across cycles 2-3 and ≥ 4, though residual confounding cannot be excluded.
在真实世界实践中比较接受阿维鲁单抗维持治疗或传统铂类一线化疗的尿路上皮癌患者的肿瘤学结局。
回顾性评估2004年3月至2024年9月期间接受不含阿维鲁单抗的铂类一线化疗（化疗组，n = 300）或阿维鲁单抗维持治疗（阿维鲁单抗组，n = 85）的晚期尿路上皮癌患者的结局。化疗组和阿维鲁单抗组的总生存期（OS）按一线化疗周期数进行分层。主要结局是在第4周期评估时无疾病进展（非PD）患者的OS（标准转换队列）。次要结局是在第2至3周期评估时非PD患者的OS（早期转换队列）。
在标准转换队列（第4周期非PD）中，化疗组和阿维鲁单抗组分别有122例和47例患者；阿维鲁单抗组的中位OS显著长于化疗组（70个月对26个月；p = 0.015）。在早期转换队列（第2 - 3周期非PD）中，化疗组和阿维鲁单抗组分别有104例和35例患者；阿维鲁单抗组的中位OS显著长于化疗组（33个月对13个月；p = 0.002）。多变量Cox回归分析显示，给予阿维鲁单抗与降低OS风险显著相关（风险比，0.37；p < 0.001）。回顾性设计是本研究的一个局限性。
阿维鲁单抗维持治疗似乎可改善第2 - 3周期和≥4周期的结局，尽管不能排除残留混杂因素。
