Kikuchi Eiji, Hayakawa Nozomi, Nakayama Masashi, Uno Masahiro, Nakatsu Hiroomi, Kitagawa Chiyoe, Miyake Hideaki, Yamada Takeshi, Fujita Kazutoshi, Shimoyama Hideaki, Nishihara Kiyoaki, Kobayashi Mizuki, Nakamura Motonobu, Fujimoto Kiyohide, Sano Takeshi, Nishiyama Naotaka, Ito Takayuki, Kajita Masahiro, Kobayashi Takashi, Kitamura Hiroshi
Department of Urology, St. Marianna University School of Medicine, Kanagawa, Japan.
Department of Urology, Osaka International Cancer Institute, Osaka, Japan.
Int J Urol. 2024 Aug;31(8):859-867. doi: 10.1111/iju.15473. Epub 2024 May 9.
The JAVELIN Bladder 100 phase 3 trial showed that avelumab first-line maintenance + best supportive care significantly prolonged overall survival and progression-free survival versus best supportive care alone in patients with advanced urothelial carcinoma who were progression-free following first-line platinum-based chemotherapy. We report findings from J-AVENUE (NCT05431777), a real-world study of avelumab first-line maintenance therapy in Japan.
Medical charts of patients with advanced urothelial carcinoma without disease progression following first-line platinum-based chemotherapy, who received avelumab maintenance between February and November 2021, were reviewed. Patients were followed until June 2022. The primary endpoint was patient characteristics; secondary endpoints included time to treatment failure and progression-free survival.
In 79 patients analyzed, median age was 72 years (range, 44-86). Primary tumor site was upper tract in 45.6% and bladder in 54.4%. The most common first-line chemotherapy regimen was cisplatin + gemcitabine (63.3%). Median number of chemotherapy cycles received was four. Best response to chemotherapy was complete response in 10.1%, partial response in 58.2%, and stable disease in 31.6%. Median treatment-free interval before avelumab was 4.9 weeks. With avelumab first-line maintenance therapy, the disease control rate was 58.2%, median time to treatment failure was 4.6 months (95% CI, 3.3-6.4), and median progression-free survival was 6.1 months (95% CI, 3.6-9.7).
Findings from J-AVENUE show the effectiveness of avelumab first-line maintenance in patients with advanced urothelial carcinoma in Japan in clinical practice, with similar progression-free survival to JAVELIN Bladder 100 and previous real-world studies, supporting its use as a standard of care.
JAVELIN Bladder 100 3期试验表明，对于一线铂类化疗后无进展的晚期尿路上皮癌患者，阿维鲁单抗一线维持治疗加最佳支持治疗与单纯最佳支持治疗相比，显著延长了总生存期和无进展生存期。我们报告了J-AVENUE（NCT05431777）的研究结果，这是一项在日本进行的关于阿维鲁单抗一线维持治疗的真实世界研究。
回顾了2021年2月至11月期间接受阿维鲁单抗维持治疗、一线铂类化疗后无疾病进展的晚期尿路上皮癌患者的病历。对患者进行随访直至2022年6月。主要终点是患者特征；次要终点包括治疗失败时间和无进展生存期。
在分析的79例患者中，中位年龄为72岁（范围44 - 86岁）。原发肿瘤部位在上尿路的占45.6%，在膀胱的占54.4%。最常见的一线化疗方案是顺铂 + 吉西他滨（占63.3%）。接受化疗的中位周期数为4个。化疗的最佳反应为完全缓解的占10.1%，部分缓解的占58.2%，病情稳定的占31.6%。阿维鲁单抗治疗前的中位无治疗间隔为4.9周。采用阿维鲁单抗一线维持治疗时，疾病控制率为58.2%，中位治疗失败时间为4.6个月（95%CI，3.3 - 6.4），中位无进展生存期为6.1个月（95%CI，3.6 - 9.7）。
J-AVENUE的研究结果表明，在日本临床实践中，阿维鲁单抗一线维持治疗对晚期尿路上皮癌患者有效，无进展生存期与JAVELIN Bladder 100及之前的真实世界研究相似，支持其作为一种标准治疗方法使用。
