TY - JOUR
T1 - J-AVENUE
T2 - A retrospective, real-world study evaluating patient characteristics and outcomes in patients with advanced urothelial carcinoma treated with avelumab first-line maintenance therapy in Japan
AU - Kikuchi, Eiji
AU - Hayakawa, Nozomi
AU - Nakayama, Masashi
AU - Uno, Masahiro
AU - Nakatsu, Hiroomi
AU - Kitagawa, Chiyoe
AU - Miyake, Hideaki
AU - Yamada, Takeshi
AU - Fujita, Kazutoshi
AU - Shimoyama, Hideaki
AU - Nishihara, Kiyoaki
AU - Kobayashi, Mizuki
AU - Nakamura, Motonobu
AU - Fujimoto, Kiyohide
AU - Sano, Takeshi
AU - Nishiyama, Naotaka
AU - Ito, Takayuki
AU - Kajita, Masahiro
AU - Kobayashi, Takashi
AU - Kitamura, Hiroshi
N1 - Publisher Copyright:
© 2024 The Authors. International Journal of Urology published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Urological Association.
PY - 2024/8
Y1 - 2024/8
N2 - Objectives: 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. Methods: 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. Results: 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). Conclusions: 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.
AB - Objectives: 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. Methods: 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. Results: 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). Conclusions: 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.
KW - avelumab
KW - immunotherapy
KW - real world clinical trials
KW - treatment outcome
KW - urothelial carcinoma
UR - http://www.scopus.com/inward/record.url?scp=85192514991&partnerID=8YFLogxK
U2 - 10.1111/iju.15473
DO - 10.1111/iju.15473
M3 - 学術論文
C2 - 38722221
AN - SCOPUS:85192514991
SN - 0919-8172
VL - 31
SP - 859
EP - 867
JO - International Journal of Urology
JF - International Journal of Urology
IS - 8
ER -