Enfortumab vedotin following platinum-based chemotherapy and immune checkpoint inhibitors for advanced urothelial carcinoma: response, survival and safety analysis from a multicentre real-world Japanese cohort

被引：22

作者：

Miyake, Makito ^{[1
,15
]}

Nishimura, Nobutaka ^{[1
,2
]}

Oda, Yuki ^{[1
]}

Miyamoto, Tatsuki ^{[3
]}

Ohmori, Chihiro ^{[4
]}

Takamatsu, Norimi ^{[5
]}

Itami, Yoshitaka ^{[6
]}

Tachibana, Akira ^{[7
]}

Matsumoto, Yoshihiro ^{[7
]}

Kiba, Keisuke ^{[8
]}

Tomioka, Atsushi ^{[9
]}

Yamamoto, Hiroaki ^{[10
]}

Okajima, Eijiro ^{[11
]}

Masaomi, Kuwata ^{[12
]}

Sakamoto, Keichi ^{[13
]}

Tomizawa, Mitsuru ^{[1
]}

Shimizu, Takuto ^{[1
]}

Ohnishi, Kenta ^{[1
]}

Hori, Shunta ^{[1
]}

Morizawa, Yosuke ^{[1
]}

Gotoh, Daisuke ^{[1
]}

Nakai, Yasushi ^{[1
]}

Torimoto, Kazumasa ^{[1
]}

Tanaka, Nobumichi ^{[1
,14
]}

Fujimoto, Kiyohide ^{[1
]}

机构：

[1] Nara Med Univ, Dept Urol, Kashihara, Nara, Japan

[2] Hirao Hosp, Dept Urol, Kashihara, Nara, Japan

[3] Takai Hosp, Dept Urol, Tenri, Nara, Japan

[4] Nara Prefecture Gen Med Ctr, Dept Urol, Nara, Nara, Japan

[5] Yamatotakada Municipal Hosp, Dept Urol, Yamatotakada, Nara, Japan

[6] Tane Gen Hosp, Dept Urol, Osaka, Osaka, Japan

[7] Hoshigaoka Med Ctr, Dept Urol, Hirakata, Osaka, Japan

[8] Kindai Univ, Nara Hosp, Dept Urol, Ikoma, Nara, Japan

[9] Saiseikai Chuwa Hosp, Dept Urol, Sakurai, Nara, Japan

[10] Minami Nara Med Ctr, Dept Urol, Yoshino, Nara, Japan

[11] Nara City Hosp, Dept Urol, Nara, Nara, Japan

[12] Matsusaka Chuo Gen Hosp, Dept Urol, Matsusaka, Mie, Japan

[13] Osaka Kaisei Hosp, Dept Urol, Osaka, Osaka, Japan

[14] Nara Med Univ, Dept Prostate Brachytherapy, Kashihara, Nara, Japan

[15] Nara Med Univ, Dept Urol, 840 Shijo Cho, Nara 6348522, Japan

来源：

JAPANESE JOURNAL OF CLINICAL ONCOLOGY | 2024年 / 54卷 / 03期

关键词：

urinary bladder neoplasms; kidney pelvis; ureter; immunotherapy; chemotherapy; survival; mortality; avelumab; pembrolizumab; enfortumab vedotin; BLADDER-CANCER; UNITED-STATES; PROGNOSIS; SCORE;

D O I：

10.1093/jjco/hyad170

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objective Real-world evidence regarding enfortumab vedotin for unresectable or metastatic urothelial carcinoma is scarce, particularly in Japan. We investigated real-world data focusing on patient background, previous treatments, response, survival and adverse events in patients receiving enfortumab vedotin.Methods A multicentre database was used to register 556 patients diagnosed with metastatic urothelial carcinoma from 2008 to 2023; 34 patients (6.1%) treated with enfortumab vedotin were included. Best radiographic objective responses were evaluated using the Response Evaluation Criteria in Solid Tumors (v1.1) during treatments. Overall survival and progression-free survival were estimated (Kaplan-Meier method). Toxicities were reported according to the Common Terminology Criteria for Adverse Events, version 5.0. The relative dose intensity, which could impact oncological outcomes, was calculated.Results The median number of enfortumab vedotin therapy cycles was 5. The best objective response to enfortumab vedotin was partial response, stable disease and progressive disease in 19 (56%), 5 (15%) and 10 (29%) patients, respectively. The median overall survival and progression-free survival after the first enfortumab vedotin dose were 16 and 9 months, respectively. No significant relationship was observed between survival outcomes after enfortumab vedotin initiation and the enfortumab vedotin relative dose intensity. The median overall survival from first-line platinum-based chemotherapy initiation was 42 months. Twenty-six (76%) patients experienced any grade of enfortumab vedotin-related toxicities; eight (24%) experienced Grades 3-4 toxicities, the most common being skin toxicity (any grade, 47%; Grades 3-4, 12%).Conclusions Here, we report real-world evidence for enfortumab vedotin therapy in Japan. Tumour responses and safety profiles were comparable with those of clinical trials on this novel treatment. Real-world evidence regarding enfortumab vedotin for advanced urothelial carcinoma is scarce in Japan. We demonstrated that the efficacy and safety profiles of our real-world cohort were comparable with those of clinical trials.

引用

页码：329 / 338

页数：10

共 27 条

[1]

[Anonymous], EUR UROL

[2] Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma [J].

Bellmunt, J. ;

de Wit, R. ;

Vaughn, D. J. ;

Fradet, Y. ;

Lee, J. -L. ;

Fong, L. ;

Vogelzang, N. J. ;

Climent, M. A. ;

Petrylak, D. P. ;

Choueiri, T. K. ;

Necchi, A. ;

Gerritsen, W. ;

Gurney, H. ;

Quinn, D. I. ;

Culine, S. ;

Sternberg, C. N. ;

Mai, Y. ;

Poehlein, C. H. ;

Perini, R. F. ;

Bajorin, D. F. .

NEW ENGLAND JOURNAL OF MEDICINE, 2017, 376 (11) :1015-1026

[3] Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician [J].

Blonde, Lawrence ;

Khunti, Kamlesh ;

Harris, Stewart B. ;

Meizinger, Casey ;

Skolnik, Neil S. .

ADVANCES IN THERAPY, 2018, 35 (11) :1763-1774

[4] Treatment Sequencing Patterns in Patients with Metastatic Urothelial Cancer Treated in the Community Practice Setting in the United States: SPEAR-Bladder (Study informing treatment Pathway dEcision in bladder cAnceR) [J].

Doshi, Gurjyot K. ;

Bhanegaonkar, Abhijeet ;

Kearney, Mairead ;

Bharmal, Murtuza ;

Cislo, Paul ;

Kim, Ruth ;

Boyd, Marley ;

Aguilar, Kathleen M. ;

Phatak, Hemant .

CLINICOECONOMICS AND OUTCOMES RESEARCH, 2020, 12 :645-656

[5] New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1) [J].

Eisenhauer, E. A. ;

Therasse, P. ;

Bogaerts, J. ;

Schwartz, L. H. ;

Sargent, D. ;

Ford, R. ;

Dancey, J. ;

Arbuck, S. ;

Gwyther, S. ;

Mooney, M. ;

Rubinstein, L. ;

Shankar, L. ;

Dodd, L. ;

Kaplan, R. ;

Lacombe, D. ;

Verweij, J. .

EUROPEAN JOURNAL OF CANCER, 2009, 45 (02) :228-247

[6] Bladder Cancer, Version 2.2022 Featured Updates to the NCCN Guidelines [J].

Flaig, Thomas W. ;

Spiess, Philippe E. ;

Abern, Michael ;

Agarwal, Neeraj ;

Bangs, Rick ;

Boorjian, Stephen A. ;

Buyyounouski, Mark K. ;

Chan, Kevin ;

Chang, Sam ;

Friedlander, Terence ;

Greenberg, Richard E. ;

Guru, Khurshid A. ;

Herr, Harry W. ;

Hoffman-Censits, Jean ;

Kishan, Amar ;

Kundu, Shilajit ;

Lele, Subodh M. ;

Mamtani, Ronac ;

Margulis, Vitaly ;

Mian, Omar Y. ;

Michalski, Jeff ;

Montgomery, Jeffrey S. ;

Nandagopal, Lakshminarayanan ;

Pagliaro, Lance C. ;

Parikh, Mamta ;

Patterson, Anthony ;

Plimack, Elizabeth R. ;

Pohar, Kamal S. ;

Preston, Mark A. ;

Richards, Kyle ;

Sexton, Wade J. ;

Siefker-Radtke, Arlene O. ;

Tollefson, Matthew ;

Tward, Jonathan ;

Wright, Jonathan L. ;

Dwyer, Mary A. ;

Cassara, Carly J. ;

Gurski, Lisa A. .

JOURNAL OF THE NATIONAL COMPREHENSIVE CANCER NETWORK, 2022, 20 (08) :866-878

[7] Administration of Enfortumab Vedotin after Immune-Checkpoint Inhibitor and the Prognosis in Japanese Metastatic Urothelial Carcinoma: A Large Database Study on Enfortumab Vedotin in Metastatic Urothelial Carcinoma [J].

Kawahara, Takashi ;

Hasizume, Akihito ;

Uemura, Koichi ;

Yamaguchi, Katsuya ;

Ito, Hiroki ;

Takeshima, Teppei ;

Hasumi, Hisashi ;

Teranishi, Jun-ichi ;

Ousaka, Kimito ;

Makiyama, Kazuhide ;

Uemura, Hiroji .

CANCERS, 2023, 15 (17)

[8] Efficacy of enfortumab vedotin in advanced urothelial cancer: Analysis from the Urothelial Cancer Network to Investigate Therapeutic Experiences (UNITE) study [J].

Koshkin, Vadim S. ;

Henderson, Nicholas ;

James, Marihella ;

Natesan, Divya ;

Freeman, Dory ;

Nizam, Amanda ;

Su, Christopher T. ;

Khaki, Ali Raza ;

Osterman, Chelsea K. ;

Glover, Michael J. ;

Chiang, Ryan ;

Makrakis, Dimitrios ;

Talukder, Rafee ;

Lemke, Emily ;

Olsen, T. Anders ;

Jain, Jayanshu ;

Jang, Albert ;

Ali, Alicia ;

Jindal, Tanya ;

Chou, Jonathan ;

Friedlander, Terence W. ;

Hoimes, Christopher ;

Basu, Arnab ;

Zakharia, Yousef ;

Barata, Pedro C. ;

Bilen, Mehmet A. ;

Emamekhoo, Hamid ;

Davis, Nancy B. ;

Shah, Sumit A. ;

Milowsky, Matthew I. ;

Gupta, Shilpa ;

Campbell, Matthew T. ;

Grivas, Petros ;

Sonpavde, Guru P. ;

Kilari, Deepak ;

Alva, Ajjai S. .

CANCER, 2022, 128 (06) :1194-1205

[9] Management of Dermatologic Events Associated With the Nectin-4-directed Antibody-Drug Conjugate Enfortumab Vedotin [J].

Lacouture, Mario E. ;

Patel, Anisha B. ;

Rosenberg, Jonathan E. ;

O'Donnell, Peter H. .

ONCOLOGIST, 2022, 27 (03) :E223-E232

[10] Japanese subgroup analysis of EV-301: An open-label, randomized phase 3 study to evaluate enfortumab vedotin versus chemotherapy in subjects with previously treated locally advanced or metastatic urothelial carcinoma [J].

Matsubara, Nobuaki ;

Yonese, Junji ;

Kojima, Takahiro ;

Azuma, Haruhito ;

Matsumoto, Hiroaki ;

Powles, Thomas ;

Rosenberg, Jonathan E. ;

Petrylak, Daniel P. ;

Matsangou, Maria ;

Wu, Chunzhang ;

Campbell, Mary ;

Yamashiro, Mayumi .

CANCER MEDICINE, 2023, 12 (03) :2761-2771

← 1 2 3 →