Real world evidence of enfortumab vedotin in patients with advanced urothelial cancer: A multicenter observational study
Objectives To explore the characteristics of patients and assess the effectiveness of enfortumab vedotin (EV) in those with treatment‐resistant advanced urothelial cancer in a real‐world setting. Patients and Methods A multicenter observational study was conducted on 103 evaluable patients with adva...
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| Veröffentlicht in: | International journal of urology 2024-04, Vol.31 (4), p.342-347 |
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| creator | Fukuokaya, Wataru Koike, Yuhei Yata, Yuji Komura, Kazumasa Uchimoto, Taizo Tsujino, Takuya Saruta, Masanobu Takahara, Kiyoshi Fujita, Kazutoshi Minami, Takafumi Adachi, Takahiro Hirasawa, Yosuke Hashimoto, Takeshi Ohno, Yoshio Uemura, Hirotsugu Shiroki, Ryoichi Azuma, Haruhito Kimura, Takahiro |
| description | Objectives
To explore the characteristics of patients and assess the effectiveness of enfortumab vedotin (EV) in those with treatment‐resistant advanced urothelial cancer in a real‐world setting.
Patients and Methods
A multicenter observational study was conducted on 103 evaluable patients with advanced urothelial cancer who received EV. Outcomes were assessed by radiographic response, progression‐free survival (PFS), and overall survival (OS), with treatment‐related adverse events (trAEs). Radiographic response was assessed using Response Evaluation Criteria in Solid Tumors version 1.1, while trAEs were studied in line with Common Terminology Criteria for Adverse Events version 5.0.
Results
The median follow‐up was 8.9 months (range, 0.1–16.4). The observed objective response rate was 50.5%. The median PFS was 6.0 months (95% CI: 4.7–9.8), and the median OS was 14.5 months (95% CI: 12.4–not reached). Out of the 103 patients, 19 (18.4%) had an Eastern Cooperative Oncology Group performance status of 2 or more, 14 (14.7%) had an non‐urothelial carcinoma histology, and 40 (38.3%) had at least one pre‐existing comorbidity. There were 26 (25.2%) patients who reported 49 trAEs, with 9 (18.3%) being grade 3 or higher. The most common trAEs included rash, occurring in 18.4%.
Conclusions
This study describes the characteristics and outcomes of patients with previously treated advanced urothelial cancer receiving EV. The findings demonstrate that EV showed robust anti‐tumor activity and had manageable safety profiles outside the clinical trial setting. |
| doi_str_mv | 10.1111/iju.15368 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2904154444</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2904154444</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3538-59204b9e5a3807c99c4035de05942116bd39ded753a64ac2d72926b511e45c23</originalsourceid><addsrcrecordid>eNp10c9rFDEUB_AgFrutHvwHJOBFD9Pm5cfOxFspWlsKBannkEne0iwzkzWZ7Hb_e1O3ehD6CATCJ19e8gh5D-wMap2HdTkDJZbdK7IAKXnDmeSvyYJp0E0HLT8mJzmvGQPBoXtDjkUHIIQUC_L4A-1AdzENnuI2eJwc0riiOK1imstoe7pFH-cw0bo2dg44zZnuwvxArd_ayj0tKc4POISa5J5O0hd6QccyzMFVjYnGPmPa1stxqibPxe_fkqOVHTK-e95Pyf23r_eX35vbu6vry4vbxgklukbp-pZeo7KiY63T2kkmlEemtOQAy94L7dG3StiltI77lmu-7BUASuW4OCWfDrGbFH8VzLMZQ3Y4DHbCWLLhmklQslalH_-j61hSbTgbwYQG0QJTVX0-KJdizglXZpPCaNPeADNP0zB1GubPNKr98JxY-hH9P_n3-ys4P4BdGHD_cpK5vvl5iPwNEzSUIQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3039137105</pqid></control><display><type>article</type><title>Real world evidence of enfortumab vedotin in patients with advanced urothelial cancer: A multicenter observational study</title><source>Wiley Online Library All Journals</source><creator>Fukuokaya, Wataru ; Koike, Yuhei ; Yata, Yuji ; Komura, Kazumasa ; Uchimoto, Taizo ; Tsujino, Takuya ; Saruta, Masanobu ; Takahara, Kiyoshi ; Fujita, Kazutoshi ; Minami, Takafumi ; Adachi, Takahiro ; Hirasawa, Yosuke ; Hashimoto, Takeshi ; Ohno, Yoshio ; Uemura, Hirotsugu ; Shiroki, Ryoichi ; Azuma, Haruhito ; Kimura, Takahiro</creator><creatorcontrib>Fukuokaya, Wataru ; Koike, Yuhei ; Yata, Yuji ; Komura, Kazumasa ; Uchimoto, Taizo ; Tsujino, Takuya ; Saruta, Masanobu ; Takahara, Kiyoshi ; Fujita, Kazutoshi ; Minami, Takafumi ; Adachi, Takahiro ; Hirasawa, Yosuke ; Hashimoto, Takeshi ; Ohno, Yoshio ; Uemura, Hirotsugu ; Shiroki, Ryoichi ; Azuma, Haruhito ; Kimura, Takahiro</creatorcontrib><description>Objectives
To explore the characteristics of patients and assess the effectiveness of enfortumab vedotin (EV) in those with treatment‐resistant advanced urothelial cancer in a real‐world setting.
Patients and Methods
A multicenter observational study was conducted on 103 evaluable patients with advanced urothelial cancer who received EV. Outcomes were assessed by radiographic response, progression‐free survival (PFS), and overall survival (OS), with treatment‐related adverse events (trAEs). Radiographic response was assessed using Response Evaluation Criteria in Solid Tumors version 1.1, while trAEs were studied in line with Common Terminology Criteria for Adverse Events version 5.0.
Results
The median follow‐up was 8.9 months (range, 0.1–16.4). The observed objective response rate was 50.5%. The median PFS was 6.0 months (95% CI: 4.7–9.8), and the median OS was 14.5 months (95% CI: 12.4–not reached). Out of the 103 patients, 19 (18.4%) had an Eastern Cooperative Oncology Group performance status of 2 or more, 14 (14.7%) had an non‐urothelial carcinoma histology, and 40 (38.3%) had at least one pre‐existing comorbidity. There were 26 (25.2%) patients who reported 49 trAEs, with 9 (18.3%) being grade 3 or higher. The most common trAEs included rash, occurring in 18.4%.
Conclusions
This study describes the characteristics and outcomes of patients with previously treated advanced urothelial cancer receiving EV. The findings demonstrate that EV showed robust anti‐tumor activity and had manageable safety profiles outside the clinical trial setting.</description><identifier>ISSN: 0919-8172</identifier><identifier>EISSN: 1442-2042</identifier><identifier>DOI: 10.1111/iju.15368</identifier><identifier>PMID: 38113343</identifier><language>eng</language><publisher>Australia: Wiley Subscription Services, Inc</publisher><subject>Adverse events ; bladder cancer ; Cancer ; Comorbidity ; enfortumab vedotin ; Observational studies ; Patients ; renal pelvic cancer ; Solid tumors ; Survival ; ureter cancer ; Urothelial cancer ; Urothelial carcinoma</subject><ispartof>International journal of urology, 2024-04, Vol.31 (4), p.342-347</ispartof><rights>2023 The Japanese Urological Association.</rights><rights>2024 The Japanese Urological Association</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3538-59204b9e5a3807c99c4035de05942116bd39ded753a64ac2d72926b511e45c23</citedby><cites>FETCH-LOGICAL-c3538-59204b9e5a3807c99c4035de05942116bd39ded753a64ac2d72926b511e45c23</cites><orcidid>0000-0002-5673-1553 ; 0000-0002-3665-9523 ; 0000-0001-5060-3932 ; 0000-0002-4766-2074 ; 0000-0002-1563-4888 ; 0000-0003-1044-912X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fiju.15368$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fiju.15368$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38113343$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fukuokaya, Wataru</creatorcontrib><creatorcontrib>Koike, Yuhei</creatorcontrib><creatorcontrib>Yata, Yuji</creatorcontrib><creatorcontrib>Komura, Kazumasa</creatorcontrib><creatorcontrib>Uchimoto, Taizo</creatorcontrib><creatorcontrib>Tsujino, Takuya</creatorcontrib><creatorcontrib>Saruta, Masanobu</creatorcontrib><creatorcontrib>Takahara, Kiyoshi</creatorcontrib><creatorcontrib>Fujita, Kazutoshi</creatorcontrib><creatorcontrib>Minami, Takafumi</creatorcontrib><creatorcontrib>Adachi, Takahiro</creatorcontrib><creatorcontrib>Hirasawa, Yosuke</creatorcontrib><creatorcontrib>Hashimoto, Takeshi</creatorcontrib><creatorcontrib>Ohno, Yoshio</creatorcontrib><creatorcontrib>Uemura, Hirotsugu</creatorcontrib><creatorcontrib>Shiroki, Ryoichi</creatorcontrib><creatorcontrib>Azuma, Haruhito</creatorcontrib><creatorcontrib>Kimura, Takahiro</creatorcontrib><title>Real world evidence of enfortumab vedotin in patients with advanced urothelial cancer: A multicenter observational study</title><title>International journal of urology</title><addtitle>Int J Urol</addtitle><description>Objectives
To explore the characteristics of patients and assess the effectiveness of enfortumab vedotin (EV) in those with treatment‐resistant advanced urothelial cancer in a real‐world setting.
Patients and Methods
A multicenter observational study was conducted on 103 evaluable patients with advanced urothelial cancer who received EV. Outcomes were assessed by radiographic response, progression‐free survival (PFS), and overall survival (OS), with treatment‐related adverse events (trAEs). Radiographic response was assessed using Response Evaluation Criteria in Solid Tumors version 1.1, while trAEs were studied in line with Common Terminology Criteria for Adverse Events version 5.0.
Results
The median follow‐up was 8.9 months (range, 0.1–16.4). The observed objective response rate was 50.5%. The median PFS was 6.0 months (95% CI: 4.7–9.8), and the median OS was 14.5 months (95% CI: 12.4–not reached). Out of the 103 patients, 19 (18.4%) had an Eastern Cooperative Oncology Group performance status of 2 or more, 14 (14.7%) had an non‐urothelial carcinoma histology, and 40 (38.3%) had at least one pre‐existing comorbidity. There were 26 (25.2%) patients who reported 49 trAEs, with 9 (18.3%) being grade 3 or higher. The most common trAEs included rash, occurring in 18.4%.
Conclusions
This study describes the characteristics and outcomes of patients with previously treated advanced urothelial cancer receiving EV. The findings demonstrate that EV showed robust anti‐tumor activity and had manageable safety profiles outside the clinical trial setting.</description><subject>Adverse events</subject><subject>bladder cancer</subject><subject>Cancer</subject><subject>Comorbidity</subject><subject>enfortumab vedotin</subject><subject>Observational studies</subject><subject>Patients</subject><subject>renal pelvic cancer</subject><subject>Solid tumors</subject><subject>Survival</subject><subject>ureter cancer</subject><subject>Urothelial cancer</subject><subject>Urothelial carcinoma</subject><issn>0919-8172</issn><issn>1442-2042</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp10c9rFDEUB_AgFrutHvwHJOBFD9Pm5cfOxFspWlsKBannkEne0iwzkzWZ7Hb_e1O3ehD6CATCJ19e8gh5D-wMap2HdTkDJZbdK7IAKXnDmeSvyYJp0E0HLT8mJzmvGQPBoXtDjkUHIIQUC_L4A-1AdzENnuI2eJwc0riiOK1imstoe7pFH-cw0bo2dg44zZnuwvxArd_ayj0tKc4POISa5J5O0hd6QccyzMFVjYnGPmPa1stxqibPxe_fkqOVHTK-e95Pyf23r_eX35vbu6vry4vbxgklukbp-pZeo7KiY63T2kkmlEemtOQAy94L7dG3StiltI77lmu-7BUASuW4OCWfDrGbFH8VzLMZQ3Y4DHbCWLLhmklQslalH_-j61hSbTgbwYQG0QJTVX0-KJdizglXZpPCaNPeADNP0zB1GubPNKr98JxY-hH9P_n3-ys4P4BdGHD_cpK5vvl5iPwNEzSUIQ</recordid><startdate>202404</startdate><enddate>202404</enddate><creator>Fukuokaya, Wataru</creator><creator>Koike, Yuhei</creator><creator>Yata, Yuji</creator><creator>Komura, Kazumasa</creator><creator>Uchimoto, Taizo</creator><creator>Tsujino, Takuya</creator><creator>Saruta, Masanobu</creator><creator>Takahara, Kiyoshi</creator><creator>Fujita, Kazutoshi</creator><creator>Minami, Takafumi</creator><creator>Adachi, Takahiro</creator><creator>Hirasawa, Yosuke</creator><creator>Hashimoto, Takeshi</creator><creator>Ohno, Yoshio</creator><creator>Uemura, Hirotsugu</creator><creator>Shiroki, Ryoichi</creator><creator>Azuma, Haruhito</creator><creator>Kimura, Takahiro</creator><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-5673-1553</orcidid><orcidid>https://orcid.org/0000-0002-3665-9523</orcidid><orcidid>https://orcid.org/0000-0001-5060-3932</orcidid><orcidid>https://orcid.org/0000-0002-4766-2074</orcidid><orcidid>https://orcid.org/0000-0002-1563-4888</orcidid><orcidid>https://orcid.org/0000-0003-1044-912X</orcidid></search><sort><creationdate>202404</creationdate><title>Real world evidence of enfortumab vedotin in patients with advanced urothelial cancer: A multicenter observational study</title><author>Fukuokaya, Wataru ; Koike, Yuhei ; Yata, Yuji ; Komura, Kazumasa ; Uchimoto, Taizo ; Tsujino, Takuya ; Saruta, Masanobu ; Takahara, Kiyoshi ; Fujita, Kazutoshi ; Minami, Takafumi ; Adachi, Takahiro ; Hirasawa, Yosuke ; Hashimoto, Takeshi ; Ohno, Yoshio ; Uemura, Hirotsugu ; Shiroki, Ryoichi ; Azuma, Haruhito ; Kimura, Takahiro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3538-59204b9e5a3807c99c4035de05942116bd39ded753a64ac2d72926b511e45c23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adverse events</topic><topic>bladder cancer</topic><topic>Cancer</topic><topic>Comorbidity</topic><topic>enfortumab vedotin</topic><topic>Observational studies</topic><topic>Patients</topic><topic>renal pelvic cancer</topic><topic>Solid tumors</topic><topic>Survival</topic><topic>ureter cancer</topic><topic>Urothelial cancer</topic><topic>Urothelial carcinoma</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fukuokaya, Wataru</creatorcontrib><creatorcontrib>Koike, Yuhei</creatorcontrib><creatorcontrib>Yata, Yuji</creatorcontrib><creatorcontrib>Komura, Kazumasa</creatorcontrib><creatorcontrib>Uchimoto, Taizo</creatorcontrib><creatorcontrib>Tsujino, Takuya</creatorcontrib><creatorcontrib>Saruta, Masanobu</creatorcontrib><creatorcontrib>Takahara, Kiyoshi</creatorcontrib><creatorcontrib>Fujita, Kazutoshi</creatorcontrib><creatorcontrib>Minami, Takafumi</creatorcontrib><creatorcontrib>Adachi, Takahiro</creatorcontrib><creatorcontrib>Hirasawa, Yosuke</creatorcontrib><creatorcontrib>Hashimoto, Takeshi</creatorcontrib><creatorcontrib>Ohno, Yoshio</creatorcontrib><creatorcontrib>Uemura, Hirotsugu</creatorcontrib><creatorcontrib>Shiroki, Ryoichi</creatorcontrib><creatorcontrib>Azuma, Haruhito</creatorcontrib><creatorcontrib>Kimura, Takahiro</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>International journal of urology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fukuokaya, Wataru</au><au>Koike, Yuhei</au><au>Yata, Yuji</au><au>Komura, Kazumasa</au><au>Uchimoto, Taizo</au><au>Tsujino, Takuya</au><au>Saruta, Masanobu</au><au>Takahara, Kiyoshi</au><au>Fujita, Kazutoshi</au><au>Minami, Takafumi</au><au>Adachi, Takahiro</au><au>Hirasawa, Yosuke</au><au>Hashimoto, Takeshi</au><au>Ohno, Yoshio</au><au>Uemura, Hirotsugu</au><au>Shiroki, Ryoichi</au><au>Azuma, Haruhito</au><au>Kimura, Takahiro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Real world evidence of enfortumab vedotin in patients with advanced urothelial cancer: A multicenter observational study</atitle><jtitle>International journal of urology</jtitle><addtitle>Int J Urol</addtitle><date>2024-04</date><risdate>2024</risdate><volume>31</volume><issue>4</issue><spage>342</spage><epage>347</epage><pages>342-347</pages><issn>0919-8172</issn><eissn>1442-2042</eissn><abstract>Objectives
To explore the characteristics of patients and assess the effectiveness of enfortumab vedotin (EV) in those with treatment‐resistant advanced urothelial cancer in a real‐world setting.
Patients and Methods
A multicenter observational study was conducted on 103 evaluable patients with advanced urothelial cancer who received EV. Outcomes were assessed by radiographic response, progression‐free survival (PFS), and overall survival (OS), with treatment‐related adverse events (trAEs). Radiographic response was assessed using Response Evaluation Criteria in Solid Tumors version 1.1, while trAEs were studied in line with Common Terminology Criteria for Adverse Events version 5.0.
Results
The median follow‐up was 8.9 months (range, 0.1–16.4). The observed objective response rate was 50.5%. The median PFS was 6.0 months (95% CI: 4.7–9.8), and the median OS was 14.5 months (95% CI: 12.4–not reached). Out of the 103 patients, 19 (18.4%) had an Eastern Cooperative Oncology Group performance status of 2 or more, 14 (14.7%) had an non‐urothelial carcinoma histology, and 40 (38.3%) had at least one pre‐existing comorbidity. There were 26 (25.2%) patients who reported 49 trAEs, with 9 (18.3%) being grade 3 or higher. The most common trAEs included rash, occurring in 18.4%.
Conclusions
This study describes the characteristics and outcomes of patients with previously treated advanced urothelial cancer receiving EV. The findings demonstrate that EV showed robust anti‐tumor activity and had manageable safety profiles outside the clinical trial setting.</abstract><cop>Australia</cop><pub>Wiley Subscription Services, Inc</pub><pmid>38113343</pmid><doi>10.1111/iju.15368</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-5673-1553</orcidid><orcidid>https://orcid.org/0000-0002-3665-9523</orcidid><orcidid>https://orcid.org/0000-0001-5060-3932</orcidid><orcidid>https://orcid.org/0000-0002-4766-2074</orcidid><orcidid>https://orcid.org/0000-0002-1563-4888</orcidid><orcidid>https://orcid.org/0000-0003-1044-912X</orcidid></addata></record> |
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| source | Wiley Online Library All Journals |
| subjects | Adverse events bladder cancer Cancer Comorbidity enfortumab vedotin Observational studies Patients renal pelvic cancer Solid tumors Survival ureter cancer Urothelial cancer Urothelial carcinoma |
| title | Real world evidence of enfortumab vedotin in patients with advanced urothelial cancer: A multicenter observational study |
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