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
© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissionoup.com..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:54 |
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| Enthalten in: |
Japanese journal of clinical oncology - 54(2024), 3 vom: 09. März, Seite 329-338 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Miyake, Makito [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 12.03.2024 Date Revised 12.03.2024 published: Print Citation Status MEDLINE |
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| doi: |
10.1093/jjco/hyad170 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM365528005 |
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| 100 | 1 | |a Miyake, Makito |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Enfortumab vedotin following platinum-based chemotherapy and immune checkpoint inhibitors for advanced urothelial carcinoma |b response, survival and safety analysis from a multicentre real-world Japanese cohort |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 12.03.2024 | ||
| 500 | |a Date Revised 12.03.2024 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissionoup.com. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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%) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
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| 650 | 7 | |a Antibodies, Monoclonal |2 NLM | |
| 700 | 1 | |a Nishimura, Nobutaka |e verfasserin |4 aut | |
| 700 | 1 | |a Oda, Yuki |e verfasserin |4 aut | |
| 700 | 1 | |a Miyamoto, Tatsuki |e verfasserin |4 aut | |
| 700 | 1 | |a Ohmori, Chihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Takamatsu, Norimi |e verfasserin |4 aut | |
| 700 | 1 | |a Itami, Yoshitaka |e verfasserin |4 aut | |
| 700 | 1 | |a Tachibana, Akira |e verfasserin |4 aut | |
| 700 | 1 | |a Matsumoto, Yoshihiro |e verfasserin |4 aut | |
| 700 | 1 | |a Kiba, Keisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Tomioka, Atsushi |e verfasserin |4 aut | |
| 700 | 1 | |a Yamamoto, Hiroaki |e verfasserin |4 aut | |
| 700 | 1 | |a Okajima, Eijiro |e verfasserin |4 aut | |
| 700 | 1 | |a Masaomi, Kuwata |e verfasserin |4 aut | |
| 700 | 1 | |a Sakamoto, Keichi |e verfasserin |4 aut | |
| 700 | 1 | |a Tomizawa, Mitsuru |e verfasserin |4 aut | |
| 700 | 1 | |a Shimizu, Takuto |e verfasserin |4 aut | |
| 700 | 1 | |a Ohnishi, Kenta |e verfasserin |4 aut | |
| 700 | 1 | |a Hori, Shunta |e verfasserin |4 aut | |
| 700 | 1 | |a Morizawa, Yosuke |e verfasserin |4 aut | |
| 700 | 1 | |a Gotoh, Daisuke |e verfasserin |4 aut | |
| 700 | 1 | |a Nakai, Yasushi |e verfasserin |4 aut | |
| 700 | 1 | |a Torimoto, Kazumasa |e verfasserin |4 aut | |
| 700 | 1 | |a Tanaka, Nobumichi |e verfasserin |4 aut | |
| 700 | 1 | |a Fujimoto, Kiyohide |e verfasserin |4 aut | |
| 700 | 0 | |a Nara Urological Research and Treatment Group |e verfasserin |4 aut | |
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