Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE‐Bladder Study
ABSTRACT Background This ambispective study was designed to assess the efficacy and safety of avelumab maintenance in a real‐world population of patients with metastatic urothelial cancer (UC). Methods Patients with metastatic UC and measurable disease that had not progressed following first‐line pl...
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Wiley
2025-02-01
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| Online Access: | https://doi.org/10.1002/cam4.70636 |
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| author | Ilya Tsimafeyeu Yana Gridneva Alexander Sultanbaev Yulia Anzhiganova Mark Gluzman Anastasia Mochalova Alexey Shkurat Edgar Israelyan Elvira Parsadanova Yulia Murzina Aleksei Ivanov Alexey Kalpinskiy Olesia Stativko Vladislav Petkau Elena Karabina Artyom Kеln Natalya Tovbik Sufia Safina Maria Turganova Evgeny Kopyltsov Varvara Bragina Olga Novikova Andrei Lebedinets Vladislav Vodolazskiy Alexey Rumyantsev Ruslan Zukov Ilya Pokataev Rashida Orlova Maria Volkova |
| author_facet | Ilya Tsimafeyeu Yana Gridneva Alexander Sultanbaev Yulia Anzhiganova Mark Gluzman Anastasia Mochalova Alexey Shkurat Edgar Israelyan Elvira Parsadanova Yulia Murzina Aleksei Ivanov Alexey Kalpinskiy Olesia Stativko Vladislav Petkau Elena Karabina Artyom Kеln Natalya Tovbik Sufia Safina Maria Turganova Evgeny Kopyltsov Varvara Bragina Olga Novikova Andrei Lebedinets Vladislav Vodolazskiy Alexey Rumyantsev Ruslan Zukov Ilya Pokataev Rashida Orlova Maria Volkova |
| author_sort | Ilya Tsimafeyeu |
| collection | DOAJ |
| description | ABSTRACT Background This ambispective study was designed to assess the efficacy and safety of avelumab maintenance in a real‐world population of patients with metastatic urothelial cancer (UC). Methods Patients with metastatic UC and measurable disease that had not progressed following first‐line platinum‐based chemotherapy were treated with maintenance avelumab (800 mg administered every 2 weeks). The primary endpoint was overall survival (OS). Results A total of 110 patients were enrolled. The majority of patients were male (81%), with a median age of 65 years (range, 36–84). The median OS was not reached, with a 1‐year OS rate of 78.7%. The median PFS was 9.5 months (95% CI, 7.8–11.2 months). The ORR to first‐line chemotherapy was 48.2%, and an additional 34.6% of patients responded to avelumab therapy (16 complete and 22 partial responses). Grade 3 adverse events during avelumab therapy were experienced by 11.8% of patients. Conclusions These findings demonstrate similar efficacy and safety of avelumab in a real‐world setting when compared to data from pivotal study. Trial Registration: KCRB registry number: RAVE‐Bladder |
| format | Article |
| id | doaj-art-058a815c54c4481bb1186be9c066df98 |
| institution | DOAJ |
| issn | 2045-7634 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-058a815c54c4481bb1186be9c066df982025-08-20T03:18:05ZengWileyCancer Medicine2045-76342025-02-01144n/an/a10.1002/cam4.70636Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE‐Bladder StudyIlya Tsimafeyeu0Yana Gridneva1Alexander Sultanbaev2Yulia Anzhiganova3Mark Gluzman4Anastasia Mochalova5Alexey Shkurat6Edgar Israelyan7Elvira Parsadanova8Yulia Murzina9Aleksei Ivanov10Alexey Kalpinskiy11Olesia Stativko12Vladislav Petkau13Elena Karabina14Artyom Kеln15Natalya Tovbik16Sufia Safina17Maria Turganova18Evgeny Kopyltsov19Varvara Bragina20Olga Novikova21Andrei Lebedinets22Vladislav Vodolazskiy23Alexey Rumyantsev24Ruslan Zukov25Ilya Pokataev26Rashida Orlova27Maria Volkova28Bureau of Cancer Research—Moscow Office Moscow Russian FederationOncological Center No.1 of Moscow City Hospital Named After S.S. Yudin Moscow Russian FederationRepublican Clinical Oncology Dispensary Ufa Russian FederationA.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center Krasnoyarsk RussiaMedical Institute Saint‐Petersburg State University Saint‐Petersburg Russian FederationClinical Hospital #1, Medsi Otradnoe Moscow Russian FederationDepartment of Medical Oncology SBHI Leningrad Regional Clinical Hospital Saint‐Petersburg Russian FederationN.N. Blokhin National Medical Research Center of Oncology Moscow Russian FederationSakhalin Regional Clinical Oncology Dispensary Yuzhno‐Sakhalinsk Russian FederationBirobidzhan Regional Cancer Center Birobidzhan Russian FederationCenter for Immunotherapy and Targeted Therapy Moscow Russian FederationP.A. Herzen Moscow Oncological Research Institute Moscow Russian FederationOncological Center No.1 of Moscow City Hospital Named After S.S. Yudin Moscow Russian FederationSverdlovskiy Regional Oncological Dispensary Ekaterinburg Russian FederationTula Regional Oncology Dispensary Tula Russian FederationDepartment of Oncology, Radiology and Radion Therapy Tyumen State Medical University Tyumen Russian FederationAmur Regional Oncology Center Blagoveshchensk Russian FederationRepublican Dispensary of Tatarstan Kazan Russian FederationNovosibirsk Regional Cancer Center Novosibirsk Russian FederationOmsk Regional Cancer Center Omsk Russian FederationTver Regional Cancer Center Tver Russian FederationKhabarovsk Regional Cancer Center Khabarovsk Russian FederationDepartment of Medical Oncology SBHI Leningrad Regional Clinical Hospital Saint‐Petersburg Russian FederationOmsk Regional Cancer Center Omsk Russian FederationN.N. Blokhin National Medical Research Center of Oncology Moscow Russian FederationDepartment of Oncology and Radiation Therapy V.F. Voyno‐Yasenetsky Krasnoyarsk State Medical University Krasnoyarsk RussiaOncological Center No.1 of Moscow City Hospital Named After S.S. Yudin Moscow Russian FederationMedical Institute Saint‐Petersburg State University Saint‐Petersburg Russian FederationOncological Center No.1 of Moscow City Hospital Named After S.S. Yudin Moscow Russian FederationABSTRACT Background This ambispective study was designed to assess the efficacy and safety of avelumab maintenance in a real‐world population of patients with metastatic urothelial cancer (UC). Methods Patients with metastatic UC and measurable disease that had not progressed following first‐line platinum‐based chemotherapy were treated with maintenance avelumab (800 mg administered every 2 weeks). The primary endpoint was overall survival (OS). Results A total of 110 patients were enrolled. The majority of patients were male (81%), with a median age of 65 years (range, 36–84). The median OS was not reached, with a 1‐year OS rate of 78.7%. The median PFS was 9.5 months (95% CI, 7.8–11.2 months). The ORR to first‐line chemotherapy was 48.2%, and an additional 34.6% of patients responded to avelumab therapy (16 complete and 22 partial responses). Grade 3 adverse events during avelumab therapy were experienced by 11.8% of patients. Conclusions These findings demonstrate similar efficacy and safety of avelumab in a real‐world setting when compared to data from pivotal study. Trial Registration: KCRB registry number: RAVE‐Bladderhttps://doi.org/10.1002/cam4.70636avelumabmaintenance therapymetastatic urothelial carcinomareal‐world data |
| spellingShingle | Ilya Tsimafeyeu Yana Gridneva Alexander Sultanbaev Yulia Anzhiganova Mark Gluzman Anastasia Mochalova Alexey Shkurat Edgar Israelyan Elvira Parsadanova Yulia Murzina Aleksei Ivanov Alexey Kalpinskiy Olesia Stativko Vladislav Petkau Elena Karabina Artyom Kеln Natalya Tovbik Sufia Safina Maria Turganova Evgeny Kopyltsov Varvara Bragina Olga Novikova Andrei Lebedinets Vladislav Vodolazskiy Alexey Rumyantsev Ruslan Zukov Ilya Pokataev Rashida Orlova Maria Volkova Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE‐Bladder Study Cancer Medicine avelumab maintenance therapy metastatic urothelial carcinoma real‐world data |
| title | Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE‐Bladder Study |
| title_full | Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE‐Bladder Study |
| title_fullStr | Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE‐Bladder Study |
| title_full_unstemmed | Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE‐Bladder Study |
| title_short | Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real‐World, Ambispective RAVE‐Bladder Study |
| title_sort | maintenance therapy with avelumab for patients with metastatic urothelial carcinoma a real world ambispective rave bladder study |
| topic | avelumab maintenance therapy metastatic urothelial carcinoma real‐world data |
| url | https://doi.org/10.1002/cam4.70636 |
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