Cancer medicine · 2025
Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real-World, Ambispective RAVE-Bladder Study.
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Tsimafeyeu Ilya, Gridneva Yana, Sultanbaev Alexander, Anzhiganova Yulia, Gluzman Mark, Mochalova Anastasia, Shkurat Alexey, Israelyan Edgar, Parsadanova Elvira, Murzina Yulia, Ivanov Aleksei, Kalpinskiy Alexey, Stativko Olesia, Petkau Vladislav, Karabina Elena, Kеln Artyom, Tovbik Natalya, Safina Sufia, Turganova Maria, Kopyltsov Evgeny, Bragina Varvara, Novikova Olga, Lebedinets Andrei, Vodolazskiy Vladislav, Rumyantsev Alexey, Zukov Ruslan, Pokataev Ilya, Orlova Rashida, Volkova Maria
Аннотация
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.
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.