Maintenance Therapy With Avelumab for Patients With Metastatic Urothelial Carcinoma: A Real-World, Ambispective RAVE-Bladder Study

IF 2.9 2区医学 Q2 ONCOLOGY Cancer Medicine Pub Date : 2025-02-14 DOI:10.1002/cam4.70636

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

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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

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来源期刊

Cancer Medicine ONCOLOGY-

CiteScore

5.50

自引率

2.50%

发文量

907

审稿时长

19 weeks

期刊介绍： Cancer Medicine is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research from global biomedical researchers across the cancer sciences. The journal will consider submissions from all oncologic specialties, including, but not limited to, the following areas: Clinical Cancer Research Translational research ∙ clinical trials ∙ chemotherapy ∙ radiation therapy ∙ surgical therapy ∙ clinical observations ∙ clinical guidelines ∙ genetic consultation ∙ ethical considerations Cancer Biology: Molecular biology ∙ cellular biology ∙ molecular genetics ∙ genomics ∙ immunology ∙ epigenetics ∙ metabolic studies ∙ proteomics ∙ cytopathology ∙ carcinogenesis ∙ drug discovery and delivery. Cancer Prevention: Behavioral science ∙ psychosocial studies ∙ screening ∙ nutrition ∙ epidemiology and prevention ∙ community outreach. Bioinformatics: Gene expressions profiles ∙ gene regulation networks ∙ genome bioinformatics ∙ pathwayanalysis ∙ prognostic biomarkers. Cancer Medicine publishes original research articles, systematic reviews, meta-analyses, and research methods papers, along with invited editorials and commentaries. Original research papers must report well-conducted research with conclusions supported by the data presented in the paper.