Real-World Efficacy and Safety of Avelumab Plus Axitinib in Metastatic Renal Cell Carcinoma: Results from the Ambispective RAVE-Renal Study.

IF 2.8 4区医学 Q2 ONCOLOGY

Current oncology Pub Date : 2024-12-27 DOI:10.3390/curroncol32010011

Ilya Tsimafeyeu, Vyacheslav Chubenko, Olga Baklanova, Alexey Kalpinskiy, Sufia Safina, Andrei Lebedinets, Vladislav Petkau, Elvira Parsadanova, Maria Turganova, Aleksei Shkurat, Natalia Tovbik, Elena Tkacheva, Yulia Anzhiganova, Olga Novikova, Varvara Bragina, Ruslan Zukov, Rashida Orlova

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引用次数: 0

Abstract

Background: The RAVE-Renal study was conducted to evaluate the real-world efficacy and safety of avelumab plus axitinib as a first-line therapy for patients with metastatic renal cell carcinoma (mRCC).

Methods: RAVE-Renal was a multicenter, noninterventional, ambispective study with both retrospective and prospective components. The study included adult patients with histologically confirmed mRCC, measurable disease per RECIST version 1.1, and no prior systemic therapy. Patients received avelumab (800 mg intravenously every 2 weeks) plus axitinib (5 mg orally twice daily). The primary endpoints were median progression-free survival (PFS) and objective response rate (ORR). The secondary endpoints included median OS, 1-year overall survival (OS) rate, and safety.

Results: A total of 125 patients from 13 sites were enrolled, with a median follow-up of 16.1 months. The median age was 61.0 years. The study population comprised 35.3% favorable, 49% intermediate, and 15.7% poor IMDC risk patients. The median PFS was 14.9 months (95% CI, 11.72-19.08). The ORR was 44.3% (95% CI, 32.5-56.1). The clinical benefit rate was 93.4%. The 1-year OS rate was 71.2%, with the median OS not reached. Any-grade treatment-related adverse events (TRAEs) occurred in 99 (79.2%) cases, including grade ≥3 TRAEs in 24 (19.2%).

Conclusions: Avelumab in combination with axitinib showed clinical benefits in a real-world setting, consistent with findings from a pivotal trial. The regimen was effective and well tolerated across various patient subgroups.

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来源期刊

Current oncology ONCOLOGY-

CiteScore

3.30

自引率

7.70%

发文量

664

审稿时长

1 months

期刊介绍： Current Oncology is a peer-reviewed, Canadian-based and internationally respected journal. Current Oncology represents a multidisciplinary medium encompassing health care workers in the field of cancer therapy in Canada to report upon and to review progress in the management of this disease. We encourage submissions from all fields of cancer medicine, including radiation oncology, surgical oncology, medical oncology, pediatric oncology, pathology, and cancer rehabilitation and survivorship. Articles published in the journal typically contain information that is relevant directly to clinical oncology practice, and have clear potential for application to the current or future practice of cancer medicine.