阿维鲁单抗联合阿昔替尼治疗转移性肾细胞癌的真实世界疗效和安全性：前瞻性-回顾性RAVE-肾研究结果

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

作者信息

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

机构信息

Bureau for Cancer Research-BUCARE, Moscow Office, 125047 Moscow, Russia.

Saint-Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care Oncological, 197110 Saint-Petersburg, Russia.

出版信息

Curr Oncol. 2024 Dec 27;32(1):11. doi: 10.3390/curroncol32010011.

DOI:10.3390/curroncol32010011

PMID:39851927

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11764420/

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.

摘要

背景

开展RAVE-肾研究以评估阿维鲁单抗联合阿昔替尼作为转移性肾细胞癌（mRCC）患者一线治疗的真实世界疗效和安全性。

方法

RAVE-肾研究是一项多中心、非干预性、兼具回顾性和前瞻性的研究。该研究纳入组织学确诊的mRCC成年患者，根据RECIST 1.1版标准有可测量病灶，且既往未接受过全身治疗。患者接受阿维鲁单抗（每2周静脉注射800 mg）联合阿昔替尼（每日口服2次，每次5 mg）治疗。主要终点为中位无进展生存期（PFS）和客观缓解率（ORR）。次要终点包括中位总生存期（OS）、1年总生存率和安全性。

结果

来自13个中心的125例患者入组，中位随访时间为16.1个月。中位年龄为61.0岁。研究人群包括35.3%低危、49%中危和15.7%高危国际转移性肾细胞癌数据库（IMDC）风险患者。中位PFS为14.9个月（95%CI，11.72 - 19.08）。ORR为44.3%（95%CI，32.5 - 56.1）。临床获益率为93.4%。1年OS率为71.2%，中位OS未达到。99例（79.2%）发生任何级别的治疗相关不良事件（TRAEs），包括24例（19.2%）≥3级TRAEs。