作者
Cristina Masini, Cinzia Iotti, Ugo De Giorgi, Roberto Salvatore Bellia, Sebastiano Buti, Francesco Salaroli, Ilaria Zampiva, Renzo Mazzarotto, Claudia Mucciarini, Maria Giuseppa Vitale, Alessio Bruni, Frank Lohr, Giuseppe Procopio, Orazio Caffo, Franco Nole, Franco Morelli, Susanne Baier, Consuelo Buttigliero, Patrizia Ciammella, Giorgia Timon, Emanuela Fantinel, Gabriele Carlinfante, Annalisa Berselli, Carmine Pinto
发表日期
2022/3/1
期刊
European Urology
卷号
81
期号
3
页码范围
274-282
出版商
Elsevier
简介
Background
Nivolumab showed an overall survival (OS) benefit in pretreated metastatic renal cell carcinoma (mRCC). The role of stereotactic body radiotherapy (SBRT) in mRCC remains to be defined.
Objective
Our aim was to evaluate the efficacy and safety of SBRT in combination with nivolumab in second- and third-line mRCC patients.
Design, setting, and participants
The NIVES study was a phase II, single-arm, multicenter trial in patients with mRCC with measurable metastatic sites who progressed after antiangiogenic therapy, of whom at least one was suitable for SBRT.
Intervention
The patients received SBRT to a lesion at a dose of 10 Gy in three fractions for 7 d from the first infusion of nivolumab. Nivolumab was given at an initial dose of 240 mg every 14 d for 6 mo and then 480 mg q4-weekly in responding patients.
Outcome measurements and statistical analysis
We hypothesized that nivolumab plus …
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