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Nivolumab in combination with stereotactic body radiotherapy in pretreated patients with metastatic renal cell carcinoma: Results of the phase II NIVES Study

European Urology Oct 06, 2021

Masini C, Iotti C, De Giorgi U, et al. - Findings failed to yield sufficient evidence in favor of an added benefit of nivolumab combined with stereotactic body radiotherapy (SBRT) in pretreated metastatic renal cell carcinoma (mRCC) patients; however, this treatment strategy should be assessed in oligometastatic cases or oligoprogressive disease.

  • This is a phase II, single-arm, multicenter trial with mRCC patients (n = 69) with measurable metastatic sites who progressed post-antiangiogenic therapy, of whom at least one was suitable for SBRT.

  • Patients were administered SBRT to a lesion at a dose of 10 Gy in three fractions for 7 d from the first infusion of nivolumab.

  • The objective response rate and the disease control rate were 17% and 55%, respectively, and median progression-free survival and median overall survival were 5.6 mo and 20 mo, respectively.

  • Deaths of 23 patients were recorded after 1.5 yr of follow-up.

  • Median time to treatment response and median duration of response were 2.8 mo and 14 mo, respectively, without any new safety concerns.

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