Korean J Urol Oncol.  2019 Aug;17(2):96-102. 10.22465/kjuo.2019.17.2.96.

Early Experiences with Nivolumab in Patients with Metastatic Renal Cell Carcinoma and Failed Target Therapy

Affiliations
  • 1Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. seongil.seo@samsung.com
  • 2Department of Hemato-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 3Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Abstract

PURPOSE
The efficacy of nivolumab in metastatic renal cell carcinoma (mRCC) has been proven. However, the nivolumab experience in Korean patients with mRCC is still poorly reported. We report initial experiences with the efficacy and safety of nivolumab in patients with mRCC.
MATERIALS AND METHODS
We retrospectively reviewed records for 25 patients with mRCC who had failed targeted therapy and were treated by nivolumab (2 mg/kg, every 2 weeks) at a single institution. The primary endpoint was objective response rate (ORR), and secondary endpoints were progression-free survival (PFS), safety profiles, and ORR in a programmed cell death receptor ligand 1 (PD-L1) expression subgroup.
RESULTS
The median age was 60 years and 16 patients (64%) were male. Objective responses were achieved in 8 patients (32.0%) (complete response, 1; partial response, 7). Median PFS was 3.0 months (95% confidence interval, 1.46-4.53). Treatment-related adverse events (AEs) of any grade were observed in 19 patients (76.0%) with 6 (24.0%) experiencing grade 3 to 4 treatment-related AEs. In subgroups by PD-L1 expression levels classified as 1% or greater and less than 1%, ORR was 50% and 0%, respectively.
CONCLUSIONS
This study showed the efficacy and safety of initial experiences with nivolumab in Korean patients with mRCC who had failed targeted therapy. Our results were comparable to recent clinical trials on nivolumab in mRCC.

Keyword

Metastasis; Monoclonal antibody; Programmed cell death 1 ligand 1; Renal cell carcinoma; Treatment outcome

MeSH Terms

Antigens, CD274
Carcinoma, Renal Cell*
Cell Death
Disease-Free Survival
Humans
Male
Neoplasm Metastasis
Retrospective Studies
Treatment Outcome
Antigens, CD274
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