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

대한비뇨기종양학회지 2019년 17권 2호 p.96 ~ 102
 ( Lee Jong-Hoon ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology

 ( Kang Min-Yong ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
 ( Chung Jae-Hoon ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
 ( Sung Hyun-Hwan ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
 ( Jeon Hwang-Gyun ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
 ( Jeong Byung-Chang ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
 ( Jeon Seong-Soo ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
 ( Lee Hyun-Moo ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
 ( Park Se-Hoon ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Hematology-Oncology
 ( Kim Binnari ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Pathology & Translational Genomics
 ( Kwon Ghee-Young ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Pathology & Translational Genomics
 ( Seo Seong-Il ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology

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.

키워드

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