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Subcutaneous Interleukin-2 Monotherapy for Metastatic Renal Cell Carcinoma in Korean Patients

Other Titles
 Subcutaneous Interleukin-2 Monotherapy for Metastatic Renal Cell Carcinoma in Korean Patients 
Authors
 Jeong Ho Kim  ;  Ki Soo Lee  ;  Choung-Soo Kim  ;  Young Deuk Choi  ;  Tae Hyo Kim 
Citation
 Korean Journal of Urological Oncology (대한비뇨기종양학술지), Vol.19(4) : 252-260, 2021-11 
Journal Title
Korean Journal of Urological Oncology(대한비뇨기종양학술지)
ISSN
 2234-4977 
Issue Date
2021-11
Keywords
Renal cell carcinoma ; Interleukin-2 ; Clinical trial ; Metastasis ; Subcutaneous injections
Abstract
Purpose
This study was a prospective single-arm clinical trial aimed at assessing the efficacy and toxicity of subcutaneous interleukin (IL)-2 monotherapy in patients with metastatic renal cell carcinoma (RCC).
Materials and Methods
We enrolled 26 patients with metastatic RCC in this multicenter con-trolled trial. The patients received subcutaneous injections of recombinant IL-2 (BMI-rh-IL2, an aldesleukin biosimilar, BMIKOREA Co., Ltd.) in 5-week cycles. In the first week, the patients received a subcutaneous IL-2 loading dose of 18×106 IU once on treatment days 1–5, followed by 2 days of rest. In the following 3 weeks, they received a dose of 18×106 IU via subcutaneous injection once on treatment days 1 and 2. Then, the patients received a dose of 9×106 IU via subcutaneous injection once on treatment days 3, 4, and 5, followed by 2 days of rest. The pri-mary end point was the objective response rate; the secondary end points were progression-free survival (PFS) and safety.
Results
Overall, 22 patients were included in the final per-protocol analysis. The objective response and the disease control rates were 13.64% (3 of 22), and 90.9% (20 of 22), respectively. The mean PFS was 5.55 months (95% confidence interval, 2.71–8.4). The proportion of patients who experienced a treatment-related grade 3 or 4 adverse event was 3.85% (1 of 26). There were no treatment-related deaths.
Conclusions
In this study, the subcutaneous IL-2 monotherapy regimen demonstrated ef-ficacy and safety comparable to those reported in previous studies of subcutaneous IL-2 mono-therapy and was effective in Korean patients with metastatic RCC.
Files in This Item:
T202125884.pdf Download
DOI
10.22465/kjuo.2021.19.4.252
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Choi, Young Deuk(최영득) ORCID logo https://orcid.org/0000-0002-8545-5797
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/188234
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