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KMID : 1001020210190040252
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Journal of Urologic Oncology
2021 Volume.19 No. 4 p.252 ~ p.260
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Subcutaneous Interleukin-2 Monotherapy for Metastatic Renal Cell Carcinoma in Korean Patients
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Kim Jeong-Ho
Lee Ki-Soo
Kim Choung-Soo
Choi Young-Deuk
Kim Tae-Hyo
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Abstract
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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.
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KEYWORD
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Renal cell carcinoma, Interleukin-2, Clinical trial, Metastasis, Subcutaneous injections
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