Clinical outcome of high-dose bolus intravenous interleukin-2 with a modified administration schedule for Asian patients with metastatic renal cell carcinoma
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The standard regimen of high-dose interleukin-2 (HDIL-2) for metastatic renal cell carcinoma (RCC) is two cycles separated by 9 days, which constitutes one course. Each course is separated by an 8–12 weeks. However, the 9-day interval between each HDIL-2 cycle is often not long enough to allow recovery from adverse effects. Therefore, we modified HDIL-2 schedules by increasing the interval between each cycle without changing the total cumulative doses of IL-2.
Clinical data from 37 patients who were treated with modified HDIL-2 schedule were reviewed. Patients received the first dose of IL-2 on day 1 and took subsequent doses every 8 h for a maximum of 14 doses each cycle. Treatment was repeated every 4 weeks, and a maximum of six cycles were planned.
The overall response rate was 35% including two patients with complete response. With a median follow-up duration of 46.9 months, median progression-free survival was 16.0 months (95% CI 10.2–21.7 months) and median overall survival was 58.9 months (95% CI 49.6–68.3 months) with a 3-year overall survival rate of 77.8%. Toxicity profile was acceptable and comparable to standard HDIL-2 schedule. There were no treatment-related mortalities. The incidence of ≥grade 3 adverse events did not differ between patients who had prior exposure to vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI) and VEGFR TKI-naïve patients.
Modified HDIL-2 schedule seems to be a safe and effective option for selected Asian patients with metastatic RCC, even in patients with prior VEGFR TKI treatment.
KeywordsRenal cell carcinoma Immunotherapy Interleukin-2 Modified regimen
This study was presented in part at the 7th European Multidisciplinary Meeting on Urological Cancers, November 12–15, 2015, Barcelona, Spain.
Compliance with ethical standards
Conflict of interest
JL Lee received speaker honoraria from Astellas, Novartis, and Pfizer, and research funding from Bayer, Exelixis, Janssen, Novartis, and Pfizer. JY Lee, C Song, BS Hong, JH Hong, and H Ahn declare that they had no conflict of interest.
This study was supported by a Grant (HI12C1788, HI14C1061, HI14C1931, HI14C1731) from the Korean Health Technology R&D Project, Ministry of Health and Welfare, Korea.
All procedures performed in this study were in accordance with the ethical standards of the Institutional Review Board of Asan Medical Center and with the 1964 Helsinki Declaration and its later amendments. For retrospective design of the current study formal informed consent was not required.
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