title: Clinical outcome of high-dose bolus intravenous interleukin-2 with a modified administration schedule for Asian patients with metastatic renal cell carcinoma.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.
authors.forename: Ji Young
authors.initials: JY
authors.lastname: Lee
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Cheryn
authors.initials: C
authors.lastname: Song
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Bum Sik
authors.initials: BS
authors.lastname: Hong
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Jun Hyuk
authors.initials: JH
authors.lastname: Hong
authors.affiliation: Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
authors.forename: Hanjong
authors.initials: H
authors.lastname: Ahn
authors.affiliation: Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea. jaelyun@amc.seoul.kr.
authors.forename: Jae Lyun
authors.initials: JL
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D040262:Receptors, Vascular Endothelial Growth Factor / Q000037:antagonists & inhibitors
chemical_list: D007376:Interleukin-2; D040262:Receptors, Vascular Endothelial Growth Factor
keywords: Immunotherapy; Interleukin-2; Modified regimen; Renal cell carcinoma