International Journal of Clinical Oncology

, Volume 11, Issue 6, pp 434–440

A low-dose combination therapy of interleukin-2 and interferon-α is effective for lung metastasis of renal cell carcinoma: a multicenter open study

  • Hideyuki Akaza
  • Taiji Tsukamoto
  • Tetsuro Onishi
  • Tsuneharu Miki
  • Toshiaki Kinouchi
  • Seiji Naito

DOI: 10.1007/s10147-006-0596-z

Cite this article as:
Akaza, H., Tsukamoto, T., Onishi, T. et al. Int J Clin Oncol (2006) 11: 434. doi:10.1007/s10147-006-0596-z



To confirm the usefulness of a combination therapy of interleukin-2 (IL-2) and interferon-α (IFN-α) against metastatic renal cell carcinoma, the recommended dose of IFN-α to use in combination with low-dose IL-2 was determined (phase 1). Efficacy and safety at this dose was evaluated (phase 2).


In phase 1, the dose of IL-2 was fixed at 0.7 × 106 Japan reference unit (JRU)/person for 5 days a week. The dose of IFN-α was increased from 3 × 106 IU for 3 days a week (level I) to 6 × 106 IU for 3 days a week (level II) and to 6 × 106 IU for 5 days a week (level III).


In phase 1, 10 patients were registered, with 9 (3 at each level) able to be evaluated. Because grade 3 and grade 4 neutropenia were observed at level III in 1 patient each, level II was found to be the recommended regimen. The response rate in phase 1 was 44.4% (4/9). In phase 2, 46 patients were registered, with a response rate in 37 patients, classified as per protocol set (PPS), of 21.6% (8/37). Toxicities observed were primarily flu-like symptoms due to cytokines, and gastrointestinal symptoms. Leukocyte abnormalities were observed, but they were milder and tolerable.


In the 46 patients evaluated in phase 1 and phase 2, the response rate was 26.1% (12/46), being highest in 38.7% (12/31) of those who were nephrectomized, and with only lung metastases.

Key words

Low-dose IL-2IFN-αCombinationRenal cell carcinoma

Copyright information

© The Japan Society of Clinical Oncology 2006

Authors and Affiliations

  • Hideyuki Akaza
    • 1
  • Taiji Tsukamoto
    • 2
  • Tetsuro Onishi
    • 3
  • Tsuneharu Miki
    • 4
  • Toshiaki Kinouchi
    • 5
  • Seiji Naito
    • 6
  1. 1.Department of Urology, Institute of Clinical MedicineUniversity of TsukubaTsukubaJapan
  2. 2.Department of UrologySapporo Medical UniversitySapporoJapan
  3. 3.Department of UrologyJikei University, School of MedicineTokyoJapan
  4. 4.Department of UrologyKyoto Prefectural University of MedicineKyotoJapan
  5. 5.Department of UrologyOsaka Medical Center for Cancer and Cardiovascular DiseasesOsakaJapan
  6. 6.Kyushu UniversitySchool of MedicineFukuokaJapan