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Keywords:

  • renal cell carcinoma;
  • subcutaneous;
  • interleukin 2;
  • interferon α

Abstract

BACKGROUND

The goal of the current report was to demonstrate the long-term efficacy of outpatient subcutaneous (sc) interferon α (IFN-α) and sc interleukin 2 (IL-2)-based combination regimens in patients with metastatic renal cell carcinoma.

METHODS

In three consecutive clinical trials, 443 patients received combined sc IFN-α and sc IL-2 (n = 97 patients); combined sc IFN-α, sc IL-2, and intravenous (iv) 5-fluorouracil (5-FU) (n = 260 patients); or combined sc IFN-α, sc IL-2, and iv 5-FU with oral 13cis-retinoic acid (n = 86 patients).

RESULTS

The median overall survival was 21+ months. The 2-year, 5-year, and 13-year survival rates were calculated at 45.26%, 15.96%, and 8.96%, respectively. The median time to disease progression was 6 months. The 2-year, 5-year, and 13-year progression free survival rates were 17.84%, 9.54%, and 9.20%, respectively.

CONCLUSIONS

The current data suggest that combined outpatient sc IFN-α and sc IL-2, according to the Atzpodien regimen, achieves long-term survival benefits in a subset of patients with metastatic renal cell carcinoma, both with and without 13-cis-retinoic acid and/or 5-fluorouracil. Cancer 2002;95:1045–50. © 2002 American Cancer Society.

DOI 10.1002/cncr.10783