Thirteen‐year, long‐term efficacy of interferon 2α and interleukin 2‐based home therapy in patients with advanced renal cell carcinoma

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