Interferon-alpha/5-fluorouracil: a novel outpatient chemo/immunotherapy for progressive metastatic renal cell carcinoma.

In metastatic renal cell carcinoma, most conventional antineoplastic drugs have yielded no or little efficacy. To evaluate the tolerance and therapeutic efficacy of second line chemo/immunotherapies, we treated patients with advanced metastatic renal cell carcinoma upon progression after previous antineoplastic therapy employing an outpatient combination of subcutaneous (SC) recombinant interferon-alpha (rIFN-alpha) and intravenous (IV) 5-fluorouracil(5-FU). Thirty-three patients with metastatic renal cell carcinoma received SC doses thrice weekly of rIFN-alpha at 10 million U/m2 over 8 consecutive weeks. Additionally, patients received IV 5-FU at 750 mg/m2 in weeks 1-3 and 5-7; treatment cycles were repeated until disease progression. Of 33 patients, one achieved a complete remission (response duration, 24 months) and two patients presented with partial remissions (median response duration, 7 months) of pulmonary metastases upon rIFN-alpha/5-FU after failing SC recombinant interleukin-2 (rIL-2) and rIFN-alpha. The present chemo/immunotherapy regimen was overall well tolerated with low to moderate systemic toxicity and predominantly constitutional symptoms i.e., fever, chills, and malaise. In summary, the second line outpatient chemo/immunotherapy regimen of SC rIFN-alpha/IV 5-FU demonstrated a limited albeit significant efficacy in pretreated patients with progressive metastatic renal cell cancer.