A COMPARISON OF 2 MODES OF ADMINISTRATION OF RECOMBINANT INTERLEUKIN-2 - CONTINUOUS INTRAVENOUS-INFUSION ALONE VERSUS SUBCUTANEOUS ADMINISTRATION PLUS INTERFERON-ALPHA IN PATIENTS WITH ADVANCED RENAL-CELL CARCINOMA

Purpose: To compare 2 treatment modalities with recombinant Interleuki n-2 (rIL-2) for patients with advanced Renal Cell carcinoma (RCC) : co ntinuous intravenous infusion (CIV) alone versus subcutaneous (s/c) rI L-2 + Interferon-alpha (IFN-alpha). Patients and Methods: Data have be en collected on 425 patients with RCC, treated CIV rIL-2 alone, (225 p atients), or rIL-2 by the s/c route (200 patients). Patients receiving s/c rIL-2 also received s/c IFN-alpha both drugs being administered o n an outpatient basis. Patients receiving CIV rIL-2 were treated as in patients. Patient eligibility criteria were similar on all studies, an d included patients with progressive, advanced disease, but with an am bulatory performance status. Results: The overall response rate for th e CIV schedules was not significantly different from the s/c regimens: 15% (95% confidence limits (CL) 10-20%) vs 20% (95%CL 14-26%) with 4% CR in both approaches. Durable responses were seen in both CIV and s/ c schedules and there was no evidence of a significant difference in s urvival in multivariate analysis. There was however an important shift in the toxicity profile. The s/c regimens do not induce a clinically detectable capillary leak syndrome, which is the dose limiting toxicit y for CIV regimens. Conclusion: Although the introduction of CIV regim ens of rIL-2 was a major step forward compared to high-dose bolus, bec ause most patients could be treated in a normal oncology ward, the s/c schedule of rIL-2 + IFN-alpha offers the possibility of outpatient (h ome) therapy, with no evidence of a reduction in efficacy.