Long-term follow-up in patients with metastatic renal cell cancer not treated with IL-2.

4597 Background: Metastatic renal cell cancer (RCC) is associated with a <10% 5-year survival and response rate to standard chemotherapy. Excellent performance status, LDH < 1.5x ULN, normal Hgb, corrected calcium, and prior nephrectomy have been associated with prolonged survival. Follow-up of 255 select patients from seven phase II trials treated with high-dose interleukin-2 (IL-2) that had no control groups suggest durable responses at 5-10 years of follow-up in about 7% of patients and significant acute toxicity. Since RCC is reported to regress spontaneously and long term survival of RCC patients treated with or without immunotherapy is limited to <5year follow-up we sought to retrospectively create a control group of patients with metastatic RCC that would have been eligible for enrollment on trials with IL-2 and assess their long-term survival.,From 1980-1993, 267 patients presented to our institution with metastatic RCC. Included were relatively asymptomatic patients with no significant co-morbidities. Those with CNS metastases or previous treatment with IL-2 were excluded. The main endpoint was survival after a 10+year follow-up.,100 patients were found to be eligible. Median overall survival for these patients was 18 months. Only 2 patients had no evidence of disease after at least 10 years of follow-up. The median survival in patients <71 years old and still alive at least 9 months after metastatic diagnosis was 28 months. Patients found to have a single, non-hepatic metastasis at initial presentation lived significantly longer than all other patients (48.5 mos. vs. 10 mos., p<.001).,Survivals of highly selected patients with metastatic renal cancer are similar whether they received high-dose IL-2 or not. Patients initially presenting with single, non-hepatic metastases have the potential for long-term survival with local therapy only. Patients with excellent performance status, initially found to have a combination of metastatic sites or any hepatic involvement, should be considered for a clinical trial or high-dose IL-2. Prospective, randomized studies are needed to determine if patients truly benefit from high-dose IL-2 therapy. No significant financial relationships to disclose.