UICC World Cancer Congress 2006

Objective: There is no standard care for MRCC pts. High and intermediate IL-2 regimens are difficult to recommend because of great toxicity. We suggest that combination of low-dose cytokines to be effective and safe in MRCC patients. Prospective randomized study was started in 2003. Methods: Eligibility criteria included confirmed MRCC, PS 0-2, no brain metastases, and normal organ function. All pts are randomized in three arms: IL-2 alone, 1.5 MIU, iv, t.i.w., weeks 1-3 or IL-2 1 MIU, iv, t.i.w., plus IFN 5 MIU, sc, t.i.w, weeks 1-3 or biochemotherapy group 5-FU, 500 mg/m2, iv, once a week, weeks 1-3 plus IL-2 1 MIU, iv, t.i.w., plus IFN 5 MIU, sc, t.i.w., weeks 1-3. Response evaluation was performed according to RECIST every 2 cycles. Results: We enrolled 63 pts with a median age of 55.4 years (range 16-74) including 44M: 20F. 55.6% pts had poor prognosis (according to Motzer et al., 2002). Bone metastases were present in 52.4 percent pts. Among 16 patients in the IL-2 group, no CR, no PRs, 2 SDs were shown. Of 23 patients in IL-2+IFN group, 5 PRs, 8 SDs (OR of 21.7%) were observed. Amongst 24 patients in biochemotherapy group, 1 CR, 3 PRs (OR of 16.7%) and 10 SDs were shown. 1-year survival was 20.0%, 81.3% and 81.0%, respectively. Treatment-related toxicity was limited to CTC grade 1 or 2. Low-dose IL-2 in combination with IFN and 5-FU in MRCC is feasible, tolerable, and the efficacy. Immunologic correlative studies will be presented at the meeting.