STANDARD INTERLEUKIN-2 (IL-2) AND INTERFERON-ALPHA IMMUNOTHERAPY VERSUS AN IL-2 AND 4-EPIRUBICIN IMMUNO-CHEMOTHERAPEUTIC ASSOCIATION IN METASTATIC RENAL-CELL CARCINOMA

Background: Recombinant human interleukin-2 (IL-2) has a well-document ed anti-tumor activity against RCC and has demonstrated a synergistic anti-tumor activity between doxorubicin and IL-2, thus providing bette r survival. This study investigated the toxicity and efficacy of the a ssociation between IL-2 and interferon-alpha and the immuno-chemoterap eutic association with IL-2 and 4-Epirubicin. Patients and methods: Pa tients with histologic evidence of metastatic ol advanced RCC were ran domized to receive either IL-2 + IFN-alpha (Arm A) or IL-2 + 4-Epi (Ar m B). Arm A patients received IFN-alpha subcutaneously at doses of 3 m illion UI on days 1,3 and 5 for 6 weeks. Ann B patients received 4-EPI at doses of 25 mg/m(2) on days 1, 8, 15, 25 29 and 36. Treatment cycl es were repeated at 10 week intervals. Results: Of 38 evaluable patien ts, we observed 2 complete responses, 2 partial responses, 1 minimal r esponse: I mixed response, 21 stationary disease and II disease progre ssions. There was no significant difference in overall survival betwee n the two groups. However in aim B the median overall survival for res ponding patients was better than that of patients who experienced a di sease progression. Performance status was the only predictive prognost ic factor: Conclusions: Our analysis confirms the low response rate as sociated with IL-2 treatments but seems to indicate a role of anthracy cline in improving the survival of responding patients with an accepta ble toxicity.