170 P Phase II trial of lnterferon-γ (LFN-γ)/interleukln-2 (1L-2) for advanced renal cell carcinoma (RCC)

Abstract

Numerous clinical studies showed efficacy of biological response modifiers (BRM) in the treatment of advanced RCC. In this phase II study, we investigated efficacy, toxicity, and feasibility of lFN-γ in combinalion with 1L-2 in patients with advanced RCC. One cycle of therapy consisted of 100 mcg lFN-γ sc 3x/week for two weeks, 4.5 MIU 1L-2 sc over four consecutive days for the next two weeks followed by a two week rest period. 3x500 mg/day paracetamol are given orally for the first two weeks of therapy to prevent or mitigate flu-like symptoms. To date 40 patients (25 males/15 females) with a median age of 59 years (range: 44– 81 years) have been accrued to the study. A median of 3 therapy cycles (range 1–9) have been given to these 40 patients (median time of observation: 5 months, range: 1–18 months) and all patients are eligible tor feasibilitv and toxicitv evaluation, and 31 patients for response documentation, respectively. 32 of the patients were trained in self-application of the cytokines und 8 patients preferred the application of therapy through their family doctor. No WHO-grade III or IV toxicity has been documented so far. Side effects consisted of flu-like syndrome grade I/II in 21 patients despite prophylactic paracetamol, local crythemas after 1L-2 application in 18 patients and hypotension grade I mainly after IL-2 application in 4 patients. Myelotoxicity was mild in general and consisted of grade I/ll leucopenia and thrombocylopenia only. No red cell transfusions had to be given. Response data of 32 patients after a median time of observation of 10 months (range: 5–16 months) are as lollows: CR: n=2 (6%), PR: n=3 (9%), SD: n=14 (44%), PD: n=13 (41%). Our preliminary data show that a treatment with lFN-γ/IL-2 is not only associated with low toxicity, but also very practical lor out, patients, and offers therefore a good quality of life. The antitumor activity of this therapy in patients with advanced RCC is proven by the response rate (CR+PR+SD) of 59%.