Randomised study using IFN-a versus IFN-a plus coumarin and cimetidine for treatment of advanced renal cell cancer

Abstract

Background: Treatment results in patients with metastatic renal cell cancer (RCC) are still extremely unsatisfactory. Rates of response to IFN-a monotherapy and/or IL-2 mono/combination therapy vary between 10% and 20%. Coumarin (Cum) together with cimetidine (Cim) has yielded objective responses in 20%-33% of patients with RCC, according to two recent phase II studies. Patients and methods: In the present study 148 patients with metastatic RCC were randomised to receive either IFN-a (5 MU 5 × weekly s.c.) + coumarin (100 mg/d p.o.) + cimetidine (3 × 400 mg/d p.o.), or IFN-a-monotherapy (5 MU 5 × weekly s.c). Results: Of the 148 patients in the study 137 were evalu-able for response. No differences in remission rates (RR IFN-a + Cum + Cim 17.1% and IFN-a 20.8%) or survival times (median survival 9 months and 8 months, respectively) were found between these two treatment arms. Conclusions: This study confirms that IFN-a has anti-tumoral activity in RCC. Adding coumarin + cimetidine to IFN-a in the dose and regimen prescribed in this study did not increase response rates or survival. © 1995 Kluwer Academic Publishers.