EXPERIMENTAL AND CLINICAL EFFICACY OF 2',2'-DIFLUORODEOXYCYTIDINE (GEMCITABINE) AGAINST RENAL-CELL CARCINOMA

Preclinical and clinical studies have been performed to evaluate the e fficacy of gemcitabine (2',2'-difluorodeoxycytidine; dFdC) in human re nal cell carcinoma. Experimental data corroborated dFdC as an effectiv e drug against cell lines from renal cell carcinomas (ACHN, A-498, SN1 2C) at concentrations much below clinically achievable doses. ACHN-bea ring nude mice showed an overall response rate of 27% to dFdC (3 mice with complete response, I with partial response, 3 with stable and 8 w ith progressive disease). Objective response from 37 evaluable patient s was 8.1% (1 patient with complete response and 2 patients with parti al response). Gemcitabine was well tolerated thus, although gemcitabin e at the dosage and schedule chosen had only small activity, the obser ved toxicity may permit further dose escalation or a more frequent adm inistration of the drug.