Gemcitabine and capecitabine chemotherapy in Japanese patients with immunotherapy-resistant renal cell carcinoma.

The objective of this study was to evaluate the efficacy and toxicity of combined gemcitabine and capecitabine (Gca) chemotherapy in patients with advanced renal cell cancer after immunotherapy failure. Nine patients were enrolled in this trial. Gemcitabine (1000 mg/m(2)) was injected on days 1 and 8, followed by oral administration of capecitabine (1660 mg/m(2)) on days 1-14. The response rate was 11%, with a partial response in one patient (11%), stable disease in five patients (56%) and disease progression in three patients (33%). Grade 3-4 neutropenia was observed in one patient (11%) and thrombocytopenia in two patients (22%). The quality of life (QOL) questionnaire scales showed no significant changes induced by chemotherapy. The median progression-free survival was 4 months with an overall 1-year survival rate of 78%. Gemcitabine and capecitabine chemotherapy can be safely administered as second-line therapy in renal cell cancer patients, maintaining QOL baseline parameters.