Capecitabine in the treatment of metastatic renal cell carcinoma failing immunotherapy.

Capecitabine is a novel fluoropyrimidine carbamate, orally administered and selectively activated to fluorouracil by a sequential triple-enzyme pathway in liver and tumor cells. This prospective trial aims to evaluate the therapeutic effects and systemic toxicities of capecitabine in patients with metastatic renal cell carcinoma in which immunotherapy failed. Twenty-six patients (median age, 58 years; range, 47 to 76 years) with disease in which first- or second-line immunotherapy treatment failed entered the trial. Median time of observation was 13+ months (range, 3 to 25+ months). Capecitabine was administered in the outpatient setting orally at a dose of 2,500 mg/m2/d divided into two daily doses for 14 days, followed by 7 days of rest. This schedule was repeated in 3-week intervals. Twenty-six patients are now assessable for toxicity, and 23 patients, for response. We observed a partial response to treatment in 2 patients (8.7%), minor response in 5 patients (21.7%), stable disease in 13 patients (56.5%), and continued disease progression despite treatment in only 3 patients (13.1%). Outpatient capecitabine therapy was well tolerated, and World Health Organization (WHO) grade III toxicity in these 26 patients consisted of hand-foot syndrome in 2 patients (7.7%) and anemia in 1 patient (3.8%). We did not observe WHO grade IV toxicity. Oral capecitabine appears to be a promising treatment with a favorable toxicity profile in patients with advanced renal cell carcinoma and should be evaluated in first- and second-line treatment schedules as monotherapy, as well as in combination with immunotherapy agents.