A pilot phase II study of capecitabine plus cisplatin in the treatment of recurrent carcinoma of the uterine cervix.

BACKGROUND: To assess the efficacy and tolerability of combination therapy with capecitabine and cisplatin in patients with recurrent carcinoma of the uterine cervix. METHODS: Sixteen patients were treated with oral capecitabine (1,000 mg/m2 twice daily, days 1-14) and intravenous cisplatin (50 mg/m(2) on day 1 every 3 weeks) for a maximum of six cycles. RESULTS: Their median age was 50 years (31-74 years). Ten patients (63%) had recurrent disease outside the radiation field. The overall response rate was 50% (95% confidence interval 26-75%); 4 patients had complete response (25%). The overall response rate was 33% in patients with recurrent disease within the previous irradiated field and 60% in patients with tumor outside the irradiated field. The median time to progression was 9 months, with a median overall survival of 23 months. The majority of adverse events were mild and there were no grade 4 adverse events. Hematological toxicity was the most frequent adverse event with grade 3 neutropenia in 19% of patients. Grade 2 and 3 hand-foot syndrome occurred in 38 and 6% of the patients, respectively. There were no chemotherapy-related deaths. CONCLUSION: The combination of capecitabine plus cisplatin is a clinically active regimen with acceptable tolerability for patients with recurrent carcinoma of the uterine cervix.