Capecitabine-Based Chemoradiotherapy with Adjuvant Capecitabine for Locally Advanced Squamous Carcinoma of the Uterine Cervix: Phase II Results

Objectives. Cisplatin-based chemoradiotherapy is the standardtreatmentforlocallyadvancedcervicalcancer but causes considerable toxicity. Capecitabine and radiotherapy show preclinical synergy and clinical activity. The activity, tolerability, and oral administration of capecitabine make it an attractive adjunctive therapy. Methods. In this phase II study, patients with untreated International Federation of Gynecology and ObstetricsstageIIB–IIIBcervicalcancerreceivedcapecitabine, 825 mg/m 2 twice daily (Monday–Friday), during radiation (45 Gy per 25 fractions external-beam radiotherapy and 26 Gy high-dose rate brachytherapy to point A, maximum 8 weeks), followed by six cycles of capecitabine, 1,000 mg/m 2 twice daily (days 1–14 every 21 days). Results. The overall response rate in 60 patients was 88% (95% confidence interval [CI], 77.4%–95.2%), including complete responses (CRs) in 80% of patients. The 1-year progression-free and overall survival rates were 86% (95% CI, 77%–95%) and 95% (95% CI, 89%–100%), respectively. At 23 months, 76% of patients were progression free (95% CI, 65%–88%) and CR was maintained in 90% (95% CI, 81%–99%) of the 48 patients achieving a CR. There were three grade 3 or 4