Phase II trial of capecitabine and cisplatin in advanced, persistent, or recurrent carcinoma of the cervix.

Purpose: Platinum-based drugs are the most active agents in cervical carcinoma. The aim of this study was to assess the activity and toxicity of the association of cisplatin and capecitabine as first-line treatment in patients with advanced, persistent, or recurrent carcinoma of the cervix.

Patients And Methods: Patients with histological proven primary carcinoma, presence of measurable tumors, age 18 years or older, performance status of 2 or less, and adequate bone marrow, renal, and hepatic functions were potentially eligible for this trial. Prior chemotherapy was allowed only in the context of radiosensitization. Treatment consisted of 50 mg/m of intravenous cisplatin on day 1 with 2500 mg/m oral capecitabine daily in 2 divided doses for 14 consecutive days in 21-day cycles. Responses were assessed using response evaluation criteria in solid tumors.

Results: Between November 2004 and October 2007, 22 women were entered into the trial. Median age was 51 years (range, 37-70 years). Seventeen patients had prior radiotherapy, and 13 received a radiation sensitizer, whereas 2 patients underwent surgery exclusively and 3 patients had no prior treatment. A median of 5 cycles was administered (range, 2-8 cycles). There were one septic death, one grade 4 neutropenia, and one grade 4 anemia. Grade 3 fatigue, gastrointestinal toxicity, renal toxicity, and hand-foot syndrome were seen in 31.8%, 22.7%, 9%, and 9% of the patients, respectively. There were 1 complete response and 6 partial responses for an overall response rate of 31.8%. Seven patients (31.8%) each had stable disease, and 8 patients showed progression. The median time to progression was 7.6 months, with a median overall survival of 20 months.

Conclusion: These results seem to suggest that the capecitabine-cisplatin combination is a moderately tolerated and active regimen in advanced, persistent, or recurrent cervical carcinoma patients. Further evaluation of this drug combination may be warranted.