Evaluation of capecitabine in patients with platinum-pretreated advanced or recurrent cervical carcinoma: a retrospective study of the IRCCS National Cancer Institute of Milan

Abstract

Background Cervical cancer is underrepresented in gynecological clinical research. The objective of this retrospective study was to evaluate the activity and safety of capecitabine in patients with platinum-pretreated recurrent cervical carcinoma. Materials and Methods We performed a retrospective review of medical records from patients with advanced or recurrent cervical carcinoma pretreated with platinum-based therapy who received oral capecitabine at the Gynecological Units of the IRCCS National Cancer Institute of Milan (Italy). We used Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 to evaluate response to therapy and Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to evaluate adverse events. Results From December 2013 to April 2015, 18 patients with advanced or recurrence cervical carcinoma, already exposed to platinum, were treated with oral capecitabine 1000 or 1250 mg/m2 bid continuously from day 1-14 every 21 days. All patients had received a combination of carboplatin plus paclitaxel as first-line therapy for advanced/recurrent disease. Median age at the first capecitabine administration was 56 (range 27-82) years. After three cycles of oral capecitabine the clinical benefit rate (CBR) was 55.5% with 5.5% of complete response (CR), 27.7% of partial response (PR) and 22.3% of stable disease (SD). No grade ≥3 adverse events were reported. CBR was 85.7% in adenocarcinomas versus 36.4% in squamous cell carcinomas (p=0.04). The most frequent grade 1 or 2 adverse events were fatigue (50%), hand-foot syndrome (38.9%) and diarrhea (22.2%). Conclusions Our study suggests that oral capecitabine should be considered an active and safe treatment in patients with platinum-pretreated advanced or recurrent cervical carcinoma.