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.


CONCLUSIONS
The combination of capecitabine plus cisplatin is a clinically active regimen with acceptable tolerability for patients with recurrent carcinoma of the uterine cervix.
Benjapibal
Mongkol
M
Department of Obstetrics and Gynecology, Siriraj Hospital, Faculty of Medicine, Mahidol University, Bangkok, Thailand. simbj@mahidol.ac.th
Thirapakawong
Chaiyod
C
Leelaphatanadit
Chairatana
C
Therasakvichya
Suwanit
S
Inthasorn
Perapong
P
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002277:Carcinoma / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil