title: Phase II study of capecitabine and cisplatin combination as first-line chemotherapy in Chinese patients with metastatic nasopharyngeal carcinoma.
abstract: OBJECTIVE
  Cisplatin combined with 5-fluorouracil (5-Fu) is widely used in the management of advanced nasopharyngeal carcinoma (NPC). However, catheters and pumps are necessary for the continuous infusion of 5-Fu, which add to the cost, immobility and inconvenience of treatment. Capecitabine, an oral fluoropyrimidine, is a potentially more active and more convenient substitute to 5-Fu. A phase II study was conducted to evaluate the efficacy and safety of a capecitabine and cisplatin combination in metastatic NPC.
  
  
  METHODS
  In the multicenter, open-label, single-arm phase II study, patients with metastatic NPC who previously received no palliative chemotherapy were enrolled. Patients received oral capecitabine (1,000 mg/m(2) twice daily from day 1 to 14) and intravenous cisplatin (80 mg/m(2), day 1) every 3 weeks.
  
  
  RESULTS
  A total of 48 patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. There were 3 patients (6.3%) with complete response and 27 patients (56.3%) with partial response, giving an overall response rate of 62.5% (95% CI, 49.1-76.4%). The median duration of response in the 30 responding patients was 7.5 months (range 1.4-22.4 months). With a median follow-up period of 13.3 months (range 2.3-50 months), the median time to progression and median overall survival for all patients were 7.7 months (95% CI, 6.3-9.2 months) and 13.3 months (95% CI, 9.4-17.2 months), respectively. Toxicities were moderate and manageable. Grade 3/4 toxicities included neutropenia (14.6%), anemia (4.2%) and thrombocytopenia (2.1%), nausea (8.3%), vomiting (10.4%), diarrhea (8.3%), stomatitis (6.3%) and hand-foot syndrome (HFS) (4.2%).
  
  
  CONCLUSIONS
  The combination of capecitabine and cisplatin is active and well tolerated as a first-line therapy for patients with metastatic NPC.
authors.affiliation: Department of Medical Oncology, Cancer Center, Sun Yat-sen University, 651 Dong Feng Road East, Guangzhou, People's Republic of China.
authors.forename: Yu-Hong
authors.initials: YH
authors.lastname: Li
authors.forename: Feng-Hua
authors.initials: FH
authors.lastname: Wang
authors.forename: Wen-Qi
authors.initials: WQ
authors.lastname: Jiang
authors.forename: Xiao-Juan
authors.initials: XJ
authors.lastname: Xiang
authors.forename: Yan-Ming
authors.initials: YM
authors.lastname: Deng
authors.forename: Guo-Qing
authors.initials: GQ
authors.lastname: Hu
authors.forename: De-Ming
authors.initials: DM
authors.lastname: Xu
authors.forename: Yan
authors.initials: Y
authors.lastname: Chen
authors.forename: Qing
authors.initials: Q
authors.lastname: Lin
authors.forename: You-Jian
authors.initials: YJ
authors.lastname: He
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D009362:Neoplasm Metastasis
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil