title: Phase II trial of capecitabine plus cisplatin as first-line therapy in patients with metastatic nasopharyngeal cancer.
abstract: BACKGROUND
  Capecitabine is an oral fluoropyrimidine with single-agent activity in metastatic nasopharyngeal carcinoma (NPC). This multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus cisplatin as a first-line treatment for metastatic NPC.
  
  
  METHODS
  Patients with metastatic NPC received cisplatin 100 mg/m(2) day 1 plus capecitabine 1000 mg/m(2) twice daily on days 1 to 14 every 3 weeks for 6-8 cycles. The primary endpoint was overall response rate.
  
  
  RESULTS
  Forty-four patients were enrolled; 39 patients were evaluable for efficacy. The overall response rate was 53.8% (95% confidence interval [CI], 37%-70%), including 1 complete response. Median time to tumor progression was 7.3 months (95% CI, 5.6-9.9 months) and median overall survival was 28.0 months (95% CI, 14.5 months-not reached). Common grade 3/4 adverse events were neutropenia (50%), vomiting (11%), thrombocytopenia (9%), and nausea (7%).
  
  
  CONCLUSIONS
  Capecitabine plus cisplatin is an active first-line combination in metastatic NPC that requires a short hospital stay.
authors.affiliation: Queen Mary Hospital, Hong Kong, China. danielchua@hksh.com
authors.forename: Daniel T T
authors.initials: DT
authors.lastname: Chua
authors.forename: Harry Ho-Yin
authors.initials: HH
authors.lastname: Yiu
authors.forename: Kasan
authors.initials: K
authors.lastname: Seetalarom
authors.forename: Alice Wan-Ying
authors.initials: AW
authors.lastname: Ng
authors.forename: Johan
authors.initials: J
authors.lastname: Kurnianda
authors.forename: Kanjana
authors.initials: K
authors.lastname: Shotelersuk
authors.forename: Gopala
authors.initials: G
authors.lastname: Krishnan
authors.forename: Ruey-Long
authors.initials: RL
authors.lastname: Hong
authors.forename: Muh-Hwa
authors.initials: MH
authors.lastname: Yang
authors.forename: Cheng-Hsu
authors.initials: CH
authors.lastname: Wang
authors.forename: Wing-Kin
authors.initials: WK
authors.lastname: Sze
authors.forename: Wai-Tong
authors.initials: WT
authors.lastname: Ng
mesh_terms: D000206:Actuarial Analysis; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy*; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil