title: Gemcitabine plus cisplatin for patients with recurrent or metastatic nasopharyngeal carcinoma in Taiwan: a multicenter prospective Phase II trial.
abstract: OBJECTIVE
  This multicenter Phase II trial evaluated the toxicity/efficacy of gemcitabine plus cisplatin as first-line chemotherapy in patients with recurrent/metastatic nasopharyngeal carcinoma.
  
  
  METHODS
  Gemcitabine 1250 mg/m(2) on Days 1 and 8 and cisplatin 75 mg/m(2) on Day 1 were administered at a 3-week interval. The primary endpoint was the response rate. Secondary endpoints included progression-free survival, overall survival, response duration and safety.
  
  
  RESULTS
  Fifty-two patients were recruited between 2004 and 2008. The response rate was 51.9% (complete remission rate, 9.6%) in the intent-to-treat group. The median progression-free and overall survivals were 9.8 and 14.6 months, respectively. The major Grade III/IV adverse event was leucopenia (61.6%). The mean number of cycles was 6.63 ± 0.40. The regimen was well-tolerated, although one treatment-related death occurred after severe sepsis from aspiration pneumonia.
  
  
  CONCLUSIONS
  Gemcitabine plus cisplatin is an effective, well-tolerated regimen as a first-line treatment for recurrent/metastatic nasopharyngeal carcinoma.
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan Department of Chemical and Materials Engineering, Chang Gung University, Taoyuan.
authors.forename: Jason Chia-Hsun
authors.initials: JC
authors.lastname: Hsieh
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan.
authors.forename: Cheng-Lung
authors.initials: CL
authors.lastname: Hsu
authors.affiliation: Department of Diagnostic Radiology, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan.
authors.forename: Shu-Hang
authors.initials: SH
authors.lastname: Ng
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Keelung and Chang Gung University, Taoyuan.
authors.forename: Cheng-Hsu
authors.initials: CH
authors.lastname: Wang
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Chiayi and Chang Gung University, Taoyuan.
authors.forename: Kuan-Der
authors.initials: KD
authors.lastname: Lee
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Chiayi and Chang Gung University, Taoyuan.
authors.forename: Chang-Hsien
authors.initials: CH
authors.lastname: Lu
authors.affiliation: Department of Hematology and Oncology, Taipei Cancer Center, Taipei Medical University, Taipei.
authors.forename: Yi-Fang
authors.initials: YF
authors.lastname: Chang
authors.affiliation: Department of Hematology and Oncology, Taipei Cancer Center, Taipei Medical University, Taipei.
authors.forename: Ruey-Kuen
authors.initials: RK
authors.lastname: Hsieh
authors.affiliation: Department of Oncology, National Taiwan University and Hospital, Taipei.
authors.forename: Kun-Huei
authors.initials: KH
authors.lastname: Yeh
authors.affiliation: Division of Oncology and Hematology, Department of Internal Medicine, Far Eastern Hospital, Taipei.
authors.forename: Chi-Huang
authors.initials: CH
authors.lastname: Hsiao
authors.affiliation: Cancer Center, Chemoradiotherapy Division, Taipei Veterans General Hospital, Taipei.
authors.forename: Sheng-Yu
authors.initials: SY
authors.lastname: Chen
authors.affiliation: Cancer Center, Radiation Oncology Division, Taipei Veterans General Hospital, Taipei, Taiwan.
authors.forename: Cheng-Ying
authors.initials: CY
authors.lastname: Shiau
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taoyuan whm526@adm.cgmh.org.tw.
authors.forename: Hung-Ming
authors.initials: HM
authors.lastname: Wang
mesh_terms: D000328:Adult; D000368:Aged; D002277:Carcinoma; D002945:Cisplatin / Q000627:therapeutic use*; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D016017:Odds Ratio; D016016:Proportional Hazards Models; D011446:Prospective Studies; D016019:Survival Analysis; D013624:Taiwan; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine
keywords: H & N-Med, supportive care; chemo-phase I–II–III; clinical trials; head and neck; palliative care