title: Phase II trial of docetaxel combined with nedaplatin for patients with recurrent and metastatic nasopharyngeal carcinoma.
abstract: OBJECTIVE
  This Phase II trial was designed to evaluate the efficacy and safety of docetaxel combined with nedaplatin as first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.
  
  
  METHODS
  In this multicenter Phase II trial, the patients were treated with intravenous docetaxel (75 mg/m(2), day 1) and nedaplatin (80 mg/m(2), day 1), each cycle repeated every 3 weeks for two cycles at least.
  
  
  RESULTS
  From January 2010 to November 2013, a total of 78 patients were recruited in this trial. Among them, 73 patients were assessable for response. The treatment was well tolerated. The main hematological adverse event was neutropenia. A total of 12 patients (15.4%) had grade 3 or grade 4 neutropenia. Grade 3 anemia was observed in six patients (7.7%) and no grade 3/4 thrombocytopenia was observed. No Grade 3/4 non-hematological toxicity was observed. There were five complete response (6.8%), 43 partial responses (58.9%), and the overall response rate was 65.8% (95% confidence interval [CI], 48.7%-81.2%). With a median follow-up period of 18.6 months, the median time to progression was 7.9 months (95% CI, 4.2-10.8 months), median overall survival was 15.7 months (95% CI, 11.6-18.5 months).
  
  
  CONCLUSIONS
  Docetaxel combined with nedaplatin offers a satisfactory clinical activity and an acceptable safety profile as first-line chemotherapy for patients with recurrent and metastatic nasopharyngeal carcinoma.
authors.affiliation: Department of Medical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, People's Republic of China.
authors.forename: Pei-Jian
authors.initials: PJ
authors.lastname: Peng
authors.affiliation: Department of Surgical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, People's Republic of China.
authors.forename: Bao-Jun
authors.initials: BJ
authors.lastname: Lv
authors.affiliation: Department of Surgical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, People's Republic of China.
authors.forename: Con
authors.initials: C
authors.lastname: Tang
authors.affiliation: Department of Medical Oncology, Cancer Centre, Sun Yat-sen University, Guangzhou, People's Republic of China.
authors.forename: Hai
authors.initials: H
authors.lastname: Liao
authors.affiliation: Department of Medical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, People's Republic of China.
authors.forename: Zhong
authors.initials: Z
authors.lastname: Lin
authors.affiliation: Department of Oncology, People's Hospital of Zhongshan City, Zhongshan, People's Republic of China.
authors.forename: Yu-Meng
authors.initials: YM
authors.lastname: Liu
authors.affiliation: Department of Medical Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, People's Republic of China.
authors.forename: Zhi-Hui
authors.initials: ZH
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong Province, People's Republic of China.
authors.forename: Si-Yang
authors.initials: SY
authors.lastname: Wang
authors.affiliation: Department of Radiation Oncology, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong Province, People's Republic of China.
authors.forename: Zhi-Bin
authors.initials: ZB
authors.lastname: Cheng
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D002277:Carcinoma; D000077143:Docetaxel; D015195:Drug Design; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use*; D043823:Taxoids / Q000008:administration & dosage* / Q000737:chemistry / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D043823:Taxoids; D000077143:Docetaxel; C053989:nedaplatin
keywords: docetaxel; nasopharyngeal carcinoma; nedaplatin