title: Phase II trial of neoadjuvant docetaxel and cisplatin followed by intensity-modulated radiotherapy with concurrent cisplatin in locally advanced nasopharyngeal carcinoma.
abstract: OBJECTIVE
  To evaluate the feasibility and efficacy of neoadjuvant chemotherapy involving docetaxel and cisplatin followed by intensity-modulated radiotherapy (IMRT) with concurrent cisplatin in patients with newly diagnosed stage III to IVB nasopharyngeal carcinoma (NPC).
  
  
  METHODS
  Docetaxel (75 mg/m(2) on day 1) and cisplatin (75 mg/m(2) on day 1) were administered on a 3-week cycle for 2 courses, followed by radical IMRT (72 Gy/33F/6.5-7 W) with concurrent cisplatin (75 mg/m(2), on day 1) every 3 weeks for 2 cycles.
  
  
  RESULTS
  From June 2008 to October 2010, forty-six patients were recruited in this trial. Forty-five patients completed neoadjuvant setting, and all patients completed planned concurrent chemoradiotherapy (CCRT). The complete and partial response rates were 28.3 and 56.5 % after neoadjuvant chemotherapy, and 91.3, 8.7 % after CCRT, respectively. After median follow-up of 26 months (range 12-39 months), one patient experienced local recurrence and 4 patients developed distant metastasis. The 3-year overall survival and progression-free survival rate were 94.1 and 72.7 %, respectively. Neutropenia (37.0 %) and vomiting (28.3 %) were the most common Grade 3-4 adverse effects during neoadjuvant course, while mucositis (30.4 %), xerostomia (30.4 %) and radiodermatitis (21.7 %) were the most common Grades 3 acute toxicities during CCRT. Xerostomia (73.9 %), dysphagia (56.5 %), hear loss (30.4 %) and skin reaction (21.7 %) were the common Grade 1-2 late effects. There were no Grades 3-4 late toxicities.
  
  
  CONCLUSIONS
  The protocol of neoadjuvant docetaxel and cisplatin followed by IMRT with concurrent cisplatin was well tolerated, with outstanding compliance and efficacy in locally advanced NPC, which deserved further follow-up.
authors.affiliation: Department of Radio-Chemotherapy, Zhongnan Hospital of Wuhan University, No 169 Donghu Road, Wuhan 430071, China.
authors.forename: Ya Hua
authors.initials: YH
authors.lastname: Zhong
authors.forename: Jing
authors.initials: J
authors.lastname: Dai
authors.forename: Xiao Yong
authors.initials: XY
authors.lastname: Wang
authors.forename: Cong Hua
authors.initials: CH
authors.lastname: Xie
authors.forename: Gang
authors.initials: G
authors.lastname: Chen
authors.forename: Lei
authors.initials: L
authors.lastname: Zeng
authors.forename: Yun Feng
authors.initials: YF
authors.lastname: Zhou
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma; D059186:Chemoradiotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D050397:Radiotherapy, Intensity-Modulated; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use; D055815:Young Adult
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin