title: Radiation therapy concurrent with weekly paclitaxel for locoregionally advanced nasopharyngeal carcinoma: outcomes of a phase I trial.
abstract: OBJECTIVE
  The purpose of this study was to define the maximum tolerated dose (MTD) by describing the dose-limiting toxicity (DLT) of paclitaxel given as a 3-hour intravenous infusion concurrently with conventional radiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC).
  
  
  METHODS
  Patients with locoregionally advanced NPC were enrolled into a dose-escalating study. Toxicity was graded according to Common Toxicity Criteria 2.0. MTD was defined when 2 of 6 patients developed DLT. The starting dose of paclitaxel was 20 mg/m2 once weekly, with a subsequent dose escalation of 10 mg/m2 in cohorts of 3 new patients. Radiation therapy was administered in a conventional technique over 7 weeks in 2.0-Gy/daily fractions for 5 days/wk up to total doses of 68-70 Gy.
  
  
  RESULTS
  From November 2000 to June 2001, 16 patients completed chemoradiotherapy. On the first-dose level (20 mg/m2), no patient experienced DLT. On the next dose level with 30 mg/m2, 1 patient experienced DLT with grade 3 mucositis, which lasted for 5 weeks, and among the additional 3 patients, no one developed DLT. On the third dose level with 40 mg/m2, 1 patient developed grade 3 mucositis and another grade 3 dermatitis, and both of them lasted more than 3 weeks. To make the trial more credible, another 4 patients were added to the 30-mg/m2 level, and no DLT occurred. Thus, the accrual of patients stopped.
  
  
  CONCLUSIONS
  Combined modality with paclitaxel given weekly, as a 3-hour infusion concomitant to conventional radiotherapy, is feasible for locoregionally advanced NPC. The dose recommended for a phase II trial is 30 mg/m2 with mucositis and dermatitis as DLT, and other toxicity is mild.
authors.affiliation: Department of Radiation Oncology, Cancer Center, Sun Yat-Sen University, Guangzhou, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Chen
authors.forename: Shao-Xiong
authors.initials: SX
authors.lastname: Wu
authors.forename: Yuan-Yuan
authors.initials: YY
authors.lastname: Chen
authors.forename: Li-Xia
authors.initials: LX
authors.lastname: Lu
authors.forename: Yong
authors.initials: Y
authors.lastname: Bao
authors.forename: Huan-Xin
authors.initials: HX
authors.lastname: Lin
authors.forename: Chao-Gui
authors.initials: CG
authors.lastname: Xian
authors.forename: Qun
authors.initials: Q
authors.lastname: Li
authors.forename: Xiao-Wu
authors.initials: XW
authors.lastname: Deng
authors.forename: Tai-Xiang
authors.initials: TX
authors.lastname: Lu
authors.forename: Nian-Ji
authors.initials: NJ
authors.lastname: Cui
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011882:Radiotherapy, High-Energy
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel