title: Multicenter phase II trial of mitoxantrone in patients with advanced nasopharyngeal carcinoma in Southeast Asia: an Asian-Oceanian Clinical Oncology Association Group study.
abstract: OBJECTIVE
  Patients with advanced nasopharyngeal carcinoma (NPC) have a high incidence of recurrence and often develop distant metastases despite local control. This prospective multicenter phase II trial was conducted to evaluate the safety and efficacy of Novantrone (mitoxantrone; Lederle Laboratories, Wayne, NJ) in the therapy of patients with advanced NPC.
  
  
  METHODS
  One hundred eight patients with advanced NPC, namely, those with recurrent or persistent disease following primary radiotherapy, or newly diagnosed metastatic disease, were treated with mitoxantrone. Mitoxantrone was administered intravenously at an initial dose of 12 mg/m2 and repeated every 3 weeks, with dose escalation to a maximum of 14 mg/m2. The distribution of histologic subtypes was representative of NPC, with the majority being (61%) undifferentiated (or anaplastic) carcinoma.
  
  
  RESULTS
  The overall response rate (complete response [CR] and partial response [PR]) was 25% (95% confidence interval, 17% to 33%). The median response duration, time to treatment failure, and survival duration were 140, 82, and 394 days, respectively. Histology (poorly differentiated squamous cell) was found to be the only important factor in predicting response (P = .04) based on a multivariate analysis of nine pretreatment characteristics. The major dose-limiting toxicity was leukopenia. The incidences of nausea/vomiting, alopecia, and stomatitis/mucositis were 34%, 6%, and 3%, respectively. None were severe. Two patients had asymptomatic, moderate Alexander-grade cardiotoxicity.
  
  
  CONCLUSIONS
  This study represents a large, controlled multicenter trial of single-agent mitoxantrone in the treatment of advanced NPC. Mitoxantrone was well tolerated and produced an overall response rate comparable to that of other single-agent therapies used in the treatment of advanced head and neck cancer. Combination trials with mitoxantrone for advanced disease should be considered.
authors.affiliation: Medical Research Division, American Cyanamid, Pearl River, NY.
authors.forename: M
authors.initials: M
authors.lastname: Dugan
authors.forename: D
authors.initials: D
authors.lastname: Choy
authors.forename: A
authors.initials: A
authors.lastname: Ngai
authors.forename: J
authors.initials: J
authors.lastname: Sham
authors.forename: P
authors.initials: P
authors.lastname: Choi
authors.forename: W
authors.initials: W
authors.lastname: Shiu
authors.forename: T
authors.initials: T
authors.lastname: Leung
authors.forename: P
authors.initials: P
authors.lastname: Teo
authors.forename: U
authors.initials: U
authors.lastname: Prasad
authors.forename: S
authors.initials: S
authors.lastname: Lee
mesh_terms: D000328:Adult; D000368:Aged; D002277:Carcinoma / Q000188:drug therapy*; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000009:adverse effects / Q000627:therapeutic use*; D009303:Nasopharyngeal Neoplasms / Q000188:drug therapy*; D011446:Prospective Studies; D012044:Regression Analysis; D016896:Treatment Outcome
chemical_list: D008942:Mitoxantrone