title: Weekly paclitaxel in patients with recurrent or metastatic head and neck cancer.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of weekly paclitaxel in patients with recurrent or metastatic head and neck cancer (HNC) by combined analysis of early and late phase II trials.
  
  
  METHODS
  Eligibility criteria included histologically proven HNC with recurrent or metastatic disease, measurable disease, PS 0-2, and one or no prior chemotherapy regimens. Treatment consisted of a 1-h infusion of paclitaxel at a dose of 100 mg/m(2) weekly for 6 weeks of a 7-week cycle. A total of 74 patients were enrolled: 37 between February and November 2004 in an early phase II trial and 37 between October 2005 and July 2006 in a late phase II trial.
  
  
  RESULTS
  The median number of treatment cycles was two, and median dose intensity was 84.2 mg/m(2)/week. The most common grade 3-4 adverse events were leukopenia (37.5%), neutropenia (30.6%), anemia (12.5%), constipation (8.3%), peripheral neuropathy (5.6%), anorexia (5.6%), and pneumonitis (5.6%). Overall response rate was 29.0% according to RECIST. The median duration of response, median time to progression, and median survival time were 7.4, 3.4, and 14.3 months, respectively.
  
  
  CONCLUSIONS
  This study demonstrates that weekly paclitaxel has promising activity with acceptable toxicity in the treatment of recurrent or metastatic HNC.
authors.affiliation: Department of Head and Neck Oncology and Plastic and Reconstructive Surgery, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. matahara@east.ncc.go.jp
authors.forename: M
authors.initials: M
authors.lastname: Tahara
authors.forename: H
authors.initials: H
authors.lastname: Minami
authors.forename: Y
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: K
authors.initials: K
authors.lastname: Tomita
authors.forename: A
authors.initials: A
authors.lastname: Watanabe
authors.forename: K
authors.initials: K
authors.lastname: Nibu
authors.forename: M
authors.initials: M
authors.lastname: Fujii
authors.forename: Y
authors.initials: Y
authors.lastname: Onozawa
authors.forename: Y
authors.initials: Y
authors.lastname: Kurono
authors.forename: D
authors.initials: D
authors.lastname: Sagae
authors.forename: T
authors.initials: T
authors.lastname: Seriu
authors.forename: M
authors.initials: M
authors.lastname: Tsukuda
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel