title: A randomized phase II study of docetaxel with or without vandetanib in recurrent or metastatic squamous cell carcinoma of head and neck (SCCHN).
abstract: OBJECTIVE
  There are limited chemotherapeutic options for advanced recurrent or metastatic SCCHN. The efficacy and toxicity of docetaxel with or without vandetanib was investigated in these patients.
  
  
  METHODS
  Patients with pathologically confirmed, recurrent or metastatic SCCHN who had progressed on platinum based therapy given as definitive or palliative treatment, were randomized in this open label, multicenter phase II study of docetaxel (75 mg/m2 IV Q3 weeks) with or without vandetanib (100 mg PO daily). The primary objective was response rate (RR) and secondary objectives were progression free survival (PFS), overall survival (OS), disease control rate (DCR) and duration of response (DOR).
  
  
  RESULTS
  29 analyzable patients were enrolled, 14 in docetaxel arm and 15 in combined arm. PR was achieved in 1 patient in the docetaxel arm and 2 patients in the combined arm. The objective RR was 7% (1/14) (95% CI 0.2-33.8%) in the single and 13% (2/15) (95% CI 1.6-40.4%) combined arm. The median PFS was 3.21 (95% CI 3.0-22.0) and 9 (95% CI (5.86-18.1) weeks; median OS was 26.8(95% CI 17.7-100.7+) and 24.1 (95% CI, 16.4-171.1+) weeks. Most common adverse events were fatigue, dysphagia, diarrhea or constipation, cytopenias and alopecia.
  
  
  CONCLUSIONS
  Although an initial benefit in response was noted and statistical criteria met there was only a minor trend towards improved PFS for the combined arm. The study was designed with low threshold for activity in each arm and results were deemed not to be of enough clinical significance in this group of patients to continue accrual.
authors.affiliation: Dana Farber Cancer Institute/Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA. SewantiA_limaye@dfci.harvard.edu
authors.forename: Sewanti
authors.initials: S
authors.lastname: Limaye
authors.forename: Sarah
authors.initials: S
authors.lastname: Riley
authors.forename: Sihai
authors.initials: S
authors.lastname: Zhao
authors.forename: Anne
authors.initials: A
authors.lastname: O'Neill
authors.forename: Marshall
authors.initials: M
authors.lastname: Posner
authors.forename: Douglas
authors.initials: D
authors.lastname: Adkins
authors.forename: Zachary
authors.initials: Z
authors.lastname: Jaffa
authors.forename: John
authors.initials: J
authors.lastname: Clark
authors.forename: Robert
authors.initials: R
authors.lastname: Haddad
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D000077143:Docetaxel; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D010880:Piperidines / Q000009:adverse effects; D011799:Quinazolines / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D010880:Piperidines; D011799:Quinazolines; D043823:Taxoids; D000077143:Docetaxel; C452423:vandetanib
keywords: Head and neck cancer; Palliative chemotherapy; Recurrent/metastatic; Targeted therapy