title: Phase II study of 3-AP Triapine in patients with recurrent or metastatic head and neck squamous cell carcinoma.
abstract: BACKGROUND
  Treatment options for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are limited with response rates to cytotoxic chemotherapy of approximately 30% and median survival of 6 months.
  
  
  METHODS
  In a multicentre phase II study, 32 patients with recurrent or metastatic HNSCC received 3-AP Triapine (3-aminopyridine-2-carboxaldehyde thiosemicarbazone), an inhibitor of ribonucleotide reductase, 96 mg/m2, daily for 4 days every 14 days (one cycle). Eligibility criteria required Eastern Cooperative Oncology Group performance status (ECOG PS) of zero to two with a life expectancy of >3 months; one prior chemotherapy regimen was allowed.
  
  
  RESULTS
  Thirty patients were assessable for response and toxicity. Median age was 57 years (range 36-79) and median ECOG PS was one (range 0-2). Thirteen patients had previously been treated with chemotherapy. A total of 130 cycles were administered with a median number of cycles of 3.5 (range 1-8). Mild anaemia (40%), nausea (22%) and fatigue (22%) were commonly reported with G3 and G4 neutropenia documented in 22% and 22%, respectively. Overall response rate was 5.9% (95% confidence interval 0.2% to 28.7%). One patient achieved a partial response, eight had stable disease and 21 progressive disease. Median time to disease progression was 3.9 months.
  
  
  CONCLUSIONS
  3-AP Triapine as a single agent, at this dose and schedule, is well tolerated but has only minor activity in the treatment of advanced HNSCC.
authors.affiliation: Head and Neck Unit, Royal Marsden Hospital and Institute of Cancer Research, London, UK. chris.nutting@rmh.nhs.uk
authors.forename: C M
authors.initials: CM
authors.lastname: Nutting
authors.forename: C M L
authors.initials: CM
authors.lastname: van Herpen
authors.forename: A B
authors.initials: AB
authors.lastname: Miah
authors.forename: S A
authors.initials: SA
authors.lastname: Bhide
authors.forename: J-P
authors.initials: JP
authors.lastname: Machiels
authors.forename: J
authors.initials: J
authors.lastname: Buter
authors.forename: C
authors.initials: C
authors.lastname: Kelly
authors.forename: D
authors.initials: D
authors.lastname: de Raucourt
authors.forename: K J
authors.initials: KJ
authors.lastname: Harrington
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011725:Pyridines / Q000008:administration & dosage*; D013882:Thiosemicarbazones / Q000008:administration & dosage*
chemical_list: D000970:Antineoplastic Agents; D011725:Pyridines; D013882:Thiosemicarbazones; C078157:3-aminopyridine-2-carboxaldehyde thiosemicarbazone