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Annals of Oncology Advance Access first published online on February 26, 2009
This version published online on March 12, 2009
Annals of Oncology, doi:10.1093/annonc/mdn775
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Phase II study of 3-AP Triapine in patients with recurrent or metastatic head and neck squamous cell carcinoma

C. M. Nutting1,*, C. M. L. van Herpen2, A. B. Miah1, S. A. Bhide1, J.-P. Machiels3, J. Buter4, C. Kelly5, D. de Raucourt6 and K. J. Harrington1

1 Head and Neck Unit, Royal Marsden Hospital and Institute of Cancer Research, London, UK
2 Department of Medical Oncology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands
3 Medical Oncology Unit, Université Catholique de Louvain, Cliniques Universitaires St-Luc, Brussels, Belgium
4 Head and Neck Unit Vrije Universiteit Medical Center, Amsterdam The Netherlands
5 Northern Centre for Cancer Treatment Newcastle General Hospital, Newcastle upon Tyne, UK
6 ‘Centre de lutte contre le cancer’, Head and Neck Unit, Centre François Baclesse, Caen, France

* Correspondence to: Dr C. Nutting, Head and Neck Unit, Royal Marsden Hospital, Fulham Road, London SW3 6JJ, UK. Tel: +44-0207 8-082586; Fax: +44-02078-082235; E-mail: chris.nutting{at}rmh.nhs.uk

Background: Treatment options for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are limited with response rates to cytotoxic chemotherapy of ~30% and median survival of 6 months.

Patients and 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.

3-AP Triapine, chemotherapy, head and neck cancer

Received for publication July 2, 2008. Revision received December 4, 2008. Accepted for publication December 5, 2008.


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