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Annals of Oncology 14:373-377, 2003
© 2003 European Society for Medical Oncology

Original Paper

Results of randomised phase II studies comparing S16020 with methotrexate in patients with recurrent head and neck cancer

X. Pivot1,+, A. Awada2, D. Gedouin3, J. Kerger4, F. Rolland5, D. Cupissol6, F. Caponigro7, G. Comella7, J. J. Lopez-Pousa8, E. Guardiola1, B. Giroux9, B. Gérard9 and M. Schneider10

1 CHU J. Minjoz, Besançon, France; 2 Institut Jules Bordet, Brussels, Belgium; 3 Centre Eugène Marquis, Rennes, France; 4 Cliniques Universitaires de Mont-Godinne, Yvoir, Belgium; 5 Centre René Gauducheau, Saint Herblain, France; 6 Centre Val d’Aurelle, Montpellier, France; 7 National Tumour Institute, Naples, Italy; 8 Hopital San Pau, Barcelona, Spain; 9 Institut de Recherches Internationales Servier, Courbevoie; 10 Centre Antoine Lacassagne, Nice, France

Received 12 August 2002; revised 24 September 2002; accepted 22 October 2002

Background:

The purpose of this study was to carry out two randomised phase II trials of S16020, a new olivacine derivative, tested as a single agent in patients with recurrent head and neck cancer, using methotrexate as the control arm to validate the results.

Patients and methods:

S16020 at either 80 or 100 mg/m2 was administered as a 3-h infusion every 3 weeks. Methotrexate, 40 or 50 mg/m2, was given by bolus injection, weekly for a minimum of 6 weeks. In total, 36 patients were entered in the randomised studies (25 in an initial study, 11 in a confirmatory study) of whom 24 received S16020 and 12 received methotrexate.

Results:

A scheduled interim analysis showed one patient having a non-confirmed objective response with S16020 and three patients having a confirmed objective response with methotrexate. In the methotrexate group, there were no patients with severe non-haematological toxicity. With S16020, there was a high incidence of severe non-haematological toxicities, including asthenia, oedema of the face, oedema and pain at the tumour sites and erythematous rash; consequently, both studies were stopped.

Conclusions:

Both studies were stopped due to the poor anticipated benefit/risk ratio for S16020, although time to progression and overall survival time were similar in both treatment arms.

Key words: head and neck squamous cell carcinoma, methotrexate, randomised trial, recurrence, S16020


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