The activity of raltitrexed (Tomudex®) in malignant pleural mesothelioma : an EORTC phase II study (08992)

Baas, P.;Ardizzoni, A.;Grossi, F.;Nackaerts, K.;Giaccone, Giuseppe;et.al.
(2003) European Journal of Cancer — Vol. 39, n° 3, p. 353-357 (2003)

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Authors
  • Baas, P.The Netherlands Cancer Institute
    Author
  • Ardizzoni, A.Instituto Nazionale per la Ricerca sul Cancro
    Author
  • Grossi, F.Università degli Studi di Udine
    Author
  • Nackaerts, K.University Hospital Gasthuisberg
    Author
  • Author
  • Giaccone, GiuseppeAcademisch Ziekenhuis der Vrije Universiteit
    Author
  • et. al.
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Abstract
We investigated the activity and toxicity of raltitrexed (Tomudex®) as a single agent treatment in patients with Malignant Pleural Mesothelioma (MPM) in a multicentre phase II European Organization for Research and Treatment of Cancer (EORTC) study. This study enrolled chemonaı̈ve patients with histologically-confirmed measurable MPM. Raltitrexed was administered at the dose of 3 mg/m2 intravenous (i.v.) bolus on an outpatient basis every 3 weeks. A maximum of eight cycles was planned in cases with an absence of progression or unacceptable toxicity. 24 patients received a total of 104 courses. 5 patients (20.8%, 95% confidence interval (CI) 7.1–42.2%) had a partial response (PR), which was confirmed by an independent radiology committee. Toxicity was mild, with diarrhoea, nausea, vomiting, fatigue and neutropenia as the major side-effects, but not exceeding grade 3 toxicity. We conclude that raltitrexed has activity as a single agent in the treatment of MPM, and that further studies with this drug in MPM are warranted.
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Citations

Baas, P., Ardizzoni, A., Grossi, F., Nackaerts, K., Numico, G., Van Marck, E., van de Vijver, M., Monetti, F., Smid-Geirnaerdt, M. J. A., van Zandwijk, N., Debruyne, C., Legrand, C., Giaccone, G., & et al. (2003). The activity of raltitrexed (Tomudex®) in malignant pleural mesothelioma : an EORTC phase II study (08992). European Journal of Cancer, 39(3), 353-357. https://doi.org/10.1016/S0959-8049(02)00668-8 (Original work published 2003)