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

P. Baas, A. Ardizzoni, F. Grossi, K. Nackaerts, G. Numico, E. Van Marck, M. Van De Vijver, F. Monetti, M. J A Smid-Geirnaerdt, N. Van Zandwijk, C. Debruyne, C. Legrand, G. Giaccone

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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 chemonaïve 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.

Original languageEnglish
Pages (from-to)353-357
Number of pages5
JournalEuropean Journal of Cancer
Issue number3
Publication statusPublished - Feb 2003


  • Malignant Pleural Mesothelioma, Tomudex, Phase II, EORTC

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology


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