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.
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)