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

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.; on behalf of the EORTC Lung Cancer Group,

« Previous Next »European Journal of Cancer
Volume 39, Issue 3 , Pages 353-357, February 2003

The activity of raltitrexed (Tomudex®) in malignant pleural mesothelioma:

an EORTC phase II study (08992)

P. Baas
- The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands
- Corresponding author
A. Ardizzoni
- Instituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
F. Grossi
- Universita degli Studi di Udine, Udine, Italy
K. Nackaerts
- University Hospital Gasthuisberg, Belgium
G. Numico
- Ospedale Santa Croce, Cuneo, Italy
E. Van Marck
- University of Antwerp, Dept of Pathology, Antwerp, Belgium
M. van de Vijver
- The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands
F. Monetti
- Instituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
M.J.A. Smid-Geirnaerdt
- Stichting Oosterschelde Ziekenhuizen, Goes, The Netherlands
N. van Zandwijk
- The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands
C. Debruyne
- The EORTC Data Center, Brussels, Belgium
C. Legrand
- The EORTC Data Center, Brussels, Belgium
G. Giaccone
- Academisch Ziekenhuis der Vrije Universiteit, Amsterdam, The Netherlands
on behalf of the EORTC Lung Cancer Group

Received 15 October 2002; accepted 16 October 2002.

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.

Keywords: Malignant Pleural Mesothelioma, Tomudex, Phase II, EORTC