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

Eur J Cancer. 2003 Feb;39(3):353-7. doi: 10.1016/s0959-8049(02)00668-8.


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 chemonaíve patients with histologically-confirmed measurable MPM. Raltitrexed was administered at the dose of 3 mg/m(2) 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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antimetabolites, Antineoplastic / adverse effects
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Mesothelioma / drug therapy*
  • Middle Aged
  • Pleural Neoplasms / drug therapy*
  • Quinazolines / administration & dosage*
  • Quinazolines / adverse effects
  • Retrospective Studies
  • Survival Analysis
  • Thiophenes / administration & dosage*
  • Thiophenes / adverse effects
  • Treatment Outcome


  • Antimetabolites, Antineoplastic
  • Quinazolines
  • Thiophenes
  • raltitrexed