Trimodality therapy for malignant pleural mesothelioma: results from an EORTC phase II multicentre trial

Eur Respir J. 2010 Dec;36(6):1362-9. doi: 10.1183/09031936.00039510. Epub 2010 Jun 4.

Abstract

The European Organisation for Research and Treatment of Cancer (EORTC; protocol 08031) phase II trial investigated the feasibility of trimodality therapy consisting of induction chemotherapy followed by extrapleural pneumonectomy and post-operative radiotherapy in patients with malignant pleural mesothelioma (with a severity of cT3N1M0 or less). Induction chemotherapy consisted of three courses of cisplatin 75 mg·m⁻² and pemetrexed 500 mg·m⁻². Nonprogressing patients underwent extrapleural pneumonectomy followed by post-operative radiotherapy (54 Gy, 30 fractions). Our primary end-point was "success of treatment" and our secondary end-points were toxicity, and overall and progression-free survival. 59 patients were registered, one of whom was ineligible. Subjects' median age was 57 yrs. The subjects' TNM scores were as follows: cT1, T2 and T3, 36, 16 and six patients, respectively; cN0 and N1, 57 and one patient, respectively. 55 (93%) patients received three cycles of chemotherapy with only mild toxicity. 46 (79%) patients received surgery and 42 (74%) had extrapleural pneumonectomy with a 90-day mortality of 6.5%. Post-operative radiotherapy was completed in 37 (65%) patients. Grade 3-4 toxicity persisted after 90 days in three (5.3%) patients. Median overall survival time was 18.4 months (95% CI 15.6-32.9) and median progression-free survival was 13.9 months (95% CI 10.9-17.2). Only 24 (42%) patients met the definition of success (one-sided 90% CI 0.36-1.00). Although feasible, trimodality therapy in patients with mesothelioma was not completed within the strictly defined timelines of this protocol and adjustments are necessary.

Trial registration: ClinicalTrials.gov NCT00227630.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Agents / therapeutic use
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Cisplatin / therapeutic use
  • Clinical Trials, Phase II as Topic
  • Combined Modality Therapy
  • Female
  • Glutamates / therapeutic use
  • Guanine / analogs & derivatives
  • Guanine / therapeutic use
  • Humans
  • Male
  • Mesothelioma / mortality
  • Mesothelioma / therapy*
  • Middle Aged
  • Multicenter Studies as Topic
  • Neoplasm Recurrence, Local / therapy
  • Pemetrexed
  • Pleural Neoplasms / mortality
  • Pleural Neoplasms / therapy*
  • Pneumonectomy
  • Radiotherapy, Adjuvant
  • Survival Rate

Substances

  • Antineoplastic Agents
  • Glutamates
  • Pemetrexed
  • Guanine
  • Cisplatin

Associated data

  • ClinicalTrials.gov/NCT00227630