title: Short-term treatment-related symptoms and quality of life: results from an international randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study.
abstract: OBJECTIVE
  For malignant pleural mesothelioma (MPM) patients with a poor prognosis, maintaining health-related quality of life (HRQOL) is important. This article compares the impact on HRQOL of first-line treatment with cisplatin versus raltitrexed and cisplatin.
  
  
  METHODS
  Patients with histologically-proven unresectable MPM, not pretreated with chemotherapy were randomly assigned to receive cisplatin 80 mg/m2 intravenously on day 1, with or without preceding infusion of raltitrexed 3 mg/m2. HRQOL was assessed with the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EORTC Lung Cancer Module (QLQ-LC13) tools. Assessments were conducted at baseline, immediately before every treatment cycle, at the end of treatment, and every six weeks for 12 months.
  
  
  RESULTS
  Two hundred fifty patients were randomly assigned, 80% were male with a median age of 58 years, WHO performance status 0, 1, and 2, in 25%, 62%, and 13% of cases. The clinical results found raltitrexed and cisplatin to be superior to cisplatin with regard to overall survival (P = .048). The global HRQOL scale was comparable at baseline on both treatment arms (P = .848); at no point was any significant difference apparent on this end point. Both treatments led to an improvement, over time, in dyspnoea. This effect is an important clinically meaningful reduction from baseline in the cisplatin/raltitrexed arm. However, the majority of scales of the EORTC QLQ-C30 or LC13 showed stabilization of HRQOL with few clinically significant differences between the treatment arms.
  
  
  CONCLUSIONS
  This study provides important information about the HRQOL of chemotherapy-treated MPM patients.
authors.affiliation: European Organisation for Research and Treatment of Cancer, EORTC Data Center, Brussels, Belgium. andrew.bottomley@eortc.be
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.forename: Rabab
authors.initials: R
authors.lastname: Gaafar
authors.forename: Rabab
authors.initials: R
authors.lastname: Gaafa
authors.forename: Christian
authors.initials: C
authors.lastname: Manegold
authors.forename: Sjaak
authors.initials: S
authors.lastname: Burgers
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.forename: Catherine
authors.initials: C
authors.lastname: Legrand
authors.forename: Mark
authors.initials: M
authors.lastname: Vincent
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giaccone
authors.forename: Jan
authors.initials: J
authors.lastname: Van Meerbeeck
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008654:Mesothelioma / Q000150:complications* / Q000188:drug therapy*; D008875:Middle Aged; D010997:Pleural Neoplasms / Q000150:complications* / Q000188:drug therapy*; D011788:Quality of Life; D011799:Quinazolines / Q000008:administration & dosage; D013876:Thiophenes / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D011799:Quinazolines; D013876:Thiophenes; C068874:raltitrexed; D002945:Cisplatin