Originally published as JCO Early Release 10.1200/JCO.2005.03.3027 on January 30 2006

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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

Andrew Bottomley, Rabab Gaafa, Christian Manegold, Sjaak Burgers, Corneel Coens, Catherine Legrand, Mark Vincent, Giuseppe Giaccone, Jan Van Meerbeeck

From the European Organisation for Research and Treatment of Cancer, EORTC Data Center, Brussels; University Hospital, Ghent, Belgium; National Cancer Center, Cairo, Egypt; Thoraxklinik Heidelberg, Germany; Erasmus MC, Rotterdam; NCIC DC, Ontario, Canada; Free University Medical Center, Amsterdam, the Netherlands

Address reprint requests Andrew Bottomley, Head of the Quality of Life Unit, European Organization for Research and Treatment of Cancer Data Center, Ave E Mounier 83, Box 11, Brussels, Belgium 1200; e-mail: andrew.bottomley{at}eortc.be

PURPOSE: 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.

PATIENTS AND 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.

CONCLUSION: This study provides important information about the HRQOL of chemotherapy-treated MPM patients.

This study was conducted by the European Organisation for Research and Treatment of Cancer and the National Cancer Institute of Canada Clinical Trials Group.

Supported by an educational Grant from AstraZeneca, and in part by Grants No. 5U10CA11488-30, 5U10CA11488-31, 5U10CA11488-32, 5U10CA11488-33, and 5U10CA11488-34 from the National Cancer Institute, Bethesda, MD.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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