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Symptoms and Patient-Reported Well-Being: Do They Predict Survival in Malignant Pleural Mesothelioma? A Prognostic Factor Analysis of EORTC-NCIC 08983: Randomized Phase III Study of Cisplatin With or Without Raltitrexed in Patients With Malignant Pleural Mesothelioma

Andrew Bottomley, Corneel Coens, Fabio Efficace, Rabab Gaafar, Christian Manegold, Sjaak Burgers, Mark Vincent, Catherine Legrand, Jan P. van Meerbeeck

From the European Organisation for Research and Treatment of Cancer Data Center, Brussels; University Hospital, Ghent, Belgium; National Cancer Center, Cairo, Egypt; University Medical Center Mannheim, Heidelberg University, Mannheim, Germany; National Cancer Institute, Amsterdam; Free University Medical Center, the Netherlands; and London Regional Cancer Center, Ontario, Canada

Address reprint requests to Andrew Bottomley, PhD, EORTC Data Center, Quality of Life Unit, Avenue E. Mounier, 83, 1200 Brussels, Belgium; e-mail: andrew.bottomley{at}eortc.be

Purpose: Malignant pleural mesothelioma (MPM) is a rare disease. Unlike other advanced cancer types, little is known about patient-reported symptoms or health-related quality of life (HRQOL) and their possible prognostic value. This study reports an evaluation of the prognostic value of these factors using data gathered from a recent randomized controlled trial.

Patients and Methods: Patients were entered onto this trial if they had a histologically proven unresectable MPM, not pretreated with chemotherapy, WHO performance status 2, and adequate hematologic, renal, and hepatic function. Patients were randomly assigned to receive cisplatin 80 mg/m² intravenously on day 1, without or with preceding infusion of raltitrexed 3 mg/m². HRQOL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30/Lung Cancer 13 tool. The Cox proportional hazards regression model was used for the univariate and multivariate analyses of survival, along with a bootstrap validation technique. Included were the EORTC prognostic index (PI) composed of stage of disease, histology type, time since diagnosis, and WBC, and, in addition, 10 selected key symptoms and HRQOL scales.

Results: Two hundred fifty patients were randomly assigned (80% male; median age, 58 years; WHO performance status 0, 1, 2 in 25%, 62%, and 13% of cases, respectively). Two hundred twenty-nine patients (91.6%) had a valid HRQOL assessment. The final multivariate model retained the PI, pain (P < .0001), and appetite loss (P = .0100) as independent prognostic indicators of survival.

Conclusion: Results suggest that the PI, pain, and appetite loss may be independent prognostic factors in patients with advanced MPM.

Supported in part by grants (5U10CA11488-30 through 5U10CA11488-34) from the National Cancer Institute. AstraZeneca provided the raltitrexed and an educational grant for data management and study conduct. This work was also supported, in part, by the EORTC Charitable Trust.

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