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Health-Related Quality of Life Parameters As Prognostic Factors in a Nonmetastatic Breast Cancer Population: An International Multicenter Study

From the European Organization for Research and Treatment of Cancer, Quality of Life Unit; Institute Jules Bordet, Brussels; Limburgs Universitair Centrum, Diepenbeek, Belgium; Harvard University, Department of Biostatistics, Boston, MA; Medical University of Gdansk, Poland; Institute of Oncology, Ljubljana, Slovenia; Medical Academy of Lodz, Poland; Cancer Research Center, Moscow, Russia; National Cancer Institute Canada, Clinical Trials Group, Kingston, Canada; and Department of Medical Psychology, University of Amsterdam, The Netherlands

Address reprint requests to Fabio Efficace, MSc, European Organisation for Research and Treatment of Cancer, EORTC Data Center, Quality of Life Unit, Ave E Mounier 83, 1200 Brussels, Belgium; e-mail: fef{at}eortc.be

PURPOSE: The purpose of this research was to evaluate whether baseline health-related quality of life (HRQOL) parameters are prognostic factors for survival in locally advanced breast cancer patients. Although the literature highlights the important role of HRQOL parameters in predicting survival in advanced metastatic disease, little evidence exists for earlier stages.

PATIENTS AND METHODS: The overall sample consisted of 448 patients randomly assigned to receive cyclophosphamide, epirubicin, and fluorouracil versus epirubicin, cyclophosphamide, and granulocyte colony-stimulating factor. Patients were enrolled in 12 countries. HRQOL baseline scores were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. The Cox proportional hazards regression model was used for both univariate and multivariate analyses of survival. In addition, a bootstrap resampling technique was used to assess the stability of the outcomes. Bootstrap results were then applied for model averaging purposes as a means to account for the observed model selection uncertainty.

RESULTS: The final multivariate model retained inflammatory breast cancer (T4d) as the only factor predicting overall survival (OS) with a hazard ratio of 1.375 (95% CI, 1.027 to 1.840; P = .03). The presence of inflammatory breast cancer lowers the median survival time from 6.6 to 4.2 years (36% reduction). None of the preselected HRQOL variables were prognostic for OS or disease-free survival, in either the univariate or multivariate analysis.

CONCLUSION: Our findings suggest that baseline HRQOL parameters have no prognostic value in a nonmetastatic breast cancer population.

F.E. is supported by the Camilla Samuel Fellowship in Memory of Lady Grierson. This work was carried out within the framework of the Belgian IUAP/PAI Network Statistical Techniques and Modeling for Complex Substantive Questions with Complex Data, and supported by grant MH59532 of the National Institutes of Health (K.V.S.).

Presented at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

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

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