[en] 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 HBQOL parameters have no prognostic value in a nonmetastatic breast cancer population.
Disciplines :
Oncology
Author, co-author :
Efficace, F.
Therasse, P.
Piccart, M. J.
Coens, C.
Van Steen, Kristel ; Université de Liège - ULiège > Dép. d'électric., électron. et informat. (Inst.Montefiore) > Bioinformatique
Priestman TJ, Baum M: Evaluation of quality of life in patients receiving treatment for advanced breast cancer. Lancet 1:899-900, 1976
Dancey J, Zee B, Osoba D, et al: Quality of life scores: An independent prognostic variable in a general population of cancer patients receiving chemotherapy. Qual Life Res 6:151-158, 1997
Coates A, Porzsolt F, Osoba D: Quality of life in oncology practice: Prognostic value of EORTC QLQ-C30 scores in patients with advanced malignancy. Eur J Cancer 33:1025-1030, 1997
Seidman AD, Portenoy R, Yao TJ, et al: Quality of life in phase II trials: A study of methodology and predictive value in patients with advanced breast cancer treated with paclitaxel plus granulocyte colony-stimulating factor. J Natl Cancer Inst 87:1316-1322, 1995
Chiarion-Sileni V, Del Bianco P, De Salvo GL, et al: Quality of life evaluation in a randomised trial of chemotherapy versus biochemotherapy in advanced melanoma patients. Eur J Cancer 39:1577-1585, 2003
de Graeff A, de Leeuw JR, Ros WJ, et al: Sociodemographic factors and quality of life as prognostic indicators in head and neck cancer. Eur J Cancer 37:332-339, 2001
Blazeby JM, Brookes ST, Alderson D: The prognostic value of quality of life scores during treatment for oesophageal cancer. Gut 49:227-230, 2001
Maisey NR, Norman A, Watson M, et al: Baseline quality of life predicts survival in patients with advanced colorectal cancer. Eur J Cancer 38:1351-1357, 2002
Herndon JE II, Fleishman S, Kornblith AB, et al: Is quality of life predictive of the survival of patients with advanced nonsmall cell lung carcinoma? Cancer 85:333-340, 1999
Coates A, Thomson D, McLeod GR, et al: Prognostic value of quality of life scores in a trial of chemotherapy with or without interferon in patients with metastatic malignant melanoma. Eur J Cancer 29A:1731-1734, 1993
Kramer JA, Curran D, Piccart M, et al: Identification and interpretation of clinical and quality of life prognostic factors for survival and response to treatment in first-line chemotherapy in advanced breast cancer. Eur J Cancer 36:1498-1506, 2000
Coates AS, Hurny C, Peterson HF, et al: Quality-of-life scores predict outcome in metastatic but not early breast cancer. J Clin Oncol 18:3768-3774, 2000
Luoma ML, Hakamies-Blomqvist L, Sjöström J, et al: Prognostic value of quality of life scores for time to progression (TTP) and overall survival time (OS) in advanced breast cancer. Eur J Cancer 39:1370-1376, 2003
Coates A, Gebski V, Signorini D, et al: Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer: Australian New Zealand Breast Cancer Trials Group. J Clin Oncol 10:1833-1838, 1992
Tross S, Herndon J II, Korzun A, et al: Psychological symptoms and disease-free and overall survival in women with stage II breast cancer: Cancer and Leukemia Group B. J Natl Cancer Inst 88:661-667, 1996
Mulder CL, Van der Pompe G, Spiegel D, et al: Do psychosocial factors influence the course of breast cancer? Psychooncology 1:155-167, 1992
Van Steen K, Curran D, Kramer J, et al: Multicollinearity in prognostic factor analyses using the EORTC QLQ-C30: Identification and impact on model selection. Stat Med 21:3865-3884, 2002
Sauerbrei W, Schumacher M: A bootstrap resampling procedure for model building: Application to the Cox regression model. Stat Med 11:2093-2109, 1992
Schumacher M, Hollander N, Sauerbrei W: Resampling and crossvalidation techniques: A tool to reduce bias caused by model building? Stat Med 16:2813-2827, 1997
Augustin NH, Sauerbrei W, Schumacher M: Incorporating model selection into prognostic factor model predictions: Freiburg Center for Data Analysis and Modeling, Preprint 76, 2002. http://www.fdm.uni-freiburg.de/pub/preprints.php
Therasse P, Mauriac L, Welnicka-Jaskiewicz M, et al: Final results of a randomized phase III trial comparing cyclophosphamide, epirubicin, and fluorouracil with a dose-intensified epirubicin and cyclophosphamide + filgrastim as neoadjuvant treatment in locally advanced breast cancer: An EORTC-NCIC-SAKK multicenter study. J Clin Oncol 21:843-850, 2003
Aaronson NK, Ahmedzai S, Bergman B, et al: The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365-376, 1993
Hakamies-Blomqvist L, Luoma ML, Sjostrom J, et al: Timing of quality of life (QoL) assessments as a source of error in oncological trials. J Adv Nurs 35:709-716, 2001
Casciato DA, Lowitz BB: Manual of Clinical Oncology (ed 4). Philadelphia, PA, Lippnicott Williams & Wilkins, 2000
Fayers P, Aaronson N, Bjordal K, et al: EORTC QLQ-C30 Scoring Manual (ed 3). Brussels, Belgium, EORTC Publications, 2001
Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
Friedman M: The use of ranks to avoid the assumption of normality implicit in the analysis of variance. J Am Stat Assoc 32:675-701, 1937
Cox DR: Regression models and life tables. J R Stat Soc 4:187-220, 1972
Hess KR: Graphical methods for assessing violations of the proportional hazards assumption in Cox regression. Stat Med 14:1707-1723, 1995
Razavi D, Farvacques C, Delvaux N, et al: Psychosocial correlates of oestrogen and progesterone receptors in breast cancer. Lancet 335:931-933, 1990
Efficace F, Biganzoli L, Piccart M, et al: Baseline health-related quality of life data as prognostic factors in a phase III multicenter study of women with metastatic breast cancer. Eur J Cancer 40:1021-1030, 2004
Sprangers MA: Quality of life assessment in oncology: Achievements and challenges. Acta Oncol 41:229-237, 2002
Osoba D: Lessons learned from measuring health-related quality of life in oncology. J Clin Oncol 12:608-616, 1994
Osoba D, Slamon DJ, Burchmore M, et al: Effects on quality of life of combined trastuzumab and chemotherapy in women with metastatic breast cancer. J Clin Oncol 20:3106-3113, 2002
Earlam S, Glover C, Fordy C, et al: Relation between tumor size, quality of life, and survival in patients with colorectal liver metastases. J Clin Oncol 14:171-175, 1996