[en] The potential value of baseline health-related quality-of-life (HRQOL) and clinical factors in predicting prognosis was examined using data from an international randomised phase III trial which compared doxorubicin and paclitaxel with doxorubicin and cylophosphamide as first line chemotherapy in 275 women with metastatic breast cancer. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the related breast module (QLQ-BR23) were used to assess baseline HRQOL data. The Cox proportional-hazards regression model was used for both univariate and multivariate analyses of survival. In the univariate analyses, performance status (P < 0.001) and number of sites involved (P = 0.001) were the most important clinical prognostic factors. The HRQOL variables at baseline most strongly associated with longer survival were better appetite, physical and role functioning, as well as less fatigue (P < 0.001). The final multivariate model retained performance status (P < 0.001) and appetite loss (P = 0.005) as the variables best predicting survival. Substantial loss of appetite was the only independent HRQOL factor predicting poor survival and was strongly correlated (\r\ > 0.5) with fatigue, role and physical functioning. In addition to known clinical factors, appetite loss appears to be a significant prognostic factor for survival in women with metastatic breast cancer. However, the mechanism underlying this association remains to be precisely defined in future studies. (C) 2004 Elsevier Ltd. All rights reserved.
Disciplines :
Oncology
Author, co-author :
Efficace, F.
Biganzoli, L.
Piccart, M.
Coens, C.
Van Steen, Kristel ; Université de Liège - ULiège > Dép. d'électric., électron. et informat. (Inst.Montefiore) > Bioinformatique
Kong, S.X., Ghandi, S.K., Methodologic assessments of quality of life measures in clinical trials (1997) Ann. Pharmacother., 31, pp. 830-836
Velikova, G., Stark, D., Selby, P., Quality of life instruments in oncology (1999) Eur J Cancer, 35, pp. 1571-1580
Schumacher, M., Olschewski, M., Schulgen, G., Assessment of quality of life in clinical trials (1991) Stat. Med., 10, pp. 1915-1930
Moinpour, C.M., Measuring quality of life: An emerging science (1994) Semin. Oncol., 21 (SUPPL. 10), pp. 48-60
Staquet, M., Berzon, R., Osoba, D., MacHin, D., Guidelines for reporting results of quality of life assessments in clinical trials (1996) Qual. Life Res., 5, pp. 496-502
Feld, R., Endpoints in cancer clinical trials: Is there a need for measuring quality of life? (1995) Support Care Cancer, 3, pp. 23-27
Sanders, C., Egger, M., Donovan, J., Tallon, D., Frankel, S., Reporting on quality of life in randomised controlled trials: Bibliographic study (1998) Br. Med. J., 317, pp. 1191-1194
Levine, M.N., Ganz, P.A., Beyond the development of quality of life instruments: Where do we go from here? [Editorial] (2002) J. Clin. Oncol., 20, pp. 2215-2216
Landis, S.H., Murray, T., Bolden, S., Wingo, P.A., Cancer statistics, 1998 (1998) CA Cancer J. Clin., 48, pp. 6-29
Biganzoli, L., Cufer, T., Bruning, P., Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: The European Organization for Research and Treatment of Cancer 10961 Multicenter Phase III Trial (2002) J. Clin. Oncol., 20, pp. 3114-3121
Coates, A., Gebski, V., Signorini, D., Prognostic value of quality-of-life scores during chemotherapy for advanced breast cancer. Australian New Zealand Breast Cancer Trials Group (1992) J. Clin. Oncol., 10, pp. 1833-1838
Kramer, J.A., Curran, D., Piccart, M., 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 (2000) Eur. J. Cancer, 36, pp. 1498-1506
Herndon II, J.E., Fleishman, S., Kornblith, A.B., Kosty, M., Green, M.R., Holland, J., Is quality of life predictive of the survival of patients with advanced nonsmall cell lung carcinoma? (1999) Cancer, 85, pp. 333-340
Ganz, P.A., Lee, J.J., Siau, J., Quality of life assessment. An independent prognostic variable for survival in lung cancer (1991) Cancer, 67, pp. 3131-3135
Buccheri, G.F., Ferrigno, D., Tamburini, M., Brunelli, C., The patient's perception of his own quality of life might have an adjunctive prognostic significance in lung cancer (1995) Lung Cancer, 12, pp. 45-58
Earlam, S., Glover, C., Fordy, C., Burke, D., Allen-Mersh, T.G., Relation between tumor size, quality of life, and survival in patients with colorectal liver metastases (1996) J. Clin. Oncol., 14, pp. 171-175
Maisey, N.R., Norman, A., Watson, M., Allen, M.J., Hill, M.E., Cunningham, D., Baseline quality of life predicts survival in patients with advanced colorectal cancer (2002) Eur. J. Cancer, 38, pp. 1351-1357
Wisloff, F., Hjorth, M., Health-related quality of life assessed before and during chemotherapy predicts for survival in multiple myeloma. Nordic Myeloma Study Group (1997) Br. J. Haematol., 97, pp. 29-37
Coates, A., Thomson, D., McLeod, G.R., Prognostic value of quality of life scores in a trial of chemotherapy with or without interferon in patients with metastatic malignant melanoma (1993) Eur. J. Cancer, 29, pp. 1731-1734
Chang, V.T., Thaler, H.T., Polyak, T.A., Kornblith, A.B., Lepore, J.M., Portenoy, R.K., Quality of life and survival: The role of multidimensional symptom assessment (1998) Cancer, 83, pp. 173-179
Dancey, J., Zee, B., Osoba, D., Quality of life scores: An independent prognostic variable in a general population of cancer patients receiving chemotherapy. The National Cancer Institute of Canada Clinical Trials Group (1997) Qual. Life Res., 6, pp. 151-158
Sprangers, M.A., Quality of life assessment in oncology. Achievements and challenges (2002) Acta Oncol., 41, pp. 229-237
Osoba, D., What has been learned from measuring health-related quality of life in clinical oncology (1999) Eur. J. Cancer, 35, pp. 1565-1570
Van Steen, K., Curran, D., Kramer, J., Multicollinearity in prognostic factor analyses using the EORTC QLQ-C30: Identification and impact on model selection (2002) Stat. Med., 21, pp. 3865-3884
Aaronson, N.K., Ahmedzai, S., Bergman, B., The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology (1993) J. Natl. Cancer Inst., 85, pp. 365-376
Sprangers, M.A., Groenvold, M., Arraras, J.I., The EORTC breast cancer-specific quality-of-life questionnaire module: First results from a three-country field study (1996) J. Clin. Oncol., 14, pp. 2756-2768
Jassem, J., Pienkowski, T., Pluzanska, A., Doxorubicin and paclitaxel versus fluorouracil, doxorubicin, and cyclophosphamide as first-line therapy for women with metastatic breast cancer: Final results of a randomized phase III multicenter trial (2001) J. Clin. Oncol., 19, pp. 1707-1715
Rayan, G., Dawson, L.A., Bezjak, A., Prospective comparison of breast pain in patients participating in a randomized trial of breast-conserving surgery and tamoxifen with or without radiotherapy (2003) Int. J. Radiat. Oncol. Biol. Phys., 55, pp. 154-161
Buzdar, A., Douma, J., Davidson, N., Phase III, multicenter, double-blind, randomized study of letrozole, an aromatase inhibitor, for advanced breast cancer versus megestrol acetate (2001) J. Clin. Oncol., 19, pp. 3357-3366
Cull, A., Sprangers, M., Bjordal, K., Aaronson, N., West, K., Bottomley, A., EORTC Quality of Life Group, Translation Procedure (2002) 2nd Edn., , Brussels: EORTC Publications
Hakamies-Blomqvist, L., Luoma, M.L., Sjostrom, J., Timing of quality of life (QoL) assessments as a source of error in oncological trials (2001) J. Adv. Nurs., 35, pp. 709-716
Fayers, P., Aaronson, N., Bjordal, K., Groenvold, M., Curran, D., Bottomley, A., EORTC QLQ-C30 Scoring Manual (2001) 3rd Edn., , Brussels: EORTC Publications
Kaplan, E.L., Meier, P., Nonparametric estimation from incomplete observations (1958) J. Am. Stat. Assoc., 53, pp. 457-481
Friedman, M., The use of ranks to avoid the assumption of normality implicit in the analysis of variance (1937) J. Am. Stat. Assoc., 32, pp. 675-701
Cox, D.R., Regression models and life tables (1972) J. Royal Stat. Soc., 34, pp. 187-220
Kenneth, R.H., Graphical methods for assessing violations of the proportional hazards assumption in Cox regression (1995) Stat. Med., 14, pp. 1707-1723
(2001) SAS/STAT Software, , Cary NC, USA, SAS Institute Inc
Williams, M.R., Todd, J.H., Nicholson, R.I., Elston, C.W., Blamey, R.W., Griffiths, K., Survival patterns in hormone treated advanced breast cancer (1986) Br. J. Surg., 73, pp. 752-755
Robertson, J.F., Dixon, A.R., Nicholson, R.I., Ellis, I.O., Elston, C.W., Blamey, R.W., Confirmation of a prognostic index for patients with metastatic breast cancer treated by endocrine therapy (1992) Breast Cancer Res. Treat., 22, pp. 221-227
Blanco, G., Holli, K., Heikkinen, M., Kallioniemi, O.P., Taskinen, P., Prognostic factors in recurrent breast cancer: Relationships to site of recurrence, disease-free interval, female sex steroid receptors, ploidy and histological malignancy grading (1990) Br. J. Cancer, 62, pp. 142-146
Zinser, J.W., Hortobagyi, G.N., Buzdar, A.U., Smith, T.L., Fraschini, G., Clinical course of breast cancer patients with liver metastases (1987) J. Clin. Oncol., 5, pp. 773-782
Swenerton, K.D., Legha, S.S., Smith, T., Prognostic factors in metastatic breast cancer treated with combination chemotherapy (1979) Cancer Res., 39, pp. 1552-1562
Ryberg, M., Nielsen, D., Osterlind, K., Skovsgaard, T., Dombernowsky, P., Prognostic factors and long-term survival in 585 patients with metastatic breast cancer treated with epirubicin-based chemotherapy (2001) Ann. Oncol., 12, pp. 81-87
Montazeri, A., Milroy, R., Hole, D., McEwen, J., Gillis, C.R., Quality of life in lung cancer patients: As an important prognostic factor (2001) Lung Cancer, 31, pp. 233-240
Roychowdhury, F., Hayden, A., Liepa, A., Health related quality of life (HRQoL) parameters as independent prognostic factors in advanced bladder cancer (2001) Proc. Am. Soc. Clin. Oncol., 20, p. 781. , (abstr)
Blazeby, J.M., Brookes, S.T., Alderson, D., The prognostic value of quality of life scores during treatment for oesophageal cancer (2001) Gut, 49, pp. 227-230
De Graeff, A., De Leeuw, J.R., Ros, W.J., Hordijk, G.J., Blijham, G.H., Winnubst, J.A., Sociodemographic factors and quality of life as prognostic indicators in head and neck cancer (2001) Eur. J. Cancer, 37, pp. 332-339
Luoma, M.L., Hakamies-Blomqvist, L., Sjöström, J., Prognostic value of quality of life scores for time to progression (TTP) and overall survival time (OS) in advanced breast cancer (2003) Eur. J. Cancer, 39, pp. 1370-1376
Coates, A.S., Hurny, C., Peterson, H.F., Quality-of-life scores predict outcome in metastatic but not early breast cancer (2000) J. Clin. Oncol., 18, pp. 3768-3774
Sauerbrei, W., Schumacher, M., A bootstrap resampling procedure for model building: Application to the Cox regression model (1992) Stat. Med., 11, pp. 2093-2109
