Antonio Llombart-Cussac1, Xavier Pivot2, Laura Biganzoli3, Hernan Cortes-Funes4, Kathleen I Pritchard5, Jean-Yves Pierga6, Ian Smith7, Christoph Thomssen8, Stefanie Srock9, Miguel Sampayo10, Javier Cortes11. 1. Medica Scientia Innovation Research (MedSIR ARO), Barcelona, Spain; Hospital Arnau de Vilanova de Valencia, Valencia, Spain. Electronic address: antonio.llombart@medsir.org. 2. Institut Regional du Cancer en Franche-Comté, Centre Hospitalier Universitaire de Besançon, Besançon, France. 3. Sandro Pitigliani Medical Oncology Department, Nuovo Ospedale di Prato, Istituto Toscano Tumori, Prato, Italy. 4. University Hospital 12 de Octubre, Madrid, Spain. 5. Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, ON, Canada. 6. Institut Curie, Université Paris Descartes, Paris, France. 7. Royal Marsden Hospital and The Institute of Cancer Research, London, UK. 8. Department of Gynaecology, Martin-Luther-Universität Halle-Wittenberg, Halle an der Saale, Germany. 9. F Hoffmann-La Roche Ltd, Basel, Switzerland. 10. Medica Scientia Innovation Research (MedSIR ARO), Barcelona, Spain; Scienco Klinico, Barcelona, Spain. 11. Medica Scientia Innovation Research (MedSIR ARO), Barcelona, Spain; Vall d'Hebron University Hospital, Barcelona, Spain.
Abstract
BACKGROUND: Evidence-based definitions of 'poor-prognosis' or 'aggressive' advanced breast cancer are lacking. PATIENTS AND METHODS: We developed a prognostic factor index using data from 2203 patients treated with first-line chemotherapy plus bevacizumab for HER2-negative advanced breast cancer. RESULTS: The risk factors most closely associated with worse OS were: disease-free interval ≤24 months; liver metastases or ≥3 involved organ sites; prior anthracycline and/or taxane therapy; triple-negative breast cancer (TNBC); and performance status 2 or prior analgesic/corticosteroid treatment. Risk of death was increased threefold in patients with ≥3 versus ≤1 risk factors (hazard ratio 3.0 [95% CI 2.6-3.4; p < 0.001]; median 16.0 vs 38.8 months, respectively). CONCLUSIONS: This prognostic index may enable identification of patients with a poorer prognosis in whom more intensive systemic regimens may be appropriate. The index may also be considered in designing new trials, although it requires validation in other datasets before extrapolation to non-bevacizumab-containing therapy. ClinicalTrials.gov identifier: NCT00448591.
BACKGROUND: Evidence-based definitions of 'poor-prognosis' or 'aggressive' advanced breast cancer are lacking. PATIENTS AND METHODS: We developed a prognostic factor index using data from 2203 patients treated with first-line chemotherapy plus bevacizumab for HER2-negative advanced breast cancer. RESULTS: The risk factors most closely associated with worse OS were: disease-free interval ≤24 months; liver metastases or ≥3 involved organ sites; prior anthracycline and/or taxane therapy; triple-negative breast cancer (TNBC); and performance status 2 or prior analgesic/corticosteroid treatment. Risk of death was increased threefold in patients with ≥3 versus ≤1 risk factors (hazard ratio 3.0 [95% CI 2.6-3.4; p < 0.001]; median 16.0 vs 38.8 months, respectively). CONCLUSIONS: This prognostic index may enable identification of patients with a poorer prognosis in whom more intensive systemic regimens may be appropriate. The index may also be considered in designing new trials, although it requires validation in other datasets before extrapolation to non-bevacizumab-containing therapy. ClinicalTrials.gov identifier: NCT00448591.
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