Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer |
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| Institution: | 1. Faculty of Medicine, Deakin University, Geelong, Australia;2. Clinical Trials Research Unit, University of Leeds, Leeds;3. Medical Research Council Clinical Trials Unit, London, UK;4. Faculty of Medicine, Kyoto University, Kyoto, Japan;5. Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland;6. Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria;7. Medical Oncology Service, University Hospital Jean Minjoz, Besançon, France;8. Medical Oncology, Cross Center Institute, Edmonton, Canada;9. Department of Obstetrics and Gynecology and Breast Cancer Center, Sana Klinikum Offenbach, Offenbach, Germany;10. Department of Medical Oncology, National Cancer Center, Singapore, Singapore, and Sunnybrook Health Sciences Center, University of Toronto, Toronto, Canada;11. Leeds Institute of Health Sciences, University of Leeds, Leeds, UK;12. Product Development Oncology, F Hoffmann-La Roche Ltd, Basel, Switzerland;13. Centre des Maladies du Sein Deschênes-Fabia, CHU de Québec-Hôpital du Saint-Sacrement, Ville de Québec, Québec, Canada;14. Oncology Department, Perola Byington Hospital/FMUSP, São Paulo, Brazil;15. Department of Medical Oncology, Centre Oscar Lambret, Lille, France;16. Onkologischer Schwerpunktam Oskar-Helene-Heim, Berlin, Germany;17. Division of Gynecologic Oncology, National Center for Tumor Diseases, University Hospital, Heidelberg, Germany;18. Department of Surgery, Breast Oncology NHO Osaka National Hospital, Osaka, Japan;19. Oncologianova, Recklinghausen, Germany;20. Edinburgh University Cancer Research Centre, University of Edinburgh and Cancer Services, NHS Lothian, Edinburgh, UK |
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| Abstract: | BackgroundThe purpose of this analysis was to assess the long-term impact of adding bevacizumab to adjuvant chemotherapy for early triple-negative breast cancer (TNBC).MethodsPatients eligible for the open-label randomized phase III BEATRICE trial had centrally confirmed triple-negative operable primary invasive breast cancer (pT1a–pT3). Investigators selected anthracycline- and/or taxane-based chemotherapy for each patient. After definitive surgery, patients were randomized 1:1 to receive ≥4 cycles of chemotherapy alone or with 1 year of bevacizumab (5 mg/kg/week equivalent). Stratification factors were nodal status, selected chemotherapy, hormone receptor status, and type of surgery. The primary end point was invasive disease-free survival (IDFS; previously reported). Secondary outcome measures included overall survival (OS) and safety.ResultsAfter 56 months’ median follow-up, 293 of 2591 randomized patients had died. There was no statistically significant difference in OS between treatment arms in either the total population (hazard ratio 0.93, 95% confidence interval CI] 0.74–1.17; P = 0.52) or pre-specified subgroups. The 5-year OS rate was 88% (95% CI 86–90%) in both treatment arms. Updated IDFS results were consistent with the primary IDFS analysis. Five-year IDFS rates were 77% (95% CI 75–79%) with chemotherapy alone versus 80% (95% CI 77–82%) with bevacizumab. From 18 months after first study dose to study end, new grade ≥3 adverse events occurred in 4.6% and 4.5% of patients in the two arms, respectively.ConclusionFinal OS results showed no significant benefit from bevacizumab therapy for early TNBC. Late-onset toxicities were rare in both groups. Five-year OS and IDFS rates suggest that the prognosis for patients with TNBC is better than previously thought.ClinicalTrials.govNCT00528567 |
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