R Bell1, J Brown2, M Parmar3, M Toi4, T Suter5, G G Steger6, X Pivot7, J Mackey8, C Jackisch9, R Dent10, P Hall11, N Xu12, L Morales12, L Provencher13, R Hegg14, L Vanlemmens15, A Kirsch16, A Schneeweiss17, N Masuda18, F Overkamp19, D Cameron20. 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.
Abstract
BACKGROUND: The purpose of this analysis was to assess the long-term impact of adding bevacizumab to adjuvant chemotherapy for early triple-negative breast cancer (TNBC). METHODS: Patients 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. RESULTS: After 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. CONCLUSION: Final 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.GOV: NCT00528567.
BACKGROUND: The purpose of this analysis was to assess the long-term impact of adding bevacizumab to adjuvant chemotherapy for early triple-negative breast cancer (TNBC). METHODS: Patients 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. RESULTS: After 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. CONCLUSION: Final 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.GOV: NCT00528567.
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