Bell, R, Brown, JM orcid.org/0000-0002-2719-7064, Parmar, M et al. (18 more authors) (2017) Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer. Annals of Oncology, 28 (4). pp. 754-760. ISSN 0923-7534
Abstract
Purpose: 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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. This is a pre-copyedited, author-produced PDF of an article accepted for publication in Annals of Oncology following peer review. The version of record, 'Bell, R, Brown, JM , Parmar, M et al (2017) Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer. Annals of Oncology, 28 (4). pp. 754-760,' doi: 10.1093/annonc/mdw665; is available online at: https://doi.org/10.1093/annonc/mdw665. |
Keywords: | breast cancer, triple negative, chemotherapy, bevacizumab, survival |
Dates: |
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Institution: | The University of Leeds |
Academic Units: | The University of Leeds > Faculty of Medicine and Health (Leeds) > School of Medicine (Leeds) > Inst of Clinical Trials Research (LICTR) (Leeds) |
Funding Information: | Funder Grant number F. Hoffman La Roche Ltd BO20289 |
Depositing User: | Symplectic Publications |
Date Deposited: | 09 Dec 2016 13:16 |
Last Modified: | 19 Dec 2017 01:38 |
Published Version: | https://doi.org/10.1093/annonc/mdw665 |
Status: | Published |
Publisher: | Oxford University Press (OUP) |
Identification Number: | 10.1093/annonc/mdw665 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:109312 |