Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer
R Bell, J Brown, M Parmar, M Toi, T Suter, G G Steger, X Pivot, J Mackey, C Jackisch, R Dent, P Hall, N Xu, L Morales, L Provencher, R Hegg, L Vanlemmens, A Kirsch, A Schneeweiss, N Masuda, F Overkamp, D Cameron, R Bell, J Brown, M Parmar, M Toi, T Suter, G G Steger, X Pivot, J Mackey, C Jackisch, R Dent, P Hall, N Xu, L Morales, L Provencher, R Hegg, L Vanlemmens, A Kirsch, A Schneeweiss, N Masuda, F Overkamp, D Cameron
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.
Keywords: bevacizumab; breast cancer; chemotherapy; survival; triple negative.
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Source: PubMed