The primary goal of this non-inferiority trial was to determine if an intermittent treatment regimen was not inferior to a continuous regimen, in first-line treatment of patients with HER2-negative, incurable, metastatic or unresectable locally advanced breast cancer.
Patients were randomised to receive 8 cycles or 2x4 cycles of paclitaxel/bevacizumab on days 1, 8 and 15 every 4 weeks, both with continuation of bevacizumab once every 21 days until disease progression or unacceptable toxicity. If progressive disease occurred ≥ 3 months after the initial 4 cycles with paclitaxel/bevacizumab in the intermittent arm, another 4 cycles were given. If progressive disease occurred in the continuous arm or
The intention-to-treat population comprised of 420 patients. The total median PFS in first-line treatment was 10.7 months (95% CI 7.03 - 12.42) for the intermittent regimen and 9.7 months (95% CI 8.94 - 10.28) for the continuous regimen (HR for disease progression or death [intermittent vs. continuous], 1.006; 95% CI 0.743 - 1.361). Results on OS were similar with a HR of 1.312 (95% CI 0.959 - 1.794). The per-protocol analysis showed comparable results. Safety results and actually delivered treatments did not reveal unexpected findings and will be presented at the meeting.
Intermittent first-line treatment with paclitaxel/bevacizumab is not non-inferior to continuous scheduling regarding PFS in patients with HER2-negative incurable locally advanced or metastatic breast cancer. Analysis of the secondary endpoint OS supported this conclusion. Therefore, intermittent first-line treatment cannot be recommended over continuous scheduling.
Clinical trial identification
EudraCT 2010-021519-18; BOOG 2010-02.
Legal entity responsible for the study
Dutch Breast Cancer Research Group (BOOG)
F. Hoffmann-La Roche Ltd, The Netherlands; TEVA Nederland B.V.
V. Tjan-Heijnen: Financial support from the Dutch Breast Research Group during the conduct of the study; Grants and non-financial support from Roche/Pfizer/Novartis/AstraZeneca, grants from Esai, outside the submitted work. F. Erdkamp: Advisory board Roche. All other authors have declared no conflicts of interest.