Paclitaxel once per week remains the preferred palliative chemotherapy in patients with chemotherapy-naive advanced breast cancer, a new study published online ahead of print in the Journal of Clinical Oncology has shown.
For the phase III trial, researchers enrolled 799 patients with chemotherapy-naive advanced breast cancer and randomly assigned them to receive bevacizumab plus paclitaxel 90 mg/m2 (arm A), nab-paclitaxel 150 mg/m2 (arm B), or ixabepilone 16 mg/m2 (arm C), once weekly for 3 weeks of each 4-week cycle. Of those, 783 patients received treatment.
At the time of first interim analysis, arm C was closed for futility. Arm A and arm B were closed for futility at the second interim analysis.
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Results showed that median progression-free survival for paclitaxel was 11 months versus 7.4 months for ixabepilone (HR = 1.59; 95% CI: 1.31, 1.93; P < 0.001) and 9.3 months for nab-paclitaxel (HR = 1.20; 95% CI: 1.00, 1.45; P = 0.054).
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Therefore, ixabepilone weekly was inferior to paclitaxel, and nab-paclitaxel was not superior to paclitaxel with a trend toward inferiority.
In regard to safety, patients who received nab-paclitaxel experienced a higher incidence of hematologic and non-hematologic toxicity, including peripheral neuropathy. Patients in that group also had more frequent and earlier dose reductions.
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