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.
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).
RELATED: Study Detects Novel Genetic Markers of Breast Cancer Survival
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.
- Rugo HS, Barry WT, Moreno-Aspita A, et al. Randomized phase III trial of paclitaxel once per week compared with nanoparticle albumin-bound nab-paclitaxel once per week or ixabepilone for locally recurrent or metastatic breast cancer: CALGB 40502/NCCTG N063H (Alliance). J Clin Oncol. 2015. [Epub ahead of print]. doi: 10.1200/JCO.2014.59.5298.