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Medline ® Abstract for Reference 22

of 'Systemic treatment of metastatic breast cancer in women: Chemotherapy'

Randomized Phase III Trial of Paclitaxel Once Per Week Compared With Nanoparticle Albumin-Bound Nab-Paclitaxel Once Per Week or Ixabepilone With Bevacizumab As First-Line Chemotherapy for Locally Recurrent or Metastatic Breast Cancer: CALGB 40502/NCCTG N063H (Alliance).
Rugo HS, Barry WT, Moreno-Aspitia A, Lyss AP, Cirrincione C, Leung E, Mayer EL, Naughton M, Toppmeyer D, Carey LA, Perez EA, Hudis C, Winer EP
J Clin Oncol. 2015 Jul;33(21):2361-9. Epub 2015 Jun 8.
PURPOSE: We compared nab-paclitaxel or ixabepilone once per week to paclitaxel with bevacizumab as first-line therapy for patients with advanced breast cancer (BC) to evaluate progression-free survival (PFS) for nab-paclitaxel or ixabepilone versus paclitaxel.
PATIENTS AND METHODS: Eligible patients were age≥18 years with chemotherapy-naive advanced BC. Patients were randomly assigned to bevacizumab with paclitaxel 90 mg/m(2) (arm A), nab-paclitaxel 150 mg/m(2) (arm B), or ixabepilone 16 mg/m(2) (arm C), once per week for 3 of 4 weeks. Planned enrollment was 900 patients, which would give 88% power to detect a hazard ratio of 0.73.
RESULTS: In all, 799 patients were enrolled, and 783 received treatment (97% received bevacizumab). Arm C was closed for futility at the first interim analysis (n = 241), and arm A (n = 267) and arm B (n = 275) were closed for futility at the second interim analysis. Median PFS for paclitaxel was 11 months, ixabepilone was inferior to paclitaxel (PFS, 7.4 months; hazard ratio, 1.59; 95% CI, 1.31 to 1.93; P<.001), and nab-paclitaxel was not superior to paclitaxel (PFS, 9.3 months; hazard ratio, 1.20; 95% CI, 1.00 to 1.45; P = .054). Results were concordant with overall survival; time to treatment failure was significantly shorter in both experimental arms v paclitaxel. Hematologic and nonhematologic toxicity, including peripheral neuropathy, was increased with nab-paclitaxel, with more frequent and earlier dose reductions.
CONCLUSION: In patients with chemotherapy-naive advanced BC, ixabepilone once per week was inferior to paclitaxel, and nab-paclitaxel was not superior with a trend toward inferiority. Toxicity was increased in the experimental arms, particularly for nab-paclitaxel. Paclitaxel once per week remains the preferred palliative chemotherapy in this setting.
Hope S. Rugo, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; William T. Barry, Alliance Statistics and Data Center, Dana-Farber Cancer Institute; Erica L. Mayer and Eric P. Winer, Dana-Farber Cancer Institute, Boston, MA; Alvaro Moreno-Aspitia and Edith A. Perez, Mayo Clinic, Jacksonville, FL; Alan P. Lyss, Heartland Cancer Research Community Clinical Oncology Program; Michael Naughton, Washington University School of Medicine, St Louis, MO; Constance Cirrincione and Eleanor Leung, Alliance Statistics and Data Center, Duke University, Durham; Lisa A. Carey, University of North Carolina, Chapel Hill, NC; Deborah Toppmeyer, Cancer Institute of New Jersey, New Brunswick, NJ; and Clifford Hudis, Memorial Sloan Kettering Cancer Center, New York, NY. hrugo@medicine.ucsf.edu.