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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).

AbstractPURPOSE:
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.
AuthorsHope S Rugo, William T Barry, Alvaro Moreno-Aspitia, Alan P Lyss, Constance Cirrincione, Eleanor Leung, Erica L Mayer, Michael Naughton, Deborah Toppmeyer, Lisa A Carey, Edith A Perez, Clifford Hudis, Eric P Winer
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 33 Issue 21 Pg. 2361-9 (Jul 20 2015) ISSN: 1527-7755 [Electronic] United States
PMID26056183 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
Copyright© 2015 by American Society of Clinical Oncology.
Chemical References
  • 130-nm albumin-bound paclitaxel
  • Albumins
  • Antibodies, Monoclonal, Humanized
  • Epothilones
  • Bevacizumab
  • ixabepilone
  • Paclitaxel
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Albumins (administration & dosage)
  • Antibodies, Monoclonal, Humanized (administration & dosage)
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Bevacizumab
  • Breast Neoplasms (drug therapy, pathology)
  • Drug Administration Schedule
  • Epothilones (administration & dosage)
  • Female
  • Humans
  • Middle Aged
  • Nanoparticles
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local (drug therapy)
  • Paclitaxel (administration & dosage)
  • Treatment Outcome

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