Abstract | PURPOSE: 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:
|
Authors | Hope 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 |
Journal | Journal 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 |
PMID | 26056183
(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
|