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Annals of Oncology Advance Access originally published online on December 15, 2008
Annals of Oncology 2009 20(3):449-453; doi:10.1093/annonc/mdn661
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

breast cancer

Phase II trial of weekly nab (nanoparticle albumin-bound)-paclitaxel (nab-paclitaxel) (Abraxane®) in combination with gemcitabine in patients with metastatic breast cancer (N0531)

V. Roy1,*, B. R. LaPlant2, G. G. Gross3, C. L. Bane4, F. M. Palmieri1 and for the North Central Cancer Treatment Group

1 Division of Hematology-Oncology, Mayo Clinic, Jacksonville
2 Division of Biostatistics, Mayo Clinic, Rochester
3 Division of Oncology, Roger Maris Cancer Center, Fargo
4 Division of Oncology, Hermatology and Oncology of Dayton Inc., Dayton, USA

* Correspondence to: Dr V. Roy, Hematology–Oncology Division, Mayo Clinic, 4500 San Pablo Road, Jacksonville, FL 32224, USA. Tel: +1-904-953-7291; Fax: +1-904-953-2315; E-mail: roy.vivek{at}mayo.edu

Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and practically eliminates the risk of hypersensitivity reactions associated with solvent-based paclitaxel. We studied weekly nab-paclitaxel and gemcitabine combination in an open-label one-stage, phase II trial in patients with previously untreated metastatic breast cancer (MBC). Nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) were administered on days 1 and 8 of a 21-day cycle until disease progression. Fifty patients were enrolled. Forty (80%) had visceral organ involvement and 30 (60%) had ≥ 3 sites of metastases. Four (8%) and 21 (42%) patients had complete and partial responses by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Median duration of response was 6.9 months [95% confidence interval (CI) 5.7, not reached], median progression-free survival (PFS) 7.9 months (95% CI 5.4–10 months), and median overall survival (OS) was not reached. PFS and OS at 6 months were 60% (95% CI 48% to 76%) and 92% (95% CI 85% to 100%), respectively. Therapy was well tolerated. Neutropenia was commonest toxicity (42% and 12% grades 3 and 4 neutropenia). Only one patient developed febrile neutropenia. Significant activity and favorable toxicity profile provides a basis for considering this regimen for further evaluation in phase III trials or in combination with biologic agents.

Key words: breast cancer, chemotherapy, gemcitabine, nab-paclitaxel

Received for publication August 25, 2008. Accepted for publication September 3, 2008.


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