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

2018 Nov 23

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-paclitaxe

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