Multicenter Phase II Trial of ABI-007, an Albumin-Bound Paclitaxel, in Women With Metastatic Breast Cancer

ABI-007 is a novel nanoparticle, albumin-bound paclitaxel that is free of solvents. This multicenter phase II study was designed to evaluate the efficacy and safety of ABI-007 for the treatment of metastatic breast cancer (MBC). Sixty-three women with histologically confirmed and measurable MBC rece...

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Bibliographic Details
Published in:	Journal of clinical oncology Vol. 23; no. 25; pp. 6019 - 6026
Main Authors:	IBRAHIM, Nuhad K, SAMUELS, Brian, PAGE, Ray, DOVAL, Dinesh, PATEL, Kirtikumar M, RAO, S. C, MADHAVAN KRISHNAN NAIR, BHAR, Paul, DESAI, Neil, HORTOBAGYI, Gabriel N
Format:	Journal Article
Language:	English
Published:	Baltimore, MD American Society of Clinical Oncology 01-09-2005 Lippincott Williams & Wilkins
Subjects:	Adult Aged Albumin-Bound Paclitaxel Albumins - administration & dosage Albumins - adverse effects Albumins - therapeutic use Biological and medical sciences Breast Neoplasms - drug therapy Breast Neoplasms - pathology Disease Progression Drug Hypersensitivity Female Gynecology. Andrology. Obstetrics Humans Infusions, Intravenous Mammary gland diseases Medical sciences Middle Aged Neoplasm Metastasis Paclitaxel - administration & dosage Paclitaxel - adverse effects Paclitaxel - therapeutic use Tumors Antineoplastic agent Human Albumin Breast cancer Malignant tumor Metastasis Mammary gland diseases Cancerology Taxane derivatives Phase II trial Paclitaxel Adult Female Advanced stage Woman Antimitotic
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Summary:	ABI-007 is a novel nanoparticle, albumin-bound paclitaxel that is free of solvents. This multicenter phase II study was designed to evaluate the efficacy and safety of ABI-007 for the treatment of metastatic breast cancer (MBC). Sixty-three women with histologically confirmed and measurable MBC received 300 mg/m2 ABI-007 by intravenous infusion over 30 minutes every 3 weeks without premedication. Forty-eight patients received prior chemotherapy; 39 patients received no prior treatment for metastatic disease. Overall response rates (complete or partial responses) were 48% (95% CI, 35.3% to 60.0%) for all patients. For patients who received ABI-007 as first-line and greater than first-line therapy for their metastatic disease, the respective response rates were 64% (95% CI, 49.0% to 79.2%) and 21% (95% CI, 7.1% to 42.1%). Median time to disease progression was 26.6 weeks, and median survival was 63.6 weeks. No severe hypersensitivity reactions were reported despite the lack of premedication. Toxicities observed were typical of paclitaxel and included grade 4 neutropenia (24%), grade 3 sensory neuropathy (11%), and grade 4 febrile neutropenia (5%). Patients received a median of six treatment cycles; 16 patients had 25% dose reductions because of toxicities, and two of these patients had subsequent dose reductions. ABI-007, the first biologically interactive albumin-bound form of paclitaxel in the nanoparticle state, uses the natural carrier albumin rather than synthetic solvents to deliver paclitaxel and allows for safe administration of high paclitaxel doses without premedication, resulting in significant antitumor activity in patients with MBC, including those receiving the drug as first-line therapy.
ISSN:	0732-183X 1527-7755
DOI:	10.1200/JCO.2005.11.013