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

From The University of Texas M.D. Anderson Cancer Center, Houston, TX; Lutheran General Cancer Center, Park Ridge, IL; The Center for Cancer and Blood Disorders, Fort Worth, TX; Rajiv Gandhi Cancer Institute, New Delhi, India; Gujarat Cancer Research Institute, Ahmedabad, India; MNJ Institute of Oncology, Hyderabad, India; Regional Cancer Center, Thiruvananthapuram, India; and American BioScience Inc, Santa Monica, CA.

Address reprint requests to Nuhad K. Ibrahim, MD, Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 424, Houston, TX 77030-4009; e-mail: nibrahim{at}mdanderson.org

PURPOSE: 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).

PATIENTS AND METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

Sponsored by American BioScience, Inc, Santa Monica, CA.

Presented in part at the 25th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 11–14, 2002; and the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18–21, 2002.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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