Abstract | PURPOSE: 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:
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Authors | Nuhad K Ibrahim, Brian Samuels, Ray Page, Dinesh Doval, Kirtikumar M Patel, S C Rao, Madhavan Krishnan Nair, Paul Bhar, Neil Desai, Gabriel N Hortobagyi |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 23
Issue 25
Pg. 6019-26
(Sep 01 2005)
ISSN: 0732-183X [Print] United States |
PMID | 16135470
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Albumin-Bound Paclitaxel
- Albumins
- Paclitaxel
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Topics |
- Adult
- Aged
- Albumin-Bound Paclitaxel
- Albumins
(administration & dosage, adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, pathology)
- Disease Progression
- Drug Hypersensitivity
- Female
- Humans
- Infusions, Intravenous
- Middle Aged
- Neoplasm Metastasis
- Paclitaxel
(administration & dosage, adverse effects, therapeutic use)
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