title: Multicenter phase II trial of ABI-007, an albumin-bound paclitaxel, in women with metastatic breast cancer.
abstract: OBJECTIVE
  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).
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 424, Houston, TX 77030-4009, USA. nibrahim@mdanderson.org
authors.forename: Nuhad K
authors.initials: NK
authors.lastname: Ibrahim
authors.forename: Brian
authors.initials: B
authors.lastname: Samuels
authors.forename: Ray
authors.initials: R
authors.lastname: Page
authors.forename: Dinesh
authors.initials: D
authors.lastname: Doval
authors.forename: Kirtikumar M
authors.initials: KM
authors.lastname: Patel
authors.forename: S C
authors.initials: SC
authors.lastname: Rao
authors.forename: Madhavan Krishnan
authors.initials: MK
authors.lastname: Nair
authors.forename: Paul
authors.initials: P
authors.lastname: Bhar
authors.forename: Neil
authors.initials: N
authors.lastname: Desai
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
mesh_terms: D000328:Adult; D000368:Aged; D000068196:Albumin-Bound Paclitaxel; D000418:Albumins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004342:Drug Hypersensitivity; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000068196:Albumin-Bound Paclitaxel; D000418:Albumins; D017239:Paclitaxel