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Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer.

Publication ,  Journal Article
Gradishar, WJ; Tjulandin, S; Davidson, N; Shaw, H; Desai, N; Bhar, P; Hawkins, M; O'Shaughnessy, J
Published in: J Clin Oncol
November 1, 2005

PURPOSE: ABI-007, the first biologically interactive albumin-bound paclitaxel in a nanameter particle, free of solvents, was compared with polyethylated castor oil-based standard paclitaxel in patients with metastatic breast cancer (MBC). This phase III study was performed to confirm preclinical studies demonstrating superior efficacy and reduced toxicity of ABI-007 compared with standard paclitaxel. PATIENTS AND METHODS: Patients were randomly assigned to 3-week cycles of either ABI-007 260 mg/m(2) intravenously without premedication (n = 229) or standard paclitaxel 175 mg/m(2) intravenously with premedication (n = 225). RESULTS: ABI-007 demonstrated significantly higher response rates compared with standard paclitaxel (33% v 19%, respectively; P = .001) and significantly longer time to tumor progression (23.0 v 16.9 weeks, respectively; hazard ratio = 0.75; P = .006). The incidence of grade 4 neutropenia was significantly lower for ABI-007 compared with standard paclitaxel (9% v 22%, respectively; P < .001) despite a 49% higher paclitaxel dose. Febrile neutropenia was uncommon (< 2%), and the incidence did not differ between the two study arms. Grade 3 sensory neuropathy was more common in the ABI-007 arm than in the standard paclitaxel arm (10% v 2%, respectively; P < .001) but was easily managed and improved rapidly (median, 22 days). No hypersensitivity reactions occurred with ABI-007 despite the absence of premedication and shorter administration time. CONCLUSION: ABI-007 demonstrated greater efficacy and a favorable safety profile compared with standard paclitaxel in this patient population. The improved therapeutic index and elimination of corticosteroid premedication required for solvent-based taxanes make the novel albumin-bound paclitaxel ABI-007 an important advance in the treatment of MBC.

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Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

November 1, 2005

Volume

23

Issue

31

Start / End Page

7794 / 7803

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Nanostructures
  • Middle Aged
  • Infusions, Intravenous
  • Humans
  • Female
  • Disease-Free Survival
 

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Gradishar, W. J., Tjulandin, S., Davidson, N., Shaw, H., Desai, N., Bhar, P., … O’Shaughnessy, J. (2005). Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol, 23(31), 7794–7803. https://doi.org/10.1200/JCO.2005.04.937
Gradishar, William J., Sergei Tjulandin, Neville Davidson, Heather Shaw, Neil Desai, Paul Bhar, Michael Hawkins, and Joyce O’Shaughnessy. “Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer.J Clin Oncol 23, no. 31 (November 1, 2005): 7794–7803. https://doi.org/10.1200/JCO.2005.04.937.
Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794–803.
Gradishar, William J., et al. “Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer.J Clin Oncol, vol. 23, no. 31, Nov. 2005, pp. 7794–803. Pubmed, doi:10.1200/JCO.2005.04.937.
Gradishar WJ, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, Hawkins M, O’Shaughnessy J. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil-based paclitaxel in women with breast cancer. J Clin Oncol. 2005 Nov 1;23(31):7794–7803.

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

November 1, 2005

Volume

23

Issue

31

Start / End Page

7794 / 7803

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Rate
  • Paclitaxel
  • Oncology & Carcinogenesis
  • Nanostructures
  • Middle Aged
  • Infusions, Intravenous
  • Humans
  • Female
  • Disease-Free Survival