PMID- 16172456
OWN - NLM
STAT- MEDLINE
DCOM- 20051209
LR  - 20231024
IS  - 0732-183X (Print)
IS  - 0732-183X (Linking)
VI  - 23
IP  - 31
DP  - 2005 Nov 1
TI  - Phase III trial of nanoparticle albumin-bound paclitaxel compared with 
      polyethylated castor oil-based paclitaxel in women with breast cancer.
PG  - 7794-803
AB  - 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.
FAU - Gradishar, William J
AU  - Gradishar WJ
AD  - Northwestern University, Breast Oncology, Division of Hematology/Oncology, 
      Department of Medicine, Chicago, IL 60611, USA. w-gradishar@northwestern.edu
FAU - Tjulandin, Sergei
AU  - Tjulandin S
FAU - Davidson, Neville
AU  - Davidson N
FAU - Shaw, Heather
AU  - Shaw H
FAU - Desai, Neil
AU  - Desai N
FAU - Bhar, Paul
AU  - Bhar P
FAU - Hawkins, Michael
AU  - Hawkins M
FAU - O'Shaughnessy, Joyce
AU  - O'Shaughnessy J
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20050919
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Albumin-Bound Paclitaxel)
RN  - 0 (Albumins)
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 61791-12-6 (polyethoxylated castor oil)
RN  - 8001-79-4 (Castor Oil)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
CIN - J Clin Oncol. 2005 Nov 1;23(31):7768-71. PMID: 16204007
MH  - Adult
MH  - Aged
MH  - Albumin-Bound Paclitaxel
MH  - Albumins/adverse effects/therapeutic use
MH  - Antineoplastic Agents, Phytogenic/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/mortality/secondary
MH  - Castor Oil/adverse effects/*analogs & derivatives/therapeutic use
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Infusions, Intravenous
MH  - Middle Aged
MH  - Nanostructures
MH  - Paclitaxel/adverse effects/*therapeutic use
MH  - Survival Rate
MH  - Treatment Outcome
EDAT- 2005/09/21 09:00
MHDA- 2005/12/13 09:00
CRDT- 2005/09/21 09:00
PHST- 2005/09/21 09:00 [pubmed]
PHST- 2005/12/13 09:00 [medline]
PHST- 2005/09/21 09:00 [entrez]
AID - JCO.2005.04.937 [pii]
AID - 10.1200/JCO.2005.04.937 [doi]
PST - ppublish
SO  - J Clin Oncol. 2005 Nov 1;23(31):7794-803. doi: 10.1200/JCO.2005.04.937. Epub 2005 
      Sep 19.