Patients With Advanced Breast Cancer Failed By Previous Treatment With Taxol and Taxotere Respond to Weekly Administration With
June 14 2004 - 12:42PM
PR Newswire (US)
Patients With Advanced Breast Cancer Failed By Previous Treatment
With Taxol and Taxotere Respond to Weekly Administration With the
Investigational Agent Abraxane(TM) HOUSTON, June 14
/PRNewswire-FirstCall/ -- US Oncology (NASDAQ:USON) announced that
data presented this week by a network physician at the American
Society of Clinical Oncology annual meeting demonstrate that the
investigational drug Abraxane(TM) (albumin nanoparticle
paclitaxel), administered weekly without steroid premedication, is
active and well tolerated in women with metastatic breast cancer
whose disease had progressed while they were treated with
paclitaxel (Taxol(R)) and/or docetaxel (Taxotere(R)). Based on
analysis to date, results showed a 15 percent (95% CI: 8-22%)
overall response rate in 106 patients who received Abraxane 100
mg/m2 administered weekly over 30 minutes a day without
premedication for three weeks followed by one week of rest, with a
38 percent probability of surviving 12 months. Additionally, 40
percent of patients were free of disease progression for as long as
four months, and almost 30 percent for as long as six months.
Ninety-one percent of patients were able to receive the full dose
throughout the study without dose reduction. Joanne Blum, M.D.,
PhD., a US Oncology Principal Investigator at Texas Oncology PA
(TOPA), who practices at Charles A. Sammons Cancer Center, Baylor
University Medical Center in Dallas, Texas, presented the update.
Charles A. Sammons Cancer Center was one of 38 US Oncology
affiliated practices that had patients participate in the Abraxane
clinical trial. All patients in the trial, sponsored by American
Bioscience, Inc., had progressive metastatic breast cancer while
being treated with Taxol or Taxotere in the metastatic setting, or
had a relapse within 12 months of adjuvant taxane therapy. The
patient population studied had a poor prognosis with 91 percent
having visceral (lung and liver) disease, 65 percent with more than
three metastatic sites and 88 percent demonstrating ongoing tumor
growth while on Taxol or Taxotere. "The activity of Abraxane and
the tolerance of the weekly regimen are impressive in this
population of taxane-refractory patients," said Dr. Joanne Blum,
Principal Investigator of the study. "Abraxane differentiates
itself from other taxanes because it enables us to administer more
cancer-fighting paclitaxel to the patient without an increase in
side effects one might expect to see with currently available
taxane therapies." "It appears that Abraxane allows for more
cancer-fighting drug to be given to a patient, more of that drug to
actually reach the tumor site in the body, and more of the drug to
get inside of the tumor to fight cancer cells." The tolerability of
the weekly regimen was demonstrated by the finding of
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