Nanoparticle form of paclitaxel is active in patients who failed taxane therapy.

2004 JUL 1 - (NewsRx.com & NewsRx.net) -- Abraxis Oncology, a division of American Pharmaceutical Partners, Inc. (APP) (NASDAQ: APPX) said that results from a 106-patient Phase II study of Abraxane in patients with advanced breast cancer whose disease had progressed while they were being treated with Taxol and Taxotere responded to subsequent treatment with Abraxane (albumin nanoparticle paclitaxel).

The results were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, by Joanne Blum, MD, PhD, of the Charles A. Sammons Cancer Center, Baylor University Medical Center in Dallas, Texas, one of 38 U.S. Oncology-affiliated practices that had patients participate in this clinical study of Abraxane.

The Phase II study, sponsored by American BioScience, included 106 patients with progressive metastatic breast cancer whose disease had progressed while being treated with Taxol (Bristol-Myers Squibb Co.) or Taxotere (Aventis) in the metastatic setting, or had a relapse within 12 months of adjuvant taxane therapy. The patients enrolled in this study had a very poor prognosis: 91% had visceral (lung and liver) disease, 65% had more than three metastatic sites, and 88% demonstrated ongoing tumor growth while receiving Taxol and/or Taxotere in the metastatic setting.

Evidence of the activity of weekly doses of Abraxane in this highly refractory population is provided by these findings:

*A 15% overall response rate (95% CI: 8%-22%) in the 106 patients studied with a 38% probability of survival at 12 months based on analysis of data to date;

*40% of patients on treatment with Abraxane were free of disease progression for as long as 4 months; and almost 30% for as long as 6 months;

*Of those patients who progressed while on Taxotere alone in the metastatic setting (n=33), a 24% response rate was noted after receiving weekly Abraxane;