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Solvent-Free Nanoparticle Paclitaxel Improves Response Rates: Presented at SABCS

By Charlene Laino

SAN ANTONIO, TX -- December 8, 2003 -- Patients with metastatic breast cancer who received the solvent-free nanoparticle paclitaxel Abraxane experienced a statistically significant higher tumor response rate and slower time to tumor progression than patients receiving Taxol, a Phase III study shows.

The investigational drug Abraxane, formerly known as ABI-007, is the first solvent-free nanoparticle taxane, said Joyce A. O'Shaughnessy, MD, Co-Director of Breast Cancer Research, and Director of Breast Cancer Prevention, Baylor-Charles A. Sammons Cancer Center, Dallas, Texas, United States. Dr. O'Shaughnessy presented the findings at a late breaking session here on December 5^th at the 26^th Annual San Antonio Breast Cancer Symposium.

Patients treated with Abraxane tolerated a higher dose of paclitaxel, experienced a significantly lower incidence of neutropenia, and did not experience the severe hypersensitivity reactions commonly seen with Taxol, Dr. O'Shaughnessy said.

The study randomized 454 patients, in a 1:1 fashion, to either 260 mg/m² Abraxane over 30 minutes once every 3 weeks without premedication or 175 mg/m² Taxol administered over 3 hours once every 3 weeks with steroid and antihistamine premedication.

The study showed that Abraxane was associated with a significantly higher overall response rate than Taxol: 33% versus 19% (P <.001). Time to progression was 21.9 weeks in the Abraxane arm, compared with 16.1 weeks in the Taxol arm (P = .029).

In the subset of nearly 200 patients receiving the drugs as first-line chemotherapy, 42% of those on Abraxane responded, compared with 27% of those on Taxol, the study showed. Higher response rates were also noted in the Abraxane arm for patients who had failed prior chemotherapy and in those with liver or lung metastases, the study showed.

There were no Grade 3 and 4 hypersensitivity reactions in the Abraxane arm, Dr. O'Shaughnessy said. Also, 9% of only patients in the Abraxane arm developed Grade 4 neutropenia, compared with 22% on Taxol (P < .001).

While patients in both arms experienced peripheral neuropathy consistent with high doses of paclitaxel, the condition was reversible, and resolved significantly more rapidly in patients taking Abraxane compared with patients receiving Taxol, Dr. O'Shaughnessy said.

The incidence of Grade 3 sensory neuropathy was 10% for Abraxane, compared with 2% for Taxol (P < .001), with no episodes of Grade 4 neuropathy in the Abraxane arm.

Grade 3 sensory neuropathy in patients receiving Abraxane resolved a median of 22 days after dose interruption and a subsequent dose reduction, usually to 220 mg/m².


[Study Title: ABI-007 (ABRAXANE), a Nanoparticle Albumin-Bound (NAB) Paclitaxel Demonstrates Superior Efficacy Vs Taxol in MBC: A Phase III Trial. Abstract 44]

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