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Brand name(s): Abraxane™

• Approved for breast cancer

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On January 7, 2005, the U.S. Food and Drug Administration approved paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane™, a trademark of American BioScience, Inc.) for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Nanoparticle paclitaxel is also called paclitaxel albumin-stabilized nanoparticle formulation. Prior therapy should have included an anthracycline unless clinically contraindicated.

The clinical database included two single arm studies enrolling a total of 106 patients and one multicenter randomized trial. The multicenter trial was conducted in 460 patients with metastatic breast cancer who were randomized to receive either nanoparticle paclitaxel 260 mg/m2 administered as a 30-minute infusion or paclitaxel 175 mg/m2 given over three hours.

Fifty-nine percent of patients had received one or more prior chemotherapy regimens, and 77 percent had received an anthracycline-containing regimen. The objective response rate verified by central review was 21.5 percent (95 percent CI: 16.2 percent to 26.7 percent) for nanoparticle paclitaxel compared to 11.1 percent (95 percent CI: 6.9 percent to 15.1 percent) for paclitaxel (p=0.003).

Clinically important adverse events (all grade) in the randomized trial comparing nanoparticle paclitaxel to paclitaxel included neutropenia (80 percent with nanoparticle paclitaxel and 82 percent with paclitaxel), anemia (33 percent vs. 25 percent), infections (24 percent vs. 20 percent), hypersensitivity reactions (4 percent vs. 12 percent), sensory neuropathy (71 percent vs. 56 percent), edema (10 percent vs. 8 percent), nausea (30 percent vs. 21 percent), vomiting (18 percent vs. 9 percent), diarrhea (26 percent vs. 15 percent), and mucositis (7 percent in both arms).

Severe adverse events (grade 3 or 4) included neutropenia (9 percent with nanoparticle paclitaxel and 22 percent with paclitaxel), myalgia/arthralgia (8 percent vs. 4 percent) and vomiting (4 percent vs. 1 percent). Ten percent (24 patients) treated with nanoparticle paclitaxel developed grade 3 peripheral neuropathy; 14 of these patients showed some improvement of neuropathy at a median of 22 days. Two percent of patients receiving paclitaxel developed grade 3 peripheral neuropathy.

The recommended dose of nanoparticle paclitaxel is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks. No premedication to prevent hypersensitivity reactions is required prior to nanoparticle paclitaxel administration.

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