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In January 2005, the U.S. Food and Drug Administration (FDA) approved the use of the
drug, Abraxane to help treat women with advanced, metastatic
breast cancer —the type of cancer that has spread past the breast and lymph nodes to other areas of the body. The drug can be used
in women who have been unsuccessfully treatment with combination chemotherapy or who have
relapsed within 6 months of chemotherapy. Abraxane is a new form of the drug, Taxol (generic name, paclitaxel) that may have fewer side
effects.
In a clinical trial comparing Abraxane and Taxol, 460 eligible women with advanced
breast were given either drug. Those who received Abraxane saw their tumors shrink by
21.5% compared with 11.1% among the women who received Taxol.
"Abraxane provides a much-needed new treatment option for women with metastatic
breast cancer," said lead clinical trial investigator William J. Gradishar, MD,
Associate Professor of Medicine at the Lynn Sage Breast Cancer Program, Northwestern
Memorial Hospital, in an American Pharmaceutical Partners news release. "The pivotal
clinical trial results demonstrated that Abraxane had superior response rate when compared
to Taxol in patients with metastatic breast cancer."
Taxol has been approved by the FDA for several years to treat breast cancer. However,
it must be dissolved in a toxic solvent before administration, which causes allergic
reactions in some patients. To counteract these reactions, steroids and antihistamines are
given to patients before treatment.
According to American Pharmaceutical Partners, Inc., the marketer of Abraxane, its drug
contains no toxic substances and does not require any premedication, as with Taxol.
Abraxane belongs to a new class of drugs of "protein-bound particle" drugs.
Patients who receive Abraxane can receive larger doses of the drug before it becomes
intolerable.
In the clinical trial, slightly fewer women who took Abraxane experienced
neutropenia—a condition marked by a sharp decrease in white blood cells—compared
to those who took Taxol (82% to 80% respectively). Neutropenia can increase the risk of
infection. However, patients on both drugs are warned that neutropenia is a possible side
effect.
Other side effects noted in the clinical trial for both Abraxane and Taxol included
anemia, infections, swelling, nausea, vomiting and diarrhea. Patients on Abraxane
experienced more cases of nerve damage, severe pain in the muscles or joints, and vomiting
than patients on Taxol.
"It's important that the entire breast cancer community constantly challenge the
status quo and push each other to provide a better treatment for those with the
disease," said Marisa Weiss, MD, oncologist, an American Pharmaceutical Partners news
release. "This advance represents an exciting new treatment option for women with
metastatic breast cancer."
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