Mayo Clinic Researchers Say Triple Drug Combination is Promising Option to Treat Metastatic HER2+ Bre...(pport a larger randomized Phase III stud...),Health

Date:5/18/2009

pport a larger, randomized Phase III study," he says. "This is a Phase II study of this triple combination, so we would need to study this treatment against the standard best two-drug treatment in a randomized Phase III study to know if this triplet is more effective."

"This regimen seems to be a very reasonable choice, and it offers the added advantage that women who use it do not lose their hair," he says. The drug combination used most commonly for patients with HER2+ breast cancer that has spread -- paclitaxel or docetaxel with trastuzumab -- always causes hair loss, Dr. Tan says.

All of the agents are approved for use by the U.S. Food and Drug Administration for cancer, although vinorelbine has not been approved for this particular treatment regimen in the U.S., the researchers say.

Capecitabine chemotherapy is not usually paired with trastuzumab because some studies had suggested it does not offer a synergistic, or additive, benefit. However, Dr. Tan says that newer research has shown the combination is in fact promising.

Among the patients studied, 28 (58 percent) had a partial response, a reduction in the size of the metastatic tumor of more than 30 percent by computed tomography. Four patients had a complete response with no more evidence of metastasized tumors on diagnostic scans, the researchers say.

Average survival was improved when compared historically to traditional treatment, Dr. Tan says. "Normally, survival for metastatic breast cancer is two years," he says. "In this study, average survival was 27 months." He cautioned that these results should be validated in a Phase III study.

"The toxicity was tolerable, no more than is seen with a two-drug regimen," he says. The majority of patients (61 percent) experienced a low white blood count, but only about ten percent of patients had fatigue or other common side effects.

Tan stressed that this
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