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Adding Trastuzumab to Docetaxel/Cisplatin Reduces Lymph Node Involvement in Advanced Breast Cancer: Presented at ASCO

By Ed Susman

ORLANDO, FL -- May 23, 2002 -- Adding the HER2 antagonist trastuzumab to a neoadjuvant treatment regimen with docetaxel and cisplatin results in node-free presurgery status for more than half of women with advanced or inflammatory breast cancer.

"This regimen proved to be highly active, yielding an unusually high rate of tumor disappearance, which hopefully will translate to an improvement in survival," said Dr. Judith Hurley, MD, assistant professor of medicine, University of Miami, and consultant, Taylor Breast Health Center, Jackson Memorial Hospital, Miami, Florida. The largest of the tumors was eight centimeters in diameter.

She presented the results here on May 21 at the 38^th Annual Meeting of the American Society of Clinical Oncology (ASCO),

Dr. Hurley and colleagues enrolled 34 women with locally advanced breast cancer who over-expressed HER2. They were treated with 4 mg/kg of trastuzumab intravenously on the first day of the regimen, and then were given the drug in a dose of 2 mg/kg intravenously weekly for 11 more cycles. The women received 70 mg/mē of docetaxel and 70 mg/mē of cisplatin on the first day of treatment, at 21-day intervals for a total of four cycles. Granulocyte colony stimulating factor (G-CSF) was administered on the second day of treatment and then on days 24, 44, and 65; epoetin alfa was administered once a week for 12 weeks. The women also were treated with radiation and tamoxifen.

Of the 34 women included in the study, 28 went to surgery. Pathology reports found no involvement of lymph nodes in 15 of the 28 women. In nine patients, lymph node involvement was limited to one to three nodes; there was involvement of more than three nodes in three women.

The researchers closely monitored left ventricular ejection fraction changes in the patients, noting decreases in 45 percent of the participants in the study. However, only two of these patients had a grade III decline

Adverse events associated with the treatment regimen included hair loss among 94 percent of the patients, nausea and vomiting in 79 percent, asthenia or weakness in 76 percent, hyperglycemia in 60 percent, and anemia in 61 percent.

The most serious adverse events were grade III hyperglycemia in 33 percent of patients, nausea and vomiting in 6 percent, and catheter site infections in 13 percent.

The study was supported by Aventis Pharmaceuticals Inc.

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