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| |  ASCO: Taxotere, Carboplatin And Herceptin Combination Effective, Safe In Metastatic Breast Cancer By Ed Susman Special to DG News
SAN FRANCISCO, CA -- May 14, 2001 -- Researchers said that a Herceptin-containing, non-anthracyline-based chemotherapy regimen for metastatic breast cancer is effective and appears to avoid cardiac toxicities seen when Herceptin and anthracyclines are combined. "The activity of Taxotere, carboplatin and Herceptin in this Phase II study warrants testing in the adjuvant setting," said Mark Pegram, MD, adjunct assistant professor of medicine at the University of California at Los Angeles (UCLA). Dr. Pegram and lead author Dennis Slamon, MD, professor of medicine at UCLA, said that they sought to use docetaxel and carboplatin with Herceptin because the first two drugs are among the most synergistic chemotherapeutics when combined with Herceptin. "This combination will also avoid Herceptin/anthracycline associated cardiotoxicity," Dr. Slamon reported. The pilot study enrolled 62 women with metastatic breast cancer at 21 centers. The women’s average age was 54 years and they had extensive metastases-20 percent of the women had cancer that had spread to three organs or more. Prior adjuvant therapy had been given to 61 percent of the patients and 45 percent of them had received anthracyclines; 9 percent received taxanes. Dr. Pegram, who presented the poster at the 37th annual meeting of the American Society of Clinical Oncology (ASCO), reported that seven patients achieved complete remission and another 45 patients achieved objective response, meaning their tumor burden decreased by 50 percent. That represented an 84 percent response rate. Eight percent of patients experienced disease stabilization but only 2 percent (two patients) had progressive disease. For enrollment, all patients in the study were required to have either locally advanced or metastatic breast cancer that was positive for the HER2 alteration. They were given docetaxel 75 mg/m2 and carboplatin on the first day of the treatment cycle, and then received the drugs every three weeks for six cycles of treatment. Herceptin was given on the first day of the first cycle at a dose of 4 mg/kg then continued weekly at 2 mg/kg for one year or until the breast cancer showed progression. In looking at the cardiac effects of treatment, the authors reported that eight of 61 evaluable patients had Grade 1 cardiac toxicity-an asymptomatic decline in ejection fraction of less than 20 percent. Nine of the 61 patients had Grade 2 cardiac toxicity-an asymptomatic decline in ejection fraction greater than 20 percent. One person had heart failure that responded to treatment-Grade 3 cardiac toxicity. William Gradishar, MD, professor of medicine at Northwestern University School of Medicine, Chicago, Illinois, said the goal of the trial appears to be to position the combination of drugs including Herceptin for use in large-scale clinical trials as adjuvant treatment for prevention of recurrence. "In this trial, the researchers wanted to make sure that side effects of the treatment-especially cardiac events-were no greater than one would expect with the drugs," said Dr. Gradishar, chairman of the communications committee of ASCO. "And this study confirmed that the treatment was effective and there were no surprises with toxicity."
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