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| |  SABCS: Addition of Paraplatin (Carboplatin) Enhances Effectiveness of Treatment for Advanced Breast Cancer By Coriene E. Hannapel SAN ANTONIO, TX -- December 12, 2002 -- Addition of carboplatin (Paraplatin®) to trastuzumab (Herceptin®) plus paclitaxel (Taxol®) can significantly enhance treatment response and time to disease progression, with acceptable toxicity, for women with advanced breast cancer that is positive for the human epidermal receptor HER-2/neu, according to phase III results. Nicholas J. Robert, MD, principal investigator and cochair of the U. S. Oncology Clinical Research Breast Committee, presented the results here December 11th at the 25th Annual San Antonio Breast Cancer Symposium. Treatment of patients with HER-2/neu-positive advanced breast cancer using the combination of trastuzumab and paclitaxel has been shown in previous studies to be superior to paclitaxel alone, Dr. Robert said. "Data also show a synergistic relationship between trastuzumab and platinum analogues." This study was conducted to compare the efficacy and safety of trastuzumab/paclitaxel/carboplatin against trastuzumab/paclitaxel without carboplatin in patients with HER-2/neu-positive stage IV breast cancer. Of the 196 patients registered for this study, 191 were evaluable. The trial was conducted at more than 40 sites from October 1998 through May 2002. The majority of patients were Caucasian (83 percent), and the average age was 55 years (range, 32-82). No prior chemotherapy for metastatic disease was permitted, but 40 percent of patients had received adjuvant chemotherapy. ECOG performance status was 0 in 60 percent of the cohort, 1 in 36 percent and 2 in four percent. Patients were monitored for cardiovascular status. All patients received the same regimen of trastuzumab and paclitaxel for two three-week cycles -- trastuzumab at 4 mg/kg, followed by 2 mg/kg weekly, and paclitaxel at 175 mg/m2 over 3 h every three weeks. Patients were also randomised to either carboplatin at an area under the curve of 6 (TPC) every three weeks or no carboplatin (TP). The response rate for the TPC group was 52 percent compared with 36 percent for the TP group (p=0.04). Time to progression was 11.2 months and 6.9 months, respectively (p=0.007). Addition of carboplatin resulted in a moderate yet acceptable increase in side effects, Dr. Robert said. Neutropaenia was 85.6 percent in the TPC group vs. 24.2 percent in the TP group, and thrombocytopaenia was 9.3 percent vs. 1.1 percent, respectively. Nausea was reported in 6.2 percent of the TPC group and in 1.1 percent of the TP group. No toxicity-related deaths occurred. Survival data should be available in 6 to 12 months, Dr. Robert said. To date, 62 percent of patients in the group who received carboplatin are still alive after 36 months, compared with 47 percent in the group that did not receive carboplatin. This study was supported by Bristol-Myers Squibb, Plainsboro, New Jersey, United States, and Genentech, Inc., San Francisco, California, United States.
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