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| |  ASCO: Adding Carboplatin to Paclitaxel and Trastuzumab Improves Response Rates in HER-2 Positive Breast Cancer By Charlene Laino NEW ORLEANS, LA -- June 9, 2004 -- The addition of carboplatin to paclitaxel and trastuzumab significantly improved response rate and time to progression in patients with metastatic breast cancer that overexpressed human epidermal growth factor receptor-2 (HER-2), according to a randomized multicenter phase 3 trial. The study results also show a trend toward improved overall survival in patients who received the triple therapy, compared with those who received trastuzumab and paclitaxel alone, reported Nicholas Robert, MD, chairman of research, Inova Fairfax Hospital's Cancer Center, and chairman, breast committee, US Oncology Research Network, Fairfax, Virginia. Dr. Robert presented the study results here on June 7th at the American Society of Clinical Oncology 40th Annual Meeting. For the study, 188 women who were determined by immunohistochemistry to have tumors that overexpressed HER-2 at the 2+ or 3+ level were randomized to either trastuzumab/paclitaxel/carboplatin or trastuzumab/paclitaxel alone. In both arms, chemotherapy was delivered every 3 weeks for at least 6 cycles and trastuzumab was given weekly, until disease progression. The overall response rate was 52% in patients receiving the carboplatin regimen, compared with 36% for patients receiving trastuzumab and paclitaxel (P =.04), Dr. Robert said. Additionally, the median time to disease progression was 10.7 months in the trastuzumab/paclitaxel/carboplatin arm, compared with 7 months for patients receiving trastuzumab and paclitaxel alone (P =.02), he said. The study also showed an overall survival of 36 months in patients who received triple therapy, compared with 32 months in those patients who receiving trastuzumab/paclitaxel (P = 0.27). At 48 months, 40% of patients who received the carboplatin regimen were alive, compared with 31% of patients who received trastuzumab and paclitaxel. Patients whose tumors overexpressed HER-2 at the 3+ level particularly benefited from the addition of carboplatin to the treatment regimen, Dr. Robert said. Their time to progression in the triple combination drug group was 14.0 months, compared with 7 months in the dual drug combination arm (P =.006), and overall survival was 42 months and 29 months (P = 0.11), respectively. Adverse events were consistent with those observed in previous studies of these agents, Dr. Robert said. Grade 3 and 4 neutropenia and thrombocytopenia were more common with the carboplatin regimen, but otherwise there was no difference in the rates of neutropenic fever, neuropathy, fatigue, or other toxicities between the 2 groups. Two patients in the trastuzumab and paclitaxel arm developed congestive heart failure. The study was funded by Bristol-Myers Squibb and Genentech, Inc.
[Presentation title: Randomized Phase III Study of Trastuzumab, Paclitaxel, and Carboplatin Versus Trastuzumab and Paclitaxel in Women With HER-2 Overexpressing Metastatic Breast Cancer: An Update Including Survival. Abstract 573]
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