First Taxane-Based Non-Anthracycline Containing Chemotherapy in Combination With Herceptin (TCH) for HER2 Positive Early Breast Cancer Patients Obtains Approval From the FDA

ข่าวต่างประเทศ Monday June 2, 2008 11:30 —Asianet Press Release

EDMONTON--2 Jun--PRNewswire-AsiaNet/InfoQuest TCH (Taxotere, Carboplatin, Herceptin) showed a significant improvement in Disease-Free Survival (DFS) and Overall Survival (OS), compared to AC-T (doxorubicin and cyclophosphamide followed by docetaxel) and a 5-fold lower cardiotoxicity compared to AC-TH (AC-T + Herceptin) in women receiving adjuvant therapy for HER2-positive ESBC The Cancer International Research Group (CIRG), a division of TRIO (Translational Research in Oncology) announced today that, based on its study BCIRG 006, the U.S. Food and Drug Administration (FDA) has approved a new treatment consisting of the chemotherapeutic agents Taxotere(R) (docetaxel) and carboplatin combined with Herceptin(R) (trastuzumab) (TCH) for the adjuvant (post-surgery) treatment of HER2 (Human Epidermal growth factor Receptor 2)-positive early breast cancer. The AC-TH regimen (doxorubicin and cyclophosphamide followed by Taxotere and Herceptin), also investigated in the BCIRG 006 study, received approval at the same time. Results from the BCIRG 006 clinical trial showed that the TCH regimen reduced the risk of disease recurrence by one third (HR=0.67, 95% CI [0.54-0.83], p=0.0003), compared to the AC-T control arm. The experimental AC-TH treatment reduced the risk of disease recurrence by 39 percent (HR=0.61, 95% CI [0.49-0.77], p

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