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First Taxane-Based Non-Anthracycline Containing Chemotherapy in Combination With Herceptin (TCH) for HER2 Positive Early Breast Cancer Patients Obtains Approval From the FDA
Date:5/29/2008

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

EDMONTON, Canada, May 29 /PRNewswire/ -- 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<0.0001), compared to the AC-T control arm.

The DFS benefit of TCH and AC-TH was present regardless of a patient's age, the tumor responsiveness to hormones (hormone receptor status), or whether or not the cancer had spread to lymph nodes (nodal status). There was no statistically significant difference in DFS between the two experimental arms (TCH and AC-TH).

OS was also significantly improved with the TCH regimen with 34% reduction in the risk of death (HR=0.66, 95% CI [0.47-0.93], p=0.0182) compared to the AC-T control arm. Similarly, AC-TH was associated with a 42% reduction in the risk of death
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SOURCE Cancer International Research Group
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