December 11, 2015
Confirmation of Long Term Benefit of Docetaxel (Taxotere®) Based Chemotherapy Combined with Trastuzumab (Herceptin®) in Early Her2positive (HER2+) Breast Cancer. An Important Benefit in Cardiac Safety for the Non Anthracycline Regimen (TCH).
EDMONTON, Canada(BUSINESS WIRE) – Translational Research in Oncology (TRIO), announced today at SABCS the results of the 10years followup analysis of the BCIRG006 trial which showed sustained significant benefits (in terms of diseasefree survival (DFS) and overall survival (OS)) of docetaxel (Taxotere®)based chemotherapy combined with trastuzumab (Herceptin®) in women with earlystage human epidermal growth factor receptor 2 positive (HER2+) breast cancer. The analysis also showed that this efficacy benefit is very similar in the anthracycline and nonanthracycline based, trastuzumabcontaining regimens; however, the non anthracycline (TCH) regimen was associated with an important improvement in longterm cardiac safety (FDA/EMEA approvals 2008).
The BCIRG006 trial evaluated three regimens after initial surgery: 4 cycles of doxorubicin and cyclophosphamide followed by 4 cycles of docetaxel (ACT) versus 4 cycles of doxorubicin and cyclophosphamide followed by 4 cycles of docetaxel and one year of Herceptin (ACTH) versus a non anthracycline regimen of 6 cycles of docetaxel plus carboplatin and one year of trastuzumab (TCH).
The BCIRG006 study enrolled 3222 patients between April 2001 and March 2004.
With long term followup (median 10.3 years), a persistent significant DFS benefit was seen in both trastuzumabcontaining arms compared to ACT: The reduction in the risk of disease recurrence was 28% for ACTH and 23% for TCH at 10 years of followup. A significant OS benefit was also seen in both trastuzumab containing arms compared to ACT, with the reduction in the risk of death being 37% for ACTH and 24% for TCH at 10 years of followup. This however came at the cost of a fivefold higher number of congestive heart failure cases in the ACTH regimen compared to TCH (21 cases vs. 4), with clinically apparent congestive heart failure being observed at a rate of 0.4% in TCH, versus 2.0% in ACTH and 0.8% in ACT. In addition, TCH significantly reduced the incidence of subclinical loss in cardiac function from 200 cases with ACTH to 97 cases with TCH.
“These longterm data from the BCIRG006 study confirm the significant impact of trastuzumab (Herceptin®) in followup analyses demonstrating significant improvements in diseasefree as well as overall survival after 10 years. The study showed this sustained efficacy benefits for both trastuzumabbased regimens, TCH and AC TH, after 10 years of followup. Since its approval, the only major safety concern with trastuzumab has been its potential impact on cardiac function. The TCH regimen essentially eliminates this safety concern by significantly reducing the incidence of congestive heart failure and/or cardiac dysfunction that is seen when trastuzumab is used with anthracyclines. We are happy that we have a way to use the drug with even better safety,” said Professor Dennis Slamon [Professor and Chief HematologyOncology UCLA Los Angeles – TRIO Chair].
The BCIRG006 study was a phase III, multinational, multicenter study conducted by TRIO (formerly known as BCIRG) and sponsored by Sanofi with additional support from Genentech.
TRIO together with its global network of dedicated investigators is a notforprofit academic oncology research organization offering full CRO services to conduct its clinical trials. We are dedicated to advancing translational cancer research by bringing innovative and targeted therapeutics to clinical practice. Our mission is to further cancer research through our translational research model involving close linkage between active preclinical and clinical research. TRIO conducts novel clinical trials using designs based scientifically on new and/or novel preclinical studies from the Translational Oncology Research Laboratory (TORL) at UCLA and other academic institutions.
Additional information is available at http://www.trioncology.org
Translational Research in Oncology Emmanuelle Mekercke or Valerie BeeMunteanu Edmonton : (780) 702 0200
Paris : (33) 158 100 909 Contact@trioncology.org