10-Year Follow-Up Analysis Of BCIRG-006 Study By TRIO

CONFIRMATION OF LONG TERM BENEFIT OF DOCETAXEL (TAXOTERE®)-BASED CHEMOTHERAPY COMBINED WITH TRASTUZUMAB (HERCEPTIN®) IN EARLY-STAGE HER2-POSITIVE (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 10-years follow-up analysis of the BCIRG-006 trial which showed sustained significant benefits (in terms of disease-free survival (DFS) and overall survival (OS)) of docetaxel (Taxotere®)-based chemotherapy combined with trastuzumab (Herceptin®) in women with early-stage 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 non-anthracycline based, trastuzumab-containing regimens; however, the non-anthracycline (TCH) regimen was associated with an important improvement in long-term cardiac safety (FDA/EMEA approvals 2008).

The BCIRG-006 trial evaluated three regimens after initial surgery: 4 cycles of doxorubicin and cyclophosphamide followed by 4 cycles of docetaxel (AC-T) versus 4 cycles of doxorubicin and cyclophosphamide followed by 4 cycles of docetaxel and one year of Herceptin (AC-TH) versus a non-anthracycline regimen of 6 cycles of docetaxel plus carboplatin and one year of trastuzumab (TCH).

The BCIRG-006 study enrolled 3222 patients between April 2001 and March 2004.

With long term follow-up (median 10.3 years), a persistent significant DFS benefit was seen in both trastuzumab-containing arms compared to AC-T: The reduction in the risk of disease recurrence was 28% for AC-TH and 23% for TCH at 10 years of follow-up. A significant OS benefit was also seen in both trastuzumab-containing arms compared to AC-T, with the reduction in the risk of death being 37% for AC-TH and 24% for TCH at 10 years of follow-up. This however came at the cost of a five-fold higher number of congestive heart failure cases in the AC-TH 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 AC-TH and 0.8% in AC-T. In addition, TCH significantly reduced the incidence of sub-clinical loss in cardiac function from 200 cases with AC-TH to 97 cases with TCH.

“These long-term data from the BCIRG-006 study confirm the significant impact of trastuzumab (Herceptin®) in follow-up analyses demonstrating significant improvements in disease-free as well as overall survival after 10 years. The study showed this sustained efficacy benefits for both trastuzumab-based regimens, TCH and AC-TH, after 10 years of follow-up. 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 Hematology-Oncology UCLA Los Angeles – TRIO Chair].

About BCIRG-006:

The BCIRG-006 study was a phase III, multinational, multicenter study conducted by TRIO (formerly known as BCIRG) and sponsored by Sanofi with additional support from Genentech.

About TRIO:

TRIO together with its global network of dedicated investigators is a not-for-profit 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