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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

Friday, May 30, 2008 General News J E 4
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EDMONTON, Canada, May 29 The Cancer International ResearchGroup (CIRG), a division of TRIO (Translational Research in Oncology)announced today that, based on its study BCIRG 006, the U.S. Food and DrugAdministration (FDA) has approved a new treatment consisting of thechemotherapeutic agents Taxotere(R) (docetaxel) and carboplatin combined withHerceptin(R) (trastuzumab) (TCH) for the adjuvant (post-surgery) treatment ofHER2 (Human Epidermal growth factor Receptor 2)-positive early breast cancer.The AC-TH regimen (doxorubicin and cyclophosphamide followed by Taxotere andHerceptin), also investigated in the BCIRG 006 study, received approval at thesame time.

Results from the BCIRG 006 clinical trial showed that the TCH regimenreduced 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 experimentalAC-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'sage, the tumor responsiveness to hormones (hormone receptor status), orwhether or not the cancer had spread to lymph nodes (nodal status). There wasno statistically significant difference in DFS between the two experimentalarms (TCH and AC-TH).

OS was also significantly improved with the TCH regimen with 34% reductionin the risk of death (HR=0.66, 95% CI [0.47-0.93], p=0.0182) compared to theAC-T control arm. Similarly, AC-TH was associated with a 42% reduction in therisk of death (HR=0.58, 95% CI [0.40-0.83], p=0.0024) compared to the AC-Tcontrol arm. There was no statistically significant difference in OS betweenthe two experimental arms (TCH and AC-TH).

Moreover, with the TCH regimen, the risk of congestive heart failure wasfive-fold lower compared to that observed with AC-TH (0.4% vs 1.9% vs 0.3% inwomen treated with TCH, AC-TH, and AC-T respectively).

"The BCIRG 006 trial results give us a new option for the treatment ofHER2 positive breast cancer. This approach exploits the most recent molecularinformation regarding the HER2 alteration allowing us to retain the remarkablebenefits of Herceptin while leaving behind almost all of the major sideeffects," said Professor Dennis Slamon, Professor and ChiefHematology-Oncology UCLA Los Angeles and CIRG Chair. "The BCIRG design, whileinitially received controversially, was based on clean preclinical evidencethat led us to test a novel combination of drugs in breast cancer."

About BCIRG 006

The BCIRG 006 was a phase III multicenter study conducted by the CIRG andsponsored by sanofi-aventis (Paris, France) with additional support fromGenentech (South San Francisco, USA).

Study design

3,222 women with HER2-positive node-positive and high-risk node-negativeoperable breast cancer were enrolled and randomly assigned to one of thefollowing treatments:

The primary endpoint of the study was to compare disease-free survival(DFS) of each of the experimental regimens (TCH or AC-TH) with standardanthracycline-based chemotherapy (AC-T).

Secondary endpoints included evaluation of overall survival (OS) andcardiac toxicity. The first analysis (considered as the primary) waspresented at the SABCS in 2006 and the updated results were communicated atSABCS in 2007.

Efficacy results

DFS was significantly improved by one third (33 percent) in the TCHtreatment arm (HR=0.67, 95% CI [0.54-0.83], p=0.0003) and 39 percent (HR=0.61,95% CI [0.49-0.77], p<0.0001) in the AC-TH arm, compared to the AC-T controlarm. The DFS benefit of TCH and AC-TH was present regardless of a patient'sage, the tumor responsiveness to hormones (hormone receptor status), orwhether or not the cancer had spread to lymph nodes (nodal status). There wasno statistically significant differe
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