12.06.2008 at 08:01
- Category:
Cancer and Oncology
The Cancer International Research Group (CIRG), a division of TRIO (Translational Research in Oncology) announced 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 (HR=0.58, 95% CI [0.40-0.83], p=0.0024) compared to the AC-T control arm. There was no statistically significant difference in OS between the two experimental arms (TCH and AC-TH).
Moreover, with the TCH regimen, the risk of congestive heart failure was five-fold lower compared to that observed with AC-TH (0.4% vs 1.9% vs 0.3% in women treated with TCH, AC-TH, and AC-T respectively).
"The BCIRG 006 trial results give us a new option for the treatment of HER2 positive breast cancer. This approach exploits the most recent molecular information regarding the HER2 alteration allowing us to retain the remarkable benefits of Herceptin while leaving behind almost all of the major side effects," said Professor Dennis Slamon, Professor and Chief Hematology-Oncology UCLA Los Angeles and CIRG Chair. "The BCIRG design, while initially received controversially, was based on clean preclinical evidence that led us to test a novel combination of drugs in breast cancer."
Copyright 2008, Medical Letter on the CDC & FDA via NewsRx.com
