FDA Approves TCH Combination for HER2-Positive Early Breast Cancer

FDA Approves TCH Combination for HER2-Positive Early Breast Cancer

The Cancer International Research Group (CIRG), a division of TRIO (Translational Research in Oncology) announced that, based on its study BCIRG 006, the US Food and Drug Administration (FDA) has approved a new regimen known as TCH (docetaxel [Taxotere] and carboplatin combined with trastuzumab [Herceptin]) for the adjuvant treatment of HER2-positive early breast cancer. The AC-TH regimen (doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab), also investigated in the BCIRG 006 study, received approval at the same time. This is the first taxane-based non–anthracycline-containing chemotherapy combined with trastuzumab to receive FDA approval.

Results from the BCIRG 006 clinical trial showed that the TCH regimen reduced the risk of disease recurrence by one-third (hazard ratio [HR] = 0.67; 95% confidence interval [CI] = 0.54–0.83; P = .0003), compared to the AC-T control arm. The experimental AC-TH treatment reduced the risk of disease recurrence by 39% (HR = 0.61; 95% CI = 0.49–0.77; P < .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).

Overall survival was also significantly improved with the TCH regimen, with a 34% reduction in the risk of death (HR = 0.66; 95% CI = 0.47–0.93; P = .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 = .0024) compared to the AC-T control arm. There was no statistically significant difference in overall survival between the TCH and AC-TH arms.

Other Key Results

Moreover, with the TCH regimen, the risk of congestive heart failure was fivefold 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 of hematology-oncology at UCLA 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.”