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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

T) and then Herceptin(R) monotherapy (6 mg/kg every

three weeks) to complete one year of Herceptin(R) treatment

- TCH (n=1.075), the non-anthracycline experimental regimen consisting of

Taxotere(R) (T, 75 mg/m2) plus carboplatin (C; AUC 6 mg/mL/min) every

three weeks for six cycles plus Herceptin(R) (H, 4 mg/kg loading dose

followed by 2 mg/kg per week concurrently with TC) and then Herceptin(R)

monotherapy (6 mg/kg every three weeks) to complete one year of

Herceptin(R) treatment.

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

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

Efficacy results

DFS was significantly improved by one third (33 percent) in the TCH treatment 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 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).

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SOURCE Cancer International Research Group
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