Researchers affiliated with the Breast Cancer International Research Group 001 Investigators have reported that Taxotere(docetaxel)/doxorubicin/cyclophosphamide (TAC) was superior to 5FU/doxorubicin/cyclophosphamide (FAC) for adjuvant therapy of node positive breast cancer. The details of this report and an accompanying editorial appeared in the June 2, 2005 issue of the New England Journal of Medicine.[1][2]
The taxanes have been an important development in the treatment of women with breast cancer. Since 1998, one standard adjuvant treatment of localized breast cancer has been doxorubicin and cyclophosphamide followed by paclitaxel. It has been demonstrated in randomized trials that the addition of paclitaxel adds significantly to overall and disease-free survival. The current clinical trial was begun in 1997 before the results of adding paclitaxel were clearly known. In this trial, 1471 women with axillary node-positive breast cancer were randomly allocated to receive post-surgical TAC or FAC. Table 1 shows the main findings of this study.
Table 1: TAC vs. FAC adjuvant therapy for node positive breast cancer
| TAC | FAC |
Number | 745 | 746 |
Relapse | 23.1% | 30.4% |
Loco-regional | 3.9% | 5/2% |
Distant Metastases | 15.4% | 21.2% |
Second Primaries | 2.7% | 3.5% |
Deaths | 91 | 130 |
OS at 5 years | 87% | 81% |
Non-Cancer Deaths | 1.1% | 0.5% |
Grade 3-4 Neutropenia | 65.5% | 49.3% |
Febrile Neutropenia | 24.7% | 2.5% |
Grade 3-4 Infections | 3.9% | 2.2% |
Deaths during Treatment | 2 | 2 |
They report that quality of life scores diminished during therapy but recovered to baseline after completion of therapy.
Comments: This study shows that the TAC regimen is superior to the FAC regimen but more toxic. However, the positive effects of the TAC regimen outweigh the toxicities, which were transient. It is not clear whether or not TAC is superior to AC followed by paclitaxel.
References:
[1] Martin M, Pienkowski T, Mackey J, et al. Adjuvant docetaxel for node-positive breast cancer. New England Journal of Medicine. 2005;352:2302-2313.
[2] Perez EA. TAC-A new standard in adjuvant therapy of Breast Cancer. New England Journal of Medicine . 2005;352:2346-2348.
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