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Sequential docetaxel improved OS, DFS
Sequential docetaxel-doxorubicin chemotherapy significantly improved OS compared with a concurrent regimen among a cohort of patients with node-positive breast cancer, according to 8-year results of the Breast International Group 02-98 trial.
The phase 3 trial was designed to evaluate the addition of docetaxel (Taxotere, Sanofi-Aventis) to doxorubicin (Adriamycin, Pharmacia & Upjohn)-based chemotherapy in women with node-positive breast cancer.
Researchers enrolled 2,887 patients who were randomly assigned to one of four treatments. Patients assigned to the sequential control arm received doxorubicin followed by cyclophosphamide, methotrexate, 5-fluorouracil (CMF), and patients assigned to the concurrent control received doxorubicin-cyclophosphamide followed by CMF. Patients assigned to the study groups received either sequential docetaxel-doxorubicin followed by CMF, or concurrent docetaxel-doxorubicin followed by CMF.
The primary comparison evaluated the efficacy of docetaxel regardless of schedule.
At 5-year follow-up, researchers observed a trend for improved DFS with docetaxel, according to background information in the study.
The updated analysis included a median follow-up of 93.4 months. During that time, researchers found no significant improvement in DFS from docetaxel in primary comparisons (HR=0.91; P=.187).
In secondary comparisons, they determined patients assigned to sequential docetaxel experienced significantly improved DFS compared with patients assigned to the sequential control arm (HR=0.81; 95% CI, 0.67-0.99). Sequential docetaxel also significantly improved DFS compared (HR=0.84; 95% CI, 0.72-0.99) and OS (HR=0.79; 95% CI, 0.65-0.98) compared with concurrent doxorubicin-docetaxel.
HRs favored the addition of sequential docetaxel in all subtypes except luminal-A disease, but that observation was not statistically supported because of limited numbers, researchers wrote.
Disclosure: The researchers report no relevant financial disclosures.