Substituting docetaxel for epirubicin in the final three cycles of chemotherapy resulted in improvement in disease-free and overall survival in a trial among postmenopausal women with node-positive early breast cancer. Following complete excision, women enrolled in the Docetaxel Epirubicin Adjuvant (DEVA) trial were randomly assigned to receive epirubicin for six cycles (n = 397) or for three cycles, followed by three cycles of docetaxel (n = 406). At a median follow-up of 64.7 months, the 5-year disease-free survival rates were 72.7% for women taking epirubicin alone and 79.5% for women taking epirubicin followed by docetaxel. The investigators found a statistically significant improvement in overall survival in favor of epirubicin/docetaxel. The 5-year survival rates were 81.8% for the epirubicin arm and 88.9% for epirubicin/docetaxel—an absolute difference in overall survival at 5 years of 7.1%, they noted.
“The improvement in overall survival, however, comes at a cost in terms of adverse effects, because patients who switch to docetaxel suffer significantly in terms of febrile neutropenia, skin disorders, and stomatitis, and they have a higher incidence of other chemotherapy-related toxicities,” the authors stated. There was, however, no impact on quality of life during the follow-up period.
“One potential benefit of reducing the anthracycline dose would be to reduce the incidence of cardiac events,” the authors added. “Indeed, cardiac failure (n = 4) was restricted to those receiving epirubicin alone.”
Other Trials Considered
“These results suggest, within a relatively small trial, that substitution of docetaxel for epirubicin for the last three cycles of chemotherapy results in improved outcome in postmenopausal women with node-positive, early breast cancer compared with six cycles of epirubicin monotherapy,” the authors concluded.
Since the initiation of the DEVA trial, other groups have reported results of adjuvant studies of taxanes. Meta-analyses of these trials “have shown modest benefits in terms of disease-free survival for taxane-treated patients,” the authors noted. “Our results represent a slightly larger benefit than that seen overall,” they added “and it is noteworthy that DEVA is the only trial with a single-agent control regimen.”