Epirubicin followed by capecitabine is effective adjuvant therapy for women with early breast cancer, according to results from the UK TACT2 trial.
"There is no single standard adjuvant chemotherapy,” Dr. David Cameron from the University of Edinburgh, U.K., told Reuters Health by email. “Our data suggest that epirubicin followed by capecitabine is an acceptable, effective, and well tolerated regimen for those patients deemed not to need a taxane.”
Adjuvant chemotherapy has improved outcomes of early breast cancer, but it causes toxicity.
Dr. Cameron and colleagues investigated whether efficacy could be improved without increasing toxicity with an accelerated epirubicin schedule and whether capecitabine instead of cyclophosphamide, methotrexate and fluorouracil (CMF) would improve tolerability without loss of efficacy in their phase 3 trial of nearly 4,400 women with early breast cancer.
Time to tumor recurrence (TTR), the primary endpoint, did not differ significantly between the accelerated and standard epirubicin schedules, the team reports in The Lancet Oncology, online June 6.
TTR did not differ significantly between the CMF and capecitabine groups, either.
The proportions of patients free from TTR events at five years were 85.9% for the standard epirubicin group versus 87.1% for the accelerated-epirubicin group and 86.5% for the CMF group versus 86.7% for the capecitabine group.
Moreover, there were no significant differences between the groups in overall survival, invasive-disease-free survival or time to distant tumor recurrence.
Overall survival at five years was 90.7% with standard epirubicin, 89.7% with accelerated epirubicin, 90.2% with CMF and 90.1% with capecitabine.
Among the 1,399 premenopausal women, disruption or discontinuation of periods during chemotherapy was significantly higher with accelerated epirubicin (83%) than with standard epirubicin (76%) and with CMF (86%) than with capecitabine (73%).
“Epirubicin followed by capecitabine resulted in less permanent induction of the menopause for premenopausal women, so can be considered an option in those women not wanting to become permanently menopausal, which is of course a risk with chemotherapy,” Dr. Cameron said.
At the end of treatment, quality of life was significantly worse and clinically meaningful deteriorations in quality of life were greater with accelerated epirubicin versus standard epirubicin and with CMF versus capecitabine.
It was “disappointing that the acceleration of epirubicin didn’t improve outcomes, and perhaps most surprising was that the toxicity and quality of life and hospital admission data showed it to be not better tolerated than conventional three-weekly epirubicin,” Dr. Cameron said.
Amgen, Pfizer and Roche provided funding for this study and had various relationships with several authors.