Randomized Phase III Trial Comparing Epirubicin/ Doxorubicin Plus Docetaxel and Epirubicin/ Doxorubicin Plus Paclitaxel as First Line Treatment in Women with Advanced Breast Cancer

Abstract

This study aimed to examine the efficacy of docetaxel plus epirubicin against docetaxel plus capecitabine as first-line therapy for women with advanced breast cancer (ABC). Patients with ABC who had not been treated in the past were split into two groups: those who received docetaxel and epirubicin (DE) on day 1 and those who received docetaxel and capecitabine (DC) on day 1 and twice daily on days 1-14 of each 21-day cycle. Prior neoadjuvant treatment with anthracyclines was permitted if it had been finished more than a year prior to enrolment. The study's major aim was to evaluate the difference in time to disease progression (TTP). Median TTP for DE was 10.6 months and for DC it was 11.0 months (P = 0.7), with each arm treating 170 women. Using the RECIST criterion, we found that the rates of complete responses were higher in DC (61%) than in DE (11%), and that the rates of partial responses were lower in DC (40%) than in DE (45%) (P = 0.8). Grade 3-4 neutropenia was more common with DE than DC (57% vs. 46%, P = 0.07), as were febrile neutropenia (11% vs. 8%, P = 0.4), hand-foot syndrome (0% vs. 4%, P = 0.02), grade 2-3 anemia (20% vs. 7%, P = 0.001), and asthenia (12% vs. 6%, P = 0.09).