Randomized phase III trial comparing docetaxel plus epirubicin versus docetaxel plus capecitabine as first-line treatment in women with advanced breast cancer

BackgroundThe purpose of this study was to compare docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as front-line treatment in women with advanced breast cancer (ABC).Patients and MethodsPreviously untreated patients with ABC were randomly assigned to receive docetaxel 75 mg/m2 plus epirubicin 75 mg/m2 (DE) on day 1 or docetaxel 75 mg/m2 on day 1 plus capecitabine 950 mg/m2 orally twice daily on days 1–14 (DC) in 21-day cycles. Previous anthracycline-based (neo)-adjuvant chemotherapy was allowed if completed >1 year before enrollment. The primary objective of the study was to compare time to disease progression (TTP).ResultsOne hundred and thirty-six women were treated on each arm and median TTP was 10.6 versus 11.0 months (P = 0.7), for DE and DC, respectively. According to RECIST criteria we observed 15 (11%) versus 11 (8%) complete responses and 55 (40%) versus 61 (45%) partial responses (P = 0.8), with DE and DC, respectively. Severe toxicity included grade 3–4 neutropenia (57% versus 46%; P = 0.07), febrile neutropenia (11% versus 8%; P = 0.4), hand–foot syndrome (0% versus 4%; P = 0.02), grade 2–3 anemia (20% versus 7%; P = 0.001) and asthenia (12% versus 6%; P = 0.09) with DE and DC, respectively.ConclusionsThe DE and DC regimens have similar efficacy but different toxicity. Either regimen can be used as front-line treatment of ABC.