[Clinical paired study of comparing docetaxel plus capecitabine versus docetaxel plus epirubicin as first-line treatment in women with HER-2 negative advanced breast cancer].

OBJECTIVE

To assess the efficacy of docetaxel plus capecitabine versus docetaxel plus epirubicin as first-line treatment in women with HER-2 negative advanced breast cancer.

METHODS

A paired study was conducted for 92 cases with HER-2 negative advanced breast cancer. They received 3 weekly cycles of either TX (docetaxel 75 mg/m(2), day 1; capecitabine 1000 mg/m(2) orally twice daily, days 1-14) or TE (docetaxel 75 mg/m(2), day 1; epirubicin 75 mg/m(2), day 1). The objective was to compare 6-month non-progression rate, time to progression (TTP) , overall response rate (ORR) and toxicities.

RESULTS

The 6-month non-progression rates were 78% with TX versus 70% with TE (P = 0.477). Medium TTP was 10.2 versus 8.7 months (P = 0.128) and ORR was 72% and 63% respectively (P = 0.505) . Severe toxicities included hand-foot syndrome (37% vs 4%, P < 0.001), grade 3-4 neutropenia (30% vs 70%, P < 0.001) and febrile neutropenia (2% vs 11%, P = 0.004) respectively. No relevant differences in other toxicities were observed in two arms.

CONCLUSION

Both regimens of TX and TE have similar efficacy and are well-tolerated as the first-line therapy for HER-2 negative advanced breast cancer.