Clinical study of adjuvant capecitabine monotherapy in Chinese elderly patients (aged 55-70) with stage IIa breast cancer.

ABSTRACT

BACKGROUND: Oral capecitabine (CAP) has shown significant benefits in early stage breast cancer (BC). Herein we evaluated CAP as adjuvant monotherapy in women 55 years of age or older with stage IIa BC. PATIENTS AND METHODS: Women with stage IIa BC received 6 cycles of either CAP or CEF (cyclophosphamide/epirubicin/5-fluorouracil) after surgery. The primary endpoint was overall survival (OS). Quality of life (QOL), patient acceptance of chemotherapy, and safety were secondary endpoints. RESULTS: A total of 71 women were enrolled. The 3- and 5-year OS rates were 96.97 and 93.33%, respectively in the CAP group versus 96.67 and 90.32%, respectively in the CEF group. The incidence of disease recurrence or metastasis was 6.67 versus 6.45%, respectively. All CAP patients completed the planned 6 cycles, while only 84% of CEF patients completed all 6 cycles. Myelosuppression, hepatic toxicity, and cardiovascular toxicity were more common with CEF, while hand-foot syndrome was more common with CAP. QOL was significantly better in the CAP group (p < 0.01). Compared with the CEF group, CAP patients had less moderate-to-severe mental disturbance (p < 0.01). CONCLUSIONS: Our results suggest that CAP monotherapy is a potential alternative to CEF adjuvant chemotherapy in patients 55 years old or older with stage IIa BC.