Metronomic Chemo-Endocrine Therapy FulVEC

The metronomic chemo-endocrine therapy FulVEC consisted of fulvestrant 500 mg i.m. administered on days 1, 14, 28, and q1m thereof combined with metronomic, continuous polychemotherapy VEC (vinorelbine 40 mg three times a week, cyclophosphamide 50 mg p.o. qd, capecitabine 500 mg p.o. tid). Dose adjustments were performed based on the evaluation of treatment-emergent adverse events, and particular drug-related AE has led to a stepwise reduction in a given drug. Upon the occurrence of vinorelbine-induced AE, the dosage was reduced from 50 mg tiw to 30 mg q2d. Capecitabine-related AE led to a stepwise reduction from 500 mg tid to 500 mg bid and then to 500 mg qd. The single-step reduction in cyclophosphamide was based on decreased frequencies from 50 mg qd to 50 mg q2d. In the case of non-sufficient dose reduction, the treatment with a particular drug was withheld until the resolution of particular AEs.
Data on the following background characteristics of the patients were collected using standardized data collection instruments: age; ECOG performance status; clinical symptoms; serum tumor markers, including CA-15.3; tumor stage (locally advanced or metastatic); sites of distant metastases; pathological diagnosis including immunohistochemistry.