Phase II study of an 'all-oral' regimen of capecitabine, idarubicin and cyclophosphamide for metastatic breast cancer--safety, efficacy and quality of life.

ABSTRACT

OBJECTIVE: Patients with metastatic breast cancer (MBC) generally have a poor prognosis. Many of these patients have a good performance status. A new all-oral regimen (XIC) was evaluated in a phase II trial. The impact of the regimen on the safety and efficacy of the drug, as well as quality of life (QOL) of the patients was assessed. PATIENTS AND METHODS: From September 2000 to September 2001, informed consent was obtained from 20 heavily pretreated women with MBC. They were placed on a 6-week cycle regimen comprising capecitabine (X; 2,000 mg/m2/day in two divided doses for 2 weeks then 1 week rest), idarubicin (I; 10 mg/m2/day, days 1, 3 and 5) and cyclophosphamide (C; 100 mg/m2/day for 2 weeks then 1 week rest). RESULTS: Toxicities were generally tolerable. One patient had grade III neutropenia, which was reversible on cessation of treatment. One patient (5%) had a complete response and 4 patients (20%) achieved partial responses, yielding an overall response rate of 25%. Eight patients (40%) had stable disease. Median time to disease progression and median survival time were 13.4 and 23.7 months, respectively. Global and physical EORTC QLQ-30 scores showed no significant decrease in QOL. CONCLUSION: This is a small-scale study. XIC was generally well tolerated and favoured by the patients. This moderately active and convenient 'all-oral' regimen deserves clinical trials at a wider scale.