Phase II Study of an ‘All-Oral’ Regimen of Capecitabine, Idarubicin and Cyclophosphamide for Metastatic Breast Cancer – Safety, Efficacy and Quality of Life

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 andMethods: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/m 2 /day in two divided doses for 2 weeks then 1 week rest), idarubicin (I; 10 mg/m 2 /day, days 1, 3 and 5) and cyclophosphamide (C; 100 mg/m 2 /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.