A phase II trial of capecitabine concomitantly with whole-brain radiotherapy followed by capecitabine and sunitinib for brain metastases from breast cancer

Background. Brain metastasis from breast cancer presents a significant threat to women’s health and quality of life. Capecitabine and sunitinib have shown some activity in this setting; there- fore, we conducted a single-arm phase II trial with these agents. Methods. Patients with breast cancer and central nervous system (CNS) metastases received whole-brain radiotherapy concurrently with capecitabine (1,000 mg/m² per day for 14 consecutive days), followed by concomitant capecitabine (2,000 mg/m² per day for 2 weeks followed by a 1-week break) and sunitinib (37.5 mg daily, continuously). The primary end- point was progression-free survival (PFS).Results. Of 25 planned patientsthat would be required to detect a 4-month improvement (from 5 to 9 months) in median PFS with 80% power, 12 were enrolled, and the study was then closed forslow accrual. Median PFS was 4.7 months, and median overall survival was 10 months. In the CNS, 25% had progressive disease, and 83% experienced extra-CNS progression. The most common side effects were fatigue and nausea.Conclusion. In 12 evaluable patients studied, concurrent capecitabine and whole-brain radiation followed by capecita- bine and sunitinib did not extend PFS over historical rates and was associated with significant toxicity. Our study was small and closed due to slow accrual.