A Phase II Trial of Capecitabine Concomitantly With Whole-Brain Radiotherapy Followed by Capecitabine and Sunitinib for Brain Metastases From Breast Cancer
Mené sur 12 patientes présentant des métastases cérébrales ayant pour origine un cancer du sein, cet essai de phase II évalue l'efficacité, du point de vue de la survie sans progression et de la survie globale, et les effets secondaires de la capécitabine en combinaison avec une radiothérapie concomitante du cerveau entier puis le sunitinib
Résumé en anglais
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; therefore, 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 endpoint was progression-free survival (PFS).
Results : Of 25 planned patients that 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 for slow 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 capecitabine 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.
