Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer

摘要: BACKGROUND: Capecitabine has antitumor activity in metastatic breast cancer (MBC); however, its optimal dose and schedule remain unclear. Mathematical modeling predicts that a capecitabine 7 days of treatment followed by rest (7—7) will improve efficacy minimize toxicity. Bevacizumab demonstrated the ability to outcomes when it is added chemotherapy, including capecitabine, first-line second-line settings. METHODS: Patients with measurable MBC received oral (2000 mg twice daily; 7—7), intravenous bevacizumab (10 mg/kg every 2 weeks). The primary endpoint was response rate. Secondary endpoints included toxicity, clinical benefit rate, progression-free survival (PFS). RESULTS: Forty-one patients were treated. After median cycles (range, 1-32 cycles), partial responses observed 20% patients, stable disease for ≥6 months noted 35% patients. PFS 8 months. most common treatment-related toxicities hand-foot syndrome (49% grade 2, 3/4) hypertension (12% 10% 3/4), fatigue 2% 3/4). Diarrhea (5% 0% nausea (0% 2-4), vomiting 2-4) rare. CONCLUSIONS: Capecitabine administered 7-day combination had modest an acceptable toxicity profile MBC. Gastrointestinal this minimal. Cancer 2011;. © 2011 American Society.