Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer Journal Article
| Authors: | Gajria, D.; Feigin, K.; Tan, L. K.; Patil, S.; Geneus, S.; Theodoulou, M.; Norton, L.; Hudis, C. A.; Traina, T. A. |
| Article Title: | Phase 2 trial of a novel capecitabine dosing schedule in combination with bevacizumab for patients with metastatic breast cancer |
| Abstract: | BACKGROUND: Capecitabine has antitumor activity in metastatic breast cancer (MBC); however, its optimal dose and schedule remain unclear. Mathematical modeling predicts that a capecitabine schedule 7 days of treatment followed by 7 days of rest (7-7) will improve efficacy and minimize toxicity. Bevacizumab has demonstrated the ability to improve outcomes when it is added to chemotherapy, including capecitabine, in the first-line and second-line settings. METHODS: Patients with measurable MBC received oral capecitabine (2000 mg twice daily; 7-7), and intravenous bevacizumab (10 mg/kg every 2 weeks). The primary endpoint was the response rate. Secondary endpoints included toxicity, the clinical benefit rate, and progression-free survival (PFS). RESULTS: Forty-one patients were treated. After a median of 7 cycles (range, 1-32 cycles), partial responses were observed in 20% of patients, and stable disease for ≥6 months was noted in 35% patients. The median PFS was 8 months. The most common treatment-related toxicities were hand-foot syndrome (49% grade 2, 20% grade 3/4) hypertension (12% grade 2, 10% grade 3/4), and fatigue (12% grade 2, 2% grade 3/4). Diarrhea (5% grade 2, 0% grade 3/4), nausea (0% grade 2-4), and vomiting (0% grade 2-4) were rare. CONCLUSIONS: Capecitabine administered for 7 days followed by a 7-day rest in combination with bevacizumab had modest efficacy and an acceptable toxicity profile in patients with MBC. Gastrointestinal toxicity with this schedule was minimal. © 2011 American Cancer Society. |
| Keywords: | bevacizumab; capecitabine; metastatic breast cancer |
| Journal Title: | Cancer |
| Volume: | 117 |
| Issue: | 18 |
| ISSN: | 0008-543X |
| Publisher: | Wiley Blackwell |
| Date Published: | 2011-09-15 |
| Start Page: | 4125 |
| End Page: | 4131 |
| Language: | English |
| DOI: | 10.1002/cncr.25992 |
| PROVIDER: | scopus |
| PUBMED: | 21387266 |
| DOI/URL: | |
| Notes: | --- - "Export Date: 3 October 2011" - "CODEN: CANCA" - "Source: Scopus" |
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