Sandwich-like neoadjuvant therapy with bevacizumab for locally advanced rectal cancer: a phase II trial.

摘要: Current neoadjuvant chemoradiotherapy had limited impact on distal metastasis and survival in locally advanced rectal cancer. Here, we investigated a new sandwich-like regimen with bevacizumab. This was single-arm, open-labeled, phase II trial. Patients cancer received therapy bevacizumab (induction FOLFOX, concurrent consolidation chemotherapy FOLFOX). Surgery performed 4–6 weeks later. The primary endpoint of this study pathologic complete response. Twenty-five eligible patients were included. All completed the protocol. During course therapy, 3 (12 %) grade 4 hematological toxicity events 12 (48 %) non-hematological events. According to RECIST criteria, 18 (72 %) achieved partial response rest seven (28 %) remained stable disease. Two (8 %) refused subsequent surgical for personal reasons, 23 (92 %) underwent operations finally. Nine (39.1 %, 95 % CI 18.0–57.5 %) them Five (21.7 %) postoperative complications. After median follow-up period 25.3 (14.4–40.9) months, four developed disease progression two died 3-year overall rate (95 % 69.5–99.3 %), disease-free 72.5 % 33.7–90.9 %). Sandwich-like is safe effective