PHASE II TRIAL OF NEOADJUVANT BEVACIZUMAB, CAPECITABINE, AND RADIOTHERAPY FOR LOCALLY ADVANCED RECTAL CANCER
PHASE II TRIAL OF NEOADJUVANT BEVACIZUMAB, CAPECITABINE, AND RADIOTHERAPY FOR LOCALLY ADVANCED RECTAL CANCER
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DOI：
10.1016/j.ijrobp.2009.02.037
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发表时间：
2010-03-01
影响因子：
7
通讯作者：
Rodriguez-Bigas, Miguel A.
中科院分区：
文献类型：
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作者：
Crane, Christopher H.;Eng, Cathy;Rodriguez-Bigas, Miguel A.
目的：我们设计了这项II期试验，以评估在局部晚期直肠癌的新辅助卡培他滨放化疗中添加贝伐单抗的有效性和安全性。方法：2004年4月至2007年12月，25例临床分期T3N1 （n = 20）或T3N0 （n = 5）直肠癌患者接受了新辅助治疗，包括放疗（50.4 Gy， 28次，超过5.5周）、贝伐单抗每2周（3次剂量，5mg /kg）和卡培他滨（900 mg/m(2)，每日口服两次，仅在放疗的几天内），然后手术切除，中位时间为7.3周。结果：手术包括腹会阴切除术（APR， 6例）、结肠直肠吻合术直结肠切除术（8例）、前低位切除术（10例）和局部切除术（1例）。25例患者中8例（32%）有病理完全缓解，6例（24%）有病理完全缓解
Purpose: We designed this Phase II trial to assess the efficacy and safety of the addition of bevacizumab to concurrent neoadjuvant capecitabine-based chemoradiation in locally advanced rectal cancer.Methods: Between April 2004 and December 2007, 25 patients with clinically staged T3N1 (n = 20) or T3N0 (n = 5) rectal cancer received neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), bevacizumab every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m(2) orally twice daily only on days of radiation), followed by surgical resection a median of 7.3 weeks later.Results: Procedures included abdominoperineal resection (APR; 6 patients), proctectomy with coloanal anastamosis (8 patients), low anterior resection (10 patients), and local excision (1 patient). Eight (32%) of 25 patients had a pathologic complete response, and 6 (24%) of 25 had