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结直肠癌肝转移不可切除患者采用西妥昔单抗联合 FOLFIRI 化疗转化治疗后序贯贝伐珠单抗联合 mFOLFOX6 方案治疗的临床研究

Conversion chemotherapy using cetuximab plus FOLFIRI followed by bevacizumab plus mFOLFOX6 in patients with unresectable liver metastases from colorectal cancer.

机构信息

Division of Surgical Oncology, Department of Surgery, Nagoya Graduate School of Medicine, 65, Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan.

出版信息

Jpn J Clin Oncol. 2011 Oct;41(10):1229-32. doi: 10.1093/jjco/hyr115. Epub 2011 Aug 11.

DOI:10.1093/jjco/hyr115
PMID:21840871
Abstract

Recently, in patients with unresectable colorectal liver metastasis, liver resection sometimes becomes possible by intensive systemic chemotherapy, i.e. conversion therapy. However, among cases that do not respond well to first-line chemotherapy, it is rare that second-line chemotherapy results in a marked response allowing liver resection. We consider that the liver resection rate may be increased by initiating second-line treatment at an earlier stage before progression subsequent to first-line chemotherapy. We are conducting a multicentre Phase II study to evaluate the efficacy and safety of sequential chemotherapy using six cycles of cetuximab plus FOLFIRI (5-fluorouracil, folinic acid and irinotecan) followed by six cycles of bevacizumab plus FOLFOX (5-fluorouracil, folinic acid and oxaliplatin) as conversion chemotherapy. The primary endpoint is the liver resection rate during the bevacizumab + FOLFOX phase. Fifty patients are required for this study.

摘要

最近,对于不可切除的结直肠癌肝转移患者,通过强化全身化疗,即转化治疗,有时可以进行肝切除术。然而,在对一线化疗反应不佳的病例中,二线化疗引起明显反应从而允许肝切除的情况很少见。我们认为,如果在一线化疗后进展之前更早地开始二线治疗,肝切除术的比例可能会增加。我们正在进行一项多中心 II 期研究,以评估使用西妥昔单抗联合 FOLFIRI(氟尿嘧啶、亚叶酸钙和伊立替康)治疗 6 个周期,然后使用贝伐珠单抗联合 FOLFOX(氟尿嘧啶、亚叶酸钙和奥沙利铂)治疗 6 个周期作为转化化疗的疗效和安全性。主要终点是贝伐珠单抗+FOLFOX 阶段的肝切除术率。这项研究需要 50 例患者。

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