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一项多中心随机II期临床研究,比较了贝伐单抗联合伊立替康、5-氟尿嘧啶和亚叶酸钙(FOLFIRI)与单纯FOLFIRI作为中国转移性结直肠癌患者二线治疗方案的疗效。

A multi-center randomized phase II clinical study of bevacizumab plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) compared with FOLFIRI alone as second-line treatment for Chinese patients with metastatic colorectal cancer.

作者信息

Cao Ranhua, Zhang Shuai, Ma Dedong, Hu Likuan

机构信息

Department of Radiation Oncology, Qilu Hospital of Shandong University, Jinan, 250012, Shandong Province, China.

出版信息

Med Oncol. 2015 Jan;32(1):325. doi: 10.1007/s12032-014-0325-9. Epub 2014 Dec 7.

Abstract

Bevacizumab is an anti-VEGF human monoclonal antibody suitable for chemotherapy for patients with metastatic colorectal cancer (mCRC). This study investigated the efficacy and safety of using bevacizumab plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as second-line chemotherapy option for patients with mCRC in China. Patients with mCRC, who had been previously treated with oxaliplatin-based chemotherapy, but not bevacizumab, were randomly assigned to two groups to receive bevacizumab plus FOLFIRI (FOLFIRI-B) or FOLFIRI alone. In FOLFIRI-B group, patients were given 10 mg/kg bevacizumab plus FOLFIRI every 2 weeks. The primary endpoints were response rates and survival rates. Between June 2010 and May 2014, 65 patients were assigned to FOLFIRI-B group and 77 to FOLFIRI alone group. The median progression-free survivals were 8.5 months (95 % CI 5.8-10.5 months) for FOLFIRI-B and 5.1 months (95 % CI 2.7-9.8 months) for FOLFIRI alone; median overall survivals were 15.2 months (95 % CI 11.8-19.4 months) for FOLFIRI-B and 11.3 months (95 % CI 6.7-16.5 months) for FOLFIRI alone. Incidence rates of grade 3 and 4 adverse events were observed and comparable between FOLFIRI-B and FOLFIRI alone groups. Chinese patients with mCRC treated with second-line chemotherapy of FOLFIRI-B had better survivals than those patients treated with FOLFIRI alone.

摘要

贝伐单抗是一种抗血管内皮生长因子(VEGF)的人源单克隆抗体,适用于转移性结直肠癌(mCRC)患者的化疗。本研究调查了在中国使用贝伐单抗联合伊立替康、5-氟尿嘧啶和亚叶酸钙(FOLFIRI)作为mCRC患者二线化疗方案的疗效和安全性。曾接受过基于奥沙利铂的化疗但未使用过贝伐单抗的mCRC患者被随机分为两组,分别接受贝伐单抗联合FOLFIRI(FOLFIRI-B)或单纯FOLFIRI治疗。在FOLFIRI-B组中,患者每2周接受10mg/kg贝伐单抗联合FOLFIRI治疗。主要终点为缓解率和生存率。2010年6月至2014年5月期间,65例患者被分配至FOLFIRI-B组,77例患者被分配至单纯FOLFIRI组。FOLFIRI-B组的中位无进展生存期为8.5个月(95%CI 5.8 - 10.5个月),单纯FOLFIRI组为5.1个月(95%CI 2.7 - 9.8个月);FOLFIRI-B组的中位总生存期为15.2个月(95%CI 11.8 - 19.4个月),单纯FOLFIRI组为11.3个月(95%CI 6.7 - 16.5个月)。观察到3级和4级不良事件的发生率,FOLFIRI-B组和单纯FOLFIRI组之间具有可比性。接受FOLFIRI-B二线化疗的中国mCRC患者的生存期优于接受单纯FOLFIRI治疗的患者。

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