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

被引:47
作者
Cao, Ranhua [1 ,2 ]
Zhang, Shuai [1 ]
Ma, Dedong [1 ]
Hu, Likuan [1 ]
机构
[1] Shandong Univ, Qilu Hosp, Dept Radiat Oncol, Jinan 250012, Shandong, Peoples R China
[2] Inner Mongolia Med Univ, Affiliated Hosp 1, Dept Chemotherapy Oncol, Hohhot 010050, Inner Mongolia, Peoples R China
关键词
Chinese metastatic colorectal cancer; Second-line chemotherapy; FOLFIRI; Bevacizumab; FLUOROURACIL; OXALIPLATIN; TRIAL; COMBINATION;
D O I
10.1007/s12032-014-0325-9
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
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页码:1 / 5
页数:5
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