单位：[a]State Key Laboratory of Oncology in South China, Guangzhou, Guangdong 510060, China[b]Sun Yatsen University Cancer Center, Guangzhou, Guangdong 510060, China[c]307 Hospital of PLA, Beijing 100071, China[d]Guangzhou Nanfang Hospital, Guangzhou, Guangdong 510515, China[e]Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China[f]Shanghai First Peoples Hospital, Shanghai 201620, China[g]Beijing Cancer Hospital, Beijing 100142, China[h]Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei 430030, China华中科技大学同济医学院附属同济医院[i]Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China[j]The Affiliated Hospital of Medical College Qingdao University, Qingdao, Shandong 266021, China[k]Third Affiliated Hospital, Third Military Medical University of Peoples Liberation Army, Chongqing 400042, China[l]The 81 Hospital of Peoples Liberation Army, Nanjing, Jiangsu 210002, China[m]Shanghai Changzheng Hospital, Shanghai 200003, China[n]Roche Product Development in Asia Pacific, Shanghai 201203, China
The efficacy and safety of bevacizum ab with modified irinotecan, leucovorin bolus, and 5-fl uorouracil intravenous infusion (mIFL) in the first-lin e treatment of metastatic colorectal cancer (mCRC) has not been well evaluated in randomized clinical trials in Chinese patients. We conducted a phrase III trial in which patients with previously untreated mCRC were randomized 2:1 to the mIFL[irinotecan(125 mg/m2), leucovorin(20 mg/m2) bolus, and 5-fl uorouracil intravenous infusion(500 mg/m2) weekly for four weeks every six weeks] plus bevacizumab (5 mg/kg every two weeks) group and the mIFL group, respectively. Co-primary objectives were progression-free survival (PFS) and 6-m onth PFS rate. In total, 214 patients were enrolled. Our results showed that addition of bevacizumab to mIFL significantly improved median PFS (4.2 months in the mIFL group vs. 8.3 months in the bevacizumab plus mIFL group, P < 0.001), 6-m onth PFS rate (25.0% vs. 62.6%, P < 0.001), median overall survival (13.4 months vs. 18.7 months, P = 0.014), and response rate (17% vs. 35%, P = 0.013). Grades 3 and 4 adverse events included diarrhea (21% in the mIFL group and 26% in the bevacizumab plus mIFL group) and neutropenia (19% in the mIFL group and 33% in the bevacizumab plus mIFL group). No wound-h ealing complications or congestive heart failure occurred. Our results suggested that bevacizumab plus mIFL is effective and well tolerated as first- line treatment for Chinese patients with mCRC. Clinical benefit and safety profiles were consistent with those observed in pivotal phase III trials with mainly Caucasian patients.
语种：
外文
PubmedID：
第一作者：
第一作者单位：[a]State Key Laboratory of Oncology in South China, Guangzhou, Guangdong 510060, China[b]Sun Yatsen University Cancer Center, Guangzhou, Guangdong 510060, China
通讯作者：
通讯机构：[a]State Key Laboratory of Oncology in South China, Guangzhou, Guangdong 510060, China[b]Sun Yatsen University Cancer Center, Guangzhou, Guangdong 510060, China
推荐引用方式(GB/T 7714)：
Guan Z.-Z,Xu J.-M,Luo R.-C,et al.Efficacy and safety of bevacizumab plus chemotherapy in chinese patients with metastatic colorectal cancer:A randomized phase iii artist trial[J].Chinese Journal of Cancer.2011,30(10):682-9.doi:10.5732/cjc.011.10188.
APA：
Guan, Z.-Z,Xu, J.-M,Luo, R.-C,Feng, F.-Y,Wang, L.-W...&Xu, R.-H.(2011).Efficacy and safety of bevacizumab plus chemotherapy in chinese patients with metastatic colorectal cancer:A randomized phase iii artist trial.Chinese Journal of Cancer,30,(10)
MLA：
Guan, Z.-Z,et al."Efficacy and safety of bevacizumab plus chemotherapy in chinese patients with metastatic colorectal cancer:A randomized phase iii artist trial".Chinese Journal of Cancer 30..10(2011):682-9
