Document Detail


Efficacy and safety of bevacizumab plus chemotherapy in Chinese patients with metastatic colorectal cancer: a randomized phase III ARTIST trial.
MedLine Citation:
PMID:  21959045     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The efficacy and safety of bevacizumab with modified irinotecan, leucovorin bolus, and 5-fluorouracil intravenous infusion (mIFL) in the first-line 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/m(2)), leucovorin (20 mg/m(2)) bolus, and 5-fluorouracil intravenous infusion (500 mg/m(2)) 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-month 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-month 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-healing 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.
Authors:
Zhong-Zhen Guan; Jian-Ming Xu; Rong-Cheng Luo; Feng-Yi Feng; Li-Wei Wang; Lin Shen; Shi-Ying Yu; Yi Ba; Jun Liang; Dong Wang; Shu-Kui Qin; Jie-Jun Wang; Jing He; Chuan Qi; Rui-Hua Xu
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Chinese journal of cancer     Volume:  30     ISSN:  1000-467X     ISO Abbreviation:  Chin J Cancer     Publication Date:  2011 Oct 
Date Detail:
Created Date:  2011-09-30     Completed Date:  2013-01-31     Revised Date:  2013-05-27    
Medline Journal Info:
Nlm Unique ID:  101498232     Medline TA:  Chin J Cancer     Country:  China    
Other Details:
Languages:  eng     Pagination:  682-9     Citation Subset:  IM    
Affiliation:
Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. guanzhzh@mail.sysu.edu.cn
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Angiogenesis Inhibitors / adverse effects,  therapeutic use
Antibodies, Monoclonal, Humanized / adverse effects,  therapeutic use*
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Asian Continental Ancestry Group
Camptothecin / administration & dosage,  adverse effects,  analogs & derivatives
Colorectal Neoplasms / drug therapy*,  pathology
Diarrhea / chemically induced
Disease-Free Survival
Female
Fluorouracil / administration & dosage,  adverse effects
Humans
Leucovorin / administration & dosage,  adverse effects
Male
Middle Aged
Neoplasm Metastasis
Neutropenia / chemically induced
Prospective Studies
Survival Rate
Young Adult
Chemical
Reg. No./Substance:
0/Angiogenesis Inhibitors; 0/Antibodies, Monoclonal, Humanized; 2S9ZZM9Q9V/bevacizumab; 51-21-8/Fluorouracil; 58-05-9/Leucovorin; 7673326042/irinotecan; 7689-03-4/Camptothecin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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