Meta-Analysis
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World J Gastroenterol. Dec 21, 2014; 20(47): 18001-18012
Published online Dec 21, 2014. doi: 10.3748/wjg.v20.i47.18001
Efficacy and safety of gemcitabine-based chemotherapies in biliary tract cancer: A meta-analysis
Heng Liu, Qi-Di Zhang, Zheng-Hong Li, Qing-Qing Zhang, Lun-Gen Lu
Heng Liu, Qi-Di Zhang, Zheng-Hong Li, Qing-Qing Zhang, Lun-Gen Lu, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China
Author contributions: Lu LG and Liu H designed the research; Liu H, Zhang QQ and Li ZH searched the databases, Liu H, Zhang QD and Lu LG performed the data extraction; Liu H analyzed the data; Liu H and Lu LG wrote the paper.
Correspondence to: Lun-Gen Lu, MD, Professor, Chief, Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, No. 100 Haining Road, Hongkou District, Shanghai 200080, China. lungenlu1965@163.com
Telephone: +86-21-63240090 Fax: +86-21-63241377
Received: April 19, 2014
Revised: June 12, 2014
Accepted: July 11, 2014
Published online: December 21, 2014
Abstract

AIM: To investigate the efficacy and safety of gemcitabine (Gem)-based combination chemotherapies for the treatment of advanced biliary tract cancer.

METHODS: Clinical trials were identified by searching scientific literature databases (PubMed, EMBASE and the Cochrane Library) for studies published between 1975 and 2013. Two reviewers independently evaluated the relevant studies and manually searched references from these reports to locate additional eligible studies. The disease response and control rates, progression-free and overall survivals, and the grade 3-4 toxicities were evaluated by a meta-analysis. Odds-ratios (ORs) of the disease response and control rates and grade 3-4 toxicities, and the mean difference (MD) of both progression-free and overall survivals were calculated and used for statistical analysis.

RESULTS: Seven randomized trials with a total of 858 patients were selected and included in the final analysis. The studies were divided into subgroups based on the chemotherapy regimens, including Gem-based and non-Gem-based chemotherapies. The overall analyses revealed that the patients treated with Gem-based combination chemotherapy had significantly higher disease response rates [OR = 1.69, 95% confidence interval (CI): 1.17-2.43; P = 0.01], a longer progression-free survival (MD = 1.95, 95%CI: 0.90-3.00; P = 0.00) and a longer overall survival (MD = 1.85, 95%CI: 0.26-3.44; P = 0.02). A higher incidence of grade 3-4 hematological toxicities, including leukopenia (OR = 2.98, 95%CI: 1.44-6.20; P = 0.00), anemia (OR = 2.96, 95%CI: 1.79-4.92; P = 0.00) and neutropenia (OR = 2.80, 95%CI: 1.39-5.64; P = 0.00) was found in the Gem-based combination chemotherapy group compared with the Gem monotherapy and non-Gem-based chemotherapy groups.

CONCLUSION: Gem-based combination chemotherapy is a potential first-line treatment for advanced biliary tract cancer as a result of improved survival, though with additional toxicity.

Keywords: Biliary tract cancer, Combination chemotherapy, Gemcitabine, Meta-analysis, Randomized trial

Core tip: To investigate the efficacy and safety of gemcitabine (Gem)-based combination chemotherapy for the treatment of advanced biliary tract cancer, the authors analyzed the potential impact of Gem-based combination chemotherapy and other regimens on the outcomes and toxicities of the patients using meta-analysis methodologies. Meta-analysis showed that compared with Gem monotherapy and non-Gem-based chemotherapy, Gem-based combination chemotherapy provided a modest improvement in survival but was associated with more toxicity.