Gemcitabine Plus Cisplatin for Advanced Biliary Tract Cancer: A Systematic Review.

Gemcitabine Plus Cisplatin for Advanced Biliary Tract Cancer: A Systematic Review.
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DOI:
10.4143/crt.2014.308
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发表时间:
2015-07
影响因子:
4.6
通讯作者:
Lim HY
Lim HY
中科院分区:
医学2区
文献类型:
--
作者:
Park JO;Oh DY;Hsu C;Chen JS;Chen LT;Orlando M;Kim JS;Lim HY

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有证据表明,吉西他滨-顺铂联合化疗可延长晚期胆道癌(BTC)患者的生存期。我们进行了一项系统评价,以整理这些证据,并评估吉西他滨-顺铂疗效是否受原发肿瘤部位、疾病分期或地理区域的影响,以及相关毒性是否与治疗方案相关。MEDLINE(1946-检索日期)、EMBASE(1966-检索日期)、ClinicalTrials。gov(2008年-检索日期)和主要肿瘤学会议的摘要(2009年-检索日期)使用BTC、吉西他滨和顺铂检索(2013年12月5日)。报告吉西他滨-顺铂治疗BTC的疗效(生存期、缓解率)或安全性(毒性)结局的所有研究类型均符合入选条件;疗效数据仅从前瞻性研究中提取。从1项荟萃分析(摘要)、4项随机对照试验、12项非随机前瞻性研究和3项回顾性研究中检索到的证据支持吉西他滨-顺铂治疗BTC的疗效和安全性。中位总生存期为4.6 - 11.7个月,缓解率为17.1%-36.6%。毒性通常是可接受和可管理的。研究设计和收集的数据中的异质性阻碍了正式的荟萃分析,然而探索性评估表明,疗效不随原发肿瘤部位(胆囊与其他)、疾病分期(转移性与局部晚期)或地理来源(亚洲与其他)而变化。3/4级毒性的发生率与吉西他滨剂量或顺铂频率无关。尽管研究设计存在个体差异,但所提供的证据表明,吉西他滨-顺铂对来自不同国家和具有异质性疾病特征的患者有效。在吉西他滨和顺铂的不同给药方案之间未观察到毒性的实质性差异。
Evidence suggests that combined gemcitabine-cisplatin chemotherapy extends survival in patients with advanced biliary tract cancer (BTC). We conducted a systematic review in order to collate this evidence and assess whether gemcitabine-cisplatin efficacy is influenced by primary tumor site, disease stage, or geographic region, and whether associated toxicities are related to regimen. MEDLINE (1946-search date), EMBASE (1966-search date), ClinicalTrials. gov (2008-search date), and abstracts from major oncology conferences (2009- search date) were searched (5 Dec 2013) using terms for BTC, gemcitabine, and cisplatin. All study types reporting efficacy (survival, response rates) or safety (toxicities) outcomes of gemcitabine-cisplatin in BTC were eligible for inclusion; efficacy data were extracted from prospective studies only. Evidence retrieved from one meta-analysis (abstract), four randomized controlled trials, 12 nonrandomized prospective studies, and three retrospective studies supported the efficacy and safety of gemcitabine-cisplatin for BTC. Median overall survival ranged from 4.6 to 11.7 months, and response rate ranged from 17.1% to 36.6%. Toxicities were generally acceptable and manageable. Heterogeneity in study designs and data collected prevented formal meta-analysis, however exploratory assessments suggested that efficacy did not vary with primary tumor site (gallbladder vs. others), disease stage (metastatic vs. locally advanced), or geographic origin (Asia vs. other). Incidence of grade 3/4 toxicities was not related to gemcitabine dose or cisplatin frequency. Despite individual variation in study designs, the evidence presented suggests that gemcitabine-cisplatin is effective in patients from a diverse range of countries and with heterogeneous disease characteristics. No substantial differences in toxicity were observed among the different dosing schedules of gemcitabine and cisplatin.