Chen Lin, Zhang Ming, Luo Shuchun
Department of Oncology, Sichuan Provincial Hospital and Sichuan Academy of Medical Science, Chengdu, Sichuan, China.
Tumour Biol. 2014 Nov;35(11):11551-8. doi: 10.1007/s13277-014-2451-6. Epub 2014 Aug 17.
The aim of this study is to assess the clinical outcome of gemcitabine (GEM) plus molecular targeted agents (MTAs) for treatment of pancreatic cancer, in the purpose of providing fundamental data for clinical practice. Databases like PubMed, EMBASE, and MEDLINE, EMBASE and Cochrane Library were searched to retrieve phase III clinical randomized controlled trials related to GEM plus MTAs for pancreatic cancer (up to Oct 2013). Literatures were independently screened by two researchers according to the inclusion and exclusion criteria. Data were extracted and analyzed by using Stata 11.0 software. Total, 11 studies were included, involving 5,451 participants who were divided into GEM plus MTAs group (n=2,729) and GEM plus placebo group (n=2,722). There was no significant difference in overall survival, progression-free survival, response rate, complete response, partial response, and clinical benefit rate between two groups. Compared with GEM plus placebo group, stable disease of GEM plus MTAs group was significantly increased (risk ratios (RRs) =1.14, 95% confidence interval (CI) 1.04-1.21, P=0.003). Further subgroup analysis indicated that GEM plus epidermal growth factor receptor (EGFR) inhibitor use induced higher response rate and clinical benefit rate than GEM plus placebo group (RRs=1.19, 95% CI 1.09-1.31, P=0.000; RR=1.18, 95% CI 1.09-1.27, P=0.000). In addition, no significant difference in 3-4 grade adverse reactions (incidence, anemia rate, neutropenia rate, and thrombocytopenia rate) was identified between two groups. GEM plus MTAs may be effective and safe for stabilizing patients suffering advanced pancreatic cancer, especially EGFR inhibitor.
本研究旨在评估吉西他滨（GEM）联合分子靶向药物（MTA）治疗胰腺癌的临床疗效，为临床实践提供基础数据。检索了PubMed、EMBASE、MEDLINE、EMBASE和Cochrane图书馆等数据库，以获取与GEM联合MTA治疗胰腺癌相关的III期临床随机对照试验（截至2013年10月）。两名研究人员根据纳入和排除标准独立筛选文献。使用Stata 11.0软件提取和分析数据。共纳入11项研究，涉及5451名参与者，分为GEM联合MTA组（n = 2729）和GEM联合安慰剂组（n = 2722）。两组在总生存期、无进展生存期、缓解率、完全缓解、部分缓解和临床获益率方面无显著差异。与GEM联合安慰剂组相比，GEM联合MTA组的疾病稳定率显著提高（风险比（RRs）= 1.14，95%置信区间（CI）1.04 - 1.21，P = 0.003）。进一步的亚组分析表明，GEM联合表皮生长因子受体（EGFR）抑制剂使用比GEM联合安慰剂组诱导更高的缓解率和临床获益率（RRs = 1.19，95% CI 1.09 - 1.31，P = 0.000；RR = 1.18，95% CI 1.09 - 1.27，P = 0.000）。此外，两组在3 - 4级不良反应（发生率、贫血率、中性粒细胞减少率和血小板减少率）方面无显著差异。GEM联合MTA对稳定晚期胰腺癌患者可能有效且安全，尤其是EGFR抑制剂。
