Comparison of Gemcitabine Combined With Targeted Agent Therapy Versus Gemcitabine Monotherapy in the Management of Advanced Pancreatic Cancer
Comparison of Gemcitabine Combined With Targeted Agent Therapy Versus Gemcitabine Monotherapy in the Management of Advanced Pancreatic Cancer
复制标题
吉西他滨联合靶向药物治疗与吉西他滨单药治疗晚期胰腺癌的比较。
DOI：
10.1016/j.clinthera.2014.05.066
复制
发表时间：
2014-07-01
影响因子：
3.2
通讯作者：
Cao, Bangwei
中科院分区：
文献类型：
--
作者：
Li, Qin;Yuan, Zhenyan;Cao, Bangwei
目的：靶向治疗为多发性实体瘤患者带来了巨大的临床获益，但其在局部晚期/转移性胰腺癌（LA/MPG）患者中的疗效存在争议。本系统评价比较了吉西他滨联合靶向药物（GEM + TA）与吉西他滨单药治疗或联合安慰剂（GEM PLC）治疗LA/MPGpatients.Methods的疗效和安全性。主要终点为总生存期（OS）和无进展生存期（PFS）;次要终点为1年生存率、客观缓解率（ORR）和毒性发生率（TR），毒性发生率定义为3/4级不良事件的发生率。使用Review Manager版本5.1.7进行系统评价。结果：系统评价共纳入10项随机对照试验，涉及3899例患者（2195例男性;平均年龄63.6岁）。结果报告，GEM + TA与GEM 11.PLC之间的OS（风险比[HR] = 0.97 [P = 0.85]）、PFS（HR = 0.95 [P = 0.14]）或ORR（比值比[OR] = 0.95 [P = 0.69]）无显著差异。然而，观察到两组之间的1年生存率略有差异（OR = 0.80 [P = 0.05]）。两组之间的贫血、腹泻、恶心、中性粒细胞减少、血小板减少和呕吐的3/4级TR无显著差异。然而，GEM + TA组中3/4级皮疹的患病率显著更高（OR = 8.31 [P < 0.01]）。意义：根据本分析的结果，吉西他滨治疗方案中添加靶向药物并没有给LA/MPG患者带来生存益处，除了1年生存率。(C)2014 Elsevier HS Journals，Inc. All rights reserved.
Purpose: Targeted therapy has brought great clinical benefits for patients with multiple solid tumors, but its effects in patients with locally advanced/metastatic pancreatic cancer (LA/MPG) are disputed. This systematic evaluation compared the efficacy and safety profiles of gemcitabine combined with targeted agents (GEM + TA) versus gemcitabine administered as monotherapy or combined with placebo (GEM PLC) in LA/MPG patients.Methods: Pub Med and EMBASE were searched for relevant randomized controlled trials published on or before April 30, 2013. The primary end points were overall survival (OS) and progression-free survival (PFS); the secondary end points were 1-year survival rate, objective response rate (ORR), and toxicity rates (TRs), defined as the prevalence of grade 3/4 adverse events. The systematic evaluation was performed by using Review Manager version 5.1.7.Findings: A total of 10 randomized controlled trials involving 3899 patients (2195 males; mean age, 63.6 years) were included in the systematic evaluation. The results reported that there was no significant difference in OS (hazard ratio [HR] = 0.97 [P = 0.85]), PFS (HR = 0.95 [P = 0.14]), or ORR (odds ratio [OR] = 0.95 [P = 0.69]) between GEM + TA and GEM 11.PLC. However, a marginal difference in 1-year survival rate (OR = 0.80 [P = 0.05]) between the 2 groups was observed. The grade 3/4 TRs of anemia, diarrhea, nausea, neutropenia, thrombocytopenia, and vomiting were not significantly different between the 2 groups. However, the prevalence of grade 3/4 rash was significantly greater in the GEM + TA group (OR = 8.31 [P < 0.01]).Implications: Based on the results from this analysis, the addition of targeted agents to a regimen of gemcitabine treatment does not bring survival benefits except 1-year survival rate to patients with LA/MPG. (C) 2014 Elsevier HS Journals, Inc. All rights reserved.