吉西他滨固定剂量率输注联合奥沙利铂一线治疗晚期胰腺癌的Meta分析

背景与目的:有研究提示吉西他滨(Gemcitabine,GEM)固定剂量率(Fixed-dose rate,FDR)输注治疗晚期胰腺癌似有较好的疗效,Meta分析也显示含铂类联合化疗优于GEM单药化疗,本文试图通过Meta分析,探讨GEM FDR输注联合奥沙利铂(GEMOX)一线治疗晚期胰腺癌的地位和价值.方法:通过MEDLINE、EMBASE、ASCO等数据库及论文集检索国内外的相关文献.选择治疗组为GEMOX方案化疗,对照组为标准GEM单药化疗的晚期胰腺癌随机对照试验.由2位评价者分别按上述检索策略收集资料,按纳入标准入选,主要对总生存率及主要不良反应进行Meta分析.结果:从182篇文献中筛选出符合纳入标准的2个随机对照试验,共涉及869例患者.与GEM单药组比较,GEMOX组半年生存率提高9%(95%CI 0.03～0.16,P=0.005),1年生存率提高5%(95%CI-0.01～0.11,P=0.08),客观有效率提高6%(95%CI 0.02～0.10,P=0.006);WHO Ⅲ/Ⅳ度贫血发生率下降5%(95%CI-0.08～-0.01,P=0.01),恶心/呕吐提高13%(95%CI 0.08～0.18,P＜0.001),神经毒性增加14%(95%CI 0.04～0.24,P=0.009),粒细胞减少症、血小板减少症两组相似,差异无统计学意义.结论:现有的证据提示,GEM固定剂量率输注联合奥沙利铂组成的GEMOX方案一线治疗晚期胰腺癌可能有较好的应用前景,值得进行进一步的临床试验.

Meta-analysis on gemcitabine of fixed-dose rate infusion plus oxaliplatin as first-line therapy for advanced pancreatic cancer

BACKGROUND & OBJECTIVE: Recent clinical trials showed that gemcitabine (GEM) of fixed-dose rate infusion has certain effect on advanced pancreatic cancer. Some meta-analyses suggest that GEM plus cisplatin (DDP) or its analogues is better than GEM alone in treating advanced pancreatic cancer. This study was to evaluate the efficacy of GEM of fixed-dose rate infusion plus oxaliplatin (GEMOX regimen) as first-line therapy for advanced pancreatic cancer by meta-analysis. METHODS: Two reviewers performed the meta-analysis of all relative studies through searching the international literature, including MEDLINE, EMBASE, ASCO abstracts. This meta-analysis included all randomized evidences to compare GEMOX regimen with GEM alone with respect to overall survival rate and adverse events in patients with advanced pancreatic cancer. RESULTS: Two randomized controlled trials (including 869 patients) were screened from 182 reports. GEMOX regimen was better than GEM alone in terms of 6-month survival rate [risk difference (RD)=0.09, 95% confidence interval (CI)=0.03-0.16, P=0.005], 1-year survival rate (RD=0.05, 95% CI=-0.01-0.11, P=0.08), and objective remission rate (RD=0.06, 95% CI=0.02-0.10, P=0.006). WHO grade 3-4 adverse events analysis revealed that GEMOX was associated with a reduction in anemia (RD=-0.05, 95% CI=-0.08 - -0.01, P=0.01); the addition of oxaliplatin, however, significantly increased neuropathy (RD= 0.14, 95% CI=0.04-0.24, P=0.009) and nausea/vomiting (RD=0.13, 95% CI=0.08-0.18, P<0.001). The occurrence rates of neutropenia and thrombocytopenia were similar in the 2 groups. CONCLUSION: Analyses of the available evidences suggest GEMOX regimen is promising as the first-line therapy for advanced pancreatic cancer, which encourages further clinical trials.