Meta-analysis of randomized trials: evaluation of benefit from gemcitabine-based combination chemotherapy applied in advanced pancreatic cancer.
Meta-analysis of randomized trials: evaluation of benefit from gemcitabine-based combination chemotherapy applied in advanced pancreatic cancer.
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DOI：
10.1186/1471-2407-8-82
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发表时间：
2008-03-28
期刊：
影响因子：
3.8
通讯作者：
Louvet, Christophe
中科院分区：
文献类型：
--
作者：
Heinemann, Volker;Boeck, Stefan;Hinke, Axel;Labianca, Roberto;Louvet, Christophe
吉西他滨（GEM）单药治疗是晚期和转移性胰腺癌的标准治疗。本研究探讨了以GEM为基础的联合化疗是否能进一步提高疗效的问题。进行荟萃分析，以评价比较GEM与GEM+X（X =细胞毒性药物）的随机试验。包括4465例患者的15项试验符合总生存期分析的条件，这是本研究的主要终点。荟萃分析显示GEM+X具有显著的生存获益，合并风险比（HR）为0.91（95% CI：0.85 - 0.97，p = 0.004）。异质性的总体检验结果为p = 0.82（I2 = 0%）。铂类联合治疗的分析表明HR为0.85（95% CI：0.76 - 0.96，p = 0.010），而氟嘧啶类联合治疗的HR为0.90（95% CI：0.81 - 0.99，p = 0.030）。在GEM联合伊立替康、依沙替康或培美曲塞的试验组中未观察到风险降低（HR = 0.99）。在5项试验（1682例患者）中对具有充足基线体能状态（PS）信息的试验进行了荟萃分析。该分析表明，PS良好的患者在接受联合化疗时具有显著的生存获益（HR = 0.76; 95% CI：0.67 - 0.87; p < 0.0001）。相比之下，对最初PS较差的患者应用联合化疗似乎无效（HR = 1.08; 95% CI：0.90 - 1.29，p = 0.40）。随机试验的荟萃分析表明，当吉西他滨与铂类似物或氟嘧啶联合使用时，具有显著的生存获益。基于初步亚组分析（占本荟萃分析中纳入的所有患者的38%），PS良好的胰腺癌患者似乎从基于GEM的细胞毒性联合治疗中获益，而PS较差的患者似乎没有从联合化疗中获益。
Single-agent gemcitabine (GEM) is a standard treatment for advanced and metastatic pancreatic cancer. This study examines the question whether GEM-based combination chemotherapy can further improve treatment efficacy. A meta-analysis was performed to evaluate randomized trials comparing GEM versus GEM+X (X = cytotoxic agent). Fifteen trials including 4465 patients were eligible for an analysis of overall survival, the primary end-point of this investigation. The meta-analysis revealed a significant survival benefit for GEM+X with a pooled hazard ratio (HR) of 0.91 (95% CI: 0.85 – 0.97, p = 0.004). The overall test for heterogeneity resulted in p = 0.82 (I2 = 0%). The analysis of platinum-based combinations indicated a HR of 0.85 (95% CI: 0.76 – 0.96, p = 0.010), while for fluoropyrimidine-based combinations the HR was 0.90 (95% CI: 0.81 – 0.99, p = 0.030). No risk reduction was observed in the group of trials combining GEM with irinotecan, exatecan or pemetrexed (HR = 0.99). A meta-analysis of the trials with adequate information on baseline performance status (PS) was performed in five trials with 1682 patients. This analysis indicated that patients with a good PS had a marked survival benefit when receiving combination chemotherapy (HR = 0.76; 95% CI: 0.67 – 0.87; p < 0.0001). By contrast, application of combination chemotherapy to patients with an initially poor PS appeared to be ineffective (HR = 1.08; 95% CI: 0.90 – 1.29, p = 0.40). The meta-analysis of randomized trials indicated a significant survival benefit when GEM was either combined with platinum analogs or fluoropyrimidines. Based on a preliminary subgroup analysis (representing 38% of all patients included in this meta-analysis), pancreatic cancer patients with a good PS appear to benefit from GEM-based cytotoxic combinations, whereas patients with a poor PS seem to have no survival benefit from combination chemotherapy.
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