Cao Chunxiang, Kuang Meng, Xu Wei, Zhang Xunlei, Chen Jinfei, Tang Cuiju
Department of Oncology, Nanjing First Hospital, Nanjing Medical University, Nanjing Department of Radiation Oncology, The First Affiliated Hospital of Soochow University, Soochow University, Suzhou.
Department of Oncology, Nanjing First Hospital, Nanjing Medical University, Nanjing.
Jpn J Clin Oncol. 2015 Dec;45(12):1122-30. doi: 10.1093/jjco/hyv141. Epub 2015 Oct 30.
Gemcitabine-based chemotherapy is widely used for unresectable advanced pancreatic cancer which contains locally advanced and metastatic pancreatic cancer. We performed meta-analysis to examine whether gemcitabine plus S-1 could improve treatment efficacy as first-line chemotherapy for those patients when compared with gemcitabine alone.
STATA was used to estimate the summary hazard ratios or odds ratios and their 95% confidence intervals. Heterogeneity among trials was examined by Cochran's χ(2) test. Publication bias was evaluated by Begg's and Egger's tests. Subgroup analysis based on the extent of disease was performed.
Four randomized controlled trials including 878 Asian patients were analyzed. In total meta-analysis, gemcitabine plus S-1 significantly improved overall survival (hazard ratio, 0.82; 95% confidence interval, 0.70-0.96; P = 0.015), progression-free survival (hazard ratio, 0.64; 95% confidence interval, 0.55-0.74; P < 0.001), overall response rate (odds ratio, 3.00; 95% confidence interval, 2.04-4.41; P < 0.001) and disease control rate (odds ratio, 1.78; 95% confidence interval, 1.32 to 2.39; P < 0.001), and was associated with more but manageable hematologic (leukocytopenia, neutropenia, thrombocytopenia) and non-hematologic (diarrhea, stomatitis, nausea, rash) adverse events. In subgroup analysis, gemcitabine plus S-1, comparing with gemcitabine, significantly improved overall survival in locally advanced patients (hazard ratio, 0.69; 95% confidence interval, 0.48 to 0.99; P = 0.022) but not in metastatic patients (hazard ratio, 0.75; 95% confidence interval, 0.46-1.23; P = 0.256).
This meta-analysis confirmed the survival benefits of gemcitabine plus S-1 as first-line treatment for unresectable advanced pancreatic cancer at least in Asia, while good Eastern Cooperative Oncology group performance status was warranted. Importantly, we highlighted the significant overall survival benefit of gemcitabine plus S-1 in locally advanced patients but not in metastatic patients.
基于吉西他滨的化疗广泛应用于不可切除的晚期胰腺癌，其中包括局部晚期和转移性胰腺癌。我们进行了荟萃分析，以检验与单用吉西他滨相比，吉西他滨联合S-1作为这些患者的一线化疗是否能提高治疗效果。
使用STATA估计汇总风险比或比值比及其95%置信区间。通过Cochran's χ(2)检验检查试验间的异质性。通过Begg检验和Egger检验评估发表偏倚。基于疾病范围进行亚组分析。
分析了四项随机对照试验，共878例亚洲患者。在总体荟萃分析中，吉西他滨联合S-1显著改善了总生存期（风险比，0.82；95%置信区间，0.70 - 0.96；P = 0.015）、无进展生存期（风险比，0.64；95%置信区间，0.55 - 0.74；P < 0.001）、总缓解率（比值比，3.00；95%置信区间，2.04 - 4.41；P < 0.001）和疾病控制率（比值比，1.78；95%置信区间，1.32至2.39；P < 0.001），并且与更多但可控制的血液学（白细胞减少、中性粒细胞减少、血小板减少）和非血液学（腹泻、口腔炎、恶心、皮疹）不良事件相关。在亚组分析中，与吉西他滨相比，吉西他滨联合S-1在局部晚期患者中显著改善了总生存期（风险比，0.69；95%置信区间，0.48至0.99；P = 0.022），但在转移性患者中未改善（风险比，0.75；95%置信区间，0.46 - 1.23；P = 0.256）。
这项荟萃分析证实了吉西他滨联合S-1作为不可切除晚期胰腺癌一线治疗的生存获益，至少在亚洲如此，同时需要良好的东部肿瘤协作组体能状态。重要的是，我们强调了吉西他滨联合S-1在局部晚期患者中显著的总生存期获益，但在转移性患者中未观察到。
