切除术后胆管癌的辅助化疗：随机试验的系统评价和荟萃分析。
Adjuvant chemotherapy in resected bile duct cancer: A systematic review and meta-analysis of randomized trials.
机构信息
Department of Medical Oncology, Santa Chiara Hospital, Trento, Italy.
Department of Medical Oncology, Santa Chiara Hospital, Trento, Italy; Unit of Medical Oncology, Department of Surgery and Oncology, University of Verona Hospital Trust, Verona, Italy.
出版信息
Crit Rev Oncol Hematol. 2019 Nov;143:124-129. doi: 10.1016/j.critrevonc.2019.09.002. Epub 2019 Sep 9.
BACKGROUND
The role of adjuvant chemotherapy (ACT) for resected biliary tract cancer (BTC) is still unclear and there is no specific recommendation by international guidelines.
AIM
To perform a meta-analysis of randomized clinical trials (RCTs) to better define the clinical benefit and risks of ACT or observation in resected BTC.
METHOD
A systematic literature search of Pubmed, Embase, and the Cochrane Library was performed up to April 2019. A meta-analysis was carried out using the random effects model.
RESULTS
ACT provided a mild improvement in recurrence free survival (RFS) (HR:0.83, 95%CI 0.69-0.99) and no effect on overall survival (OS) (HR:0.91, 95%CI 0.75-1.09). Similarly, ACT showed no effect on OS in lymph-node positive subgroup (HR:0.84, 95% CI 0.65-1.08) and surgical margin positive subgroup (HR:0.95, 95%CI 0.69-1.31). Moreover, ACT led to a substantial increase of chemotherapy-associated adverse events (RR:3.03, 95%CI 2.22-4.15).
CONCLUSION
ACT for resected BTC patients modestly improved RFS with no effect on OS and a substantial increase in chemotherapy associated AEs.
背景
辅助化疗（ACT）在可切除胆道癌（BTC）中的作用仍不清楚，国际指南也没有具体推荐。
目的
对随机临床试验（RCT）进行荟萃分析，以更好地确定 ACT 或观察在可切除 BTC 中的临床获益和风险。
方法
对 Pubmed、Embase 和 Cochrane 图书馆进行了系统的文献检索，检索时间截至 2019 年 4 月。使用随机效应模型进行荟萃分析。
结果
ACT 可轻度改善无复发生存率（RFS）（HR：0.83，95%CI 0.69-0.99），但对总生存期（OS）无影响（HR：0.91，95%CI 0.75-1.09）。同样，ACT 对淋巴结阳性亚组（HR：0.84，95%CI 0.65-1.08）和手术切缘阳性亚组（HR：0.95，95%CI 0.69-1.31）的 OS 也没有影响。此外，ACT 导致化疗相关不良事件显著增加（RR：3.03，95%CI 2.22-4.15）。
结论
ACT 可适度改善可切除 BTC 患者的 RFS，对 OS 无影响，但与化疗相关的 AEs 显著增加。
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