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2
A randomized Phase III trial of adjuvant S-1 therapy vs. observation alone in resected biliary tract cancer: Japan Clinical Oncology Group Study (JCOG1202, ASCOT).一项关于辅助性S-1治疗与单纯观察在切除的胆管癌中对比的随机III期试验:日本临床肿瘤学组研究(JCOG1202,ASCOT)
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Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer.随机对照临床试验:辅助吉西他滨化疗对比观察用于胆管癌根治术后。
Br J Surg. 2018 Feb;105(3):192-202. doi: 10.1002/bjs.10776.
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Cancer statistics, 2018.癌症统计数据,2018 年。
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Adjuvant chemotherapy for resected biliary tract cancers: a systematic review and meta-analysis.切除术后胆道癌的辅助化疗:一项系统评价和荟萃分析。
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6
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7
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Ann Oncol. 2016 Sep;27(suppl 5):v28-v37. doi: 10.1093/annonc/mdw324.
8
Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - a randomized, multidisciplinary, multinational phase III trial.吉西他滨和顺铂辅助化疗与胆管癌及肌层浸润性胆囊癌根治性切除术后观察的比较(ACTICCA-1试验)——一项随机、多学科、多国III期试验
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9
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对根治性切除的胆道癌辅助治疗的系统评价和网状Meta分析。

A systematic review and network meta-analysis of adjuvant therapy for curatively resected biliary tract cancers.

作者信息

Kish M, Chan K, Perry K, Ko Y J

机构信息

Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, ON.

Department of Medicine, Queen's University, Kingston, ON.

出版信息

Curr Oncol. 2020 Feb;27(1):e20-e26. doi: 10.3747/co.27.5465. Epub 2020 Feb 1.

DOI:10.3747/co.27.5465
PMID:32218664
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7096209/
Abstract

BACKGROUND

Recent randomized controlled trials (rcts) have contributed high-quality data about adjuvant therapy in curatively resected biliary tract cancer (btc); however, a standard approach to treating those patients still has not been developed.

METHODS

We conducted a systematic review of published studies and abstracts up to and including June 2018, choosing rcts involving patients with btc receiving adjuvant chemotherapy after complete surgical resection. Network meta-analysis methods were used for indirect comparisons of overall survival (os) and relapse-free survival (rfs) for various adjuvant therapies.

RESULTS

Five rcts were included in qualitative synthesis, and three rcts (bilcap, prodige 12-accord 18, and bcat) had data sufficient for inclusion in the meta-analysis. Results from the indirect comparison demonstrated no significant improvement in os for capecitabine compared with gemcitabine or with gemcitabine-oxaliplatin (gemox), the hazard ratios (hrs) being 0.82 [95% confidence interval (ci): 0.53 to 1.27] and 0.86 (95% ci: 0.56 to 1.34) respectively. Similarly, no significant improvement in rfs was observed for capecitabine compared with gemcitabine or gemox.

CONCLUSIONS

Although in the present analysis, we found no statistically significant improvements in os or rfs for capecitabine compared with gemox or gemcitabine, capecitabine can-until further prospective trials are completed-be considered the standard of care in the adjuvant setting based on a single randomized phase iii study.

摘要

背景

近期的随机对照试验(RCT)为根治性切除的胆管癌(BTC)辅助治疗提供了高质量数据;然而,尚未制定出治疗这些患者的标准方法。

方法

我们对截至2018年6月(含该月)发表的研究和摘要进行了系统评价,选择了涉及BTC患者在完全手术切除后接受辅助化疗的RCT。采用网状Meta分析方法对各种辅助治疗的总生存期(OS)和无复发生存期(RFS)进行间接比较。

结果

定性综合纳入了5项RCT,3项RCT(BILCAP、PRODIGE 12-ACCORD 18和BCAT)的数据足以纳入Meta分析。间接比较结果显示,与吉西他滨或吉西他滨-奥沙利铂(GEMOX)相比,卡培他滨的OS无显著改善,风险比(HR)分别为0.82[95%置信区间(CI):0.53至1.27]和0.86(95%CI:0.56至1.34)。同样,与吉西他滨或GEMOX相比,卡培他滨的RFS也未观察到显著改善。

结论

尽管在本分析中,我们发现与GEMOX或吉西他滨相比,卡培他滨的OS或RFS无统计学显著改善,但在进一步的前瞻性试验完成之前,基于一项单一的随机III期研究,卡培他滨可被视为辅助治疗中的标准治疗方案。