Network meta-analysis of adjuvant chemotherapy in biliary tract cancers: Setting the scene for new randomized evidence

IF 6 2区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Liver International Pub Date : 2024-07-29 DOI:10.1111/liv.16047

Francesca Salani, Guglielmo Vetere, Daniele Rossini, Virginia Genovesi, Martina Carullo, Linda Bartalini, Valentina Massa, Laura Bernardini, Miriam Caccese, Silvia Cesario, Jessica Graziani, Giada Grelli, Francesco Mangogna, Caterina Vivaldi, Gianluca Masi, Lorenzo Fornaro

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引用次数: 0

Abstract

Background and Aims

The best adjuvant chemotherapy for resected biliary tract cancer (BTC) is under debate, with capecitabine supported by weak evidence. Aim of this network meta-analysis is to estimate the efficacy of different phase II/III regimens, comparing monotherapies (gemcitabine or fluoropyrimidines) head-to-head, against observation and combination regimens.

Methods

A comprehensive literature search was conducted on PubMed and EMBASE for phase II/III randomized clinical trials (RCTs) available as of December 2023, reporting hazard ratios (HRs) of overall survival (OS) and event-free survival (EFS). A frequentist framework employing a random-effects model was applied; treatment rankings were outlined according to P-score, based on direct and indirect evidence. Exploratory subgroup analyses for OS were also performed (primary site, resected margin status and nodal involvement).

Results

Six RCTs (1979 total patients) were identified. Fluoropyrimidine monotherapy showed significantly better OS (HR .84 [.72–.97]) and EFS (HR .79 [.69–.91]) than observation, as any monotherapy did (HR .84 [.74–.96]; HR .79 [.70–.89]). In the head-to-head comparison for OS, only S1 confirmed to be superior to observation alone (HR .69 [.49–.98]) while fluoropyrimidines achieved the best P score (.81), similarly to any monotherapy (0.92). Combinations failed to prove superior to monotherapies with respect both to OS and EFS. Subgroup analyses were inconclusive due to results' inconsistency and limited sample size.

Conclusions

Our work confirmed that adjuvant chemotherapy grants OS and EFS benefit for resected BTC patients. Fluoropyrimidines appeared the most effective option, confirming capecitabine as the preferred choice for the Western population.

查看原文本刊更多论文

胆道癌症辅助化疗的网络荟萃分析：为新的随机证据做好准备。

背景和目的：切除胆道癌（BTC）的最佳辅助化疗方案尚存争议，其中卡培他滨证据不足。本网络荟萃分析旨在估算不同II/III期治疗方案的疗效，将单一疗法（吉西他滨或氟嘧啶类）与观察和联合疗法进行头对头比较：在 PubMed 和 EMBASE 上对截至 2023 年 12 月的 II/III 期随机临床试验（RCT）进行了全面的文献检索，这些试验报告了总生存期（OS）和无事件生存期（EFS）的危险比（HRs）。该研究采用随机效应模型的频数主义框架；根据直接和间接证据，按照P-得分对治疗进行排序。还对OS进行了探索性亚组分析（原发部位、切除边缘状态和结节受累）：结果：共确定了 6 项 RCT（共 1979 名患者）。氟嘧啶单药的OS（HR .84[.72-.97]）和EFS（HR .79 [.69-.91]）明显优于观察组，任何单药均是如此（HR .84 [.74-.96]；HR .79 [.70-.89]）。在OS的头对头比较中，只有S1被证实优于单独观察（HR .69 [.49-.98] ），而氟嘧啶类药物获得了最好的P评分（0.81），与任何单一疗法（0.92）相似。在OS和EFS方面，联合疗法未能证明优于单一疗法。由于结果不一致和样本量有限，亚组分析没有得出结论：我们的研究证实，辅助化疗可使切除的BTC患者在OS和EFS方面获益。氟嘧啶类药物似乎是最有效的选择，证实卡培他滨是西方人群的首选。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Liver International 医学-胃肠肝病学

CiteScore

13.90

自引率

4.50%

发文量

348

审稿时长

2 months

期刊介绍： Liver International promotes all aspects of the science of hepatology from basic research to applied clinical studies. Providing an international forum for the publication of high-quality original research in hepatology, it is an essential resource for everyone working on normal and abnormal structure and function in the liver and its constituent cells, including clinicians and basic scientists involved in the multi-disciplinary field of hepatology. The journal welcomes articles from all fields of hepatology, which may be published as original articles, brief definitive reports, reviews, mini-reviews, images in hepatology and letters to the Editor.