Filetti Marco, Lombardi Pasquale, Giusti Raffaele, Falcone Rosa, Scotte Florian, Giannarelli Diana, Carcagnì Antonella, Altamura Valeria, Scambia Giovanni, Daniele Gennaro
Phase 1 Unit, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.
Medical Oncology Unit, Sant'Andrea Hospital of Rome, Rome, Italy.
Cancer Treat Rev. 2023 Apr;115:102512. doi: 10.1016/j.ctrv.2023.102512. Epub 2023 Jan 21.
Several regimens have been introduced in clinical practice in the last twenty years to treat chemotherapy-induced nausea and vomiting (CINV). However, direct comparative data remain insufficient, as many new regimes lack head-to-head comparisons. In this study, through an indirect comparison, we overcome this limit by providing the most up-to-date estimate of the efficacy and safety of all combinations used for HEC-induced nausea and vomiting.
We retrieved randomized controlled trials (RCTs) published in Pubmed, Embase, and Cochrane Library until June, 30th 2022. We included phase II-III RCTs, including adults with any cancer receiving HEC, and compared different antiemetic regimes to prevent CINV. The primary outcome was the overall complete response (defined as the absence of vomiting and of the use of rescue drugs from 0 to 120 hrs since chemotherapy); secondary outcomes were acute (absence of vomiting and use of rescue medicine 0-24 hrs after chemotherapy) and delayed (24-120 hrs) response and adverse events.
A total of 53 RCTs enrolling 22 228 patients were included. We classified the different antiemetic regimes into 21 different groups. Overall, 3- or 4-drug regimens containing a combination of dexamethasone, 5HT3 antagonists, mirtazapine or olanzapine with or without NK antagonists, yielded the highest probability to be the most effective regimen in terms of complete response. Regimens containing a combination of dexamethasone and 5-HT3 antagonist have the lowest probability of being the most effective regimen in terms of complete, acute, and delayed response.
In our network meta-analysis, 4-drug regimens with olanzapine displayed the highest probability of efficacy in terms of complete response. A 3-drug regimen with olanzapine represents a valid option in a limited resource context.
在过去二十年的临床实践中，已经引入了几种治疗化疗引起的恶心和呕吐（CINV）的方案。然而，直接的比较数据仍然不足，因为许多新方案缺乏直接对比。在本研究中，通过间接比较，我们通过提供用于高度致吐性化疗（HEC）引起的恶心和呕吐的所有组合的疗效和安全性的最新估计来克服这一限制。
我们检索了截至2022年6月30日发表在PubMed、Embase和Cochrane图书馆的随机对照试验（RCT）。我们纳入了II-III期RCT，包括接受HEC的任何癌症的成年人，并比较了不同止吐方案预防CINV的效果。主要结局是总体完全缓解（定义为自化疗后0至120小时无呕吐且未使用救援药物）；次要结局是急性（化疗后0至24小时无呕吐且未使用救援药物）和延迟（24至120小时）缓解以及不良事件。
共纳入53项RCT，涉及22228名患者。我们将不同的止吐方案分为21个不同的组。总体而言，包含地塞米松、5-羟色胺3（5HT3）拮抗剂、米氮平或奥氮平联合或不联合NK拮抗剂的三药或四药方案，在完全缓解方面成为最有效方案的可能性最高。就完全、急性和延迟缓解而言，包含地塞米松和5-HT3拮抗剂组合的方案成为最有效方案的可能性最低。
在我们的网络荟萃分析中，含奥氮平的四药方案在完全缓解方面显示出最高的疗效可能性。含奥氮平的三药方案在资源有限的情况下是一个有效的选择。
