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Safety outcomes of low versus high dose imatinib mesylate in patients with advanced, metastatic, or nonresectable gastrointestinal stromal tumors: A systematic review. 甲磺酸伊马替尼治疗晚期、转移性或不可切除胃肠道间质瘤患者的低剂量与高剂量安全性结果:系统综述。
Pub Date : 2024-01-01 Epub Date: 2024-03-12 DOI: 10.54844/git.2023.482
Marena A Marucci, Doreen W Lechner, Barbara A Tafuto

Background and objectives: Gastrointestinal stromal tumors (GIST) are a rare cancer where tumors grow along the gastrointestinal tract. While treatment options aim towards surgical resection, some patients present with advanced metastatic and/or nonresectable diseases. The tyrosine kinase inhibitor imatinib mesylate is approved for this indication. However, dose escalation from 400 to 600 mg/d or 800 mg/d is allowed. The present study systematically evaluates the safety outcomes, particularly the incidence of grade ⩾ 3 adverse events (AEs) with low dose compared with high dose imatinib in these patients.

Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines were utilized to identify relevant studies through the PubMed, Cochrane Library, and Ovid databases and included randomized and non-randomized clinical trials comparing a low dose intervention of imatinib 400 mg/d with a high dose comparator of 600 or 800 mg/d in patients with histologically confirmed advanced metastatic and/or nonresectable GIST. Four studies were reviewed regarding study summaries and patient characteristics, patient demographics, and risk of bias, with a main emphasis on the evaluation of both efficacy outcomes and safety outcomes.

Results: Three of the four studies did not provide significant differences in response outcomes; however, all four studies reported a higher incidence of grade ⩾ 3 AEs in the high dose imatinib groups. Individual study reports of more high dose patients experiencing a grade ⩾ 3 event ranged from 0.6% to 19.8%, while combined low and high dose patient arms revealed a 17.1% difference favoring a high dose patient event. A sub-analysis of the three most frequently occurring categories, blood and lymphatic system disorders, gastrointestinal disorders, and general disorders and administration site conditions each revealed more high dose patients experiencing said category events compared to those low dose counterparts.

Conclusion: Low dose imatinib provides clinically meaningful response and demonstrated better tolerability with less frequently reported reactions. This evidence supports further research into the maintenance of 400 mg/d for this patient population compared to a dose escalation.

背景和目的:胃肠道间质瘤(GIST)是一种罕见的癌症,肿瘤沿着胃肠道生长。虽然治疗方案以手术切除为目标,但一些患者会出现晚期转移性和/或不可切除性疾病。酪氨酸激酶抑制剂甲磺酸伊马替尼被批准用于这一适应症。不过,该药的剂量可以从 400 mg/d 增加到 600 mg/d 或 800 mg/d。本研究系统评估了这些患者使用低剂量与高剂量伊马替尼的安全性结果,尤其是3级不良事件(AEs)的发生率:利用《2020 年系统综述和荟萃分析首选报告项目》指南,通过 PubMed、Cochrane 图书馆和 Ovid 数据库确定相关研究,并纳入随机和非随机临床试验,对组织学确诊的晚期转移性和/或不可切除 GIST 患者进行伊马替尼 400 毫克/天的低剂量干预与 600 或 800 毫克/天的高剂量比较。研究人员对四项研究的研究摘要、患者特征、患者人口统计学和偏倚风险进行了审查,重点是疗效和安全性结果的评估:结果:四项研究中的三项在反应结果方面没有显著差异;但所有四项研究均报告称,高剂量伊马替尼组的 3 级 AE 发生率较高。个别研究报告称,更多的高剂量患者发生了⩾3级事件,其发生率从0.6%到19.8%不等,而合并低剂量和高剂量患者组后发现,17.1%的差异有利于高剂量患者事件的发生。对血液和淋巴系统疾病、胃肠道疾病以及一般疾病和用药部位状况这三个最常发生的类别进行的子分析表明,与低剂量患者相比,高剂量患者发生上述类别事件的人数更多:结论:低剂量伊马替尼能提供有临床意义的反应,并显示出较好的耐受性和较少报告的不良反应。这些证据支持对这一患者群体维持400 mg/d的剂量进行进一步研究,而不是进行剂量升级。
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Gastrointestinal tract (Hong Kong, China)
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