伴随诊断在推进以患者为中心的抗癌药物治疗中的作用。

IF 1.7 4区 医学 Q3 PHARMACOLOGY & PHARMACY
Nanaki Shingyo, Manaka Taguchi, Mizuki Matsubara, Michitaka Shichijo, Naoki Matsumaru, Katsura Tsukamoto
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引用次数: 0

摘要

癌症是一种与年龄相关的疾病,影响着每两个日本人中就有一个人,由于其临床特征、高昂的治疗费用和相关的不良事件(ae),给患者和护理人员带来了沉重的负担。因此,癌症治疗仍然是公众关注的主要问题。近年来,以患者为中心的医疗服务越来越受到重视,并在癌症治疗中得到强烈要求。伴随诊断(CDx)有望促进个性化治疗;然而,他们目前的状况尚不清楚。在这项研究中,我们基于药物批准时的可用数据评估了CDx在抗癌药物治疗中的作用。我们的分析显示,在日本患者中,需要CDx的抗癌药物(wCDx)的获益-风险比(定义为抗癌药物的客观反应率除以严重不良事件的发生率)明显高于不需要CDx的抗癌药物(1.54倍,p < 0.0135)。虽然两组间客观有效率无差异,但wCDx组严重不良反应发生率较低。这些发现表明,CDx有助于确定更适合特定抗癌治疗的患者和/或wCDx治疗中的活性药物成分具有较低的严重ae风险。为了进一步促进以患者为中心的医疗保健,应该通过监管支持,鼓励CDx与新的抗癌药物一起积极开发,尽管开发障碍更高,特别是因为两组药物之间的药物定价没有差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Role of Companion Diagnostics in Advancing Patient-Centered Anticancer Drug Treatment.

Cancer is an age-related disease that affects one in two Japanese individuals, placing a significant burden on both patients and caregivers due to its clinical characteristics, high treatment costs, and associated adverse events (AEs). Consequently, cancer treatment remains a major public concern. In recent years, patient-centered medical care has gained increasing attention and is strongly desired in cancer treatment. Companion diagnostics (CDx) are expected to facilitate personalized treatment; however, their current status remains unclear. In this study, we evaluated the role of CDx in anticancer drug treatment based on data available at the time of drug approval. Our analysis revealed that the benefit-risk ratio, defined as the objective response rate of an anticancer drug divided by the incidence of severe AEs, was significantly higher for anticancer drugs requiring CDx (wCDx) in Japanese patients (1.54-fold, p < 0.0135) than for anticancer drugs not requiring CDx. Although the objective response rate did not differ between the 2 groups, the incidence of severe AEs was lower in the wCDx group. These findings suggest that CDx helps identify patients who are better suited for specific anticancer treatments and/or that active pharmaceutical ingredients in wCDx therapies carry a lower risk of severe AEs. To further promote patient-centered medical care, the active development of CDx alongside new anticancer drugs should be encouraged, despite the higher development hurdles, through regulatory support, particularly since drug pricing does not differ between the 2 groups.

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来源期刊
CiteScore
3.50
自引率
5.00%
发文量
247
审稿时长
2 months
期刊介绍: Biological and Pharmaceutical Bulletin (Biol. Pharm. Bull.) began publication in 1978 as the Journal of Pharmacobio-Dynamics. It covers various biological topics in the pharmaceutical and health sciences. A fourth Society journal, the Journal of Health Science, was merged with Biol. Pharm. Bull. in 2012. The main aim of the Society’s journals is to advance the pharmaceutical sciences with research reports, information exchange, and high-quality discussion. The average review time for articles submitted to the journals is around one month for first decision. The complete texts of all of the Society’s journals can be freely accessed through J-STAGE. The Society’s editorial committee hopes that the content of its journals will be useful to your research, and also invites you to submit your own work to the journals.
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