免疫检查点抑制剂在日本治疗恶性胸膜间皮瘤中的真正优势。

IF 1.6 4区 医学 Q4 ONCOLOGY
Kozo Kuribayashi, Jun Hirano
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引用次数: 0

摘要

2004 年 2 月,美国食品和药物管理局(FDA)率先批准将顺铂(CDDP)和培美曲塞(PEM)联合疗法作为标准一线化疗药物,用于治疗未经治疗、无法切除的恶性胸膜间皮瘤(MPM)。然而,在获得批准后的近 15 年里,MPM 的标准一线治疗一直没有取得进展。2015 年 12 月,《柳叶刀》杂志发表了一项 3 期研究(间皮瘤阿瓦斯汀-顺铂-培美曲塞研究:MAPS)的积极结果,验证了在 CDDP/PEM 中添加抗血管生成药物贝伐单抗治疗不可切除的 MPM 的效果;然而,这并没有促使国家药品监管机构批准该药物。此外,CDDP/PEM难治性病例的二线治疗尚未确立。2018 年 8 月,日本药品和医疗器械管理局在世界上率先批准使用免疫检查点抑制剂(ICI)nivolumab 单药治疗既往不可切除的晚期或复发性 MPM。继日本之后,美国食品和药物管理局于 2020 年 10 月批准了 nivolumab 和 ipilimumab 联合疗法,用于治疗既往未经治疗、无法切除的 MPM。在本文中,我们将结合历史背景回顾 MPM 药物治疗的转型,重点介绍 ICIs 的益处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
True Benefits of Immune Checkpoint Inhibitors in the Treatment of Malignant Pleural Mesothelioma in Japan.

In February 2004, the Food and Drug Administration (FDA) was the first to approve the combination of cisplatin (CDDP) and pemetrexed (PEM) as standard first-line chemotherapy for untreated, unresectable malignant pleural mesothelioma (MPM). However, after that approval, no progress was made in the standard first-line treatment of MPM for almost 15 years. Positive results from a phase 3 study (Mesothelioma Avastin Cisplatin Pemetrexed Study: MAPS) verifying the effect of bevacizumab, an anti-angiogenesis agent added to CDDP/PEM for unresectable MPM, were published in The Lancet in December 2015; however, this did not lead to approval by national drug regulatory agencies. Furthermore, no second-line treatment was established for cases refractory to CDDP/PEM. In August 2018, the Pharmaceuticals and Medical Devices Agency of Japan was the first in the world to approve monotherapy with nivolumab, an immune checkpoint inhibitor (ICI), for previously unresectable, advanced, or recurrent MPM. Following Japan, in October 2020, the FDA approved the combination of nivolumab and ipilimumab for the treatment of previously untreated, unresectable MPM. In this article, we review the transition of drug treatment for MPM, in light of the historical background, focusing on the benefits of ICIs.

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来源期刊
Anticancer research
Anticancer research 医学-肿瘤学
CiteScore
3.70
自引率
10.00%
发文量
566
审稿时长
2 months
期刊介绍: ANTICANCER RESEARCH is an independent international peer-reviewed journal devoted to the rapid publication of high quality original articles and reviews on all aspects of experimental and clinical oncology. Prompt evaluation of all submitted articles in confidence and rapid publication within 1-2 months of acceptance are guaranteed. ANTICANCER RESEARCH was established in 1981 and is published monthly (bimonthly until the end of 2008). Each annual volume contains twelve issues and index. Each issue may be divided into three parts (A: Reviews, B: Experimental studies, and C: Clinical and Epidemiological studies). Special issues, presenting the proceedings of meetings or groups of papers on topics of significant progress, will also be included in each volume. There is no limitation to the number of pages per issue.
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