通俗易懂的摘要:不同类型癌症患者接受福替替尼治疗的安全性分析。

IF 3 4区 医学 Q2 ONCOLOGY
Funda Meric-Bernstam, Antoine Hollebecque, Junji Furuse, Do-Youn Oh, John A Bridgewater, Bailey Anderson, Nanae Hangai, Volker Wacheck, Lipika Goyal
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引用次数: 0

摘要

研究人员综合了三项独立的1期和2期临床试验的信息,其中包括超过400名患有33种不同癌症类型的患者,他们都在临床试验中接受了福替巴替尼治疗。这类研究被称为集合分析。福替巴替尼是一种口服片剂,通过降低一组名为成纤维细胞生长因子受体(FGFR)的蛋白质的活性来发挥作用。成纤维细胞生长因子受体会促进某些癌症的生长,尤其是成纤维细胞生长因子受体基因发生变化的癌细胞,这种变化会使这些蛋白更加活跃。研究人员希望了解一些副作用在接受福替替尼治疗的人群中的常见程度、服用福替替尼后副作用发生的时间以及如何控制这些副作用。研究人员还希望就如何控制癌症患者的这些副作用向其他医护人员提供建议:在这项分析中,研究人员重点研究了他们在之前完成的福替替尼试验中发现的副作用。总的来说,福替替尼是安全和可耐受的。大多数人(82%)的血液中磷酸盐水平较高(高磷酸盐血症),27%的人出现指甲病变,27%的人出现肝脏副作用(肝脏相关实验室检查的变化),19%的人出现口腔溃疡(口腔炎),13%的人出现手足综合征(掌跖红斑综合征),9%的人出现皮疹,8%的人出现眼底病变(视网膜病变),4%的人出现白内障。大多数副作用为轻度/中度,且可逆。从开始治疗到出现严重副作用的中位时间从 9 天(高磷血症)到 125 天(白内障)不等。有些副作用发生较早,有些则较晚。只有2%的人因与治疗相关的副作用而停止服用福替巴替尼,而且福替巴替尼没有导致死亡。 结果意味着什么?要全面了解福替替尼的安全性,研究人员需要研究在实际环境中(临床试验之外)长期服用福替替尼的患者会出现哪些副作用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Plain language summary: an analysis of the safety of futibatinib treatment in people with different types of cancer.

What is this summary about?: Researchers combined information from three separate phase 1 and 2 clinical trials, including over 400 people who had one of 33 different cancer types and who all received futibatinib in their clinical trial. This type of study is called a pooled analysis. Futibatinib is taken orally (by mouth) as a tablet and works by reducing the activity of a group of proteins called fibroblast growth factor receptors (FGFRs). FGFRs drive the growth of some cancers, especially cancer cells with changes in FGFR genes that make the proteins more active. Researchers wanted to look at how common some side effects were in people treated with futibatinib, how soon the side effects happened after taking futibatinib, and how they could be managed. Researchers also wanted to provide recommendations to other health care professionals on how to manage these side effects in people with cancer.

What were the results?: In this analysis, the researchers focused on side effects that they had seen in previously completed trials of futibatinib. Overall, futibatinib was safe and tolerable. Most people (82%) had a high phosphate level in their blood (hyperphosphatemia), 27% had nail disorders, 27% had liver side effects (changes in liver-related laboratory tests), 19% had a sore mouth (stomatitis), 13% had hand-foot syndrome (palmar-plantar erythrodysesthesia syndrome), 9% had a rash, 8% developed changes in the back of the eye (retinal disorders), and 4% of people developed cataracts. Most side effects were mild/moderate and reversible. The median time it took from starting treatment to experiencing a severe side effect ranged from 9 days (hyperphosphatemia) to 125 days (cataracts). Some side effects tended to occur early, while others developed later. Only 2% of people stopped taking futibatinib due to treatment-related side effects, and futibatinib caused no deaths.

What do the results mean?: The side effects from taking futibatinib were manageable and similar in people with different types of cancer. To fully understand the safety of futibatinib, researchers will need to look at what side effects are reported in people taking futibatinib over a longer time in the real-world setting (outside of clinical trials).

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来源期刊
Future oncology
Future oncology ONCOLOGY-
CiteScore
5.40
自引率
3.00%
发文量
335
审稿时长
4-8 weeks
期刊介绍: Future Oncology (ISSN 1479-6694) provides a forum for a new era of cancer care. The journal focuses on the most important advances and highlights their relevance in the clinical setting. Furthermore, Future Oncology delivers essential information in concise, at-a-glance article formats - vital in delivering information to an increasingly time-constrained community. The journal takes a forward-looking stance toward the scientific and clinical issues, together with the economic and policy issues that confront us in this new era of cancer care. The journal includes literature awareness such as the latest developments in radiotherapy and immunotherapy, concise commentary and analysis, and full review articles all of which provide key findings, translational to the clinical setting.
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