德国一项单中心研究对胶质母细胞瘤患者的治疗模式和生存结果的现实分析:随机对照试验的生存率能否实现?

IF 3.7 Q1 CLINICAL NEUROLOGY
Neuro-oncology advances Pub Date : 2025-01-17 eCollection Date: 2025-01-01 DOI:10.1093/noajnl/vdaf009
Samuel Paus, Johannes Hoffmann, Julia Roeper, Frank Griesinger
{"title":"德国一项单中心研究对胶质母细胞瘤患者的治疗模式和生存结果的现实分析:随机对照试验的生存率能否实现?","authors":"Samuel Paus, Johannes Hoffmann, Julia Roeper, Frank Griesinger","doi":"10.1093/noajnl/vdaf009","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>The reported survival data for glioblastoma patients vary strongly between different studies. In our study, we therefore examined which data are applicable in a real-world population in a German center and how these real-world data perform in comparison to survival data presented in randomized controlled trials (RCTs).</p><p><strong>Methods: </strong>Data of all patients treated with newly diagnosed glioblastoma in a single German center between 2010 and 2019 were analyzed and treatment patterns plus survival rates were matched to existing real-world data and results of RCTs.</p><p><strong>Results: </strong>Two hundred thirty-three patients were analyzed. Median age was 63 years, f/m ratio was 1:162, and 73% of patients underwent surgery, while 27% had biopsy only. The extent of resection had a significant impact on overall survival (OS; <i>P</i> <.001), as well as age (<i>P</i> <.001), methylguanine methyltransferase methylation status (<i>P</i> <.001), and eastern cooperative oncology group performance status (<i>P</i> <.001). The median OS of our whole study population was 10.55 months. While a fictitious Stupp study cohort (built by using eligibility criteria of the EORTC-22981-26981 trial) with an OS of 14.3 months nearly achieved the survival results of the presented data from the EORTC-22981-26981 trial, the OS of the patients who did not fulfill the eligibility criteria was only 6.9 months.</p><p><strong>Conclusion: </strong>Survival of patients with unfavorable prognostic factors is still poor and these patients are not represented in recent RCTs. Outcome data of RCTs can be transferred to real world cohorts, if in- and exclusion criteria are fulfilled, while outcome is significantly inferior in cohorts that do not fulfill these criteria.</p>","PeriodicalId":94157,"journal":{"name":"Neuro-oncology advances","volume":"7 1","pages":"vdaf009"},"PeriodicalIF":3.7000,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11822374/pdf/","citationCount":"0","resultStr":"{\"title\":\"Real-world analysis of treatment patterns and survival outcome of glioblastoma patients in a German single-center study: Can survival rates of randomized controlled trials be achieved?\",\"authors\":\"Samuel Paus, Johannes Hoffmann, Julia Roeper, Frank Griesinger\",\"doi\":\"10.1093/noajnl/vdaf009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>The reported survival data for glioblastoma patients vary strongly between different studies. In our study, we therefore examined which data are applicable in a real-world population in a German center and how these real-world data perform in comparison to survival data presented in randomized controlled trials (RCTs).</p><p><strong>Methods: </strong>Data of all patients treated with newly diagnosed glioblastoma in a single German center between 2010 and 2019 were analyzed and treatment patterns plus survival rates were matched to existing real-world data and results of RCTs.</p><p><strong>Results: </strong>Two hundred thirty-three patients were analyzed. Median age was 63 years, f/m ratio was 1:162, and 73% of patients underwent surgery, while 27% had biopsy only. The extent of resection had a significant impact on overall survival (OS; <i>P</i> <.001), as well as age (<i>P</i> <.001), methylguanine methyltransferase methylation status (<i>P</i> <.001), and eastern cooperative oncology group performance status (<i>P</i> <.001). The median OS of our whole study population was 10.55 months. While a fictitious Stupp study cohort (built by using eligibility criteria of the EORTC-22981-26981 trial) with an OS of 14.3 months nearly achieved the survival results of the presented data from the EORTC-22981-26981 trial, the OS of the patients who did not fulfill the eligibility criteria was only 6.9 months.</p><p><strong>Conclusion: </strong>Survival of patients with unfavorable prognostic factors is still poor and these patients are not represented in recent RCTs. Outcome data of RCTs can be transferred to real world cohorts, if in- and exclusion criteria are fulfilled, while outcome is significantly inferior in cohorts that do not fulfill these criteria.</p>\",\"PeriodicalId\":94157,\"journal\":{\"name\":\"Neuro-oncology advances\",\"volume\":\"7 1\",\"pages\":\"vdaf009\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-01-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11822374/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Neuro-oncology advances\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1093/noajnl/vdaf009\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Neuro-oncology advances","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/noajnl/vdaf009","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0

摘要

背景:不同研究中胶质母细胞瘤患者的生存数据差异很大。因此,在我们的研究中,我们检查了哪些数据适用于德国中心的真实人群,以及这些真实数据与随机对照试验(rct)中提供的生存数据相比表现如何。方法:分析2010年至2019年在德国单一中心接受新诊断胶质母细胞瘤治疗的所有患者的数据,并将治疗模式和生存率与现有的现实世界数据和随机对照试验结果相匹配。结果:分析了233例患者。中位年龄63岁,f/m比为1:162,73%的患者行手术,27%的患者仅行活检。切除程度对总生存期(OS;结论:具有不良预后因素的患者的生存率仍然很低,这些患者在最近的随机对照试验中未被代表。如果符合纳入标准和排除标准,rct的结果数据可以转移到现实世界的队列中,而不符合这些标准的队列的结果明显较差。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-world analysis of treatment patterns and survival outcome of glioblastoma patients in a German single-center study: Can survival rates of randomized controlled trials be achieved?

Background: The reported survival data for glioblastoma patients vary strongly between different studies. In our study, we therefore examined which data are applicable in a real-world population in a German center and how these real-world data perform in comparison to survival data presented in randomized controlled trials (RCTs).

Methods: Data of all patients treated with newly diagnosed glioblastoma in a single German center between 2010 and 2019 were analyzed and treatment patterns plus survival rates were matched to existing real-world data and results of RCTs.

Results: Two hundred thirty-three patients were analyzed. Median age was 63 years, f/m ratio was 1:162, and 73% of patients underwent surgery, while 27% had biopsy only. The extent of resection had a significant impact on overall survival (OS; P <.001), as well as age (P <.001), methylguanine methyltransferase methylation status (P <.001), and eastern cooperative oncology group performance status (P <.001). The median OS of our whole study population was 10.55 months. While a fictitious Stupp study cohort (built by using eligibility criteria of the EORTC-22981-26981 trial) with an OS of 14.3 months nearly achieved the survival results of the presented data from the EORTC-22981-26981 trial, the OS of the patients who did not fulfill the eligibility criteria was only 6.9 months.

Conclusion: Survival of patients with unfavorable prognostic factors is still poor and these patients are not represented in recent RCTs. Outcome data of RCTs can be transferred to real world cohorts, if in- and exclusion criteria are fulfilled, while outcome is significantly inferior in cohorts that do not fulfill these criteria.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
6.20
自引率
0.00%
发文量
0
审稿时长
12 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信