Endpoints for trials of adjuvant anticancer therapies.
作者信息
Pastorino Alessandro, Sobrero Alberto, Bruzzi Paolo
机构信息
Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genova, Liguria, Italy.
出版信息
BMJ Oncol. 2023 Dec 21;2(1):e000179. doi: 10.1136/bmjonc-2023-000179. eCollection 2023.
Abstract
摘要
相似文献
1
Endpoints for trials of adjuvant anticancer therapies.辅助抗癌治疗试验的终点指标。
BMJ Oncol. 2023 Dec 21;2(1):e000179. doi: 10.1136/bmjonc-2023-000179. eCollection 2023.
2
Accrual and statistical power failure in published adjuvant phase III oncology trials: a comprehensive analysis from 2013 to 2023.已发表的辅助性III期肿瘤学试验中的入组和统计效能失败：2013年至2023年的综合分析
ESMO Open. 2024 Jul;9(7):103603. doi: 10.1016/j.esmoop.2024.103603. Epub 2024 Jun 25.
3
Optimal two-stage randomized multinomial designs for Phase II oncology trials.用于II期肿瘤学试验的最优两阶段随机多项设计。
J Biopharm Stat. 2009;19(3):485-93. doi: 10.1080/10543400902802417.
4
Analysis of Health-Related Quality of Life Reporting in Phase III RCTs of Advanced Genitourinary Tumors.晚期泌尿生殖系统肿瘤III期随机对照试验中健康相关生活质量报告的分析
Cancers (Basel). 2023 Dec 4;15(23):5703. doi: 10.3390/cancers15235703.
5
Significance of emerging clinical oncology endpoints in support of overall survival.新兴临床肿瘤学终点在支持总生存期方面的意义。
Indian J Cancer. 2022 Mar;59(Supplement):S106-S118. doi: 10.4103/ijc.IJC_1417_20.
6
Endpoints in paediatric oncology.儿科肿瘤的终点。
Eur J Clin Pharmacol. 2011 May;67 Suppl 1:33-40. doi: 10.1007/s00228-010-0923-1. Epub 2010 Nov 18.
7
Evaluation of Selective Outcome Reporting Bias in Efficacy Endpoints in Print and Television Advertisements for Oncology Drugs.评估肿瘤药物的印刷和电视广告中疗效终点的选择性结局报告偏倚。
J Gen Intern Med. 2020 Oct;35(10):2853-2857. doi: 10.1007/s11606-020-06028-1. Epub 2020 Jul 13.
8
Underperformance of Contemporary Phase III Oncology Trials and Strategies for Improvement.当代 III 期肿瘤学临床试验的表现不佳及改进策略。
J Natl Compr Canc Netw. 2021 Jun 21;19(9):1072-1078. doi: 10.6004/jnccn.2020.7690.
9
Endpoints and other considerations in phase I studies of targeted anticancer therapy: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT).靶向抗癌治疗I期研究中的终点及其他考量：创新癌症治疗方法研发（MDICT）工作组的建议
Eur J Cancer. 2008 Jan;44(1):19-24. doi: 10.1016/j.ejca.2007.07.034. Epub 2007 Sep 24.
10
Oncology phase I trial design and conduct: time for a change - MDICT Guidelines 2022.肿瘤学 I 期临床试验设计与实施：变革之时——MDICT 指南 2022。
Ann Oncol. 2023 Jan;34(1):48-60. doi: 10.1016/j.annonc.2022.09.158. Epub 2022 Sep 29.
本文引用的文献
1
Regulatory Challenges: Is a Surrogate End Point Instead of Overall Survival Enough for Regulatory Approval of (Neo)Adjuvant Cancer Treatment? The Swissmedic Perspective.监管挑战：替代终点而非总生存期是否足以用于（新）辅助癌症治疗的监管批准？瑞士药品监管局的观点。
J Clin Oncol. 2023 Nov 10;41(32):4973-4975. doi: 10.1200/JCO.23.01442. Epub 2023 Sep 21.
2
Overall Survival with Osimertinib in Resected -Mutated NSCLC.奥希替尼治疗可切除突变型 NSCLC 的总生存期。
N Engl J Med. 2023 Jul 13;389(2):137-147. doi: 10.1056/NEJMoa2304594. Epub 2023 Jun 4.
3
Evaluating Trials of Adjuvant Therapy: Is There Benefit for People With Resected Renal Cancer?评估辅助治疗试验：对接受肾切除的肾癌患者有益吗？
J Clin Oncol. 2023 May 20;41(15):2713-2717. doi: 10.1200/JCO.23.00280. Epub 2023 Mar 24.
4
You're Cured Till You're Not: Should Disease-Free Survival Be Used as a Regulatory or Clinical End Point for Adjuvant Therapy of Cancer?治愈只是暂时的：无病生存期应作为癌症辅助治疗的监管终点还是临床终点？
J Clin Oncol. 2022 Dec 10;40(35):4044-4047. doi: 10.1200/JCO.22.01531. Epub 2022 Oct 31.
5
Inappropriate censoring in Kaplan-Meier analyses.Kaplan-Meier分析中的不恰当删失。
Lancet Oncol. 2021 Oct;22(10):1358-1360. doi: 10.1016/S1470-2045(21)00473-3.
6
An urgent call to raise the bar in oncology.呼吁提高肿瘤学水平。
Br J Cancer. 2021 Nov;125(11):1477-1485. doi: 10.1038/s41416-021-01495-7. Epub 2021 Aug 16.
7
Lessons From ADAURA on Adjuvant Cancer Drug Trials: Evidence, Ethics, and Economics.ADAURA辅助性抗癌药物试验的经验教训：证据、伦理与经济学
J Clin Oncol. 2021 Jan 20;39(3):175-177. doi: 10.1200/JCO.20.01762. Epub 2020 Dec 4.
8
Informative censoring - a neglected cause of bias in oncology trials.信息删失——肿瘤学试验中一个被忽视的偏倚原因。
Nat Rev Clin Oncol. 2020 Jun;17(6):327-328. doi: 10.1038/s41571-020-0368-0.
9
10
Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.纳武利尤单抗辅助治疗与伊匹单抗用于切除的 III 期或 IV 期黑色素瘤。
N Engl J Med. 2017 Nov 9;377(19):1824-1835. doi: 10.1056/NEJMoa1709030. Epub 2017 Sep 10.
Zotero 插件