Surrogate endpoints in clinical trials: when is good...good enough?
作者信息
Schnuck Jamie Olapo, Chauhan Sardar Shahmir B, Sham Jonathan G
机构信息
Department of Surgery, University of Washington, Seattle, WA, USA.
Fred Hutchinson Cancer Center, Seattle, WA, USA.
出版信息
Hepatobiliary Surg Nutr. 2024 Dec 1;13(6):1062-1064. doi: 10.21037/hbsn-24-607. Epub 2024 Nov 21.
Abstract
摘要
相似文献
1
Surrogate endpoints in clinical trials: when is good...good enough?临床试验中的替代终点：何时“良好”……才算足够好？
Hepatobiliary Surg Nutr. 2024 Dec 1;13(6):1062-1064. doi: 10.21037/hbsn-24-607. Epub 2024 Nov 21.
2
Surrogacy of Recurrence-free Survival for Overall Survival as an Endpoint of Clinical Trials of Perioperative Adjuvant Therapy in Hepatobiliary-pancreatic Cancers: A Retrospective Study and Meta-analysis.作为肝胆胰腺癌症围手术期辅助治疗临床试验的终点，无复发生存率替代总生存率的代理：一项回顾性研究和荟萃分析。
Ann Surg. 2024 Jun 1;279(6):1025-1035. doi: 10.1097/SLA.0000000000006084. Epub 2023 Aug 28.
3
Surrogate endpoints for overall survival in digestive oncology trials: which candidates? A questionnaires survey among clinicians and methodologists.消化系统肿瘤临床试验中总生存的替代终点：哪些候选物？临床医生和方法学家问卷调查。
BMC Cancer. 2010 Jun 10;10:277. doi: 10.1186/1471-2407-10-277.
4
Recurrence-free survival as a putative surrogate for overall survival in phase III trials of curative-intent treatment of colorectal liver metastases: Systematic review.无复发生存作为结直肠肝转移瘤根治性治疗Ⅲ期试验中总生存的假定替代指标：系统评价
World J Clin Oncol. 2017 Jun 10;8(3):266-272. doi: 10.5306/wjco.v8.i3.266.
5
Meta-analyses evaluating surrogate endpoints for overall survival in cancer randomized trials: A critical review.Meta 分析评估癌症随机试验中总生存的替代终点：批判性评价。
Crit Rev Oncol Hematol. 2018 Mar;123:21-41. doi: 10.1016/j.critrevonc.2017.11.014. Epub 2017 Nov 23.
6
Intermediate clinical endpoints in early-stage breast cancer: an analysis of individual patient data from the Gruppo Italiano Mammella and Mammella Intergruppo trials.早期乳腺癌的中期临床终点：来自意大利乳腺癌研究组（Gruppo Italiano Mammella）和乳腺癌跨组研究（Mammella Intergruppo）试验的个体患者数据分析
EClinicalMedicine. 2024 Mar 20;70:102501. doi: 10.1016/j.eclinm.2024.102501. eCollection 2024 Apr.
7
Tumor response and progression-free survival as potential surrogate endpoints for overall survival in extensive stage small-cell lung cancer: findings on the basis of North Central Cancer Treatment Group trials.广泛期小细胞肺癌中肿瘤缓解和无进展生存期作为总生存期替代终点的潜力：基于西北肿瘤协作组试验的结果。
Cancer. 2011 Mar 15;117(6):1262-71. doi: 10.1002/cncr.25526. Epub 2010 Oct 19.
8
Relapse-Free Survival as a Surrogate for Overall Survival in the Evaluation of Stage II-III Melanoma Adjuvant Therapy.无复发生存率可作为评估 II-III 期黑色素瘤辅助治疗的总生存率替代指标。
J Natl Cancer Inst. 2018 Jan 1;110(1). doi: 10.1093/jnci/djx133.
9
Surrogate endpoints for overall survival in lung cancer trials: a review.肺癌试验中总生存期的替代终点：综述
Expert Rev Anticancer Ther. 2017 May;17(5):447-454. doi: 10.1080/14737140.2017.1316196. Epub 2017 Apr 12.
10
Major pathologic response as a prognostic surrogate in esophageal squamous cell carcinoma patients receiving neoadjuvant chemotherapy/chemoimmunotherapy: A multi-center cohort study.主要病理反应作为接受新辅助化疗/化疗免疫治疗的食管鳞状细胞癌患者的预后替代指标：一项多中心队列研究。
Eur J Surg Oncol. 2025 Feb;51(2):109500. doi: 10.1016/j.ejso.2024.109500. Epub 2024 Nov 24.
本文引用的文献
1
Survival benefit of adjuvant chemotherapy based on molecular residual disease detection in resected colorectal liver metastases: subgroup analysis from CIRCULATE-Japan GALAXY.基于分子残留病灶检测的辅助化疗在结直肠癌肝转移切除术后的生存获益：来自 CIRCULATE-Japan GALAXY 的亚组分析。
Ann Oncol. 2024 Nov;35(11):1015-1025. doi: 10.1016/j.annonc.2024.08.2240. Epub 2024 Sep 16.
2
Clinical outcomes for previously treated patients with advanced biliary tract cancer: a meta-analysis.既往接受过治疗的晚期胆管癌患者的临床结局：一项荟萃分析。
Future Oncol. 2024 Apr;20(13):863-876. doi: 10.2217/fon-2023-0006. Epub 2024 Feb 14.
3
Surrogacy of Recurrence-free Survival for Overall Survival as an Endpoint of Clinical Trials of Perioperative Adjuvant Therapy in Hepatobiliary-pancreatic Cancers: A Retrospective Study and Meta-analysis.作为肝胆胰腺癌症围手术期辅助治疗临床试验的终点，无复发生存率替代总生存率的代理：一项回顾性研究和荟萃分析。
Ann Surg. 2024 Jun 1;279(6):1025-1035. doi: 10.1097/SLA.0000000000006084. Epub 2023 Aug 28.
4
How we treat advanced biliary tract cancers in the second-line setting.我们如何在二线治疗中治疗晚期胆管癌。
Clin Adv Hematol Oncol. 2023 Jan;21(1):35-42.
5
Adjuvant -Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial.辅助 - 紫杉醇 + 吉西他滨治疗切除术后胰腺导管腺癌：一项随机、开放标签、III 期临床试验的结果。
J Clin Oncol. 2023 Apr 10;41(11):2007-2019. doi: 10.1200/JCO.22.01134. Epub 2022 Dec 15.
6
Disease-free survival as a surrogate endpoint for overall survival in adjuvant trials of pancreatic cancer: a meta-analysis of 20 randomized controlled trials.无病生存期作为胰腺癌辅助治疗试验中总生存期的替代终点：20 项随机对照试验的荟萃分析。
BMC Cancer. 2020 May 14;20(1):421. doi: 10.1186/s12885-020-06910-5.
7
Neoadjuvant plus adjuvant or only adjuvant nab-paclitaxel plus gemcitabine for resectable pancreatic cancer - the NEONAX trial (AIO-PAK-0313), a prospective, randomized, controlled, phase II study of the AIO pancreatic cancer group.新辅助治疗加辅助治疗或仅辅助纳武利尤单抗联合吉西他滨治疗可切除胰腺癌- NEONAX 试验（AIO-PAK-0313），AIO 胰腺癌组的一项前瞻性、随机、对照、II 期研究。
BMC Cancer. 2018 Dec 29;18(1):1298. doi: 10.1186/s12885-018-5183-y.
8
Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review.与失败的临床试验相关的因素及提高成功可能性的机会：一项综述。
Contemp Clin Trials Commun. 2018 Aug 7;11:156-164. doi: 10.1016/j.conctc.2018.08.001. eCollection 2018 Sep.
9
Evaluation of disease-free survival as an intermediate metric of overall survival in patients with localized renal cell carcinoma: A trial-level meta-analysis.评估无疾病生存作为局限性肾细胞癌患者总体生存的中间指标：一项试验水平的荟萃分析。
Cancer. 2018 Mar 1;124(5):925-933. doi: 10.1002/cncr.31154. Epub 2017 Dec 19.
10
Disease-free survival is not a surrogate endpoint for overall survival in adjuvant trials of pancreatic cancer: a systematic review of randomized trials.在胰腺癌辅助治疗试验中，无病生存期并非总生存期的替代终点：一项随机试验的系统评价
HPB (Oxford). 2017 Nov;19(11):944-950. doi: 10.1016/j.hpb.2017.07.005. Epub 2017 Jul 29.
Zotero 插件