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Totality of the Evidence: Optimizing Dosage Selection Strategies in Oncology.

作者信息

Levit Laura A, Shah Mirat, Ratain Mark J, Garrett-Mayer Elizabeth, Rahman Atiqur, Theoret Marc, Harvey R Donald

机构信息

American Society of Clinical Oncology, Alexandria, VA.

U.S. Food and Drug Administration, Silver Spring, MD.

出版信息

J Clin Oncol. 2025 Jul 24:JCO2500488. doi: 10.1200/JCO-25-00488.

DOI:10.1200/JCO-25-00488
PMID:40706003
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12313202/
Abstract
摘要

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本文引用的文献

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J Natl Cancer Inst Monogr. 2025 Mar 1;2025(68):14-21. doi: 10.1093/jncimonographs/lgae047.
2
The Retrofit: Lessons From Sotorasib's Dosing Conundrum.改造：索托拉西布给药难题的教训
J Clin Oncol. 2025 Jan 20;43(3):248-250. doi: 10.1200/JCO.24.00310. Epub 2024 Oct 7.
3
Dose optimization of sotorasib: Has the burden of proof for the labeled dose been met?索托拉西布的剂量优化：标签剂量的证据负担是否已得到满足？
Eur J Cancer. 2024 Nov;212:115044. doi: 10.1016/j.ejca.2024.115044. Epub 2024 Sep 27.
4
The Right Dose: Results of a Patient Advocate-Led Survey of Individuals With Metastatic Breast Cancer Regarding Treatment-Related Side Effects and Views About Dosage Assessment to Optimize Quality of Life.合适剂量：一项由患者权益倡导者主导的针对转移性乳腺癌患者的调查结果，内容涉及治疗相关副作用以及关于优化生活质量的剂量评估观点。
JCO Oncol Pract. 2024 Jul;20(7):972-983. doi: 10.1200/OP.23.00539. Epub 2024 Mar 22.
5
An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012-2022.2012-2022 年美国食品和药物管理局批准的新型肿瘤药物与剂量相关的上市后要求分析。
Clin Cancer Res. 2024 Mar 1;30(5):937-941. doi: 10.1158/1078-0432.CCR-23-2268.
6
Backfilling cohorts in phase I dose-escalation studies.填补 I 期剂量递增研究中的队列。
Clin Trials. 2023 Jun;20(3):261-268. doi: 10.1177/17407745231160092. Epub 2023 Mar 23.
7
The earlier the better? Or better late than never? Dose optimization in oncology.越早越好？还是亡羊补牢，为时未晚？肿瘤学中的剂量优化。
J Natl Cancer Inst. 2023 May 8;115(5):485-487. doi: 10.1093/jnci/djad042.
8
Off-label, but on target: the evidence needed to implement alternative dosing regimens of anticancer drugs.标签外用药，但靶向明确：实施抗癌药物替代给药方案所需的证据
ESMO Open. 2023 Feb;8(1):100749. doi: 10.1016/j.esmoop.2022.100749. Epub 2023 Jan 3.
9
Dose optimization during drug development: whether and when to optimize.药物开发过程中的剂量优化：是否以及何时进行优化。
J Natl Cancer Inst. 2023 May 8;115(5):492-497. doi: 10.1093/jnci/djac232.
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Oncologist-Reported Barriers and Facilitators to Enrolling Patients in Optimization Trials That Test Less Intense Cancer Treatment.肿瘤学家报告的在优化试验中招募患者的障碍和促进因素，这些试验测试强度较低的癌症治疗。
JCO Oncol Pract. 2023 Feb;19(2):e263-e273. doi: 10.1200/OP.22.00472. Epub 2022 Dec 6.