Broadening Eligibility Criteria for Clinical Trials May Benefit Participating Patients

Author:

,Hofland PeterORCID

Abstract

Results of a review published in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR), seem to suggest that patients with treatment-refractory cancers who received eligibility and testing waivers to participate in a large basket/umbrella oncology trial, had similar rates of clinical benefit and adverse events as patients who participated in the trial without waivers.

Publisher

Sunvalley Communication

Reference4 articles.

1. [1] Van Berge Henegouwen JM, Zeverijn LJ, Geurts BS, Hoes LR, van der Wijngaart H, van der Noort V, Huitema ADR, De Vos FYF, Grünberg K, Bloemendal HJ, Verheul HMW, Voest EE, Gelderblom H. Maximizing treatment opportunities: assessing protocol waivers' impact on safety and outcome in the Drug Rediscovery Protocol. Clin Cancer Res. 2024 Jun 27. doi: 10.1158/1078-0432.CCR-23-3917. Epub ahead of print. PMID: 38926908.

2. [2] Mitchell AP, Harrison MR, Walker MS, George DJ, Abernethy AP, Hirsch BR. Clinical Trial Participants With Metastatic Renal Cell Carcinoma Differ From Patients Treated in Real-World Practice. J Oncol Pract. 2015 Nov;11(6):491-7. doi: 10.1200/JOP.2015.004929. Epub 2015 Sep 1. PMID: 26330533.

3. [3] Lin L, Smit EF, de Langen AJ, van Balen DEM, Beijnen JH, Huitema ADR. Representativeness of Phase III Trial for Osimertinib in Pretreated Advanced EGFR-Mutated Non-small-cell Lung Cancer Patients and Treatment Outcomes in Clinical Practice. Target Oncol. 2022 Jan;17(1):53-59. doi: 10.1007/s11523-021-00862-x. Epub 2021 Dec 11. PMID: 34894319; PMCID: PMC8783869.

4. [4] Van der Velden DL, Hoes LR, van der Wijngaart H, van Berge Henegouwen JM, van Werkhoven E, Roepman P, Schilsky RL, de Leng WWJ, Huitema ADR, Nuijen B, Nederlof PM, van Herpen CML, de Groot DJA, Devriese LA, Hoeben A, de Jonge MJA, Chalabi M, Smit EF, de Langen AJ, Mehra N, Labots M, Kapiteijn E, Sleijfer S, Cuppen E, Verheul HMW, Gelderblom H, Voest EE. The Drug Rediscovery protocol facilitates the expanded use of existing anticancer drugs. Nature. 2019 Oct;574(7776):127-131. doi: 10.1038/s41586-019-1600-x. Epub 2019 Sep 30. PMID: 31570881.

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