Association of differential censoring with survival and suboptimal control arms among oncology clinical trials.

Autor:	Hsu EJ; Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX, USA., Lin TA; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.; Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Dabush DR; Davidoff Cancer Center, Rabin Medical Center, Petah-Tikva, Israel., McCaw Z; Department of Biostatistics, The University of North Carolina at Chapel Hill, Chapel Hill, NC, USA., Koong A; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Lin C; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Abi Jaoude J; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Patel R; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Kouzy R; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., El Alam MB; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Noticewala S; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Yang Y; School of Bioinformatics, University of Texas Health Science Center at Houston, Houston, TX, USA., Sherry AD; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Fuller CD; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Thomas CR Jr; Radiation Oncology, Dartmouth Cancer Center, Geisel School of Medicine, Lebanon, NH, USA., Tang C; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Msaouel P; Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Das P; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Huang B; Pfizer Inc, Groton, CT, USA., Tian L; Department of Health Research and Policy, Stanford University, Stanford, CA, USA., Sun R; Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Lee JJ; Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA., Meirson T; Davidoff Cancer Center, Rabin Medical Center, Petah-Tikva, Israel.; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Ludmir EB; Division of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.; Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Jazyk:	angličtina
Zdroj:	Journal of the National Cancer Institute [J Natl Cancer Inst] 2024 Jun 07; Vol. 116 (6), pp. 990-994.
DOI:	10.1093/jnci/djae028
Abstrakt:	Differential censoring, which refers to censoring imbalance between treatment arms, may bias the interpretation of survival outcomes in clinical trials. In 146 phase III oncology trials with statistically significant time-to-event surrogate primary endpoints, we evaluated the association between differential censoring in the surrogate primary endpoints, control arm adequacy, and the subsequent statistical significance of overall survival results. Twenty-four (16%) trials exhibited differential censoring that favored the control arm, whereas 15 (10%) exhibited differential censoring that favored the experimental arm. Positive overall survival was more common in control arm differential censoring trials (63%) than in trials without differential censoring (37%) or with experimental arm differential censoring (47%; odds ratio = 2.64, 95% confidence interval = 1.10 to 7.20; P = .04). Control arm differential censoring trials more frequently used suboptimal control arms at 46% compared with 20% without differential censoring and 13% with experimental arm differential censoring (odds ratio = 3.60, 95% confidence interval = 1.29 to 10.0; P = .007). The presence of control arm differential censoring in trials with surrogate primary endpoints, especially in those with overall survival conversion, may indicate an inadequate control arm and should be examined and explained. (© The Author(s) 2024. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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