1. Non-small cell lung cancer clinical trials requiring biopsies with biomarker-specific results for enrollment provide unique challenges.
- Author
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Spiegel ML, Goldman JW, Wolf BR, Nameth DJ, Grogan TR, Lisberg AE, Wong DJL, Ledezma BA, Mendenhall MA, Genshaft SJ, Gutierrez AJ, Abtin F, Wallace WD, Adame CR, McKenzie JR, Abarca PA, Li AJ, Strunck JL, Famenini S, Carroll JM, Tucker DA, Sauer LM, Moghadam NM, Elashoff DA, Abaya CD, Brennan MB, and Garon EB
- Subjects
- Adult, Biopsy, Needle, Carcinoma, Non-Small-Cell Lung therapy, Clinical Trials as Topic, Female, Humans, Immunohistochemistry, Logistic Models, Lung Neoplasms therapy, Male, Middle Aged, Multivariate Analysis, Odds Ratio, Predictive Value of Tests, Prognosis, Risk Assessment, Statistics, Nonparametric, Treatment Outcome, Biomarkers, Tumor metabolism, Carcinoma, Non-Small-Cell Lung blood, Carcinoma, Non-Small-Cell Lung pathology, Lung Neoplasms blood, Lung Neoplasms pathology, Patient Selection
- Abstract
Background: Clinical trials in lung cancer increasingly require patients to provide fresh tumor tissue as a prerequisite to enrollment. The effects of this requirement on enrollment rates, enrollment durations, and patient selection have not been fully elucidated., Methods: The authors retrospectively reviewed data generated by patients who consented to 1 or more interventional lung cancer clinical trials at the University of California-Los Angeles Jonsson Comprehensive Cancer Center between January 2013 and December 2014. Trials were considered to require a biopsy when enrollment was conditional on the procurement of tissue without intervening therapy between procurement and enrollment., Results: In total, 311 patients underwent 368 screening incidents for 1 or more of 19 trials. Trials that required a new biopsy had a longer median screening duration (34 vs 14 days) than trials that did not require a biopsy (P < .001). Trials that required a biopsy had a greater screen failure rate (49.1% vs 26.5%; P < .001), which was largely driven by patients who did not undergo the required biopsy or lacked the required biomarker. Worsening performance status led to the majority of screen failures (56.5%) among biomarker-eligible patients., Conclusions: Although the scientific benefits of obtaining a new biopsy and requiring specific results for trial enrollment are clear, these requirements lead to a lengthening of the screening period, which, in some patients, is associated with clinical decline before enrollment. Implications for the interpretation of data from studies of this design should be explored. Cancer 2017;123:4800-7. © 2017 American Cancer Society., (© 2017 American Cancer Society.)
- Published
- 2017
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