Non-small cell lung cancer clinical trials requiring biopsies with biomarker-specific results for enrollment provide unique challenges

Marshall L Spiegel; Jonathan W Goldman; Brian R Wolf; Danielle J Nameth; Tristan R Grogan; Aaron E Lisberg; Deborah J L Wong; Blanca A Ledezma; Melody A Mendenhall; Scott J Genshaft; Antonio J Gutierrez; Fereidoun Abtin; W Dean Wallace; Carlos R Adame; Jordan R McKenzie; Phillip A Abarca; Alice J Li; Jennifer L Strunck; Sina Famenini; James M Carroll; D Andrew Tucker; Lauren M Sauer; Nima M Moghadam; David A Elashoff; Christina D Abaya; Meghan B Brennan; Edward B Garon

doi:10.1002/cncr.31056

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Non-small cell lung cancer clinical trials requiring biopsies with biomarker-specific results for enrollment provide unique challenges

Journal article

Open access

Peer reviewed

Non-small cell lung cancer clinical trials requiring biopsies with biomarker-specific results for enrollment provide unique challenges

Marshall L Spiegel, Jonathan W Goldman, Brian R Wolf, Danielle J Nameth, Tristan R Grogan, Aaron E Lisberg, Deborah J L Wong, Blanca A Ledezma, Melody A Mendenhall, Scott J Genshaft, …

Cancer, Vol.123(24), pp.4800-4807

12/15/2017

DOI: 10.1002/cncr.31056

PMCID: PMC6263029

PMID: 29125624

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https://doi.org/10.1002/cncr.31056View

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Abstract

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. 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. 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. 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.

Adult

Biomarkers, Tumor - metabolism

Biopsy, Needle

Carcinoma, Non-Small-Cell Lung - blood

Carcinoma, Non-Small-Cell Lung - pathology

Carcinoma, Non-Small-Cell Lung - therapy

Clinical Trials as Topic

Female

Humans

Immunohistochemistry

Logistic Models

Lung Neoplasms - blood

Lung Neoplasms - pathology

Lung Neoplasms - therapy

Male

Middle Aged

Multivariate Analysis

Odds Ratio

Patient Selection

Predictive Value of Tests

Prognosis

Risk Assessment

Statistics, Nonparametric

Treatment Outcome

Details

Title: Subtitle: Non-small cell lung cancer clinical trials requiring biopsies with biomarker-specific results for enrollment provide unique challenges
Creators: Marshall L Spiegel - University of California, Los Angeles
Jonathan W Goldman - University of California, Los Angeles
Brian R Wolf - University of California, Los Angeles
Danielle J Nameth - University of California, Los Angeles
Tristan R Grogan - Department of Medicine, Statistics CoreGeffen School of Medicine at the University of California-Los AngelesLos Angeles California
Aaron E Lisberg - University of California, Los Angeles
Deborah J L Wong - University of California, Los Angeles
Blanca A Ledezma - University of California, Los Angeles
Melody A Mendenhall - University of California, Los Angeles
Scott J Genshaft - University of California, Los Angeles
Antonio J Gutierrez - University of California, Los Angeles
Fereidoun Abtin - University of California, Los Angeles
W Dean Wallace - University of California, Los Angeles
Carlos R Adame - University of California, Los Angeles
Jordan R McKenzie - University of California, Los Angeles
Phillip A Abarca - University of California, Los Angeles
Alice J Li - University of California, Los Angeles
Jennifer L Strunck - University of California, Los Angeles
Sina Famenini - University of California, Los Angeles
James M Carroll - University of California, Los Angeles
D Andrew Tucker - University of California, Los Angeles
Lauren M Sauer - University of California, Los Angeles
Nima M Moghadam - University of California, Los Angeles
David A Elashoff - University of California, Los Angeles
Christina D Abaya - University of California, Los Angeles
Meghan B Brennan - University of California, Los Angeles
Edward B Garon - University of California, Los Angeles
Resource Type: Journal article
Publication Details: Cancer, Vol.123(24), pp.4800-4807
DOI: 10.1002/cncr.31056
PMID: 29125624
PMCID: PMC6263029
NLM abbreviation: Cancer
ISSN: 0008-543X
eISSN: 1097-0142
Grant note: R01 CA208403 / NCI NIH HHS UL1 TR001881 / NCATS NIH HHS
Language: English
Date published: 12/15/2017
Academic Unit: Orthopedics and Rehabilitation; Physical Therapy and Rehabilitation Science
Record Identifier: 9984295046502771

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