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Tytuł:
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Impact of Clinical Trial Participation on Survival of Patients with Metastatic Non-Small Cell Lung Cancer.
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Autorzy:
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Merkhofer CM; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington, United States; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States. Electronic address: .
Eaton KD; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington, United States; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States. Electronic address: .
Martins RG; Division of Medical Oncology, Department of Medicine, University of Washington, Seattle, Washington, United States; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States. Electronic address: .
Ramsey SD; Hutchinson Institute for Cancer Outcomes Research, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States; Division of General Internal Medicine, Department of Medicine, University of Washington, Seattle, Washington, United States. Electronic address: .
Goulart BHL; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States. Electronic address: .
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Źródło:
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Clinical lung cancer [Clin Lung Cancer] 2021 Nov; Vol. 22 (6), pp. 523-530. Date of Electronic Publication: 2021 Apr 22.
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Typ publikacji:
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Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: 2011-: [New York] : Elsevier
Original Publication: Dallas, Tex. : Cancer Information Group, c1999-
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MeSH Terms:
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Clinical Trials as Topic*
Lung Neoplasms*
Neoplasm Metastasis*
Patient Participation*
Survival Analysis*
Carcinoma, Non-Small-Cell Lung/*pathology
Aged ; Female ; Humans ; Male ; Middle Aged ; Mutation ; Registries ; Washington
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Grant Information:
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T32 CA009515 United States CA NCI NIH HHS
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Contributed Indexing:
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Keywords: Clinical trial outcomes; Health outcomes; Health services research; Non-small cell lung cancer; Survival analysis
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Entry Date(s):
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Date Created: 20210601 Date Completed: 20220214 Latest Revision: 20221102
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Update Code:
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20240105
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PubMed Central ID:
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PMC8531178
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DOI:
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10.1016/j.cllc.2021.04.003
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PMID:
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34059474
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Introduction: The impact of clinical trial participation on overall survival is unclear. We hypothesized that enrollment in a therapeutic drug clinical trial is associated with longer overall survival in patients with metastatic non-small cell lung cancer (NSCLC).
Patients and Methods: We linked electronic medical record and Washington State cancer registry data to identify patients with metastatic NSCLC diagnosed between January 1, 2007, and December 31, 2015 who received treatment at a National Cancer Institute-designated cancer center. The exposure was trial enrollment. The primary outcome was overall survival, defined as the date of second-line treatment initiation to date of death or last follow-up. We used a conditional landmark analysis starting at the date of second-line treatment initiation and propensity scores with inverse probability of treatment weighting to estimate the association between trial enrollment and survival.
Results: Of 215 patients, 40 (19%) participated in a second-line trial. Trial participants were more likely to be never smokers (45% vs 27%), have a good performance status (88% vs 77%) and have EGFR (48% vs 14%) and ALK mutations (8% vs 5%) than nonparticipants. Trial participants had similar overall survival to nonparticipants (HR 1.05; 95% CI, 0.72, 1.53; p = 0.81) after adjusting for sociodemographic and disease characteristics.
Conclusion: Accounting for the immortal time bias and selection bias, trial participation does not appear detrimental to survival. This finding may be reassuring to patients and supports programs and policies to improve clinical trial access.
Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest. They declare the following disclosures, none of which represent a conflict of interest. Keith D. Eaton has clinical trial research support from Mirati Therapeutics. Renato G. Martins has clinical trial research support from AstraZeneca, Merck & Company, Inc., Pfizer, and Roche. Scott D. Ramsey has the following disclosures: employment with Flatiron Health; consulting or advisory roles with Bayer Corporation, Bristol-Myers Squibb, AstraZeneca, Merck & Company, Inc., GRAIL, Pfizer, Seattle Genetics, Biovica, and Genentech; research funding from Bayer Corporation, Bristol-Myers Squibb, and Microsoft Corporation; travel, accommodations, and expenses from Bayer Schering Pharma, Bristol-Myers Squibb, Flatiron Health, Bayer, and GRAIL.
(Copyright © 2021. Published by Elsevier Inc.)
