RT Journal Article
T1 Trends in endpoint selection and result interpretation in advanced non-small cell lung cancer clinical trials published between 2000 and 2012: A retrospective cohort study.
A1 Fernandez-Lopez, Cristina
A1 Calleja-Hernandez, Miguel Angel
A1 Balbino, Jaime Espin
A1 Cabeza-Barrera, Jose
A1 Exposito-Hernandez, Jose
K1 Non-small-cell lung cancer
K1 outcome assessment (health care)
K1 quality of life
K1 retrospective study
K1 survival analysis
AB The objective of this review was to investigate trends in clinical trial design, specifically, the primary outcomes used, interpretation of results, and the magnitude of the benefits described in phase III controlled clinical trials in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). Seventy-six trials published between 2000 and 2012 were selected from a total of 122 identified in a structured search. Overall survival (OS) was evaluated as the primary study endpoint in 50 (65.8%) trials, followed by progression-free survival (PFS) in 15 (19.7%), and other variables, such as toxicity, quality of life (QoL), and response rate in 11 (14.5%). Ten (66.7%) out of 15 clinical trials using PFS as the primary endpoint were published between 2010 and 2012. Median overall survival (mOS) was 9.90 months (interquartile range: 3.5) with an increase of 0.384 months per year of publication (P  These findings raise important questions about how clinical benefits are measured in clinical trials in advanced NSCLC. Appropriate clinically relevant outcome variables should be established and validated, and post-marketing studies should be requested by regulatory authorities to ensure meaningful clinical benefits in OS and QoL.
PB John Wiley & Sons, Inc.
YR 2019
FD 2019-02-01
LK http://hdl.handle.net/10668/13701
UL http://hdl.handle.net/10668/13701
LA en
NO Fernández-López C, Calleja-Hernández MÁ, Balbino JE, Cabeza-Barrera J, Expósito-Hernández J. Trends in endpoint selection and result interpretation in advanced non-small cell lung cancer clinical trials published between 2000 and 2012: A retrospective cohort study. Thorac Cancer. 2019 Apr;10(4):904-908.
DS RISalud
RD Apr 12, 2025