dc.contributor
Institut Català de la Salut
dc.contributor
[Fernández-López C] Servei de Farmàcia, Hospital Universitari Vall d'Hebron, Barcelona, Spain. [Calleja-Hernández MÁ] Department of Pharmacy, Pharmacy Clinical Management Unit (UGC), Virgen Macarena University Hospital, Seville, Spain. [Espín Balbino J] Andalusian School of Public Health (EASP), Granada, Spain.Health Research Institute of Granada (ibs.GRANADA), University Hospitals of Granada, Granada, Spain. University of Granada, Granada, Spain. [Cabeza-Barrera J] Department of Pharmacy, Biosanitary Research Institute of Granada, San Cecilio University Hospital, Granada, Spain. [Expósito-Hernández J] Department of Oncology, University Hospitals of Granada, Health Research Institute of Granada (ibs.GRANADA), Granada, Spain.
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Fernandez Lopez, Cristina
dc.contributor.author
Calleja‐Hernández, Miguel Ángel
dc.contributor.author
Espín Balbino, Jaime
dc.contributor.author
Expósito‐Hernández, José
dc.contributor.author
Cabeza Barrera, Jose
dc.date.accessioned
2025-10-24T10:18:35Z
dc.date.available
2025-10-24T10:18:35Z
dc.date.issued
2019-05-21T10:33:09Z
dc.date.issued
2019-05-21T10:33:09Z
dc.date.issued
2019-03-13
dc.identifier
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;10(4):904–8.
dc.identifier
https://hdl.handle.net/11351/4079
dc.identifier
10.1111/1759-7714.13024
dc.identifier
WOS:000465162800038
dc.identifier.uri
https://hdl.handle.net/11351/4079
dc.description.abstract
Non-small-cell lung cancer; Outcome assessment (health care); Quality of life
dc.description.abstract
Càncer pulmonar de cèl·lules no petites; Avaluació de resultats (sanitat); Qualitat de vida
dc.description.abstract
Cáncer pulmonar de células no pequeñas; Evaluación de resultados (sanidad); Calidad de vida
dc.description.abstract
BACKGROUND:
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).
METHODS:
Seventy-six trials published between 2000 and 2012 were selected from a total of 122 identified in a structured search.
RESULTS:
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 < 0.001). A statistically significant improvement in mOS was obtained in only 13 (18.8%) trials. A total of 41 (53.9%) studies concluded that the result was positive. Of these, only 16 (39.1%) showed a statistically significant benefit in OS. QoL was assessed in 46 trials (60.5%) and of these, 10 (21.7%) reported significant improvements.
CONCLUSIONS:
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.
dc.format
application/pdf
dc.publisher
Wiley Open Access
dc.relation
Thoracic Cancer;10(4)
dc.relation
https://onlinelibrary.wiley.com/doi/full/10.1111/1759-7714.13024
dc.rights
Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Pulmons - Càncer - Estadístiques
dc.subject
Anàlisi de supervivència (Biometria)
dc.subject
Assaigs clínics
dc.subject
DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung
dc.subject
Other subheadings::Other subheadings::/statistics & numerical data
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Survival Analysis
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PUBLICATION CHARACTERISTICS::Study Characteristics::Clinical Study::Clinical Trial::Clinical Trial, Phase III
dc.subject
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas
dc.subject
Otros calificadores::Otros calificadores::/estadística & datos numéricos
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::métodos epidemiológicos::estadística como asunto::análisis de supervivencia
dc.subject
CARACTERÍSTICAS DE PUBLICACIONES::características del estudio::estudio clínico::ensayo clínico::ensayo clínico fase III
dc.title
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
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
