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Association between control group therapy and magnitude of clinical benefit of cancer drugs

Little is known about the impact of control group therapy on clinical benefit scales such as American Society of Clinical Oncology Value Framework (ASCO-VF), European Society for Medical Oncology Magnitude Clinical Benefit Scale (ESMO-MCBS), National Comprehensive Cancer Network (NCCN) Evidence Bloc...

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Autores principales: Molto, Consolacion, Tibau, Ariadna, Bujosa, Aida, Tapia, Jose Carlos, Mittal, Abhenil, Tamimi, Faris, Amir, Eitan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group UK 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734169/
https://www.ncbi.nlm.nih.gov/pubmed/36494465
http://dx.doi.org/10.1038/s41598-022-25983-9
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author Molto, Consolacion
Tibau, Ariadna
Bujosa, Aida
Tapia, Jose Carlos
Mittal, Abhenil
Tamimi, Faris
Amir, Eitan
author_facet Molto, Consolacion
Tibau, Ariadna
Bujosa, Aida
Tapia, Jose Carlos
Mittal, Abhenil
Tamimi, Faris
Amir, Eitan
author_sort Molto, Consolacion
collection PubMed
description Little is known about the impact of control group therapy on clinical benefit scales such as American Society of Clinical Oncology Value Framework (ASCO-VF), European Society for Medical Oncology Magnitude Clinical Benefit Scale (ESMO-MCBS), National Comprehensive Cancer Network (NCCN) Evidence Blocks and ASCO Cancer Research Committee (ASCO-CRC). We searched Drugs@FDA to identify cancer drugs approved between January 2012 and December 2021 based on randomized trials (RCTs). Definition of substantial clinical benefit was based on recommendations for each scale. Associations between characteristics of control group therapy and clinical benefit were explored using logistic regression. RCTs with a control group of active treatment plus placebo were associated with significantly lower odds of substantial benefit with ESMO-MCBS (OR 0.27, P = 0.003) and ASCO-VF (OR 0.30, P = 0.008) but not with NCCN Evidence Blocks or ASCO-CRC. This effect was attenuated and lost statistical significance without adjustment for quality of life (QoL) and/or toxicity (ESMO-MCBS OR 0.50, P = 0.17; ASCO-VF OR 0.49, P = 0.11). Clinical benefit scales can be sensitive to control group therapy. RCTs with substantial overlap between experimental and control therapy showed lower magnitude of clinical benefit using ESMO-MCBS and ASCO-VF scales; possibly due to differences in the weighting of QoL and toxicity between different frameworks.
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spelling pubmed-97341692022-12-11 Association between control group therapy and magnitude of clinical benefit of cancer drugs Molto, Consolacion Tibau, Ariadna Bujosa, Aida Tapia, Jose Carlos Mittal, Abhenil Tamimi, Faris Amir, Eitan Sci Rep Article Little is known about the impact of control group therapy on clinical benefit scales such as American Society of Clinical Oncology Value Framework (ASCO-VF), European Society for Medical Oncology Magnitude Clinical Benefit Scale (ESMO-MCBS), National Comprehensive Cancer Network (NCCN) Evidence Blocks and ASCO Cancer Research Committee (ASCO-CRC). We searched Drugs@FDA to identify cancer drugs approved between January 2012 and December 2021 based on randomized trials (RCTs). Definition of substantial clinical benefit was based on recommendations for each scale. Associations between characteristics of control group therapy and clinical benefit were explored using logistic regression. RCTs with a control group of active treatment plus placebo were associated with significantly lower odds of substantial benefit with ESMO-MCBS (OR 0.27, P = 0.003) and ASCO-VF (OR 0.30, P = 0.008) but not with NCCN Evidence Blocks or ASCO-CRC. This effect was attenuated and lost statistical significance without adjustment for quality of life (QoL) and/or toxicity (ESMO-MCBS OR 0.50, P = 0.17; ASCO-VF OR 0.49, P = 0.11). Clinical benefit scales can be sensitive to control group therapy. RCTs with substantial overlap between experimental and control therapy showed lower magnitude of clinical benefit using ESMO-MCBS and ASCO-VF scales; possibly due to differences in the weighting of QoL and toxicity between different frameworks. Nature Publishing Group UK 2022-12-09 /pmc/articles/PMC9734169/ /pubmed/36494465 http://dx.doi.org/10.1038/s41598-022-25983-9 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Molto, Consolacion
Tibau, Ariadna
Bujosa, Aida
Tapia, Jose Carlos
Mittal, Abhenil
Tamimi, Faris
Amir, Eitan
Association between control group therapy and magnitude of clinical benefit of cancer drugs
title Association between control group therapy and magnitude of clinical benefit of cancer drugs
title_full Association between control group therapy and magnitude of clinical benefit of cancer drugs
title_fullStr Association between control group therapy and magnitude of clinical benefit of cancer drugs
title_full_unstemmed Association between control group therapy and magnitude of clinical benefit of cancer drugs
title_short Association between control group therapy and magnitude of clinical benefit of cancer drugs
title_sort association between control group therapy and magnitude of clinical benefit of cancer drugs
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9734169/
https://www.ncbi.nlm.nih.gov/pubmed/36494465
http://dx.doi.org/10.1038/s41598-022-25983-9
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