Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin

Frameworks that associate cancer dynamic disease progression models with parametric survival models for clinical outcome have recently been proposed to support decision making in early clinical development. Here we developed such a disease progression clinical outcome model for castration-resistant...

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Main Authors:	van Hasselt, JGC, Gupta, A, Hussein, Z, Beijnen, JH, Schellens, JHM, Huitema, ADR
Format:	Online
Language:	English
Published:	John Wiley & Sons, Ltd 2015
Online Access:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4544052/

id	pubmed-4544052
recordtype	oai_dc
spelling	pubmed-45440522015-08-26 Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin van Hasselt, JGC Gupta, A Hussein, Z Beijnen, JH Schellens, JHM Huitema, ADR Original Articles Frameworks that associate cancer dynamic disease progression models with parametric survival models for clinical outcome have recently been proposed to support decision making in early clinical development. Here we developed such a disease progression clinical outcome model for castration-resistant prostate cancer (CRPC) using historical phase II data of the anticancer agent eribulin. Disease progression was captured using the dynamics of prostate-specific antigen (PSA). For clinical outcome, overall survival (OS) was used. The model for PSA dynamics comprised parameters for baseline PSA (23.2 ng/ml, relative standard error (RSE) 16.5%), growth rate (0.00879 day−1, RSE 12.6%), drug effect (0.241 µg·h·l−1 day−1, RSE 32.6%), and resistance development (0.0113 day−1, RSE 44.3%). OS was modeled according to a Weibull distribution. Predictors for survival included model-predicted PSA time to nadir (TTN), PSA growth rate, Eastern Cooperative Oncology Group (ECOG) score, and baseline PSA. The developed framework can be considered to support informative design and analysis of drugs developed for CRPC. John Wiley & Sons, Ltd 2015-07 2015-06-30 /pmc/articles/PMC4544052/ /pubmed/26312162 http://dx.doi.org/10.1002/psp4.49 Text en © 2015 The Authors CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
repository_type	Open Access Journal
institution_category	Foreign Institution
institution	US National Center for Biotechnology Information
building	NCBI PubMed
collection	Online Access
language	English
format	Online
author	van Hasselt, JGC Gupta, A Hussein, Z Beijnen, JH Schellens, JHM Huitema, ADR
spellingShingle	van Hasselt, JGC Gupta, A Hussein, Z Beijnen, JH Schellens, JHM Huitema, ADR Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin
author_facet	van Hasselt, JGC Gupta, A Hussein, Z Beijnen, JH Schellens, JHM Huitema, ADR
author_sort	van Hasselt, JGC
title	Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin
title_short	Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin
title_full	Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin
title_fullStr	Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin
title_full_unstemmed	Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin
title_sort	disease progression/clinical outcome model for castration-resistant prostate cancer in patients treated with eribulin
description	Frameworks that associate cancer dynamic disease progression models with parametric survival models for clinical outcome have recently been proposed to support decision making in early clinical development. Here we developed such a disease progression clinical outcome model for castration-resistant prostate cancer (CRPC) using historical phase II data of the anticancer agent eribulin. Disease progression was captured using the dynamics of prostate-specific antigen (PSA). For clinical outcome, overall survival (OS) was used. The model for PSA dynamics comprised parameters for baseline PSA (23.2 ng/ml, relative standard error (RSE) 16.5%), growth rate (0.00879 day−1, RSE 12.6%), drug effect (0.241 µg·h·l−1 day−1, RSE 32.6%), and resistance development (0.0113 day−1, RSE 44.3%). OS was modeled according to a Weibull distribution. Predictors for survival included model-predicted PSA time to nadir (TTN), PSA growth rate, Eastern Cooperative Oncology Group (ECOG) score, and baseline PSA. The developed framework can be considered to support informative design and analysis of drugs developed for CRPC.
publisher	John Wiley & Sons, Ltd
publishDate	2015
url	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4544052/
_version_	1613261966852227072

Disease Progression/Clinical Outcome Model for Castration-Resistant Prostate Cancer in Patients Treated With Eribulin

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