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Population exposure-response model of 131I in patients with benign thyroid disease

Authorized Users Only
2021
Authors
Topić-Vučenović, Valentina
Rajkovača, Zvezdana
Jelić, Dijana
Stanimirović, Dragi
Mikov, Momir
Miljković, Branislava
Vučićević, Katarina
Article (Published version)
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Abstract
Purpose: The study aimed to explore the relationship of different exposure measures with 131I therapy response in patients with benign thyroid disease, estimate the variability in the response, investigate possible covariates, and discuss dosing implications of the results. Methods: A population exposure-response analysis was performed using nonlinear mixed-effects modelling. Data from 95 adult patients with benign thyroid disease were analysed. Evaluated exposure parameters were: administered radioactivity dose (Aa) [MBq], total absorbed dose (ABD) [Gy], maximum of absorbed dose-rate (MXR) [Gy/h] and biologically effective dose (BED) [Gy]. The response was modelled as ordered categorical data: hyper-, eu- and hypothyroidism. The final model performance was evaluated by a visual predictive check. Results: The probability of the outcome following 131I therapy was best described by a proportional-odds model, including the log-linear model of 131I effect and the exponential model of the r...esponse-time relationship. All exposure measures were statistically significant with p<0.001, with BED and ABD being statistically better than the other two. Nevertheless, as BED resulted in the lowest AIC value, it was included in the final model. Accordingly, BED value of 289.7 Gy is associated with 80% probability of successful treatment outcome 12 months after 131I application in patients with median thyroid volume (32.28 mL). The target thyroid volume was a statistically significant covariate. The visual predictive check of the final model showed good model performance. Conclusion: Our results imply that BED formalism could aid in therapy individualisation. The larger thyroid volume is associated with a lower probability of a successful outcome.

Keywords:
Benign thyroid disorders / Biologically effective dose / Dose-rate effects / Outcome probability / Proportional odds model / Radioiodine therapy
Source:
European Journal of Pharmaceutical Sciences, 2021, 165
Publisher:
  • Elsevier B.V.

DOI: 10.1016/j.ejps.2021.105942

ISSN: 0928-0987

WoS: 000704184800001

Scopus: 2-s2.0-85110609435
[ Google Scholar ]
1
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/3927
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Topić-Vučenović, Valentina
AU  - Rajkovača, Zvezdana
AU  - Jelić, Dijana
AU  - Stanimirović, Dragi
AU  - Mikov, Momir
AU  - Miljković, Branislava
AU  - Vučićević, Katarina
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3927
AB  - Purpose: The study aimed to explore the relationship of different exposure measures with 131I therapy response in patients with benign thyroid disease, estimate the variability in the response, investigate possible covariates, and discuss dosing implications of the results. Methods: A population exposure-response analysis was performed using nonlinear mixed-effects modelling. Data from 95 adult patients with benign thyroid disease were analysed. Evaluated exposure parameters were: administered radioactivity dose (Aa) [MBq], total absorbed dose (ABD) [Gy], maximum of absorbed dose-rate (MXR) [Gy/h] and biologically effective dose (BED) [Gy]. The response was modelled as ordered categorical data: hyper-, eu- and hypothyroidism. The final model performance was evaluated by a visual predictive check. Results: The probability of the outcome following 131I therapy was best described by a proportional-odds model, including the log-linear model of 131I effect and the exponential model of the response-time relationship. All exposure measures were statistically significant with p<0.001, with BED and ABD being statistically better than the other two. Nevertheless, as BED resulted in the lowest AIC value, it was included in the final model. Accordingly, BED value of 289.7 Gy is associated with 80% probability of successful treatment outcome 12 months after 131I application in patients with median thyroid volume (32.28 mL). The target thyroid volume was a statistically significant covariate. The visual predictive check of the final model showed good model performance. Conclusion: Our results imply that BED formalism could aid in therapy individualisation. The larger thyroid volume is associated with a lower probability of a successful outcome.
PB  - Elsevier B.V.
T2  - European Journal of Pharmaceutical Sciences
T1  - Population exposure-response model of 131I in patients with benign thyroid disease
VL  - 165
DO  - 10.1016/j.ejps.2021.105942
ER  - 
@article{
author = "Topić-Vučenović, Valentina and Rajkovača, Zvezdana and Jelić, Dijana and Stanimirović, Dragi and Mikov, Momir and Miljković, Branislava and Vučićević, Katarina",
year = "2021",
abstract = "Purpose: The study aimed to explore the relationship of different exposure measures with 131I therapy response in patients with benign thyroid disease, estimate the variability in the response, investigate possible covariates, and discuss dosing implications of the results. Methods: A population exposure-response analysis was performed using nonlinear mixed-effects modelling. Data from 95 adult patients with benign thyroid disease were analysed. Evaluated exposure parameters were: administered radioactivity dose (Aa) [MBq], total absorbed dose (ABD) [Gy], maximum of absorbed dose-rate (MXR) [Gy/h] and biologically effective dose (BED) [Gy]. The response was modelled as ordered categorical data: hyper-, eu- and hypothyroidism. The final model performance was evaluated by a visual predictive check. Results: The probability of the outcome following 131I therapy was best described by a proportional-odds model, including the log-linear model of 131I effect and the exponential model of the response-time relationship. All exposure measures were statistically significant with p<0.001, with BED and ABD being statistically better than the other two. Nevertheless, as BED resulted in the lowest AIC value, it was included in the final model. Accordingly, BED value of 289.7 Gy is associated with 80% probability of successful treatment outcome 12 months after 131I application in patients with median thyroid volume (32.28 mL). The target thyroid volume was a statistically significant covariate. The visual predictive check of the final model showed good model performance. Conclusion: Our results imply that BED formalism could aid in therapy individualisation. The larger thyroid volume is associated with a lower probability of a successful outcome.",
publisher = "Elsevier B.V.",
journal = "European Journal of Pharmaceutical Sciences",
title = "Population exposure-response model of 131I in patients with benign thyroid disease",
volume = "165",
doi = "10.1016/j.ejps.2021.105942"
}
Topić-Vučenović, V., Rajkovača, Z., Jelić, D., Stanimirović, D., Mikov, M., Miljković, B.,& Vučićević, K.. (2021). Population exposure-response model of 131I in patients with benign thyroid disease. in European Journal of Pharmaceutical Sciences
Elsevier B.V.., 165.
https://doi.org/10.1016/j.ejps.2021.105942
Topić-Vučenović V, Rajkovača Z, Jelić D, Stanimirović D, Mikov M, Miljković B, Vučićević K. Population exposure-response model of 131I in patients with benign thyroid disease. in European Journal of Pharmaceutical Sciences. 2021;165.
doi:10.1016/j.ejps.2021.105942 .
Topić-Vučenović, Valentina, Rajkovača, Zvezdana, Jelić, Dijana, Stanimirović, Dragi, Mikov, Momir, Miljković, Branislava, Vučićević, Katarina, "Population exposure-response model of 131I in patients with benign thyroid disease" in European Journal of Pharmaceutical Sciences, 165 (2021),
https://doi.org/10.1016/j.ejps.2021.105942 . .

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