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6. In vivo fitness of carbapenem-resistant Acinetobacter baumannii strains in murine infection is associated with treatment failure in human infections

Author

Paul, Mical, Benattar, Yael Dishon, Dickstein, Yaakov, Bitterman, Roni, Zayyad, Hiba, Koppel, Fidi, Zak-Doron, Yael, Altunin, Sergey, Andria, Nizar, Neuberger, Ami, Stern, Anat, Petersiel, Neta, Raines, Marina, Karban, Amir, Leibovici, Leonard, Yahav, Dafna, Eliakim-Raz, Noa, Zusman, Oren, Elbaz, Michal, Atamna, Heyam, Daitch, Vered, Babich, Tanya, Carmeli, Yehuda, Nutman, Amir, Adler, Amos, Levi, Inbar, Daikos, George L., Skiada, Anna, Pavleas, Ioannis, Antoniadou, Anastasia, Kotsaki, Antigoni, Durante-Mangoni, Emanuele, Andini, Roberto, Iossa, Domenico, Bernardo, Mariano, Cavezza, Giusi, Bertolino, Lorenzo, Giuffre, Giuseppe, Giurazza, Roberto, Ruocco, Giuseppe, Galdo, Maria, Murino, Patrizia, Cristinziano, Adriano, Corcione, Antonio, Zampino, Rosa, Mouton, Johan, Friberg, Lena, Theuretzbacher, Ursula, Temkin, Elizabeth, Lellouche, Jonathan, Rakovitsky, Nadya, Hameir, Amichay, Daikos, George, Dishon, Yael, Eliakim, Noa, and Friberg, Lena E.

Published
2022
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7. Integration of individual preclinical and clinical anti‐infective PKPD data to predict clinical study outcomes.

Author

Aranzana‐Climent, Vincent, van Os, Wisse, Nutman, Amir, Lellouche, Jonathan, Dishon‐Benattar, Yael, Rakovitsky, Nadya, Daikos, George L., Skiada, Anna, Pavleas, Ioannis, Durante‐Mangoni, Emanuele, Theuretzbacher, Ursula, Paul, Mical, Carmeli, Yehuda, and Friberg, Lena E.

Subjects
TREATMENT effectiveness, ACINETOBACTER baumannii, ODDS ratio, LOGISTIC regression analysis, COLISTIN, SURVIVAL analysis (Biometry)
Abstract

The AIDA randomized clinical trial found no significant difference in clinical failure or survival between colistin monotherapy and colistin–meropenem combination therapy in carbapenem‐resistant Gram‐negative infections. The aim of this reverse translational study was to integrate all individual preclinical and clinical pharmacokinetic–pharmacodynamic (PKPD) data from the AIDA trial in a pharmacometric framework to explore whether individualized predictions of bacterial burden were associated with the trial outcomes. The compiled dataset included for each of the 207 patients was (i) information on the infecting Acinetobacter baumannii isolate (minimum inhibitory concentration, checkerboard assay data, and fitness in a murine model), (ii) colistin plasma concentrations and colistin and meropenem dosing history, and (iii) disease scores and demographics. The individual information was integrated into PKPD models, and the predicted change in bacterial count at 24 h for each patient, as well as patient characteristics, was correlated with clinical outcomes using logistic regression. The in vivo fitness was the most important factor for change in bacterial count. A model‐predicted growth at 24 h of ≥2‐log10 (164/207) correlated positively with clinical failure (adjusted odds ratio, aOR = 2.01). The aOR for one unit increase of other significant predictors were 1.24 for SOFA score, 1.19 for Charlson comorbidity index, and 1.01 for age. This study exemplifies how preclinical and clinical anti‐infective PKPD data can be integrated through pharmacodynamic modeling and identify patient‐ and pathogen‐specific factors related to clinical outcomes – an approach that may improve understanding of study outcomes. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Quantitative modeling of tumor dynamics and development of drug resistance in non‐small cell lung cancer patients treated with erlotinib

Author

Yin, Anyue, primary, Veerman, G. D. Marijn, additional, van Hasselt, Johan G. C., additional, Steendam, Christi M. J., additional, Dubbink, Hendrikus Jan, additional, Guchelaar, Henk‐Jan, additional, Friberg, Lena E., additional, Dingemans, Anne‐Marie C., additional, Mathijssen, Ron H. J., additional, and Moes, Dirk Jan A. R., additional

Published
2024
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11. Colistin plus meropenem for carbapenem-resistant Gram-negative infections: in vitro synergism is not associated with better clinical outcomes

Author

Paul, Mical, Benattar, Yael Dishon, Dickstein, Yaakov, Bitterman, Roni, Zayyad, Hiba, Koppel, Fidi, Zak-Doron, Yael, Altunin, Sergey, Andria, Nizar, Neuberger, Ami, Stern, Anat, Petersiel, Neta, Raines, Marina, Karban, Amir, Leibovici, Leonard, Yahav, Dafna, Eliakim-Raz, Noa, Zusman, Oren, Elbaz, Michal, Atamna, Heyam, Daitch, Vered, Babich, Tanya, Carmeli, Yehuda, Nutman, Amir, Adler, Amos, Levi, Inbar, Daikos, George L., Skiada, Anna, Pavleas, Ioannis, Antoniadou, Anastasia, Kotsaki, Antigoni, Durante-Mangoni, Emanuele, Andini, Roberto, Iossa, Domenico, Bernardo, Mariano, Cavezza, Giusi, Bertolino, Lorenzo, Giuffre, Giuseppe, Giurazza, Roberto, Cuccurullo, Susanna, Galdo, Maria, Murino, Patrizia, Cristinziano, Adriano, Corcione, Antonio, Zampino, Rosa, Pafundi, Pia Clara, Mouton, Johan, Friberg, Lena, Kristoffersson, Anders, Theuretzbacher, Ursula, Lellouche, Jonathan, Temkin, Elizabeth, Daikos, George, Dishon-Benattar, Yael, Friberg, Lena E., and Mouton, Johan W.

Published
2020
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13. A model‐based approach leveraging in vitro data to support dose selection from the outset: A framework for bispecific antibodies in immuno‐oncology

Author

Sánchez, Javier, primary, Claus, Christina, additional, Albrecht, Rosmarie, additional, Gaillard, Brenda C., additional, Marinho, Joana, additional, McIntyre, Christine, additional, Tanos, Tamara, additional, Boehnke, Axel, additional, Friberg, Lena E., additional, Jönsson, Siv, additional, and Frances, Nicolas, additional

Published
2023
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15. Excluded versus included patients in a randomized controlled trial of infections caused by carbapenem-resistant Gram-negative bacteria: relevance to external validity

Author

Daitch, Vered, Paul, Mical, Daikos, George L., Durante-Mangoni, Emanuele, Yahav, Dafna, Carmeli, Yehuda, Benattar, Yael Dishon, Skiada, Anna, Andini, Roberto, Eliakim-Raz, Noa, Nutman, Amir, Zusman, Oren, Antoniadou, Anastasia, Cavezza, Giusi, Adler, Amos, Dickstein, Yaakov, Pavleas, Ioannis, Zampino, Rosa, Bitterman, Roni, Zayyad, Hiba, Koppel, Fidi, Zak-Doron, Yael, Levi, Inbar, Babich, Tanya, Turjeman, Adi, Ben-Zvi, Haim, Friberg, Lena E., Mouton, Johan W., Theuretzbacher, Ursula, and Leibovici, Leonard

Published
2021
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16. Multistate modeling for survival analysis in critically ill patients treated with meropenem.

Author

Peng, Yaru, Minichmayr, Iris K., Liu, Han, Xie, Feifan, and Friberg, Lena E.

Subjects
MEROPENEM, CRITICALLY ill, SURVIVAL analysis (Biometry), TERMINATION of treatment, SURVIVAL rate, CREATININE, VORICONAZOLE
Abstract

Appropriate antibiotic dosing to ensure early and sufficient target attainment is crucial for improving clinical outcome in critically ill patients. Parametric survival analysis is a preferred modeling method to quantify time‐varying antibiotic exposure – response effects, whereas bias may be introduced in hazard functions and survival functions when competing events occur. This study investigated predictors of in‐hospital mortality in critically ill patients treated with meropenem by pharmacometric multistate modeling. A multistate model comprising five states (ongoing meropenem treatment, other antibiotic treatment, antibiotic treatment termination, discharge, and death) was developed to capture the transitions in a cohort of 577 critically ill patients treated with meropenem. Various factors were investigated as potential predictors of the transitions, including patient demographics, creatinine clearance calculated by Cockcroft–Gault equation (CLCRCG), time that unbound concentrations exceed the minimum inhibitory concentration (fT>MIC), and microbiology‐related measures. The probabilities to transit to other states from ongoing meropenem treatment increased over time. A 10 mL/min decrease in CLCRCG was found to elevate the hazard of transitioning from states of ongoing meropenem treatment and antibiotic treatment termination to the death state by 18%. The attainment of 100% fT>MIC significantly increased the transition rate from ongoing meropenem treatment to antibiotic treatment termination (by 9.7%), and was associated with improved survival outcome. The multistate model prospectively assessed predictors of death and can serve as a useful tool for survival analysis in different infection scenarios, particularly when competing risks are present. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Prevalence and Clinical Consequences of Colistin Heteroresistance and Evolution into Full Resistance in Carbapenem-Resistant Acinetobacter baumannii

Author

Kon, Hadas, primary, Hameir, Amichay, additional, Nutman, Amir, additional, Temkin, Elizabeth, additional, Keren Paz, Alona, additional, Lellouche, Jonathan, additional, Schwartz, David, additional, Weiss, David S., additional, Kaye, Keith S., additional, Daikos, George L., additional, Skiada, Anna, additional, Durante-Mangoni, Emanuele, additional, Dishon Benattar, Yael, additional, Yahav, Dafna, additional, Daitch, Vered, additional, Bernardo, Mariano, additional, Iossa, Domenico, additional, Friberg, Lena E., additional, Theuretzbacher, Ursula, additional, Leibovici, Leonard, additional, Dickstein, Yaakov, additional, Pollak, Dina, additional, Mendelsohn, Sigal, additional, Paul, Mical, additional, Carmeli, Yehuda, additional, Bitterman, Roni, additional, Zayyad, Hiba, additional, Koppel, Fidi, additional, Zak-Doron, Yael, additional, Altunin, Sergey, additional, Andria, Nizar, additional, Neuberger, Ami, additional, Stern, Anat, additional, Petersiel, Neta, additional, Raines, Marina, additional, Karban, Amir, additional, Eliakim-Raz, Noa, additional, Zusman, Oren, additional, Elbaz, Michal, additional, Atamna, Heyam, additional, Babich, Tanya, additional, Adler, Amos, additional, Levi, Inbar, additional, Pavleas, Ioannis, additional, Antoniadou, Anastasia, additional, Kotsaki, Antigoni, additional, Andini, Roberto, additional, Cavezza, Giusi, additional, Bertolino, Lorenzo, additional, Giuffre, Giuseppe, additional, Giurazza, Roberto, additional, Ruocco, Giuseppe, additional, Galdo, Maria, additional, Murino, Patrizia, additional, Cristinziano, Adriano, additional, Corcione, Antonio, additional, Zampino, Rosa, additional, Mouton, Johan, additional, and Friberg, Lena, additional

Published
2023
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19. A multistate modeling and simulation framework to learn dose–response of oncology drugs: Application to bintrafusp alfa in non‐small cell lung cancer

Author

Liu, Han, primary, Milenković‐Grišić, Ana‐Marija, additional, Krishnan, Sreenath M., additional, Jönsson, Siv, additional, Friberg, Lena E., additional, Girard, Pascal, additional, Venkatakrishnan, Karthik, additional, Vugmeyster, Yulia, additional, Khandelwal, Akash, additional, and Karlsson, Mats O., additional

Published
2023
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23. Research priorities towards precision antibiotic therapy to improve patient care

Author

Bulman, Zackery P, primary, Wicha, Sebastian G, additional, Nielsen, Elisabet I, additional, Lenhard, Justin R, additional, Nation, Roger L, additional, Theuretzbacher, Ursula, additional, Derendorf, Hartmut, additional, Tängdén, Thomas, additional, Zeitlinger, Markus, additional, Landersdorfer, Cornelia B, additional, Bulitta, Jürgen B, additional, Friberg, Lena E, additional, Li, Jian, additional, and Tsuji, Brian T, additional

Published
2022
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24. Pharmacokinetics and Immunogenicity of the First Doses of PEG-Asparaginase

Author

Dam, Merete Eybye, Centanni, Maddalena, Friberg, Lena E, Karlsson, Mats, Lynggaard, Line Stensig, Johannsdottir , Inga Maria, Wik, Hilde Skuterud, Malmros, Johan, Heyman, Mats, Hallböök, Helene, Vaitkevičienė, Goda, Griskevicius, Laimonas, Jónsson, Ólafur Gísli, Schmiegelow, Kjeld, and Albertsen, BK

Published
2022

25. Expert workshop summary: Advancing toward a standardized murine model to evaluate treatments for antimicrobial resistance lung infections

Author

Arrazuria, Rakel, primary, Kerscher, Bernhard, additional, Huber, Karen E., additional, Hoover, Jennifer L., additional, Lundberg, Carina Vingsbo, additional, Hansen, Jon Ulf, additional, Sordello, Sylvie, additional, Renard, Stephane, additional, Aranzana-Climent, Vincent, additional, Hughes, Diarmaid, additional, Gribbon, Philip, additional, Friberg, Lena E., additional, and Bekeredjian-Ding, Isabelle, additional

Published
2022
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26. Variability of murine bacterial pneumonia models used to evaluate antimicrobial agents

Author

Arrazuria, Rakel, primary, Kerscher, Bernhard, additional, Huber, Karen E., additional, Hoover, Jennifer L., additional, Lundberg, Carina Vingsbo, additional, Hansen, Jon Ulf, additional, Sordello, Sylvie, additional, Renard, Stephane, additional, Aranzana-Climent, Vincent, additional, Hughes, Diarmaid, additional, Gribbon, Philip, additional, Friberg, Lena E., additional, and Bekeredjian-Ding, Isabelle, additional

Published
2022
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28. In vivo fitness of carbapenem-resistant Acinetobacter baumannii strains in murine infection is associated with treatment failure in human infections

Author

Nutman, Amir Temkin, Elizabeth Lellouche, Jonathan and Rakovitsky, Nadya Hameir, Amichay Daikos, George and Durante-Mangoni, Emanuele Pavleas, Ioannis Dishon, Yael and Petersiel, Neta Yahav, Dafna Eliakim, Noa Bernardo, Mariano and Iossa, Domenico Friberg, Lena E. Theuretzbacher, Ursula and Leibovici, Leonard Paul, Mical Carmeli, Yehuda AIDA Study Grp

Abstract

Objectives: Mortality among patients with carbapenem-resistant Acinetobacter baumannii (CRAB) infections varies between studies. We examined whether in vivo fitness of CRAB strains is associated with clinical outcomes in patients with CRAB infections. Methods: Isolates were collected from patients enrolled in the AIDA trial with hospital-acquired pneumonia, bloodstream infections and/or urinary tract infections caused by CRAB. The primary outcome was 14-day clinical failure, defined as failure to meet all criteria: alive; haemodynamically stable; improved or stable Sequential Organ Failure Assessment (SOFA) score; improved or stable oxygenation; and microbiological cure of bacteraemia. The secondary outcome was 14-day mortality. We tested in vivo growth using a neutropenic murine thigh infection model. Fitness was defined based on the CFU count 24 hours after injection of an inoculum of 105 CFU. We used mixed-effects logistic regression to test the association between fitness and the two outcomes. Results: The sample included 266 patients; 215 (80.8%) experienced clinical failure. CRAB fitness ranged from 5.23 to 10.08 log CFU/g. The odds of clinical failure increased by 62% for every 1-log CFU/g increase in fitness (OR 1.62, 95% CI 1.04-2.52). After adjusting for age, Charlson score, SOFA score and acquisition in the intensive care unit, fitness remained significant (adjusted OR 1.63, 95% CI 1.03-2.59). CRAB fitness had a similar effect on 14-day mortailty, although the association was not statistically significant (OR 1.56, 95% CI 0.95-2.57). It became significant after adjusting for age, Charlson score, SOFA score and recent surgery (adjusted OR 1.88, 95% CI 1.09-3.25). Conclusions: In vivo CRAB fitness was associated with clinical failure in patients with CRAB infection. Amir Nutman, Clin Microbiol Infect 2022;28:73 (c) 2021 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Published
2022

29. Large-scale WGS of carbapenem-resistant Acinetobacter baumannii isolates reveals patterns of dissemination of ST clades associated with antibiotic resistance

Author

Frenk, Sammy Temkin, Elizabeth Lurie-Weinberger, Mor N. Keren-Paz, Alona Rov, Reut Rakovitsky, Nadya Wullfhart, Liat Nutman, Amir Daikos, George L. Skiada, Anna Durante-Mangoni, Emanuele Dishon Benattar, Yael Bitterman, Roni Yahav, Dafna Daitch, Vered Bernardo, Mariano Iossa, Domenico Zusman, Oren Friberg, Lena E. Mouton, Johan W. Theuretzbacher, Ursula Leibovici, Leonard Geffen, Yuval Gershon, Rina Paul, Mical Carmeli, Yehuda

Abstract

OBJECTIVES: To describe the population genetics and antibiotic resistance gene distribution of carbapenem-resistant Acinetobacter baumannii (CRAB) isolates causing infections in three Mediterranean countries. METHODS: Isolates were collected during the 2013-17 AIDA clinical trial in six hospitals in Israel, Greece and Italy. WGS, bioinformatic characterization and antibiotic resistance profiling were performed. RESULTS: In the 247 CRAB isolates characterized in this study, ST distribution varied by country: 29/31 (93.5%) Greek isolates, 34/41 (82.9%) Italian isolates and 70/175 (40.0%) Israeli isolates belonged to ST2. The identified ST2 isolates included eight distinct clades: 2C, 2D and 2H were significantly more common in Italy, while 2F was unique to Greece. The uncommon ST3 was not present among Greek isolates and constituted only 5/41 (12%) Italian isolates. On the other hand, it was much more common among Israeli isolates: 78/175 (44.6%) belonged to ST3. The vast majority of isolates, 240/247 (97.2%), were found to harbour acquired carbapenemases, primarily blaOXA-23. The chromosomal oxaAb (blaOXA-51-like) and ampC genes characteristic of this organism were also ubiquitous. Most (96.4%) ST3 isolates carried a broad-host-range plasmid IncP1α. CONCLUSIONS: The geographical differences in CRAB populations support the theory that clonal spread of CRAB leads to endemicity in hospitals and regions. The close association between antibiotic resistance genes and clades, and between plasmids and STs, suggest that de novo creation of MDR A. baumannii is rare. The clustering of antibiotic resistance genes and plasmids that is unique to each clade/ST, and nearly uniform within clades/STs, suggests that horizontal transmission is rare but crucial to the clade’s/ST’s success.

Published
2022

30. Rituximab pharmacokinetic and pharmacokinetic–pharmacodynamic evaluation based on a study in diffuse large B‐cell lymphoma: Influence of tumor size on pharmacokinetic and assessment of pharmacokinetic similarity.

Author

Svensson, Robin J., Ooi, Qing Xi, Friberg, Lena E., Maharaj, Narendra, Reddy, Pramod Kumar, López‐Lázaro, Luis, and Hansson, Emma

Subjects
DIFFUSE large B-cell lymphomas, RITUXIMAB, B cells, PHARMACOKINETICS
Abstract

Dr. Reddy's Laboratories rituximab (DRL_RI; Dr. Reddy's Laboratories SA, Basel, Switzerland) is under development as a rituximab biosimilar. Study RI‐01‐002 (Clinical Trials Registry ‐ India/2012/11/003129), comparing DRL_RI to the reference medicinal product (RMP) MabThera® (Roche, Grenzach‐Wyhlen, Germany), demonstrated pharmacokinetic (PK) equivalence and showed comparable pharmacodynamic, efficacy, safety, and immunogenicity profiles. We used data from the same study to perform population PK and PK–pharmacodynamic analyses: first exploring possible factors influencing the PK similarity assessment between products and then performing simulations to investigate the impact of tumor size on rituximab PK. Nonlinear mixed‐effects models for PK, tumor size, tumor size–PK, and tumor response were developed independently. The final PK model included drug product as a dose‐scaling parameter and predicted a 6.75% higher dose reaching the system in RMP‐treated patients. However, when tumor size was included in the tumor size–PK model, the drug product effect was no longer observed. The model rather indicated that patients with larger tumor size have higher clearance. Further simulations confirmed that higher baseline tumor size is associated to slightly lower rituximab exposure. Tumor response, described by a continuous‐time Markov model, did not differ between drug products. Both had higher effects during the first 20 weeks of treatment. Also, the model described a subpopulation of nonresponders to treatment (42%) with faster transitions to a worse state. The different rituximab exposure initially detected between drug products (6.75%) was shown using PK/PK–pharmacodynamic analysis to be attributed to a tumor size imbalance between treatment groups. PK/PK–pharmacodynamic analyses may contribute to PK similarity assessments. [ABSTRACT FROM AUTHOR]

Published
2023
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31. Optimization of blood pressure measurement practices for pharmacodynamic analyses of tyrosine-kinase inhibitors.

Author

Centanni, Maddalena, Thijs, Abel, Desar, Ingrid, Karlsson, Mats O., and Friberg, Lena E.

Subjects
BLOOD pressure measurement, KINASE inhibitors, PROTEIN-tyrosine kinase inhibitors, BLOOD pressure
Abstract

Blood pressure measurements form a critical component of adverse event monitoring for tyrosine kinase inhibitors, but might also serve as a biomarker for dose titrations. This study explored the impact of various sources of within-individual variation on blood pressure readings to improve measurement practices and evaluated the utility for individual-and population-level dose selection. A pharmacokinetic-pharmacodynamic modeling framework was created to describe circadian blood pressure changes, inter-and intra-day variability, changes from dipper to non-dipper profiles, and the relationship between drug exposure and blood pressure changes over time. The framework was used to quantitatively evaluate the influence of physiological and pharmacological aspects on blood pressure measurements, as well as to compare measurement techniques, including office-based, home-based, and ambulatory 24-h blood pressure readings. Circadian changes, as well as random intra-day and inter-day variability, were found to be the largest sources of within-individual variation in blood pressure. Office-based and ambulatory 24-h measurements gave rise to potential bias (>5 mmHg), which was mitigated by model-based estimations. Our findings suggest that 5-8 consecutive, home-based, measurements taken at a consistent time around noon, or alternatively within a limited time frame (e.g., 8.00 a.m. to 12.00 p.m. or 12.00 p.m. to 5.00 p.m.), will give rise to the most consistent blood pressure estimates. Blood pressure measurements likely do not represent a sufficiently accurate method for individual-level dose selection, but may be valuable for population-level dose identification. A user-friendly tool has been made available to allow for interactive blood pressure simulations and estimations for the investigated scenarios. [ABSTRACT FROM AUTHOR]

Published
2023
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33. In vivo fitness of carbapenem-resistant Acinetobacter baumannii strains in murine infection is associated with treatment failure in human infections

Author

Nutman, Amir, primary, Temkin, Elizabeth, additional, Lellouche, Jonathan, additional, Rakovitsky, Nadya, additional, Hameir, Amichay, additional, Daikos, George, additional, Durante-Mangoni, Emanuele, additional, Pavleas, Ioannis, additional, Dishon, Yael, additional, Petersiel, Neta, additional, Yahav, Dafna, additional, Eliakim, Noa, additional, Bernardo, Mariano, additional, Iossa, Domenico, additional, Friberg, Lena E., additional, Theuretzbacher, Ursula, additional, Leibovici, Leonard, additional, Paul, Mical, additional, Carmeli, Yehuda, additional, Benattar, Yael Dishon, additional, Dickstein, Yaakov, additional, Bitterman, Roni, additional, Zayyad, Hiba, additional, Koppel, Fidi, additional, Zak-Doron, Yael, additional, Altunin, Sergey, additional, Andria, Nizar, additional, Neuberger, Ami, additional, Stern, Anat, additional, Raines, Marina, additional, Karban, Amir, additional, Eliakim-Raz, Noa, additional, Zusman, Oren, additional, Elbaz, Michal, additional, Atamna, Heyam, additional, Daitch, Vered, additional, Babich, Tanya, additional, Nutman, Amir, additional, Adler, Amos, additional, Levi, Inbar, additional, Daikos, George L., additional, Skiada, Anna, additional, Antoniadou, Anastasia, additional, Kotsaki, Antigoni, additional, Andini, Roberto, additional, Cavezza, Giusi, additional, Bertolino, Lorenzo, additional, Giuffre, Giuseppe, additional, Giurazza, Roberto, additional, Ruocco, Giuseppe, additional, Galdo, Maria, additional, Murino, Patrizia, additional, Cristinziano, Adriano, additional, Corcione, Antonio, additional, Zampino, Rosa, additional, Mouton, Johan, additional, and Friberg, Lena, additional

Published
2022
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34. Model-Based Characterization of the Bidirectional Interaction Between Pharmacokinetics and Tumor Growth Dynamics in Patients with Metastatic Merkel Cell Carcinoma Treated with Avelumab

Author

Grisic, Ana-Marija, primary, Xiong, Wenyuan, additional, Tanneau, Lénaïg, additional, Jönsson, Siv, additional, Friberg, Lena E., additional, Karlsson, Mats O., additional, Dai, Haiqing, additional, Zheng, Jenny, additional, Girard, Pascal, additional, and Khandelwal, Akash, additional

Published
2021
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36. Tissue Type Differences in ABCB1 Expression and Paclitaxel Tissue Pharmacokinetics in Patients With Esophageal Cancer

Author

van Eerden, Ruben A. G., primary, van Doorn, Leni, additional, de Man, Femke M., additional, Heersche, Niels, additional, Doukas, Michail, additional, van den Bosch, Thierry P. P., additional, Oomen-de Hoop, Esther, additional, de Bruijn, Peter, additional, Bins, Sander, additional, Ibrahim, Eman, additional, Nikkessen, Suzan, additional, Friberg, Lena E., additional, Koolen, Stijn L. W., additional, Spaander, Manon C. W., additional, and Mathijssen, Ron H. J., additional

Published
2021
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37. Antibacterial activity of apramycin at acidic pH warrants wide therapeutic window in the treatment of complicated urinary tract infections and acute pyelonephritis

Author

Becker, Katja, primary, Cao, Sha, additional, Nilsson, Anna, additional, Erlandsson, Maria, additional, Hotop, Sven-Kevin, additional, Kuka, Janis, additional, Hansen, Jon, additional, Haldimann, Klara, additional, Grinberga, Solveiga, additional, Berruga-Fernández, Talia, additional, Huseby, Douglas L., additional, Shariatgorji, Reza, additional, Lindmark, Evelina, additional, Platzack, Björn, additional, Böttger, Erik C., additional, Crich, David, additional, Friberg, Lena E., additional, Vingsbo Lundberg, Carina, additional, Hughes, Diarmaid, additional, Brönstrup, Mark, additional, Andrén, Per E., additional, Liepinsh, Edgars, additional, and Hobbie, Sven N., additional

Published
2021
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40. Effect of Scalp Cooling on the Pharmacokinetics of Paclitaxel

Author

van Doorn, Leni, primary, van Rosmalen, Mandy M., additional, van der Deure, Wendy M., additional, Oomen-de Hoop, Esther, additional, Porrazzo, Robert, additional, Wijngaard, Sophie M., additional, Boere, Ingrid A., additional, Veenstra, Paola, additional, Ibrahim, Eman, additional, de Bruijn, Peter, additional, Friberg, Lena E., additional, Koolen, Stijn L. W., additional, Mathijssen, Ron H. J., additional, and Jager, Agnes, additional

Published
2021
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45. Model-Informed Translation of In Vitro Effects of Short-, Prolonged- and Continuous-Infusion Meropenem against Pseudomonas aeruginosa to Clinical Settings.

Author

Minichmayr, Iris K., Kappetein, Suzanne, Brill, Margreke J. E., and Friberg, Lena E.

Subjects
PSEUDOMONAS aeruginosa, MEROPENEM, BACTERIAL growth, CRITICALLY ill, ANTIBIOTICS
Abstract

Pharmacokinetic-pharmacodynamic (PKPD) models have met increasing interest as tools to identify potential efficacious antibiotic dosing regimens in vitro and in vivo. We sought to investigate the impact of diversely shaped clinical pharmacokinetic profiles of meropenem on the growth/killing patterns of Pseudomonas aeruginosa (ARU552, MIC = 16 mg/L) over time using a semi-mechanistic PKPD model and a PK/PD index-based approach. Bacterial growth/killing were driven by the PK profiles of six patient populations (infected adults, burns, critically ill, neurosurgery, obese patients) given varied pathogen features (e.g., EC50, growth rate, inoculum), patient characteristics (e.g., creatinine clearance), and ten dosing regimens (including two dose levels and 0.5-h, 3-h and continuous-infusion regimens). Conclusions regarding the most favourable dosing regimen depended on the assessment of (i) the total bacterial load or fT>MIC (time that unbound concentrations exceed the minimum inhibitory concentration); (ii) the median or P0.95 profile of the population; and (iii) 8 h or 24 h time points. Continuous infusion plus loading dose as well as 3-h infusions (3-h infusions: e.g., for scenarios associated with low meropenem concentrations, P0.95 profiles, and MIC ≥ 16 mg/L) appeared superior to standard 0.5-h infusions at 24 h. The developed platform can serve to identify promising strategies of efficacious dosing for clinical trials. [ABSTRACT FROM AUTHOR]

Published
2022
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50. Comparing Circulating Tumor Cell Counts with Dynamic Tumor Size Changes as Predictor of Overall Survival: A Quantitative Modeling Framework: A Quantitative Modeling Framework

Author

Netterberg, Ida, Karlsson, Mats O., Terstappen, Leon W. M. M., Koopman, Miriam, Punt, Cornelis J. A., Friberg, Lena E., Oncology, and CCA - Imaging and biomarkers

Subjects
digestive system diseases
Abstract

Purpose: Quantitative relationships between treatment-induced changes in tumor size and circulating tumor cell (CTC) counts, and their links to overall survival (OS), are lacking. We present a population modeling framework identifying and quantifying such relationships, based on longitudinal data collected in patients with metastatic colorectal cancer (mCRC) to evaluate the value of tumor size and CTC counts as predictors of OS. Experimental Design: A pharmacometric approach (i.e., population pharmacodynamic modeling) was used to characterize the changes in tumor size and CTC count and evaluate them as predictors of OS in 451 patients with mCRC treated with chemotherapy and targeted therapy in a prospectively randomized phase III study (CAIRO2). Results: A tumor size model of tumor quiescence and drug resistance was used to characterize the tumor size time-course, and was, in addition to the total normalized dose (i.e., of all administered drugs) in a given cycle, related to the CTC counts through a negative binomial model (CTC model). Tumor size changes did not contribute additional predictive value when the mean CTC count was a predictor of OS. Treatment reduced the typical mean count from 1.43 to 0.477 (HR ¼ 3.94). The modeling framework was applied to explore whether dose modifications (increased and reduced) would result in a CTC count below 1/7.5 mL after 1 to 2 weeks of treatment. Conclusions: Time-varying CTC counts can be useful for early predicting OS in patients with mCRC, and may therefore have potential for model-based treatment individualization. Although tumor size was connected to CTC, its link to OS was weaker.

Published
2020

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