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Pharmaceutics
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Population Pharmacokinetics in Oncology and Its Clinical Applications
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Population Pharmacokinetics in Oncology and Its Clinical Applications

A special issue of Pharmaceutics (ISSN 1999-4923). This special issue belongs to the section "Clinical Pharmaceutics".

Deadline for manuscript submissions: closed (20 January 2023) | Viewed by 18724

Special Issue Editors

Dr. Nicolas Widmer

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Guest Editor
1. Service of Clinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
2. Pharmacy of the Eastern Vaud Hospitals, 1847 Rennaz, Switzerland
Interests: therapeutic drug monitoring; clinical pharmacokinetics; targeted anticancer drugs
Dr. Monia Guidi

E-Mail Website
Guest Editor
1. Service of Clinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
2. Center of Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
Interests: clinical pharmacokinetics; modeling and simulation; population pharmacokinetics; model-based therapeutic drug monitoring
Prof. Dr. Thierry Buclin

E-Mail Website
Guest Editor
Service of Clinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
Interests: therapeutic drug monitoring; precision medicine; evidence-based medicine; clinical pharmacokinetics; clinical trials

Special Issue Information

Dear Colleagues,

We are pleased to invite you to contribute to a Special issue of the peer-reviewed, open-access journal Pharmaceutics, which will be devoted to “Population Pharmacokinetics in Oncology and Its Clinical Applications”. Most traditional cytotoxic drugs are characterized by steep dose–response relationships and narrow therapeutic windows. Inter-individual pharmacokinetic (PK) variability is often substantial, making standard dosages produce very different circulating concentration profiles between patients. In recent decades, rationally designed small-molecule targeted anticancer drugs—namely, protein kinase inhibitors—were also developed. They are currently the mainstay of systemic treatment for a number of hematological malignancies and metastatic solid tumors. Because of their oral administration, they offer a greater autonomy and simpler outpatient care than cytotoxic chemotherapies and immunotherapies, thus improving the patient quality of life. However, the therapeutic response to oral targeted drugs varies widely between patients, with insufficient efficacy in certain cases and unacceptable toxicities in others. Here again, one of the main causes of this heterogeneity is their PK variability, besides fluctuating medication adherence and constitutive or acquired drug resistance of cancer cells (i.e., pharmacodynamic (PD) variability). PK variability appears also to affect to a clinically significant degree certain monoclonal antibodies which have recently entered the anticancer armamentarium, such as checkpoint inhibitors. It is increasingly recognized that definite improvements in the usage of anticancer drugs could be achieved by a better understanding of their PK–PD characteristics and by the individualization of their dosage regimen, based on both the thorough adaptation to influential patient characteristics and the measurement of plasma circulating drug concentrations (therapeutic drug monitoring, TDM).

This Special Issue aims to encourage scientists and clinicians to publish their observations, experimental results, and theoretical assumptions to capture the current state-of-the-art advances in the PK–PD characterization of anticancer agents, encompassing traditional chemotherapies, recent protein kinase inhibitors, and monoclonal antibodies. Our goal is to encourage translational efforts in bringing this knowledge closer to medical applications, such as therapeutic drug monitoring and further treatment individualization approaches. We believe that these efforts represent an important component of the widely advocated precision oncology, alongside the approaches capitalizing on tumor genetics.

In this Special Issue, original research articles and reviews are welcome. Research areas may include (but are not limited to) the following: population pharmacokinetic modeling of traditional cytotoxic, small-molecule targeted anticancer drugs, monoclonal antibodies and immunotherapies; pharmacodynamic–pharmacokinetic relationship analyses of anticancer treatments (correlation between concentration, efficacy, and toxicity); and therapeutic drug monitoring development in the field of oncology.

We look forward to receiving your contributions.

Dr. Nicolas Widmer
Dr. Monia Guidi
Prof. Dr. Thierry Buclin
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • clinical pharmacokinetics
  • population pharmacokinetics
  • pharmacometrics
  • therapeutic drug monitoring
  • modeling and simulation
  • precision medicine
  • oncology
  • targeted anticancer drugs
  • protein kinase inhibitors

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Published Papers (9 papers)

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Editorial

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5 pages, 162 KiB  
Editorial
Population Pharmacokinetics in Oncology and Its Clinical Applications
by Nicolas Widmer, Monia Guidi and Thierry Buclin
Pharmaceutics 2024, 16(6), 711; https://doi.org/10.3390/pharmaceutics16060711 - 25 May 2024
Viewed by 617
Abstract
Most traditional cytotoxic drugs are characterized by steep dose–response relationships and narrow therapeutic windows [...] Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)

Research

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17 pages, 1593 KiB  
Article
From Personalized to Precision Medicine in Oncology: A Model-Based Dosing Approach to Optimize Achievement of Imatinib Target Exposure
by Sylvain Goutelle, Monia Guidi, Verena Gotta, Chantal Csajka, Thierry Buclin and Nicolas Widmer
Pharmaceutics 2023, 15(4), 1081; https://doi.org/10.3390/pharmaceutics15041081 - 28 Mar 2023
Cited by 1 | Viewed by 1909
Abstract
Imatinib is a targeted cancer therapy that has significantly improved the care of patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumor (GIST). However, it has been shown that the recommended dosages of imatinib are associated with trough plasma concentration (Cmin) lower [...] Read more.
Imatinib is a targeted cancer therapy that has significantly improved the care of patients with chronic myeloid leukemia (CML) and gastrointestinal stromal tumor (GIST). However, it has been shown that the recommended dosages of imatinib are associated with trough plasma concentration (Cmin) lower than the target value in many patients. The aims of this study were to design a novel model-based dosing approach for imatinib and to compare the performance of this method with that of other dosing methods. Three target interval dosing (TID) methods were developed based on a previously published PK model to optimize the achievement of a target Cmin interval or minimize underexposure. We compared the performance of those methods to that of traditional model-based target concentration dosing (TCD) as well as fixed-dose regimen using simulated patients (n = 800) as well as real patients’ data (n = 85). Both TID and TCD model-based approaches were effective with about 65% of Cmin achieving the target imatinib Cmin interval of 1000–2000 ng/mL in 800 simulated patients and more than 75% using real data. The TID approach could also minimize underexposure. The standard 400 mg/24 h dosage of imatinib was associated with only 29% and 16.5% of target attainment in simulated and real conditions, respectively. Some other fixed-dose regimens performed better but could not minimize over- or underexposure. Model-based, goal-oriented methods can improve initial dosing of imatinib. Combined with subsequent TDM, these approaches are a rational basis for precision dosing of imatinib and other drugs with exposure–response relationships in oncology. Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)
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13 pages, 1824 KiB  
Article
Machine-Learning Exploration of Exposure-Effect Relationships of Cisplatin in Head and Neck Cancer Patients
by Céleste Cauvin, Laurent Bourguignon, Laure Carriat, Abel Mence, Pauline Ghipponi, Sébastien Salas and Joseph Ciccolini
Pharmaceutics 2022, 14(11), 2509; https://doi.org/10.3390/pharmaceutics14112509 - 18 Nov 2022
Cited by 2 | Viewed by 1462
Abstract
Background: Cisplatin is a pivotal drug in the treatment of head and neck cancer, and personalized dosage should help the preservation of an optimal toxicity–efficacy ratio. Methods: We analyzed the exposure-effect relationships of 80 adult patients with head and neck cancers and treated [...] Read more.
Background: Cisplatin is a pivotal drug in the treatment of head and neck cancer, and personalized dosage should help the preservation of an optimal toxicity–efficacy ratio. Methods: We analyzed the exposure-effect relationships of 80 adult patients with head and neck cancers and treated with standard Cisplatin-based regimen administered as three-hour infusion. Individual pharmacokinetics (PK) parameters of Cisplatin were identified using a Bayesian approach. Nephrotoxicity and ototoxicity were considered as typical Cisplatin-related toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) standards. Efficacy was evaluated based upon Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Up to nine different machine-learning algorithms were tested to decipher the exposure-effect relationships with Cisplatin. Results: The generalized linear model was the best algorithm with an accuracy of 0.71, a recall of 0.55 and a precision of 0.75. Among the various metrics for exposure (i.e., maximal concentration (Cmax), area-under-the-curve (AUC), trough levels), Cmax, comprising a range between 2.4 and 4.1 µg/mL, was the best one to be considered. When comparing a consequent, model-informed dosage with the standard dosage in 20 new patients, our strategy would have led to a reduced dosage in patients who would eventually prove to have severe toxicities while increasing dosage in patients with progressive disease. Conclusion: Determining a target Cmax could pave the way for PK-guided precision dosage with Cisplatin given as three-hour infusion. Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)
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13 pages, 1140 KiB  
Article
Implementation and Cross-Validation of a Pharmacokinetic Model for Precision Dosing of Busulfan in Hematopoietic Stem Cell Transplanted Children
by Sylvain Goutelle, Yann Thoma, Roxane Buffet, Michael Philippe, Thierry Buclin, Monia Guidi and Chantal Csajka
Pharmaceutics 2022, 14(10), 2107; https://doi.org/10.3390/pharmaceutics14102107 - 1 Oct 2022
Cited by 2 | Viewed by 1820
Abstract
Busulfan, a drug used in conditioning prior to hematopoietic stem cell transplantation (HSCT) in children, has a narrow therapeutic margin. The model-informed precision dosing (MIPD) of busulfan is desirable, but there is a lack of validated tools. The objective of this study was [...] Read more.
Busulfan, a drug used in conditioning prior to hematopoietic stem cell transplantation (HSCT) in children, has a narrow therapeutic margin. The model-informed precision dosing (MIPD) of busulfan is desirable, but there is a lack of validated tools. The objective of this study was to implement and cross-validate a population pharmacokinetic (PK) model in the Tucuxi software for busulfan MIPD in HSCT children. A search of the literature was performed to identify candidate population PK models. The goodness of fit of three selected models was assessed in a dataset of 178 children by computing the mean error (ME) and root-mean-squared error of prediction (RMSE). The best model was implemented in Tucuxi. The individual predicted concentrations, the area under the concentration-time curve (AUC), and dosage requirements were compared between the Tucuxi model and a reference model available in the BestDose software in a subset of 61 children. The model from Paci et al. best fitted the data in the full dataset. In a subset of 61 patients, the predictive performance of Tucuxi and BestDose models was comparable with ME values of 6.4% and −2.5% and RMSE values of 11.4% and 13.6%, respectively. The agreement between the estimated AUC and the predicted dose was good, with 6.6% and 4.9% of the values being out of the 95% limits of agreement, respectively. To conclude, a PK model for busulfan MIPD was cross-validated and is now available in the Tucuxi software. Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)
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18 pages, 1486 KiB  
Article
Exposure–Response Analysis of Osimertinib in Patients with Advanced Non-Small-Cell Lung Cancer
by Thomas Rodier, Alicja Puszkiel, Evelina Cardoso, David Balakirouchenane, Céline Narjoz, Jennifer Arrondeau, Vincent Fallet, Nihel Khoudour, Monia Guidi, Michel Vidal, Xavier Declèves, Chantal Csajka, Jérôme Alexandre, Jacques Cadranel, Elizabeth Fabre, Marie Wislez, François Goldwasser and Benoit Blanchet
Pharmaceutics 2022, 14(9), 1844; https://doi.org/10.3390/pharmaceutics14091844 - 1 Sep 2022
Cited by 16 | Viewed by 2269
Abstract
High interindividual variability (IIV) of the clinical response to epidermal growth factor receptor (EGFR) inhibitors such as osimertinib in non-small-cell lung cancer (NSCLC) might be related to the IIV in plasma exposure. The aim of this study was to evaluate the exposure–response relationship [...] Read more.
High interindividual variability (IIV) of the clinical response to epidermal growth factor receptor (EGFR) inhibitors such as osimertinib in non-small-cell lung cancer (NSCLC) might be related to the IIV in plasma exposure. The aim of this study was to evaluate the exposure–response relationship for toxicity and efficacy of osimertinib in unselected patients with advanced EGFR-mutant NSCLC. This retrospective analysis included 87 patients treated with osimertinib. Exposure–toxicity analysis was performed in the entire cohort and survival analysis only in second-line patients (n = 45). No significant relationship between occurrence of dose-limiting toxicity and plasma exposure was observed in the entire cohort (p = 0.23, n = 86). The median overall survival (OS) was approximately two-fold shorter in the 4th quartile (Q4) of osimertinib trough plasma concentration (>235 ng/mL) than in the Q1–Q3 group (12.2 months [CI95% = 8.0–not reached (NR)] vs. 22.7 months [CI95% = 17.1–34.1]), but the difference was not statistically significant (p = 0.15). To refine this result, the exposure–survival relationship was explored in a cohort of 41 NSCLC patients treated with erlotinib. The Q4 erlotinib exposure group (>1728 ng/mL) exhibited a six-fold shorter median OS than the Q1–Q3 group (4.8 months [CI95% = 3.3-NR] vs. 22.8 months (CI95% = 10.6–37.4), p = 0.00011). These results suggest that high exposure to EGFR inhibitors might be related to worse survival in NSCLC patients. Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)
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12 pages, 1125 KiB  
Article
Imatinib Optimized Therapy Improves Major Molecular Response Rates in Patients with Chronic Myeloid Leukemia
by Hyacinthe Johnson-Ansah, Benjamin Maneglier, Françoise Huguet, Laurence Legros, Martine Escoffre-Barbe, Martine Gardembas, Pascale Cony-Makhoul, Valérie Coiteux, Laurent Sutton, Wajed Abarah, Camille Pouaty, Jean-Michel Pignon, Bachra Choufi, Sorin Visanica, Bénédicte Deau, Laure Morisset, Emilie Cayssials, Mathieu Molimard, Stéphane Bouchet, François-Xavier Mahon, Franck Nicolini, Philippe Aegerter, Jean-Michel Cayuela, Marc Delord, Heriberto Bruzzoni-Giovanelli and Philippe Rousselotadd Show full author list remove Hide full author list
Pharmaceutics 2022, 14(8), 1676; https://doi.org/10.3390/pharmaceutics14081676 - 12 Aug 2022
Cited by 6 | Viewed by 2487
Abstract
The registered dose for imatinib is 400 mg/d, despite high inter-patient variability in imatinib plasmatic exposure. Therapeutic drug monitoring (TDM) is routinely used to maximize a drug’s efficacy or tolerance. We decided to conduct a prospective randomized trial (OPTIM-imatinib trial) to assess the [...] Read more.
The registered dose for imatinib is 400 mg/d, despite high inter-patient variability in imatinib plasmatic exposure. Therapeutic drug monitoring (TDM) is routinely used to maximize a drug’s efficacy or tolerance. We decided to conduct a prospective randomized trial (OPTIM-imatinib trial) to assess the value of TDM in patients with chronic phase chronic myelogenous treated with imatinib as first-line therapy (NCT02896842). Eligible patients started imatinib at 400 mg daily, followed by imatinib [C]min assessment. Patients considered underdosed ([C]min < 1000 ng/mL) were randomized in a dose-increase strategy aiming to reach the threshold of 1000 ng/mL (TDM arm) versus standard imatinib management (control arm). Patients with [C]min levels ≥ 1000 ng/mL were treated following current European Leukemia Net recommendations (observational arm). The primary endpoint was the rate of major molecular response (MMR, BCR::ABL1IS ≤ 0.1%) at 12 months. Out of 133 evaluable patients on imatinib 400 mg daily, 86 patients had a [C]min < 1000 ng/mL and were randomized. The TDM strategy resulted in a significant increase in [C]min values with a mean imatinib daily dose of 603 mg daily. Patients included in the TDM arm had a 12-month MMR rate of 67% (95% CI, 51–81) compared to 39% (95% CI, 24–55) for the control arm (p = 0.017). This early advantage persisted over the 3-year study period, in which we considered imatinib cessation as a censoring event. Imatinib TDM was feasible and significantly improved the 12-month MMR rate. This early advantage may be beneficial for patients without easy access to second-line TKIs. Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)
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17 pages, 1524 KiB  
Article
Population Pharmacokinetics of Palbociclib and Its Correlation with Clinical Efficacy and Safety in Patients with Advanced Breast Cancer
by Perrine Courlet, Evelina Cardoso, Carole Bandiera, Athina Stravodimou, Jean-Philippe Zurcher, Haithem Chtioui, Isabella Locatelli, Laurent Arthur Decosterd, Léa Darnaud, Benoit Blanchet, Jérôme Alexandre, Anna Dorothea Wagner, Khalil Zaman, Marie Paule Schneider, Monia Guidi and Chantal Csajka
Pharmaceutics 2022, 14(7), 1317; https://doi.org/10.3390/pharmaceutics14071317 - 21 Jun 2022
Cited by 5 | Viewed by 2737
Abstract
Neutropenia is the most frequent dose-limiting toxicity reported in patients with metastatic breast cancer receiving palbociclib. The objective of this study was to investigate the pharmacokinetic–pharmacodynamic (PK/PD) relationships for toxicity (i.e., absolute neutrophil count, ANC) and efficacy (i.e., progression-free survival, PFS). A semi-mechanistic [...] Read more.
Neutropenia is the most frequent dose-limiting toxicity reported in patients with metastatic breast cancer receiving palbociclib. The objective of this study was to investigate the pharmacokinetic–pharmacodynamic (PK/PD) relationships for toxicity (i.e., absolute neutrophil count, ANC) and efficacy (i.e., progression-free survival, PFS). A semi-mechanistic PK/PD model was used to predict neutrophils’ time course using a population approach (NONMEM). Influence of demographic and clinical characteristics was evaluated. Cox proportional hazards models were developed to evaluate the influence of palbociclib PK on PFS. A two-compartment model with first-order absorption and a lag time adequately described the 255 palbociclib concentrations provided by 44 patients. The effect of the co-administration of proton-pump inhibitors in fasting conditions increased palbociclib clearance by 56%. None of the tested covariates affected the PD parameters. Model-based simulations confirmed the concentration-dependent and non-cumulative properties of palbociclib-induced neutropenia, reversible after treatment withdrawal. The ANC nadir occurred approximately at day 24 of each cycle. Cox analyses revealed a trend for better PFS with increasing palbociclib exposure in older patients. By characterizing palbociclib-induced neutropenia, this model offers support to clinicians to rationally optimize treatment management through patient-individualized strategies. Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)
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12 pages, 1283 KiB  
Article
Relation between Plasma Trough Concentration of Pazopanib and Progression-Free Survival in Metastatic Soft Tissue Sarcoma Patients
by Marie-Sophie Minot-This, Pascaline Boudou-Rouquette, Anne Jouinot, Sixtine de Percin, David Balakirouchenane, Nihel Khoudour, Camille Tlemsani, Jonathan Chauvin, Audrey Thomas-Schoemann, François Goldwasser, Benoit Blanchet and Jérôme Alexandre
Pharmaceutics 2022, 14(6), 1224; https://doi.org/10.3390/pharmaceutics14061224 - 9 Jun 2022
Cited by 6 | Viewed by 1795
Abstract
Background: Pazopanib (PAZ) is an oral angiogenesis inhibitor approved to treat soft tissue sarcoma (STS) but associated with a large interpatient pharmacokinetic (PK) variability and narrow therapeutic index. We aimed to define the specific threshold of PAZ trough concentration (Cmin) associated [...] Read more.
Background: Pazopanib (PAZ) is an oral angiogenesis inhibitor approved to treat soft tissue sarcoma (STS) but associated with a large interpatient pharmacokinetic (PK) variability and narrow therapeutic index. We aimed to define the specific threshold of PAZ trough concentration (Cmin) associated with better progression-free survival (PFS) in STS patients. Methods: In this observational study, PAZ Cmin was monitored over the treatment course. For the primary endpoint, the 3-month PFS in STS was analyzed with logistic regression. Second, we performed exposure–overall survival (OS) (Cox model plus Kaplan–Meier analysis/log-rank test) and exposure–toxicity analyses. Results: Ninety-five STS patients were eligible for pharmacokinetic/pharmacodynamic (PK/PD) assessment. In the multivariable analysis, PAZ Cmin < 27 mg/L was independently associated with a risk of progression at 3 months (odds ratio (OR) 4.21, 95% confidence interval (CI) (1.47–12.12), p = 0.008). A higher average of PAZ Cmin over the first 3 months was associated with a higher risk of grade 3–4 toxicities according to the NCI-CTCAE version 5.0 (OR 1.07 per 1 mg/L increase, CI95 (1.02–1.13), p = 0.007). Conclusion: PAZ Cmin ≥ 27 mg/L was independently associated with improved 3-month PFS in STS patients. Pharmacokinetically-guided dosing could be helpful to optimize the clinical management of STS patients in daily clinical practice. Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)
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Review

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16 pages, 367 KiB  
Review
Precision Oncology by Point-of-Care Therapeutic Drug Monitoring and Dosage Adjustment of Conventional Cytotoxic Chemotherapies: A Perspective
by Myriam Briki, Pascal André, Yann Thoma, Nicolas Widmer, Anna D. Wagner, Laurent A. Decosterd, Thierry Buclin, Monia Guidi and Sandro Carrara
Pharmaceutics 2023, 15(4), 1283; https://doi.org/10.3390/pharmaceutics15041283 - 19 Apr 2023
Cited by 6 | Viewed by 1990
Abstract
Therapeutic drug monitoring (TDM) of conventional cytotoxic chemotherapies is strongly supported yet poorly implemented in daily practice in hospitals. Analytical methods for the quantification of cytotoxic drugs are instead widely presented in the scientific literature, while the use of these therapeutics is expected [...] Read more.
Therapeutic drug monitoring (TDM) of conventional cytotoxic chemotherapies is strongly supported yet poorly implemented in daily practice in hospitals. Analytical methods for the quantification of cytotoxic drugs are instead widely presented in the scientific literature, while the use of these therapeutics is expected to keep going for longer. There are two main issues hindering the implementation of TDM: turnaround time, which is incompatible with the dosage profiles of these drugs, and exposure surrogate marker, namely total area under the curve (AUC). Therefore, this perspective article aims to define the adjustment needed from current to efficient TDM practice for cytotoxics, namely point-of-care (POC) TDM. For real-time dose adjustment, which is required for chemotherapies, such POC TDM is only achievable with analytical methods that match the sensitivity and selectivity of current methods, such as chromatography, as well as model-informed precision dosing platforms to assist the oncologist with dose fine-tuning based on quantification results and targeted intervals. Full article
(This article belongs to the Special Issue Population Pharmacokinetics in Oncology and Its Clinical Applications)
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