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  1. Book: Cancer clinical pharmacology

    Schellens, Jan H. M.

    2005  

    Author's details ed. by Jan H. M. Schellens
    Keywords Cytostatikum
    Subject Zytostatikum ; Cancerotoxischer Stoff ; Carcinostatikum ; Krebsmittel ; Antineoplastikum ; Anticarcinogen ; Antikarzinogen ; Anticancerogen ; Antineoplastisches Mittel
    Language English
    Size XII, 267 S. : Ill., graph. Darst.
    Publisher Oxford Univ. Press
    Publishing place Oxford u.a.
    Publishing country Great Britain
    Document type Book
    HBZ-ID HT014066415
    ISBN 0-19-262966-2 ; 978-0-19-262966-1
    Database Catalogue ZB MED Medicine, Health

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  2. Article ; Online: Potential Benefit of Low-Dose Candesartan in Trastuzumab-Induced Cardiotoxic Effect-Reply.

    Schellens, Jan H M

    JAMA oncology

    2016  Volume 3, Issue 2, Page(s) 279–280

    Language English
    Publishing date 2016-10-20
    Publishing country United States
    Document type Journal Article
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2016.3595
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: A Nomogram to Predict Severe Toxicity in DPYD Wild-Type Patients Treated With Capecitabine-Based Anticancer Regimens.

    Knikman, Jonathan E / Lopez-Yurda, Marta / Meulendijks, Didier / Deenen, Maarten J / Schellens, Jan H M / Beijnen, Jos / Cats, Annemieke / Guchelaar, Henk-Jan

    Clinical pharmacology and therapeutics

    2023  Volume 115, Issue 2, Page(s) 269–277

    Abstract: DPYD-guided dosing has improved the safety of fluoropyrimidine-based chemotherapy in recent years. However, severe toxicity remains in ~ 23% of patients not carrying DPYD variant alleles treated with capecitabine. Therefore, we developed a predictive ... ...

    Abstract DPYD-guided dosing has improved the safety of fluoropyrimidine-based chemotherapy in recent years. However, severe toxicity remains in ~ 23% of patients not carrying DPYD variant alleles treated with capecitabine. Therefore, we developed a predictive model based on patient-related and treatment-related factors aimed at estimating the risk of developing severe capecitabine-related toxicity. The nomogram was developed using data from two large clinical trials (NCT00838370 and NCT02324452). Patients with cancer carrying a DPYD variant allele (DPYD*2A, c.1236G>A, c.2846A>T, and c.1679T>G) were excluded. Univariable and multivariable logistic regression using predetermined predictors based on previous findings, including age, sex, body surface area, type of treatment regimen, and creatinine levels were used to develop the nomogram. The developed model was internally validated using bootstrap resampling and cross-validation. This model was not externally or clinically validated. A total of 2,147 DPYD wild-type patients with cancer treated with capecitabine-based chemotherapy regimens were included of which complete data of 1,745 patients were available and used for the development of the nomogram. Univariable and multivariable logistic regression showed that age, sex, and type of treatment regimen were strong predictors of severe capecitabine-related toxicity in DPYD wild-type patients. Internal validation demonstrated a concordance index of 0.68 which indicates a good discriminative ability for prediction of severe capecitabine-related toxicity. The developed nomogram includes readily available parameters and may be a helpful tool for clinicians to assess the risk of developing severe capecitabine-related toxicity in patients without known risk DPYD variant alleles treated with capecitabine-based anticancer regimens.
    MeSH term(s) Humans ; Capecitabine/adverse effects ; Fluorouracil/adverse effects ; Antimetabolites, Antineoplastic/adverse effects ; Nomograms ; Dihydrouracil Dehydrogenase (NADP)/genetics ; Neoplasms/drug therapy ; Neoplasms/genetics ; Neoplasms/chemically induced ; Genotype
    Chemical Substances Capecitabine (6804DJ8Z9U) ; Fluorouracil (U3P01618RT) ; Antimetabolites, Antineoplastic ; Dihydrouracil Dehydrogenase (NADP) (EC 1.3.1.2)
    Language English
    Publishing date 2023-11-29
    Publishing country United States
    Document type Journal Article
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.3100
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  4. Article ; Online: Clinical Trials Series — Large Pharma.

    Schellens, Jan H M / Bernards, René

    The New England journal of medicine

    2017  Volume 376, Issue 14, Page(s) e28

    Language English
    Publishing date 2017--06
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc1701621
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  5. Article ; Online: Response to "Plasma Uracil as a DPD Phenotyping Test: Pre-analytical Handling Matters".

    de With, Mirjam / Knikman, Jonathan / Schellens, Jan H M / Gelderblom, Hans / Cats, Annemieke / Guchelaar, Henk-Jan / Mathijssen, Ron H J / Swen, Jesse J / Meulendijks, Didier

    Clinical pharmacology and therapeutics

    2022  Volume 113, Issue 3, Page(s) 473–475

    MeSH term(s) Humans ; Uracil ; Fluorouracil ; Dihydrouracil Dehydrogenase (NADP)
    Chemical Substances Uracil (56HH86ZVCT) ; Fluorouracil (U3P01618RT) ; Dihydrouracil Dehydrogenase (NADP) (EC 1.3.1.2)
    Language English
    Publishing date 2022-11-09
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.2775
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  6. Article: Molecular Pathways: Targeting the Protein Kinase Wee1 in Cancer.

    Geenen, Jill J J / Schellens, Jan H M

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2017  Volume 23, Issue 16, Page(s) 4540–4544

    Abstract: Wee1 is a protein kinase that regulates the ... ...

    Abstract Wee1 is a protein kinase that regulates the G
    Language English
    Publishing date 2017-08-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-17-0520
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Breakthrough therapy-designated oncology drugs: are they rightfully criticized?

    Mulder, Jorn / Pasmooij, Anna M G / Stoyanova-Beninska, Violeta V / Schellens, Jan H M

    Drug discovery today

    2020  Volume 25, Issue 9, Page(s) 1580–1584

    Abstract: The US Food and Drug Administration (FDA) has four expedited programs, including the breakthrough therapy designation (BTD). Recently, this program has been criticized. In this feature, we determine whether BTD oncology drugs were truly a breakthrough, ... ...

    Abstract The US Food and Drug Administration (FDA) has four expedited programs, including the breakthrough therapy designation (BTD). Recently, this program has been criticized. In this feature, we determine whether BTD oncology drugs were truly a breakthrough, based on the outcome of a validated instrument to measure clinical benefit. We find that only a few drugs were likely a breakthrough, indicating that the success rate of the BTD program is somewhat low. Despite this, we believe that programs for fast drug approval do have a place in the current regulatory practice and that the necessary efforts for their improvement should be further explored, especially considering the remaining unmet medical need for patients with cancer.
    MeSH term(s) Antineoplastic Agents/therapeutic use ; Drug Approval ; Humans ; Medical Oncology ; Neoplasms/drug therapy ; Treatment Outcome
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2020-06-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 1324988-5
    ISSN 1878-5832 ; 1359-6446
    ISSN (online) 1878-5832
    ISSN 1359-6446
    DOI 10.1016/j.drudis.2020.06.009
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  8. Article ; Online: Survival of Patients With Cancer With

    Knikman, Jonathan E / Wilting, Tycho A / Lopez-Yurda, Marta / Henricks, Linda M / Lunenburg, Carin A T C / de Man, Femke M / Meulendijks, Didier / Nieboer, Peter / Droogendijk, Helga J / Creemers, Geert-Jan / Mandigers, Caroline M P W / Imholz, Alexander L T / Mathijssen, Ron H J / Portielje, Johanneke E A / Valkenburg-van Iersel, Liselot / Vulink, Annelie / van der Poel, Marlene H W / Baars, Arnold / Swen, Jesse J /
    Gelderblom, Hans / Schellens, Jan H M / Beijnen, Jos H / Guchelaar, Henk-Jan / Cats, Annemieke

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2023  Volume 41, Issue 35, Page(s) 5411–5421

    Abstract: Purpose: DPYD: Methods: Data from a prospective multicenter study (ClinicalTrials.gov identifier: NCT02324452) in which : Results: In total, 156 : Conclusion: In this exploratory analysis, ...

    Abstract Purpose: DPYD
    Methods: Data from a prospective multicenter study (ClinicalTrials.gov identifier: NCT02324452) in which
    Results: In total, 156
    Conclusion: In this exploratory analysis,
    MeSH term(s) Humans ; Capecitabine ; Fluorouracil ; Alleles ; Retrospective Studies ; Prospective Studies ; Matched-Pair Analysis ; Dihydrouracil Dehydrogenase (NADP)/genetics ; Neoplasms/drug therapy ; Neoplasms/genetics ; Genotype
    Chemical Substances Capecitabine (6804DJ8Z9U) ; Fluorouracil (U3P01618RT) ; Dihydrouracil Dehydrogenase (NADP) (EC 1.3.1.2)
    Language English
    Publishing date 2023-08-28
    Publishing country United States
    Document type Multicenter Study ; Journal Article
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.22.02780
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Bioanalytical LC-MS/MS validation of therapeutic drug monitoring assays in oncology.

    van Nuland, Merel / Rosing, Hilde / Schellens, Jan H M / Beijnen, Jos H

    Biomedical chromatography : BMC

    2019  Volume 34, Issue 1, Page(s) e4623

    Abstract: Therapeutic drug monitoring (TDM) has shown to benefit patients treated with drugs of many drug classes, among which is oncology. With an increasing demand for drug monitoring, new assays have to be developed and validated. Guidelines for bioanalytical ... ...

    Abstract Therapeutic drug monitoring (TDM) has shown to benefit patients treated with drugs of many drug classes, among which is oncology. With an increasing demand for drug monitoring, new assays have to be developed and validated. Guidelines for bioanalytical validation issued by the European Medicines Agency and US Food and Drug Administration are applicable for clinical trials and toxicokinetic studies and demand fully validated bioanalytical methods to yield reliable results. However, for TDM assays a limited validation approach is suggested based on the intended use of these methods. This review presents an overview of publications that describe method validation of assays specifically designed for TDM. In addition to evaluating current practice, we provide recommendations that could serve as a guide for future validations of TDM assays.
    MeSH term(s) Antineoplastic Agents/analysis ; Antineoplastic Agents/pharmacokinetics ; Antineoplastic Agents/therapeutic use ; Chromatography, Liquid/methods ; Drug Monitoring/methods ; Humans ; Linear Models ; Neoplasms/drug therapy ; Reproducibility of Results ; Sensitivity and Specificity ; Tandem Mass Spectrometry/methods
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2019-11-27
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 632848-9
    ISSN 1099-0801 ; 0269-3879
    ISSN (online) 1099-0801
    ISSN 0269-3879
    DOI 10.1002/bmc.4623
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: DPYD genotype-guided dose individualisation of fluoropyrimidine therapy: who and how? - Authors' reply.

    Henricks, Linda M / Lunenburg, Carin A T C / Cats, Annemieke / Mathijssen, Ron H J / Guchelaar, Henk-Jan / Schellens, Jan H M

    The Lancet. Oncology

    2019  Volume 20, Issue 2, Page(s) e67

    MeSH term(s) Capecitabine ; Dihydrouracil Dehydrogenase (NADP)/genetics ; Genotype ; Humans ; Neoplasms ; Prospective Studies
    Chemical Substances Capecitabine (6804DJ8Z9U) ; Dihydrouracil Dehydrogenase (NADP) (EC 1.3.1.2)
    Language English
    Publishing date 2019-02-01
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 2049730-1
    ISSN 1474-5488 ; 1470-2045
    ISSN (online) 1474-5488
    ISSN 1470-2045
    DOI 10.1016/S1470-2045(19)30010-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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