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Article ; Online: No need for H

Gelderblom, Hans / Zwaveling, Juliette

2021 Volume 124, Issue 10, Page(s) 1613–1614

Abstract: The theoretical basis for use of histamine 2 ( ... ...

Abstract	The theoretical basis for use of histamine 2 (H
MeSH term(s)	Drug Hypersensitivity ; Histamine H2 Antagonists ; Humans ; Paclitaxel ; Premedication ; Ranitidine
Chemical Substances	Histamine H2 Antagonists ; Ranitidine (884KT10YB7) ; Paclitaxel (P88XT4IS4D)
Language	English
Publishing date	2021-03-24
Publishing country	England
Document type	Editorial ; Comment
ZDB-ID	80075-2
ISSN	1532-1827 ; 0007-0920
ISSN (online)	1532-1827
ISSN	0007-0920
DOI	10.1038/s41416-021-01316-x
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Article: Application of Electronic Health Record Text Mining: Real-World Tolerability, Safety, and Efficacy of Adjuvant Melanoma Treatments.

van Laar, Sylvia A / Kapiteijn, Ellen / Gombert-Handoko, Kim B / Guchelaar, Henk-Jan / Zwaveling, Juliette

Cancers

2022 Volume 14, Issue 21

Abstract: ... ...

Abstract	Introduction
Language	English
Publishing date	2022-11-03
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers14215426
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Article ; Online: Real-world evaluation of supportive care using an electronic health record text-mining tool: G-CSF use in breast cancer patients.

van Laar, Sylvia A / Gombert-Handoko, Kim B / Wassenaar, Sophie / Kroep, Judith R / Guchelaar, Henk-Jan / Zwaveling, Juliette

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

2022 Volume 30, Issue 11, Page(s) 9181–9189

Abstract: Purpose: Chemotherapy-induced febrile neutropenia (FN) is a life-threatening and chemotherapy dose-limiting adverse event. FN can be prevented with granulocyte-colony stimulating factors (G-CSFs). Guidelines recommend primary G-CSF use for patients ... ...

Abstract	Purpose: Chemotherapy-induced febrile neutropenia (FN) is a life-threatening and chemotherapy dose-limiting adverse event. FN can be prevented with granulocyte-colony stimulating factors (G-CSFs). Guidelines recommend primary G-CSF use for patients receiving either high (> 20%) FN risk (HR) chemotherapy, or intermediate (10-20%) FN risk (IR) chemotherapy if the overall risk with additional patient-related risk factors exceeds 20%. In this study, we applied an EHR text-mining tool for real-world G-CSF treatment evaluation in breast cancer patients. Methods: Breast cancer patients receiving IR or HR chemotherapy treatments between January 2015 and February 2021 at LUMC, the Netherlands, were included. We retrospectively collected data from EHR with a text-mining tool and assessed G-CSF use, risk factors, and the FN and neutropenia (grades 3-4) and incidence. Results: A total of 190 female patients were included, who received 77 HR and 113 IR treatments. In 88.3% of the HR regimens, G-CSF was administered; 7.3% of these patients developed FN vs. 33.3% without G-CSF. Although most IR regimen patients had ≥ 2 risk factors, only 4% received G-CSF, of which none developed neutropenia. However, without G-CSF, 11.9% developed FN and 31.2% severe neutropenia. Conclusions: Our text-mining study shows high G-CSF use among HR regimen patients, and low use among IR regimen patients, although most had ≥ 2 risk factors. Therefore, current practice is not completely in accordance with the guidelines. This shows the need for increased awareness and clarity regarding risk factors. Also, text-mining can effectively be implemented for the evaluation of patient care.
MeSH term(s)	Humans ; Female ; Granulocyte Colony-Stimulating Factor ; Breast Neoplasms/epidemiology ; Retrospective Studies ; Electronic Health Records ; Chemotherapy-Induced Febrile Neutropenia/prevention & control ; Data Mining ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Febrile Neutropenia/drug therapy
Chemical Substances	Granulocyte Colony-Stimulating Factor (143011-72-7)
Language	English
Publishing date	2022-08-31
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1134446-5
ISSN	1433-7339 ; 0941-4355
ISSN (online)	1433-7339
ISSN	0941-4355
DOI	10.1007/s00520-022-07343-5
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Zs.A 3697: Show issues

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Article ; Online: A text-mining approach to study the real-world effectiveness and potentially fatal immune-related adverse events of PD-1 and PD-L1 inhibitors in older patients with stage III/IV non-small cell lung cancer.

Abedian Kalkhoran, Hanieh / Zwaveling, Juliëtte / Storm, Bert N / van Laar, Sylvia A / Portielje, Johanneke Ea / Codrington, Henk / Luijten, Dieuwke / Brocken, Pepijn / Smit, Egbert F / Visser, Loes E

BMC cancer

2023 Volume 23, Issue 1, Page(s) 247

Abstract: Background: This study was designed to investigate the impact of age on the effectiveness and immune-related adverse events (irAEs) of programmed death-(ligand)1 [PD-(L)1] inhibitors in patients with non-small cell lung cancer (NSCLC) using a novel text- ...

Abstract	Background: This study was designed to investigate the impact of age on the effectiveness and immune-related adverse events (irAEs) of programmed death-(ligand)1 [PD-(L)1] inhibitors in patients with non-small cell lung cancer (NSCLC) using a novel text-mining technique. Methods: This retrospective study included patients with stage III/IV NSCLC treated with a PD-(L)1 inhibitor (nivolumab, pembrolizumab, atezolizumab and durvalumab) at Leiden University Medical Centre and Haga Teaching hospital, (both in The Netherlands) from September 2016 to May 2021. All the relevant data was extracted from the structured and unstructured fields of the Electronic Health Records using a novel text-mining tool. Effectiveness [progression-free survival (PFS) and overall survival (OS)] and safety (the incidence of nine potentially fatal irAEs and systemic corticosteroid requirement) outcomes were compared across age subgroups (young: < 65 years, Middle-aged: 65-74 years, and old: ≥ 75 years) after adjustment for confounding. Results: Of 689 patients, 310 patients (45.0%) were < 65 years, 275 patients (39.9%) were aged between 65 and 74 years, and 104 patients (15.1%) were ≥ 75 years. There was no significant difference between younger and older patients regarding PFS (median PFS 12, 8, 13 months respectively; Hazard ratio (HR) Conclusions: The use of PD-(L)1 inhibitors is not associated with age related decrease of PFS and OS, nor with increased incidence of serious irAEs compared to younger patients receiving these treatments. Chronological age must therefore not be used as a predictor for the effectiveness or safety of ICIs.
MeSH term(s)	Middle Aged ; Humans ; Aged ; Carcinoma, Non-Small-Cell Lung ; Immune Checkpoint Inhibitors/adverse effects ; Programmed Cell Death 1 Receptor/therapeutic use ; Lung Neoplasms ; Retrospective Studies ; Antineoplastic Agents, Immunological/adverse effects
Chemical Substances	Immune Checkpoint Inhibitors ; Programmed Cell Death 1 Receptor ; Antineoplastic Agents, Immunological
Language	English
Publishing date	2023-03-14
Publishing country	England
Document type	Journal Article
ZDB-ID	2041352-X
ISSN	1471-2407 ; 1471-2407
ISSN (online)	1471-2407
ISSN	1471-2407
DOI	10.1186/s12885-023-10701-z
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Article ; Online: An Electronic Health Record Text Mining Tool to Collect Real-World Drug Treatment Outcomes: A Validation Study in Patients With Metastatic Renal Cell Carcinoma.

van Laar, Sylvia A / Gombert-Handoko, Kim B / Guchelaar, Henk-Jan / Zwaveling, Juliëtte

Clinical pharmacology and therapeutics

2020 Volume 108, Issue 3, Page(s) 644–652

Abstract: Real-world evidence can close the inferential gap between marketing authorization studies and clinical practice. However, the current standard for real-world data extraction from electronic health records (EHRs) for treatment evaluation is manual review ( ...

Abstract	Real-world evidence can close the inferential gap between marketing authorization studies and clinical practice. However, the current standard for real-world data extraction from electronic health records (EHRs) for treatment evaluation is manual review (MR), which is time-consuming and laborious. Clinical Data Collector (CDC) is a novel natural language processing and text mining software tool for both structured and unstructured EHR data and only shows relevant EHR sections improving efficiency. We investigated CDC as a real-world data (RWD) collection method, through application of CDC queries for patient inclusion and information extraction on a cohort of patients with metastatic renal cell carcinoma (RCC) receiving systemic drug treatment. Baseline patient characteristics, disease characteristics, and treatment outcomes were extracted and these were compared with MR for validation. One hundred patients receiving 175 treatments were included using CDC, which corresponded to 99% with MR. Calculated median overall survival was 21.7 months (95% confidence interval (CI) 18.7-24.8) vs. 21.7 months (95% CI 18.6-24.8) and progression-free survival 8.9 months (95% CI 5.4-12.4) vs. 7.6 months (95% CI 5.7-9.4) for CDC vs. MR, respectively. Highest F1-score was found for cancer-related variables (88.1-100), followed by comorbidities (71.5-90.4) and adverse drug events (53.3-74.5), with most diverse scores on international metastatic RCC database criteria (51.4-100). Mean data collection time was 12 minutes (CDC) vs. 86 minutes (MR). In conclusion, CDC is a promising tool for retrieving RWD from EHRs because the correct patient population can be identified as well as relevant outcome data, such as overall survival and progression-free survival.
MeSH term(s)	Aged ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Carcinoma, Renal Cell/drug therapy ; Carcinoma, Renal Cell/mortality ; Carcinoma, Renal Cell/secondary ; Data Collection ; Data Mining ; Electronic Health Records ; Female ; Humans ; Kidney Neoplasms/drug therapy ; Kidney Neoplasms/mortality ; Kidney Neoplasms/pathology ; Male ; Natural Language Processing ; Progression-Free Survival ; Reproducibility of Results ; Retrospective Studies ; Software ; Time Factors
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2020-07-18
Publishing country	United States
Document type	Journal Article ; Observational Study ; Validation Study
ZDB-ID	123793-7
ISSN	1532-6535 ; 0009-9236
ISSN (online)	1532-6535
ISSN	0009-9236
DOI	10.1002/cpt.1966
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Article ; Online: Effect of Busulfan and Treosulfan on Gonadal Function after Allogeneic Stem Cell Transplantation in Children and Adolescents with Nonmalignant Diseases Is Not Exposure-Dependent.

van der Stoep, M Y Eileen C / Bense, Joëll E / de Kloet, Liselotte C / von Asmuth, Erik G J / de Pagter, Anne P J / Hannema, Sabine E / Guchelaar, Henk-Jan / Zwaveling, Juliette / Lankester, Arjan C

Transplantation and cellular therapy

2023 Volume 29, Issue 8, Page(s) 529.e1–529.e5

Abstract: With an increasing number of young patients surviving into adulthood after hematopoietic stem cell transplantation (HSCT), gonadal dysfunction becomes an important late effect with significant impact on quality of life. In this retrospective study, we ... ...

Abstract	With an increasing number of young patients surviving into adulthood after hematopoietic stem cell transplantation (HSCT), gonadal dysfunction becomes an important late effect with significant impact on quality of life. In this retrospective study, we evaluated the exposure of busulfan (Bu) and treosulfan (Treo) in relation to gonadal function in pediatric patients who underwent HSCT for a nonmalignant disease between 1997 and 2018. In the Bu group, 56 patients could be evaluated, and gonadal dysfunction was found in 35 (63%). Lower Bu exposure (ie, cumulative area under the curve [AUC] <70 mgh/L) was not associated with a reduced risk of gonadal dysfunction (odds ratio [OR], .92; 95% confidence interval [CI], .25 to 3.49; P = .90). In the Treo cohort, 32 patients were evaluable and gonadal insufficiency occurred in 9 patients (28%). Lower Treo exposure (AUC <1750 mgh/L on day 1) was not associated with a reduced risk of gonadal dysfunction (OR, 1.6; 95% CI, .16 to 36.6; P = .71). Our data do not support the premise that reduced-intensity Bu-based conditioning reduces the risk for gonadal toxicity, and it is unlikely that therapeutic drug monitoring-based reduced treosulfan exposure will further limit the risk of gonadal dysfunction.
MeSH term(s)	Humans ; Child ; Adolescent ; Busulfan/adverse effects ; Retrospective Studies ; Quality of Life ; Transplantation Conditioning/adverse effects ; Hematopoietic Stem Cell Transplantation/adverse effects ; Precancerous Conditions/drug therapy
Chemical Substances	treosulfan (CO61ER3EPI) ; Busulfan (G1LN9045DK)
Language	English
Publishing date	2023-05-06
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3062231-1
ISSN	2666-6367
ISSN (online)	2666-6367
DOI	10.1016/j.jtct.2023.05.003
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Article ; Online: Liver and kidney function in patients with Covid-19 treated with remdesivir.

van Laar, Sylvia A / de Boer, Mark G J / Gombert-Handoko, Kim B / Guchelaar, Henk-Jan / Zwaveling, Juliette

British journal of clinical pharmacology

2021 Volume 87, Issue 11, Page(s) 4450–4454

Abstract: For the treatment of Covid-19 patients with remdesivir, poor renal and liver function were both exclusion criteria in randomized clinical trials and contraindication for treatment. Also, nephrotoxicity and hepatotoxicity are reported as adverse events. ... ...

Abstract	For the treatment of Covid-19 patients with remdesivir, poor renal and liver function were both exclusion criteria in randomized clinical trials and contraindication for treatment. Also, nephrotoxicity and hepatotoxicity are reported as adverse events. We retrospectively reviewed renal and liver functions of Covid-19 103 patients who received remdesivir in the 15 days after treatment initiation. Approximately 20% of the patient population met randomized clinical trial exclusion criteria. In total, 11% of the patients had a decrease in estimated glomerular filtration rate >10 mL/min/1.73m
MeSH term(s)	Adenosine Monophosphate/analogs & derivatives ; Alanine/analogs & derivatives ; Antiviral Agents/therapeutic use ; COVID-19/drug therapy ; Humans ; Kidney ; Liver ; Retrospective Studies ; SARS-CoV-2 ; Treatment Outcome
Chemical Substances	Antiviral Agents ; remdesivir (3QKI37EEHE) ; Adenosine Monophosphate (415SHH325A) ; Alanine (OF5P57N2ZX)
Language	English
Publishing date	2021-05-04
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.14831
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Article: Therapeutic Drug Monitoring of Conditioning Agents in Pediatric Allogeneic Stem Cell Transplantation; Where do We Stand?

van der Stoep, M Y Eileen C / Oostenbrink, Lisa V E / Bredius, Robbert G M / Moes, Dirk Jan A R / Guchelaar, Henk-Jan / Zwaveling, Juliette / Lankester, Arjan C

Frontiers in pharmacology

2022 Volume 13, Page(s) 826004

Abstract: Allogeneic hematopoietic stem cell transplantation (HSCT) is an established curative treatment that has significantly improved clinical outcome of pediatric patients with malignant and non-malignant disorders. This is partly because of the use of safer ... ...

Abstract	Allogeneic hematopoietic stem cell transplantation (HSCT) is an established curative treatment that has significantly improved clinical outcome of pediatric patients with malignant and non-malignant disorders. This is partly because of the use of safer and more effective combinations of chemo- and serotherapy prior to HSCT. Still, complications due to the toxicity of these conditioning regimens remains a major cause of transplant-related mortality (TRM). One of the most difficult challenges to further improve HSCT outcome is reducing toxicity while maintaining efficacy. The use of personalized dosing of the various components of the conditioning regimen by means of therapeutic drug monitoring (TDM) has been the topic of interest in the last decade. TDM could play an important role, especially in children who tend to show greater pharmacokinetic variability. However, TDM should only be performed when it has clear added value to improve clinical outcome or reduce toxicity. In this review, we provide an overview of the available evidence for the relationship between pharmacokinetic parameters and clinical outcome or toxicities of the most commonly used conditioning agents in pediatric HSCT.
Language	English
Publishing date	2022-03-07
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2587355-6
ISSN	1663-9812
ISSN	1663-9812
DOI	10.3389/fphar.2022.826004
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Article ; Online: Treosulfan-induced myalgia in pediatric hematopoietic stem cell transplantation identified by an electronic health record text mining tool.

van der Stoep, M Y Eileen C / Berghuis, Dagmar / Bredius, Robbert G M / Buddingh, Emilie P / Mohseny, Alexander B / Smiers, Frans J W / Guchelaar, Henk-Jan / Lankester, Arjan C / Zwaveling, Juliette

Scientific reports

2021 Volume 11, Issue 1, Page(s) 19084

Abstract: Treosulfan is increasingly used as myeloablative agent in conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (HSCT). In our pediatric HSCT program, myalgia was regularly observed after treosulfan-based conditioning, which is ...

Abstract	Treosulfan is increasingly used as myeloablative agent in conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (HSCT). In our pediatric HSCT program, myalgia was regularly observed after treosulfan-based conditioning, which is a relatively unknown side effect. Using a natural language processing and text-mining tool (CDC), we investigated whether treosulfan compared with busulfan was associated with an increased risk of myalgia. Furthermore, among treosulfan users, we studied the characteristics of given treatment of myalgia, and studied prognostic factors for developing myalgia during treosulfan use. Electronic Health Records (EHRs) until 28 days after HSCT were screened using the CDC for myalgia and 22 synonyms. Time to myalgia, location of pain, duration, severity and drug treatment were collected. Pain severity was classified according to the WHO pain relief ladder. Logistic regression was performed to assess prognostic factors. 114 patients received treosulfan and 92 busulfan. Myalgia was reported in 37 patients; 34 patients in the treosulfan group and 3 patients in the busulfan group (p = 0.01). In the treosulfan group, median time to myalgia was 7 days (0-12) and median duration of pain was 19 days (4-73). 44% of patients needed strong acting opiates and adjuvant medicines (e.g. ketamine). Hemoglobinopathy was a significant risk factor, as compared to other underlying diseases (OR 7.16 95% CI 2.09-30.03, p = 0.003). Myalgia appears to be a common adverse effect of treosulfan in pediatric HSCT, especially in hemoglobinopathy. Using the CDC, EHRs were easily screened to detect this previously unknown side effect, proving the effectiveness of the tool. Recognition of treosulfan-induced myalgia is important for adequate pain management strategies and thereby for improving the quality of hospital stay.
MeSH term(s)	Adolescent ; Busulfan/adverse effects ; Busulfan/analogs & derivatives ; Child ; Child, Preschool ; Data Mining/methods ; Electronic Health Records/statistics & numerical data ; Graft vs Host Disease/etiology ; Graft vs Host Disease/prevention & control ; Hematopoietic Stem Cell Transplantation/adverse effects ; Humans ; Male ; Myalgia/chemically induced ; Myalgia/diagnosis ; Myalgia/epidemiology ; Pain Measurement/statistics & numerical data ; Retrospective Studies ; Severity of Illness Index ; Transplantation Conditioning/adverse effects ; Transplantation Conditioning/methods
Chemical Substances	treosulfan (CO61ER3EPI) ; Busulfan (G1LN9045DK)
Language	English
Publishing date	2021-09-27
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-021-98669-3
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Article ; Online: Impact of Treosulfan Exposure on Early and Long-Term Clinical Outcomes in Pediatric Allogeneic Hematopoietic Stem Cell Transplantation Recipients: A Prospective Multicenter Study.

van der Stoep, M Y Eileen C / Bertaina, Alice / Moes, Dirk Jan A R / Algeri, Mattia / Bredius, Robbert G M / Smiers, Frans J W / Berghuis, Dagmar / Buddingh, Emilie P / Mohseny, Alexander B / Guchelaar, Henk-Jan / Locatelli, Franco / Zwaveling, Juliette / Lankester, Arjan C

Transplantation and cellular therapy

2021 Volume 28, Issue 2, Page(s) 99.e1–99.e7

Abstract: Treosulfan-based conditioning has gained popularity in pediatric allogeneic hematopoietic stem cell transplantation (HSCT) because of its presumed favorable efficacy and toxicity profile. Treosulfan is used in standardized dosing regimens based on body ... ...

Abstract	Treosulfan-based conditioning has gained popularity in pediatric allogeneic hematopoietic stem cell transplantation (HSCT) because of its presumed favorable efficacy and toxicity profile. Treosulfan is used in standardized dosing regimens based on body surface area. The relationships between systemic treosulfan exposure and early and long-term clinical outcomes in pediatric patients undergoing allogeneic HSCT for nonmalignant diseases remain unclear. In this a multicenter, prospective observational study, we assessed the association between treosulfan exposure and early and, in particular, long-term clinical outcomes. Our study cohort comprised 110 pediatric patients with nonmalignant diseases who underwent HSCT between 2011 and 2019 in Leiden, The Netherlands and Rome, Italy. Blood samples were collected, and treosulfan area under the receiver operating characteristic curve (AUC
MeSH term(s)	Busulfan/analogs & derivatives ; Child ; Child, Preschool ; Hematopoietic Stem Cell Transplantation/adverse effects ; Humans ; Infant ; Mucositis/etiology ; Prospective Studies ; Transplantation Conditioning/adverse effects
Chemical Substances	treosulfan (CO61ER3EPI) ; Busulfan (G1LN9045DK)
Language	English
Publishing date	2021-10-01
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	3062231-1
ISSN	2666-6367
ISSN (online)	2666-6367
DOI	10.1016/j.jtct.2021.09.018
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