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Article ; Online: Osimertinib with Chemotherapy in EGFR-Mutated NSCLC.

van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / Badrising, Sushil K / Burgers, Sjaak

2023 Volume 390, Issue 5, Page(s) 478

MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Acrylamides/therapeutic use ; Aniline Compounds/therapeutic use ; ErbB Receptors/genetics ; Indoles ; Pyrimidines
Chemical Substances	osimertinib (3C06JJ0Z2O) ; Acrylamides ; Aniline Compounds ; ErbB Receptors (EC 2.7.10.1) ; EGFR protein, human (EC 2.7.10.1) ; Indoles ; Pyrimidines
Language	English
Publishing date	2023-10-31
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/NEJMc2314600
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Article ; Online: The DRUG Access Protocol: access inequality and European harmonisation - Authors' reply.

van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / Zeverijn, Laurien J / Voest, Emile E

The Lancet. Oncology

2022 Volume 23, Issue 5, Page(s) e203

MeSH term(s)	Humans ; Socioeconomic Factors
Language	English
Publishing date	2022-04-11
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(22)00210-8
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 460: Show issues

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Article ; Online: Adjuvant immune checkpoint blockade revisited.

van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / Huisman, Atse / Roy, Anke Pisters-van / Koole, Simone / Timmers, Lonneke / Blank, Christian / Gelderblom, Hans

The Lancet. Oncology

2023 Volume 24, Issue 7, Page(s) 717–719

MeSH term(s)	Humans ; Immune Checkpoint Inhibitors ; Antibodies, Monoclonal ; Immunotherapy/adverse effects
Chemical Substances	Immune Checkpoint Inhibitors ; Antibodies, Monoclonal
Language	English
Publishing date	2023-07-07
Publishing country	England
Document type	Journal Article ; Comment
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(23)00233-4
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 460: Show issues

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Article ; Online: Lessons learned from postmarketing withdrawals of expedited approvals for oncology drug indications.

Koole, Simone N / Huisman, Atse H / Timmers, Lonneke / Westgeest, Hans M / van Breugel, Edwin / Sonke, Gabe S / van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh

The Lancet. Oncology

2024 Volume 25, Issue 3, Page(s) e126–e135

Abstract: In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Besides the EMA's conditional marketing authorisation programme and the FDA's ... ...

Abstract	In the past decade, there have been a record number of oncology therapy approvals by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Besides the EMA's conditional marketing authorisation programme and the FDA's Accelerated Approval Program, we observe a tendency towards fast approval for exploratory studies with non-randomised, uncontrolled designs and surrogate endpoints. This issue raises concerns about the robustness and effectiveness of accepted treatments, leaving patients and health-care professionals in a state of uncertainty. A substantial number of accelerated approvals have recently been withdrawn in the USA, with some still authorised in Europe, emphasising discrepancies in regulatory standards that affect both patients and society as a whole. We highlight examples of drugs, authorised on the basis of surrogate endpoints, that were later withdrawn due to an absence of overall survival benefit. Our findings address the challenges and consequences of accelerated approval pathways in oncology. In conclusion, this Policy Review calls for regulatory bodies to better align their procedures and insist on robust evidence, preferably through unbiased randomised controlled trials. Drug approval processes should prioritise patient benefit, overall survival, and quality of life to minimise risks and uncertainties for patients.
MeSH term(s)	Humans ; Drug Approval ; Europe ; Medical Oncology ; Product Surveillance, Postmarketing ; Safety-Based Drug Withdrawals
Language	English
Publishing date	2024-02-02
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(23)00592-2
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 460: Show issues

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Article: Outcome-based reimbursement in Central-Eastern Europe and Middle-East.

Frontiers in medicine

2022 Volume 9, Page(s) 940886

Abstract: Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers in lower ... ...

Abstract	Outcome-based reimbursement models can effectively reduce the financial risk to health care payers in cases when there is important uncertainty or heterogeneity regarding the clinical value of health technologies. Still, health care payers in lower income countries rely mainly on financial based agreements to manage uncertainties associated with new therapies. We performed a survey, an exploratory literature review and an iterative brainstorming in parallel about potential barriers and solutions to outcome-based agreements in Central and Eastern Europe (CEE) and in the Middle East (ME). A draft list of recommendations deriving from these steps was validated in a follow-up workshop with payer experts from these regions. 20 different barriers were identified in five groups, including transaction costs and administrative burden, measurement issues, information technology and data infrastructure, governance, and perverse policy outcomes. Though implementing outcome-based reimbursement models is challenging, especially in lower income countries, those challenges can be mitigated by conducting pilot agreements and preparing for predictable barriers. Our guidance paper provides an initial step in this process. The generalizability of our recommendations can be improved by monitoring experiences from pilot reimbursement models in CEE and ME countries and continuing the multistakeholder dialogue at national levels.
Language	English
Publishing date	2022-09-23
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2022.940886
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Article ; Online: Harmonising patient-access programmes: the Dutch DRUG Access Protocol platform.

Zeverijn, Laurien J / van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / van Roy, Anke A M G Pisters / Timmers, Lonneke / Ly Tran, T H / de Boer, Jolanda E / de Wit, Gijsbrecht F / Geurts, Birgit S / Gelderblom, Hans / Verheul, Henk M W / Blijlevens, Nicole / Wymenga, A N Machteld / Eskens, Ferry A L M / Smit, Egbert F / Bloemendal, Haiko J / Voest, Emile E

The Lancet. Oncology

2022 Volume 23, Issue 2, Page(s) 198–201

MeSH term(s)	Antineoplastic Agents/therapeutic use ; Health Services Accessibility ; Humans ; Netherlands
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2022-02-03
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(21)00707-5
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Zs.A 5696: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 460: Show issues

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Article ; Online: Kidney involvement in tuberous sclerosis complex: the impact on healthcare resource use and costs.

Vekeman, Francis / Magestro, Matthew / Karner, Paul / Duh, Mei Sheng / Nichols, Timothy / van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / Zonnenberg, Bernard A

Journal of medical economics

2015 Volume 18, Issue 12, Page(s) 1060–1070

Abstract: Objective: Tuberous sclerosis complex (TSC) is associated with non-malignant kidney lesions-angiomyolipomata-that may be associated with chronic kidney disease (CKD). This study investigated the relationship between renal angiomyolipomata and CKD in TSC, ...

Abstract	Objective: Tuberous sclerosis complex (TSC) is associated with non-malignant kidney lesions-angiomyolipomata-that may be associated with chronic kidney disease (CKD). This study investigated the relationship between renal angiomyolipomata and CKD in TSC, including the impact on healthcare resource utilization (HCRU) and costs. Methods: This was a retrospective, longitudinal cohort study based on medical record data spanning January 1990-April 2012 for 369 TSC patients treated at a specialty center in the Netherlands. Cohorts were established based on CKD stage and angiomyolipoma size. Rates of HCRU (physician visits, monitoring, and interventions) were compared across cohorts using rate ratios. Healthcare costs were compared across cohorts using cost differences. Regression models were used to identify predictive factors for HCRU and healthcare costs. Results: Sixteen per cent of patients reached CKD stage 3 or higher during follow-up. Patients at more advanced stages of CKD more frequently had either large or multiple small angiomyolipomata and higher HCRU rates and healthcare costs. In the multivariate analyses, male gender, CKD stage >1, angiomyolipoma size ≥3.5 cm, embolization, and the presence of moderate or severe lymphangioleiomyomatosis (LAM) were associated with greater HCRU (p ≤ 0.002 for all comparisons). Definite (vs suspected) TSC diagnosis, CKD stage 5 (vs CKD stage 1), angiomyolipoma size ≥3.5 cm, and moderate or severe LAM were associated with higher costs (p = 0.050 for TSC diagnosis, p ≤ 0.002 for other comparisons). Costs in CKD stage 5 were driven primarily by dialysis. Conclusions: A substantial proportion of patients with TSC developed moderate-to-severe CKD, which was associated with renal angiomyolipomata and increased HCRU and costs.
MeSH term(s)	Adult ; Age Distribution ; Aged ; Angiomyolipoma/economics ; Angiomyolipoma/etiology ; Angiomyolipoma/pathology ; Female ; Glomerular Filtration Rate ; Health Care Costs/statistics & numerical data ; Health Services/economics ; Health Services/utilization ; Humans ; Kidney Neoplasms/economics ; Kidney Neoplasms/etiology ; Kidney Neoplasms/pathology ; Linear Models ; Longitudinal Studies ; Male ; Medical Records/statistics & numerical data ; Middle Aged ; Netherlands ; Poisson Distribution ; Renal Insufficiency, Chronic/economics ; Renal Insufficiency, Chronic/etiology ; Renal Insufficiency, Chronic/pathology ; Retrospective Studies ; Severity of Illness Index ; Sex Distribution ; Tuberous Sclerosis/complications ; Tuberous Sclerosis/economics ; Tuberous Sclerosis/pathology ; Young Adult
Language	English
Publishing date	2015
Publishing country	England
Document type	Journal Article
ZDB-ID	2270945-9
ISSN	1941-837X ; 1369-6998
ISSN (online)	1941-837X
ISSN	1369-6998
DOI	10.3111/13696998.2015.1075995
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Zs.A 6450: Show issues

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Article: Maternal quercetin intake during pregnancy results in an adapted iron homeostasis at adulthood

Vanhees, Kimberly / Godschalk, Roger W / Sanders, Anneke / van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / van Schooten, Frederik J

Toxicology. 2011 Dec. 18, v. 290, no. 2-3

2011

Abstract: The flavonoid quercetin is a powerful iron chelator, capable of oxidizing heme iron in hemoglobin from Fe²⁺ to Fe³⁺. Moreover, quercetin crosses the placenta and accumulates in the fetus. Since adaptations made by the fetus to cope with inappropriate ... ...

Abstract	The flavonoid quercetin is a powerful iron chelator, capable of oxidizing heme iron in hemoglobin from Fe²⁺ to Fe³⁺. Moreover, quercetin crosses the placenta and accumulates in the fetus. Since adaptations made by the fetus to cope with inappropriate nutrition may lead to permanent changes, a relative high intake of quercetin may have detrimental affects later in life. Therefore, we investigated the effects of maternal exposure to quercetin (302mg/kg feed), starting from 3 days before conception until the end of gestation, on erythropoiesis and iron homeostasis at embryonic day 14.5 and in 12-week old mice. During fetal development, quercetin exposure had no effect on the erythroid lineage switch and concomitant globin switch. However, adult mice prenatally exposed to quercetin had significant increase iron storage in the liver, by upregulating iron-associated cytokine expression (hepcidin, IL-1β, IL-6 and IL-10). These long term changes in gene expression could be mediated through epigenetic modifications, as prenatal quercetin exposure resulted in a modest hypermethylation of repetitive elements. Despite the increased iron levels, oxidative stress was significantly decreased in the liver of these animals as assessed by 8-oxo-dG levels. These data suggest that prenatal quercetin exposure results in increased iron storage, while decreasing oxidative stress induced DNA damage together with a shift towards increased expression of inflammation associated cytokines in the liver at adult age.
Keywords	DNA damage ; adulthood ; adults ; chelating agents ; conception ; epigenetics ; erythropoiesis ; fetal development ; fetus ; gene expression regulation ; heme iron ; hemoglobin ; hepcidin ; homeostasis ; inflammation ; interleukin-10 ; interleukin-1beta ; interleukin-6 ; liver ; maternal effect ; mice ; nutrition ; oxidative stress ; placenta ; pregnancy ; quercetin ; toxicology
Language	English
Dates of publication	2011-1218
Size	p. 350-358.
Publishing place	Elsevier Ireland Ltd
Document type	Article
ZDB-ID	184557-3
ISSN	1879-3185 ; 0300-483X
ISSN (online)	1879-3185
ISSN	0300-483X
DOI	10.1016/j.tox.2011.10.017
Database	NAL-Catalogue (AGRICOLA)

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Zs.A 888: Show issues

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Article ; Online: Long-term Follow-up Assessing Renal Angiomyolipoma Treatment Patterns, Morbidity, and Mortality: An Observational Study in Tuberous Sclerosis Complex Patients in the Netherlands.

Eijkemans, Marinus J C / van der Wal, Willem / Reijnders, Leida J / Roes, Kit C B / van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh / Pelletier, Corey / Magestro, Matthew / Zonnenberg, Bernard

American journal of kidney diseases : the official journal of the National Kidney Foundation

2015 Volume 66, Issue 4, Page(s) 638–645

Abstract: Background: Long-term data from patients with tuberous sclerosis complex (TSC)-associated renal angiomyolipoma (angiomyolipoma) are limited.: Study design: Retrospective observational study.: Setting & participants: Adult patients with TSC treated ...

Abstract	Background: Long-term data from patients with tuberous sclerosis complex (TSC)-associated renal angiomyolipoma (angiomyolipoma) are limited. Study design: Retrospective observational study. Setting & participants: Adult patients with TSC treated at the University Medical Center Utrecht (the Netherlands) from January 1990 through April 2012. Predictors: Patient age and angiomyolipoma stage, based on computed tomography lesion count, size, and impact on renal anatomy, with higher stage representing higher angiomyolipoma burden. Patients in stages 3 or higher were considered at high risk for hemorrhage and candidates for selective arterial embolization. Outcomes: Kidney-related outcomes included hypertension, anemia, decreased kidney function, dialysis, kidney transplantation, nephrectomy, kidney-related blood transfusions, and mortality. Observed mortality was compared to the Dutch National Bureau of Statistics using standardized mortality ratio. Results: Median follow-up was 15.8 years, of which staging was available for 5.4 years. Of 351 patients with TSC, 244 (69.5%) had confirmed angiomyolipoma; 144 (59.0%) reached stage 3 or higher. Age and angiomyolipoma stage were positively correlated: median age in the none-detected stage was 36.8 years, increasing to 43.6 years for stage 6. Embolization was performed in 117 patients; 57 had 2 or more embolization procedures. Higher stage was associated with hypertension, anemia, decreased kidney function, and transfusion. Hypertension, anemia, and decreased kidney function were more common in patients who underwent selective arterial embolization. 7 patients required dialysis, 7 received a kidney transplant, and 16 underwent nephrectomy. 29 deaths were recorded, most commonly related to renal complications (n=9[31%]). Mortality was significantly higher in the study cohort versus the general population (standardized mortality ratio, 4.8; 95% CI, 3.4-6.9). Limitations: Duration of follow-up with staging was too short to observe stage progression in most patients. Conclusions: Despite the use of preventive selective arterial embolization, patients with TSC exhibit clinically significant kidney disease and excess mortality, largely because of kidney-related complications.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; Angiomyolipoma/diagnostic imaging ; Angiomyolipoma/mortality ; Angiomyolipoma/therapy ; Cohort Studies ; Embolization, Therapeutic/methods ; Embolization, Therapeutic/mortality ; Female ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Kidney Neoplasms/diagnostic imaging ; Kidney Neoplasms/mortality ; Kidney Neoplasms/therapy ; Male ; Middle Aged ; Neoplasm Invasiveness/pathology ; Neoplasm Staging ; Netherlands ; Poisson Distribution ; Proportional Hazards Models ; Retrospective Studies ; Risk Assessment ; Survival Analysis ; Time Factors ; Tomography, X-Ray Computed/methods ; Treatment Outcome ; Tuberous Sclerosis/diagnostic imaging ; Tuberous Sclerosis/mortality ; Tuberous Sclerosis/therapy ; Young Adult
Language	English
Publishing date	2015-10
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	604539-x
ISSN	1523-6838 ; 0272-6386
ISSN (online)	1523-6838
ISSN	0272-6386
DOI	10.1053/j.ajkd.2015.05.016
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Zs.A 1669: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 468: Show issues

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Article ; Online: Prenatal exposure to flavonoids: implication for cancer risk.

Vanhees, Kimberly / de Bock, Laura / Godschalk, Roger W L / van Schooten, Frederik J / van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh

Toxicological sciences : an official journal of the Society of Toxicology

2011 Volume 120, Issue 1, Page(s) 59–67

Abstract: Flavonoids are potent antioxidants, freely available as high-dose dietary supplements. However, they can induce DNA double-strand breaks (DSB) and rearrangements in the mixed-lineage leukemia (MLL) gene, which are frequently observed in childhood ... ...

Abstract	Flavonoids are potent antioxidants, freely available as high-dose dietary supplements. However, they can induce DNA double-strand breaks (DSB) and rearrangements in the mixed-lineage leukemia (MLL) gene, which are frequently observed in childhood leukemia. We hypothesize that a deficient DSB repair, as a result of an Atm mutation, may reinforce the clastogenic effect of dietary flavonoids and increase the frequency of Mll rearrangements. Therefore, we examined the effects of in vitro and transplacental exposure to high, but biological amounts of flavonoids in mice with different genetic capacities for DSB repair (homozygous/heterozygous knock-in for human Atm mutation [Atm-ΔSRI] vs. wild type [wt]). In vitro exposure to genistein/quercetin induced higher numbers of Mll rearrangements in bone marrow cells of Atm-ΔSRI mutant mice compared with wt mice. Subsequently, heterozygous Atm-ΔSRI mice were placed on either a flavonoid-poor or a genistein-enriched (270 mg/kg) or quercetin-enriched (302 mg/kg) feed throughout pregnancy. Prenatal exposure to flavonoids associated with higher frequencies of Mll rearrangements and a slight increase in the incidence of malignancies in DNA repair-deficient mice. These data suggest that prenatal exposure to both genistein and quercetin supplements could increase the risk on Mll rearrangements especially in the presence of compromised DNA repair.
MeSH term(s)	Animals ; Ataxia Telangiectasia Mutated Proteins ; Blood Cell Count ; Bone Marrow Cells/drug effects ; Bone Marrow Cells/metabolism ; Cell Cycle Proteins/genetics ; Cells, Cultured ; Chromosome Aberrations/chemically induced ; DNA Breaks, Double-Stranded ; DNA Repair/genetics ; DNA-Binding Proteins/genetics ; Female ; Flavonoids/toxicity ; Genistein/toxicity ; Heterozygote ; Histone-Lysine N-Methyltransferase ; Humans ; Mice ; Mice, Mutant Strains ; Mutation ; Myeloid-Lymphoid Leukemia Protein/genetics ; Neoplasms/blood ; Neoplasms/chemically induced ; Neoplasms/genetics ; Polymerase Chain Reaction ; Pregnancy ; Prenatal Exposure Delayed Effects/blood ; Prenatal Exposure Delayed Effects/chemically induced ; Prenatal Exposure Delayed Effects/genetics ; Protein-Serine-Threonine Kinases/genetics ; Quercetin/toxicity ; Translocation, Genetic ; Tumor Suppressor Proteins/genetics
Chemical Substances	Cell Cycle Proteins ; DNA-Binding Proteins ; Flavonoids ; Tumor Suppressor Proteins ; Myeloid-Lymphoid Leukemia Protein (149025-06-9) ; Quercetin (9IKM0I5T1E) ; Genistein (DH2M523P0H) ; Histone-Lysine N-Methyltransferase (EC 2.1.1.43) ; Mll protein, mouse (EC 2.1.1.43) ; ATM protein, human (EC 2.7.11.1) ; Ataxia Telangiectasia Mutated Proteins (EC 2.7.11.1) ; Atm protein, mouse (EC 2.7.11.1) ; Protein-Serine-Threonine Kinases (EC 2.7.11.1)
Language	English
Publishing date	2011-03
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1420885-4
ISSN	1096-0929 ; 1096-6080
ISSN (online)	1096-0929
ISSN	1096-6080
DOI	10.1093/toxsci/kfq388
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