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Article ; Online: Retrospective Comparison of Survival Projections for CAR T-Cell Therapies in Large B-Cell Lymphoma.

Peterse, Elisabeth F P / Verburg-Baltussen, Elisabeth J M / Stewart, Alexa / Liu, Fei Fei / Parker, Christopher / Treur, Maarten / Malcolm, Bill / Klijn, Sven L

PharmacoEconomics - open

2023 Volume 7, Issue 6, Page(s) 941–950

Abstract: Background: Durable remission has been observed in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) treated with chimeric antigen receptor (CAR) T-cell therapy. Consequently, hazard functions for overall survival (OS) are often ... ...

Abstract	Background: Durable remission has been observed in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) treated with chimeric antigen receptor (CAR) T-cell therapy. Consequently, hazard functions for overall survival (OS) are often complex, requiring the use of flexible methods for extrapolations. Objectives: We aimed to retrospectively compare the predictive accuracy of different survival extrapolation methods and evaluate the validity of goodness-of-fit (GOF) criteria-based model selection for CAR T-cell therapies in R/R LBCL. Methods: OS data were sourced from JULIET, ZUMA-1, and TRANSCEND NHL 001. Standard parametric, mixture cure, cubic spline, and mixture models were fit to multiple database locks (DBLs), with varying follow-up durations. GOF was assessed using the Akaike information criterion and Bayesian information criterion. Predictive accuracy was calculated as the mean absolute error (MAE) relative to OS observed in the most mature DBL. Results: For all studies, mixture cure and cubic spline models provided the best predictive accuracy for the least mature DBL (MAE 0.013‒0.085 and 0.014‒0.128, respectively). The predictive accuracy of the standard parametric and mixture models showed larger variation (MAE 0.024‒0.162 and 0.013‒0.176, respectively). With increasing data maturity, the predictive accuracy of standard parametric models remained poor. Correlation between GOF criteria and predictive accuracy was low, particularly for the least mature DBL. Conclusions: Our analyses demonstrated that mixture cure and cubic spline models provide the most accurate survival extrapolations of CAR T-cell therapies in LBCL. Furthermore, GOF should not be the only criteria used when selecting the optimal survival model.
Language	English
Publishing date	2023-08-31
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2874287-4
ISSN	2509-4254 ; 2509-4262
ISSN (online)	2509-4254
ISSN	2509-4262
DOI	10.1007/s41669-023-00435-w
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Article ; Online: Modeling Monthly Migraine-Day Distributions Using Longitudinal Regression Models and Linking Quality of Life to Inform Cost-Effectiveness Analysis: A Case Study of Fremanezumab in Japanese-Korean Migraine Patients.

Wang, Xinyu / Yamato, Kentaro / Kojima, Yoshitsugu / Paris, Josef J / Peterse, Elisabeth F P / Simons, Martijn J H G / Bennison, Craig

PharmacoEconomics

2023 Volume 41, Issue 10, Page(s) 1263–1274

Abstract: Background and objectives: As regression approaches have been used more recently to model the effectiveness and health-related quality of life (HRQOL) of novel migraine treatments, an example is provided for fremanezumab. The objective is to estimate ... ...

Abstract	Background and objectives: As regression approaches have been used more recently to model the effectiveness and health-related quality of life (HRQOL) of novel migraine treatments, an example is provided for fremanezumab. The objective is to estimate the distribution of mean monthly migraine days (MMD) as a continuous variable and corresponding migraine-specific utility values as a function of the MMD, to inform health states in a cost-effectiveness model (CEM). Methods: Three longitudinal regression models (zero-adjusted gamma [ZAGA], zero-inflated beta-binomial [ZIBB], and zero-inflated negative binomial [ZINBI]) were fitted to Japanese-Korean clinical trial data of episodic (EM) and chronic migraine (CM) patients treated with fremanezumab or placebo, to estimate MMD over a period of 12 months. The EQ-5D-5L and the migraine-specific quality-of-life (MSQ), mapped to the EQ-5D-3L, questionnaires were used to measure HRQOL. Migraine-specific utility values were estimated as a function of MMD using a linear mixed effects model. Results: The ZIBB models fitted the data best in estimating the distribution of mean MMD over time. MSQ-derived values were more sensitive than the EQ-5D-5L values for the effect of the number of MMD on HRQOL, with higher values for less MMD and more time on treatment. Conclusions: Using longitudinal regression models to estimate MMD distributions and linking utility values as a function is an appropriate method to inform CEMs and capture inter-patient heterogeneity. The observed distribution shifts demonstrated fremanezumab's effect at reducing MMD for both EM and CM patients, while treatment effect on HRQOL was captured by MMD and time on treatment.
MeSH term(s)	Humans ; Cost-Benefit Analysis ; Double-Blind Method ; East Asian People ; Migraine Disorders/drug therapy ; Quality of Life ; Treatment Outcome
Chemical Substances	fremanezumab
Language	English
Publishing date	2023-06-15
Publishing country	New Zealand
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1100273-6
ISSN	1179-2027 ; 1170-7690
ISSN (online)	1179-2027
ISSN	1170-7690
DOI	10.1007/s40273-023-01288-1
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Article ; Online: Comparative benefit and cost-effectiveness of mailed-out faecal immunochemical tests vs collection at the general practitioner.

Peterse, Elisabeth F P / Osoro, Caroline B / Bardou, Marc / Lansdorp-Vogelaar, Iris

Alimentary pharmacology & therapeutics

2021 Volume 53, Issue 10, Page(s) 1118–1125

Abstract: Background: Participation in the colorectal cancer screening programme in France has been well below the 45% considered acceptable by European guidelines, potentially attributable to the need to collect the faecal immunochemical test (FIT) at the ... ...

Abstract	Background: Participation in the colorectal cancer screening programme in France has been well below the 45% considered acceptable by European guidelines, potentially attributable to the need to collect the faecal immunochemical test (FIT) at the general practitioner. Aim: To estimate the potential benefits and costs of including the FIT in the invitation letter. Methods: A well-established microsimulation model was used to simulate the French population 35 years and older in 2018. We estimated quality-adjusted life-years (QALY) gained, costs and cost-effectiveness of the current screening programme, and compared it to a variation of the programme where the FIT was mailed to participants and adherence was assumed to increase to 45%. We also estimated the threshold increase in participation needed to make this intervention cost-effective. Results: Under the current programme, 53.8 colorectal cancer (CRC) cases and 25.2 CRC deaths per 1000 individuals are expected to occur over a lifetime. If sending out the FIT increases screening participation to 45%, this intervention would result in 6% fewer CRC deaths and 3% fewer CRC cases, resulting in an estimated cost-effectiveness ratio of €2149 per QALY gained. Sending out the FIT would only need to increase participation by 0.7% point for this intervention to be considered cost-effective. Conclusion: Including the FIT in the invitation letter is likely a very cost-effective intervention to increase participation in CRC screening. These results for France are also informative for many other countries around the world where FIT needs to be collected at pharmacies or general practitioners.
MeSH term(s)	Colonoscopy ; Colorectal Neoplasms/diagnosis ; Cost-Benefit Analysis ; Early Detection of Cancer ; France/epidemiology ; General Practitioners ; Humans ; Mass Screening ; Occult Blood
Language	English
Publishing date	2021-03-08
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	639012-2
ISSN	1365-2036 ; 0269-2813 ; 0953-0673
ISSN (online)	1365-2036
ISSN	0269-2813 ; 0953-0673
DOI	10.1111/apt.16317
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Zs.A 2206: Show issues

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Article ; Online: A Guide to Selecting Flexible Survival Models to Inform Economic Evaluations of Cancer Immunotherapies.

Palmer, Stephen / Borget, Isabelle / Friede, Tim / Husereau, Don / Karnon, Jonathan / Kearns, Ben / Medin, Emma / Peterse, Elisabeth F P / Klijn, Sven L / Verburg-Baltussen, Elisabeth J M / Fenwick, Elisabeth / Borrill, John

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

2022 Volume 26, Issue 2, Page(s) 185–192

Abstract: Objectives: Parametric models are routinely used to estimate the benefit of cancer drugs beyond trial follow-up. The advent of immune checkpoint inhibitors has challenged this paradigm, and emerging evidence suggests that more flexible survival models, ... ...

Abstract	Objectives: Parametric models are routinely used to estimate the benefit of cancer drugs beyond trial follow-up. The advent of immune checkpoint inhibitors has challenged this paradigm, and emerging evidence suggests that more flexible survival models, which can better capture the shapes of complex hazard functions, might be needed for these interventions. Nevertheless, there is a need for an algorithm to help analysts decide whether flexible models are required and, if so, which should be chosen for testing. This position article has been produced to bridge this gap. Methods: A virtual advisory board comprising 7 international experts with in-depth knowledge of survival analysis and health technology assessment was held in summer 2021. The experts discussed 24 questions across 6 topics: the current survival model selection procedure, data maturity, heterogeneity of treatment effect, cure and mortality, external evidence, and additions to existing guidelines. Their responses culminated in an algorithm to inform selection of flexible survival models. Results: The algorithm consists of 8 steps and 4 questions. Key elements include the systematic identification of relevant external data, using clinical expert input at multiple points in the selection process, considering the future and the observed hazard functions, assessing the potential for long-term survivorship, and presenting results from all plausible models. Conclusions: This algorithm provides a systematic, evidence-based approach to justify the selection of survival extrapolation models for cancer immunotherapies. If followed, it should reduce the risk of selecting inappropriate models, partially addressing a key area of uncertainty in the economic evaluation of these agents.
MeSH term(s)	Humans ; Cost-Benefit Analysis ; Antineoplastic Agents ; Survival Analysis ; Immunotherapy ; Neoplasms/therapy
Chemical Substances	Antineoplastic Agents
Language	English
Publishing date	2022-08-13
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1471745-1
ISSN	1524-4733 ; 1098-3015
ISSN (online)	1524-4733
ISSN	1098-3015
DOI	10.1016/j.jval.2022.07.009
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Zs.A 5904: Show issues

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Article ; Online: CORR Insights(®): Transcriptional Profiling Identifies the Signaling Axes of IGF and Transforming Growth Factor-β as Involved in the Pathogenesis of Osteosarcoma.

Peterse, Elisabeth F P / Bovée, Judith V M G

Clinical orthopaedics and related research

2016 Volume 474, Issue 1, Page(s) 190–192

MeSH term(s)	Animals ; Biomarkers, Tumor/genetics ; Bone Neoplasms/genetics ; Female ; Gene Expression Profiling ; Humans ; Male ; Osteosarcoma/genetics ; Signal Transduction/genetics ; Somatomedins/genetics ; Transforming Growth Factor beta/genetics
Chemical Substances	Biomarkers, Tumor ; Somatomedins ; Transforming Growth Factor beta
Language	English
Publishing date	2016-01
Publishing country	United States
Document type	Comment ; Journal Article
ZDB-ID	80301-7
ISSN	1528-1132 ; 0009-921X
ISSN (online)	1528-1132
ISSN	0009-921X
DOI	10.1007/s11999-015-4620-3
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Article: A researcher's perspective on the quantity of osteosarcoma

Peterse, Elisabeth F P / van Leeuwen, Thed N / Cleton-Jansen, Anne-Marie

Journal of bone oncology

2017 Volume 7, Page(s) 29–31

Abstract: Osteosarcoma is a primary malignant bone tumour, for which no improvement in survival rate has been made since the nineteen seventies. We set out to systemically identify ... ...

Abstract	Osteosarcoma is a primary malignant bone tumour, for which no improvement in survival rate has been made since the nineteen seventies. We set out to systemically identify the
Language	English
Publishing date	2017-04-07
Publishing country	Netherlands
Document type	Journal Article
ISSN	2212-1366
ISSN	2212-1366
DOI	10.1016/j.jbo.2017.04.004
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Article ; Online: Cost-effectiveness of prophylactic hysterectomy in first-degree female relatives with Lynch syndrome of patients diagnosed with colorectal cancer in the United States: a microsimulation study.

Alblas, Maaike / Peterse, Elisabeth F P / Du, Mengmeng / Zauber, Ann G / Steyerberg, Ewout W / van Leeuwen, Nikki / Lansdorp-Vogelaar, Iris

Cancer medicine

2021 Volume 10, Issue 19, Page(s) 6835–6844

Abstract: Background: To evaluate the cost-effectiveness of prophylactic hysterectomy (PH) in women with Lynch syndrome (LS).: Methods: We developed a microsimulation model incorporating the natural history for the development of hyperplasia with and without ... ...

Abstract	Background: To evaluate the cost-effectiveness of prophylactic hysterectomy (PH) in women with Lynch syndrome (LS). Methods: We developed a microsimulation model incorporating the natural history for the development of hyperplasia with and without atypia into endometrial cancer (EC) based on the MISCAN-framework. We simulated women identified as first-degree relatives (FDR) with LS of colorectal cancer patients after universal testing for LS. We estimated costs and benefits of offering this cohort PH, accounting for reduced quality of life after PH and for having EC. Three minimum ages (30/35/40) and three maximum ages (70/75/80) were compared to no PH. Results: In the absence of PH, the estimated number of EC cases was 300 per 1,000 women with LS. Total associated costs for treatment of EC were $5.9 million. Offering PH to FDRs aged 40-80 years was considered optimal. This strategy reduced the number of endometrial cancer cases to 5.4 (-98%), resulting in 516 quality-adjusted life years (QALY) gained and increasing the costs (treatment of endometrial cancer and PH) to $15.0 million (+154%) per 1,000 women. PH from earlier ages was more costly and resulted in fewer QALYs, although this finding was sensitive to disutility for PH. Conclusions: Offering PH to 40- to 80-year-old women with LS is expected to add 0.5 QALY per person at acceptable costs. Women may decide to have PH at a younger age, depending on their individual disutility for PH and premature menopause.
MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Colorectal Neoplasms, Hereditary Nonpolyposis/therapy ; Cost-Benefit Analysis/methods ; Female ; Humans ; Hysterectomy/economics ; Hysterectomy/methods ; Middle Aged ; Quality of Life ; United States
Language	English
Publishing date	2021-09-12
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2659751-2
ISSN	2045-7634 ; 2045-7634
ISSN (online)	2045-7634
ISSN	2045-7634
DOI	10.1002/cam4.4080
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Article ; Online: Risk-Stratified Screening for Colorectal Cancer Using Genetic and Environmental Risk Factors: A Cost-Effectiveness Analysis Based on Real-World Data.

van den Puttelaar, Rosita / Meester, Reinier G S / Peterse, Elisabeth F P / Zauber, Ann G / Zheng, Jiayin / Hayes, Richard B / Su, Yu-Ru / Lee, Jeffrey K / Thomas, Minta / Sakoda, Lori C / Li, Yi / Corley, Douglas A / Peters, Ulrike / Hsu, Li / Lansdorp-Vogelaar, Iris

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association

2023 Volume 21, Issue 13, Page(s) 3415–3423.e29

Abstract: Background & aims: Previous studies on the cost-effectiveness of personalized colorectal cancer (CRC) screening were based on hypothetical performance of CRC risk prediction and did not consider the association with competing causes of death. In this ... ...

Abstract	Background & aims: Previous studies on the cost-effectiveness of personalized colorectal cancer (CRC) screening were based on hypothetical performance of CRC risk prediction and did not consider the association with competing causes of death. In this study, we estimated the cost-effectiveness of risk-stratified screening using real-world data for CRC risk and competing causes of death. Methods: Risk predictions for CRC and competing causes of death from a large community-based cohort were used to stratify individuals into risk groups. A microsimulation model was used to optimize colonoscopy screening for each risk group by varying the start age (40-60 years), end age (70-85 years), and screening interval (5-15 years). The outcomes included personalized screening ages and intervals and cost-effectiveness compared with uniform colonoscopy screening (ages 45-75, every 10 years). Key assumptions were varied in sensitivity analyses. Results: Risk-stratified screening resulted in substantially different screening recommendations, ranging from a one-time colonoscopy at age 60 for low-risk individuals to a colonoscopy every 5 years from ages 40 to 85 for high-risk individuals. Nevertheless, on a population level, risk-stratified screening would increase net quality-adjusted life years gained (QALYG) by only 0.7% at equal costs to uniform screening or reduce average costs by 1.2% for equal QALYG. The benefit of risk-stratified screening improved when it was assumed to increase participation or costs less per genetic test. Conclusions: Personalized screening for CRC, accounting for competing causes of death risk, could result in highly tailored individual screening programs. However, average improvements across the population in QALYG and cost-effectiveness compared with uniform screening are small.
MeSH term(s)	Humans ; Middle Aged ; Adult ; Aged ; Aged, 80 and over ; Cost-Effectiveness Analysis ; Cost-Benefit Analysis ; Early Detection of Cancer/methods ; Colonoscopy ; Colorectal Neoplasms/epidemiology ; Mass Screening/methods
Language	English
Publishing date	2023-03-09
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2119789-1
ISSN	1542-7714 ; 1542-3565
ISSN (online)	1542-7714
ISSN	1542-3565
DOI	10.1016/j.cgh.2023.03.003
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Zs.A 5836: Show issues

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Article ; Online: Correction: Effects of cancer screening restart strategies after COVID-19 disruption.

Kregting, Lindy M / Kaljouw, Sylvia / de Jonge, Lucie / Jansen, Erik E L / Peterse, Elisabeth F P / Heijnsdijk, Eveline A M / van Ravesteyn, Nicolien T / Lansdorp-Vogelaar, Iris / de Kok, Inge M C M

British journal of cancer

2021 Volume 125, Issue 1, Page(s) 145

Language	English
Publishing date	2021-04-19
Publishing country	England
Document type	Published Erratum
ZDB-ID	80075-2
ISSN	1532-1827 ; 0007-0920
ISSN (online)	1532-1827
ISSN	0007-0920
DOI	10.1038/s41416-021-01427-5
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Article ; Online: Effects of cancer screening restart strategies after COVID-19 disruption.

Kregting, Lindy M / Kaljouw, Sylvia / de Jonge, Lucie / Jansen, Erik E L / Peterse, Elisabeth F P / Heijnsdijk, Eveline A M / van Ravesteyn, Nicolien T / Lansdorp-Vogelaar, Iris / de Kok, Inge M C M

British journal of cancer

2021 Volume 124, Issue 9, Page(s) 1516–1523

Abstract: Background: Many breast, cervical, and colorectal cancer screening programmes were disrupted due to the COVID-19 pandemic. This study aimed to estimate the effects of five restart strategies after the disruption on required screening capacity and cancer ...

Abstract	Background: Many breast, cervical, and colorectal cancer screening programmes were disrupted due to the COVID-19 pandemic. This study aimed to estimate the effects of five restart strategies after the disruption on required screening capacity and cancer burden. Methods: Microsimulation models simulated five restart strategies for breast, cervical, and colorectal cancer screening. The models estimated required screening capacity, cancer incidence, and cancer-specific mortality after a disruption of 6 months. The restart strategies varied in whether screens were caught up or not and, if so, immediately or delayed, and whether the upper age limit was increased. Results: The disruption in screening programmes without catch-up of missed screens led to an increase of 2.0, 0.3, and 2.5 cancer deaths per 100 000 individuals in 10 years in breast, cervical, and colorectal cancer, respectively. Immediately catching-up missed screens minimised the impact of the disruption but required a surge in screening capacity. Delaying screening, but still offering all screening rounds gave the best balance between required capacity, incidence, and mortality. Conclusions: Strategies with the smallest loss in health effects were also the most burdensome for the screening organisations. Which strategy is preferred depends on the organisation and available capacity in a country.
MeSH term(s)	Adult ; Aged ; Breast Neoplasms/complications ; Breast Neoplasms/diagnosis ; COVID-19/complications ; COVID-19/epidemiology ; COVID-19/virology ; Colorectal Neoplasms/complications ; Colorectal Neoplasms/diagnosis ; Early Detection of Cancer ; Female ; Humans ; Male ; Middle Aged ; Pandemics ; SARS-CoV-2/isolation & purification ; Uterine Cervical Neoplasms/complications ; Uterine Cervical Neoplasms/diagnosis
Language	English
Publishing date	2021-03-15
Publishing country	England
Document type	Journal Article
ZDB-ID	80075-2
ISSN	1532-1827 ; 0007-0920
ISSN (online)	1532-1827
ISSN	0007-0920
DOI	10.1038/s41416-021-01261-9
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