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Article ; Online: Economic Evaluation of a Tumour-Agnostic Therapy: Dutch Economic Value of Larotrectinib in TRK Fusion-Positive Cancers.

Michels, Renée E / Arteaga, Carlos H / Peters, Michel L / Kapiteijn, Ellen / Van Herpen, Carla M L / Krol, Marieke

Applied health economics and health policy

2022 Volume 20, Issue 5, Page(s) 717–729

Abstract: Background: Larotrectinib is the first tumour-agnostic therapy that has been approved by the European Medicines Agency. Tumour-agnostic therapies are indicated for a multitude of tumour types. The economic models supporting reimbursement submissions of ... ...

Abstract	Background: Larotrectinib is the first tumour-agnostic therapy that has been approved by the European Medicines Agency. Tumour-agnostic therapies are indicated for a multitude of tumour types. The economic models supporting reimbursement submissions of tumour-agnostic therapies are complex because of the multitude of indications per model. Objective: The objective of this paper was to evaluate the cost effectiveness of larotrectinib compared with standard of care in patients with cancer with tropomyosin receptor kinase fusion-positive tumour types in the Netherlands. Methods: A previously constructed cost-effectiveness model with a partitioned survival approach was adapted to the Dutch setting, simulating costs and effects of treatment in patients with tropomyosin receptor kinase fusion-positive cancer. The cost-effectiveness model conducts a naïve comparison of larotrectinib to a weighted comparator standard-of-care arm. Dutch specific resource use and costs were implemented and inflated to reflect 2019 euros. The analysis includes a lifetime horizon and a societal perspective. Results: Larotrectinib versus Dutch standard of care resulted in 5.61 incremental (QALYs) and €232,260 incremental costs, leading to an incremental cost-effectivenes ratio of €41,424/QALY. The probabilistic sensitivity analysis reveals a 88% chance of larotrectinib being cost effective compared with the pooled comparator standard-of-care arm at the applicable €80,000/QALY willingness-to-pay threshold in the Netherlands. Conclusions: The incremental cost-effectivenes ratio was well below the applicable threshold for diseases with a high burden of disease in the Netherlands (€80,000). At this threshold, larotrectinib was estimated to be a cost-effective treatment for patients with tropomyosin receptor kinase fusion-positive cancer compared with current standard of care in the Netherlands.
MeSH term(s)	Cost-Benefit Analysis ; Humans ; Neoplasms/drug therapy ; Pyrazoles ; Pyrimidines/therapeutic use ; Quality-Adjusted Life Years ; Tropomyosin
Chemical Substances	Pyrazoles ; Pyrimidines ; Tropomyosin ; larotrectinib (PF9462I9HX)
Language	English
Publishing date	2022-07-18
Publishing country	New Zealand
Document type	Journal Article
ZDB-ID	2171420-4
ISSN	1179-1896 ; 1175-5652
ISSN (online)	1179-1896
ISSN	1175-5652
DOI	10.1007/s40258-022-00740-1
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Zs.A 6060: Show issues

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Article ; Online: Kidney absorbed radiation doses for [ 177 Lu]Lu-PSMA-617 and [ 177 Lu]Lu-PSMA-I&T determined by 3D clinical dosimetry.

Uijen, Maike J M / Privé, Bastiaan M / van Herpen, Carla M L / Westdorp, Harm / van Gemert, Willemijn A / de Bakker, Maarten / Gotthardt, Martin / Konijnenberg, Mark W / Peters, Steffie M B / Nagarajah, James

Nuclear medicine communications

2023 Volume 44, Issue 4, Page(s) 270–275

Abstract: Purpose: For prostate-specific membrane antigen-directed radioligand therapy (PSMA-RLT), [ 177 Lu]Lu-PSMA-617 and [ 177 Lu]Lu-PSMA-I&T are the currently preferred compounds. Recent preclinical studies suggested ~30x higher kidney absorbed dose for [ 177 ...

Abstract	Purpose: For prostate-specific membrane antigen-directed radioligand therapy (PSMA-RLT), [ 177 Lu]Lu-PSMA-617 and [ 177 Lu]Lu-PSMA-I&T are the currently preferred compounds. Recent preclinical studies suggested ~30x higher kidney absorbed dose for [ 177 Lu]Lu-PSMA-I&T compared to [ 177 Lu]Lu-PSMA-617, which may lead to an increased risk of kidney toxicity. We performed two single-centre, prospective dosimetry studies with either [ 177 Lu]Lu-PSMA-617 or [ 177 Lu]Lu-PSMA-I&T, using an identical dosimetry protocol. We evaluated the absorbed doses of both 177 Lu-labelled radioligands in human kidneys. Methods: 3D SPECT/computed tomography (CT) imaging of the kidneys was performed after PSMA-RLT in cancer patients with PSMA-positive disease and an adequate glomerular filtration rate (≥50 mL/min). Ten metastatic hormone-sensitive prostate cancer patients (mHSPC) were treated with [ 177 Lu]Lu-PSMA-617 and 10 advanced salivary gland cancer (SGC) patients were treated with [ 177 Lu]Lu-PSMA-I&T. SPECT/CT imaging was performed at five timepoints (1 h, 24 h, 48 h, 72 h, and 168 h post-injection). In mHSPC patients, SPECT/CT imaging was performed after cycles 1 and 2 (cumulative activity: 9 GBq) and in SGC patients only after cycle 1 (activity: 7.4 GBq). Kidney absorbed dose was calculated using organ-based dosimetry. Results: The median kidney absorbed dose was 0.49 Gy/GBq (range: 0.34-0.66) and 0.73 Gy/GBq (range: 0.42-1.31) for [ 177 Lu]Lu-PSMA-617 and [ 177 Lu]Lu-PSMA-I&T, respectively (independent samples t test; P = 0.010). Conclusion: This study shows that the kidney absorbed dose for [ 177 Lu]Lu-PSMA-617 and [ 177 Lu]Lu-PSMA-I&T differs, with a ~1.5x higher median kidney absorbed dose for [ 177 Lu]Lu-PSMA-I&T. This difference in the clinical setting is considerably smaller than observed in preclinical studies and may not hamper treatments with [ 177 Lu]Lu-PSMA-I&T.
MeSH term(s)	Male ; Humans ; Prospective Studies ; Kidney ; Prostatic Neoplasms ; Radiation Dosage
Chemical Substances	PSMA-617 ; Lutetium-177 (BRH40Y9V1Q)
Language	English
Publishing date	2023-01-04
Publishing country	England
Document type	Journal Article
ZDB-ID	758141-5
ISSN	1473-5628 ; 0143-3636
ISSN (online)	1473-5628
ISSN	0143-3636
DOI	10.1097/MNM.0000000000001658
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Article ; Online: The solitary versus supported experience: Care inequality between rare and common cancer patients.

de Heus, Eline / van de Camp, Kalinka / Driehuis, Esmee / van der Zwan, Jan Maarten / van Herpen, Carla M L / Merkx, Matthias A W / Duijts, Saskia F A

Psycho-oncology

2023 Volume 32, Issue 11, Page(s) 1667–1674

Abstract: Objective: Patients with a rare cancer (RC) often have a more complex disease trajectory than patients with a common cancer. Research involving both patient groups is needed to identify differences and resemblances. In this study, we aimed to explore ... ...

Abstract	Objective: Patients with a rare cancer (RC) often have a more complex disease trajectory than patients with a common cancer. Research involving both patient groups is needed to identify differences and resemblances. In this study, we aimed to explore and compare experiences, needs and quality of life of patients with rare and common cancer throughout the disease trajectory. Methods: A qualitative focus group study was conducted, including patients with rare and common cancer (n = 25). Participants were purposively selected to reflect heterogeneity of cancer types. A semi-structured topic list was used. Focus groups (n = 4) were recorded, transcribed verbatim and analysed, using thematic analysis. Results: Three themes were identified emphasizing care inequality between patients with rare and common cancer: (1) The solitary experience: lack of information and support impact the RC patient, (2) Sudden impact, but recognition reduces the common cancer burden, and (3) Absence of psychosocial care requires being empowered as a cancer patient. Conclusions: Patients with RC are faced with enormous challenges due to the high impact of their solitary experience on their quality of life, while patients with common cancer generally experience social support and recognition alleviating their burden. Centralisation of care for patients with RC is needed and tailored psychosocial care should be provided to overcome inequalities.
MeSH term(s)	Humans ; Quality of Life/psychology ; Neoplasms ; Qualitative Research ; Focus Groups ; Social Support
Language	English
Publishing date	2023-09-12
Publishing country	England
Document type	Journal Article
ZDB-ID	1118536-3
ISSN	1099-1611 ; 1057-9249
ISSN (online)	1099-1611
ISSN	1057-9249
DOI	10.1002/pon.6216
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Zs.A 3550: Show issues

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Article ; Online: The safety risk of information overload and bureaucracy in oncology clinical trial conduct.

van Ravensteijn, Stefan G / Meijerink, Mirte / Nijenhuis-van Schayk, Renée / Desar, Ingrid M E / Bol, Kalijn F / van Herpen, Carla M L / Verheul, Henk M W

European journal of cancer (Oxford, England : 1990)

2023 Volume 183, Page(s) 90–94

Abstract: Performance of clinical trials has led to major therapeutic developments and substantial improvements in the field of medical oncology. To ensure patient's safety, regulatory aspects for proper clinical trial conduct have been increased over the past two ...

Abstract	Performance of clinical trials has led to major therapeutic developments and substantial improvements in the field of medical oncology. To ensure patient's safety, regulatory aspects for proper clinical trial conduct have been increased over the past two decades but seem to cause information overload and ineffective bureaucracy, possibly even impacting patient safety. To put this in perspective, after the implementation of Directive 2001/20/EC in the European Union, a 90 per cent increase in trial launching time, a 25 per cent decrease in patient participation and a 98 per cent rise in administrative trial costs were reported. The time to initiate a clinical trial has increased from a few months to several years in the past three decades. Moreover, there is a serious risk that information overload with relatively unimportant data endangers the decision-making processes and distracts from essential patient safety information. It is now a critical moment in time to improve efficient clinical trial conduct for our future patients diagnosed with cancer. We are convinced that a reduction of the administrative regulations, information overload, and simplification of the procedures for trial conductance may improve patient safety. In this Current Perspective, we give insight in the current regulatory aspects of clinical research, evaluate the practical consequences of these regulations, and propose specific improvements for optimal clinical trial conduct.
MeSH term(s)	Humans ; Medical Oncology ; European Union ; Neoplasms/therapy
Language	English
Publishing date	2023-01-30
Publishing country	England
Document type	Journal Article
ZDB-ID	82061-1
ISSN	1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0277-5379 ; 0959-8049 ; 0964-1947
DOI	10.1016/j.ejca.2023.01.018
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Zs.A 456: 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)
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Article: Case Report: Two Cases of Salivary Duct Carcinoma in Workers With a History of Chromate Exposure.

Seçin, Imran / Uijen, Maike J M / Driessen, Chantal M L / van Herpen, Carla M L / Scheepers, Paul T J

Frontiers in medicine

2021 Volume 8, Page(s) 730403

Abstract: Background: ...

Abstract	Background:
Language	English
Publishing date	2021-10-18
Publishing country	Switzerland
Document type	Case Reports
ZDB-ID	2775999-4
ISSN	2296-858X
ISSN	2296-858X
DOI	10.3389/fmed.2021.730403
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Article ; Online: Prognostic factor analysis and long-term results of the TAX 323 (EORTC 24971) study in unresectable head and neck cancer patients.

Szturz, Petr / Vinches, Marie / Remenár, Éva / van Herpen, Carla M L / Abdeddaim, Cyril / Stewart, John S / Fortpied, Catherine / Vermorken, Jan B

European journal of cancer (Oxford, England : 1990)

2021 Volume 156, Page(s) 109–118

Abstract: Background: In the TAX 323 (EORTC 24971) phase III trial enrolling patients with unresectable locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN), the addition of docetaxel (T) to cisplatin and 5-fluorouracil (PF)-based ... ...

Abstract	Background: In the TAX 323 (EORTC 24971) phase III trial enrolling patients with unresectable locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN), the addition of docetaxel (T) to cisplatin and 5-fluorouracil (PF)-based induction chemotherapy prior to definite radiotherapy significantly improved progression-free survival (PFS) and overall survival (OS). Methods: The data were updated for PFS, OS and treatment-related long-term side-effects. Baseline clinical and laboratory data of 17 variables were collected and subjected to univariate and multivariate prognostic factor analyses for OS. Results: All 358 patients randomised between 1999 and 2002 were included in the long-term analysis with a median follow-up of 8.6 years. The primary end-point of PFS remained significantly improved with TPF compared with PF (adjusted hazard ratio [HR], 0.70; 95% CI, 0.56-0.88, p = 0.002), translating into a persisting benefit in OS (adjusted HR, 0.75; 95% CI, 0.60-0.95, p = 0.015). Long-term side-effects in the TPF/PF arms comprised tracheostomy (7%/5%), feeding tube dependency (3%/6%) and gastrostomy (11%/11%). Second malignancy occurred in 8%/3%, respectively. Out of 177 patients randomised to the TPF arm, 160 were included in the multivariate analysis. Grade 2 or more dysphagia (p = 0.002) and grade 2 or more pain (p = 0.004) at baseline were identified as independent negative prognostic factors. In addition, OS differed across primary tumour sites (p = 0.027) and was worse in patients with a higher N-stage (p = 0.025). Conclusions: In LA-SCCHN patients treated with sequential chemoradiotherapy, TPF induction chemotherapy demonstrated long-lasting efficacy, superior to the PF regimen. Higher-grade dysphagia and pain are unfavourable prognosticators.
MeSH term(s)	Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Cisplatin/therapeutic use ; Clinical Trials, Phase III as Topic ; Databases, Factual ; Disease Progression ; Docetaxel/therapeutic use ; Europe ; Female ; Fluorouracil/therapeutic use ; Head and Neck Neoplasms/drug therapy ; Head and Neck Neoplasms/mortality ; Head and Neck Neoplasms/pathology ; Humans ; Male ; Middle Aged ; Progression-Free Survival ; Retrospective Studies ; Risk Assessment ; Risk Factors ; Squamous Cell Carcinoma of Head and Neck/drug therapy ; Squamous Cell Carcinoma of Head and Neck/mortality ; Squamous Cell Carcinoma of Head and Neck/pathology ; Time Factors
Chemical Substances	Docetaxel (15H5577CQD) ; Cisplatin (Q20Q21Q62J) ; Fluorouracil (U3P01618RT)
Language	English
Publishing date	2021-08-20
Publishing country	England
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	82061-1
ISSN	1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
ISSN (online)	1879-0852
ISSN	0277-5379 ; 0959-8049 ; 0964-1947
DOI	10.1016/j.ejca.2021.07.034
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Zs.A 456: 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)
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Article ; Online: Cemiplimab in locally advanced or metastatic cutaneous squamous cell carcinoma: prospective real-world data from the DRUG Access Protocol.

Verkerk, Karlijn / Geurts, Birgit S / Zeverijn, Laurien J / van der Noort, Vincent / Verheul, Henk M W / Haanen, John B A G / van der Veldt, Astrid A M / Eskens, Ferry A L M / Aarts, Maureen J B / van Herpen, Carla M L / Jalving, Mathilde / Gietema, Jourik A / Devriese, Lot A / Labots, Mariette / Barjesteh van Waalwijk van Doorn-Khosrovani, Sahar / Smit, Egbert F / Bloemendal, Haiko J

The Lancet regional health. Europe

2024 Volume 39, Page(s) 100875

Abstract: Background: The DRUG Access Protocol provides patients with cancer access to registered anti-cancer drugs that are awaiting reimbursement in the Netherlands and simultaneously collects prospective real-world data (RWD). Here, we present RWD from PD-1 ... ...

Abstract	Background: The DRUG Access Protocol provides patients with cancer access to registered anti-cancer drugs that are awaiting reimbursement in the Netherlands and simultaneously collects prospective real-world data (RWD). Here, we present RWD from PD-1 blocker cemiplimab in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (laCSCC; mCSCC). Methods: Patients with laCSCC or mCSCC received cemiplimab 350 mg fixed dose every three weeks. Primary endpoints were objective clinical benefit rate (CBR), defined as objective response (OR) or stable disease (SD) at 16 weeks, physician-assessed CBR, defined as clinician's documentation of improved disease or SD based on evaluation of all available clinical parameters at 16 weeks, objective response rate (ORR), and safety, defined as grade ≥ 3 treatment related adverse events (TRAEs) occurring up to 30 days after last drug administration. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), and overall survival (OS). Findings: Between February 2021 and December 2022, 151 patients started treatment. Objective and physician-assessed CBR were 54.3% (95% CI, 46.0-62.4) and 59.6% (95% CI, 51.3-67.5), respectively. ORR was 35.1% (95% CI, 27.5-43.3). After a median follow-up of 15.2 months, median DoR was not reached. Median PFS and OS were 12.2 (95% CI, 7.0-not reached) and 24.2 months (95% CI, 18.8-not reached), respectively. Sixty-eight TRAEs occurred in 29.8% of patients. Most commonly reported TRAE was a kidney transplant rejection (9.5%). Interpretation: Cemiplimab proved highly effective and safe in this real-world cohort of patients with laCSCC or mCSCC, confirming its therapeutic value in the treatment of advanced CSCC in daily clinical practice. Funding: The DRUG Access Protocol is supported by all participating pharmaceutical companies: Bayer, Janssen, Lilly, Merck, Novartis, Roche, and Sanofi.
Language	English
Publishing date	2024-03-05
Publishing country	England
Document type	Journal Article
ISSN	2666-7762
ISSN (online)	2666-7762
DOI	10.1016/j.lanepe.2024.100875
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Article: Methylated Cell-Free DNA Sequencing (MeD-seq) of LpnPI Digested Fragments to Identify Early Progression in Metastatic Renal Cell Carcinoma Patients on Watchful Waiting.

Bos, Manouk K / Verhoeff, Sarah R / Oosting, Sjoukje F / Menke-van der Houven van Oordt, Willemien C / Boers, Ruben G / Boers, Joachim B / Gribnau, Joost / Martens, John W M / Sleijfer, Stefan / van Herpen, Carla M L / Wilting, Saskia M

Cancers

2023 Volume 15, Issue 5

Abstract: According to the current guidelines, watchful waiting (WW) is a feasible option for patients with good or intermediate prognosis renal-cell carcinoma (RCC). However, some patients rapidly progress during WW, requiring the initiation of treatment. Here, ... ...

Abstract	According to the current guidelines, watchful waiting (WW) is a feasible option for patients with good or intermediate prognosis renal-cell carcinoma (RCC). However, some patients rapidly progress during WW, requiring the initiation of treatment. Here, we explore whether we can identify those patients using circulating cell-free DNA (cfDNA) methylation. We first defined a panel of RCC-specific circulating methylation markers by intersecting differentially methylated regions from a publicly available dataset with known RCC methylation markers from the literature. The resulting RCC-specific methylation marker panel of 22 markers was subsequently evaluated for an association with rapid progression by methylated DNA sequencing (MeD-seq) in serum from 10 HBDs and 34 RCC patients with a good or intermediate prognosis starting WW in the IMPACT-RCC study. Patients with an elevated RCC-specific methylation score compared to HBDs had a shorter progression-free survival (PFS,
Language	English
Publishing date	2023-02-21
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15051374
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Article: The Prognostic Relevance of MRI Characteristics in Myxofibrosarcoma Patients Treated with Neoadjuvant Radiotherapy.

van Ravensteijn, Stefan G / Nederkoorn, Maikel J L / Wal, Tom C P / Versleijen-Jonkers, Yvonne M H / Braam, Pètra M / Flucke, Uta E / Bonenkamp, Johannes J / Schreuder, Bart H W / van Herpen, Carla M L / de Wilt, Johannes H W / Desar, Ingrid M E / de Rooy, Jacky W J

Cancers

2023 Volume 15, Issue 10

Abstract: To improve local control, neoadjuvant radiotherapy (nRT) followed by surgery is the standard of care in myxofibrosarcoma (MFS) because of its infiltrative growth pattern. Nevertheless, local recurrence rates are high. Data on prognostic factors for poor ... ...

Abstract	To improve local control, neoadjuvant radiotherapy (nRT) followed by surgery is the standard of care in myxofibrosarcoma (MFS) because of its infiltrative growth pattern. Nevertheless, local recurrence rates are high. Data on prognostic factors for poor clinical outcomes are lacking. This retrospective study thus investigates the prognostic relevance of magnetic resonance imaging (MRI) characteristics before and after nRT in 40 MFS patients, as well as their association with disease-free survival (DFS) and overall survival (OS). A vascular pedicle, defined as extra-tumoral vessels at the tumor periphery, was observed in 12 patients (30.0%) pre-nRT and remained present post-nRT in all cases. Patients with a vascular pedicle had worse DFS (HR 5.85; 95% CI 1.56-21.90;
Language	English
Publishing date	2023-05-19
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15102843
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Article ; Online: Precision oncology using organoids of a secretory carcinoma of the salivary gland treated with TRK-inhibitors.

Lassche, Gerben / van Engen-van Grunsven, Adriana C H / van Hooij, Onno / Aalders, Tilly W / Am Weijers, Jetty / Cocco, Emiliano / Drilon, Alexander / Hoischen, Alexander / Neveling, Kornelia / Schalken, Jack A / Verhaegh, Gerald W / van Herpen, Carla M L

Oral oncology

2023 Volume 137, Page(s) 106297

Abstract: The use of anticancer drugs targeting specific molecular tumor characteristics is rapidly increasing in clinical practice, but selecting patients to benefit from these remains a challenge. It has been suggested that organoid cultures would be ideally ... ...

Abstract	The use of anticancer drugs targeting specific molecular tumor characteristics is rapidly increasing in clinical practice, but selecting patients to benefit from these remains a challenge. It has been suggested that organoid cultures would be ideally suited to test drug responses in vitro. Here we describe and characterize in depth a case of ETV6-NTRK3 gene fusion-positive secretory carcinoma of the salivary glands and corresponding organoid cultures that responded and subsequently acquired resistance to TRK targeting therapy with larotrectinib. This case-culture-characterization illustrates the advances made in precision oncology, but also exposes important caveats in using organoids to predict treatment response.
MeSH term(s)	Humans ; Salivary Gland Neoplasms/drug therapy ; Salivary Gland Neoplasms/genetics ; Salivary Gland Neoplasms/pathology ; Oncogene Proteins, Fusion/genetics ; Immunohistochemistry ; Precision Medicine ; Salivary Glands/pathology ; Carcinoma/pathology ; Biomarkers, Tumor/genetics
Chemical Substances	Oncogene Proteins, Fusion ; Biomarkers, Tumor
Language	English
Publishing date	2023-01-05
Publishing country	England
Document type	Case Reports ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1120465-5
ISSN	1879-0593 ; 0964-1955 ; 1368-8375
ISSN (online)	1879-0593
ISSN	0964-1955 ; 1368-8375
DOI	10.1016/j.oraloncology.2022.106297
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