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Expansion and extension of the use of cancer registry data as HTA tool in pharmacotherapy

Projectomschrijving

Veel dure- en weesgeneesmiddelen worden gebruikt voor de behandeling van patiënten met kanker. Gegevens uit de dagelijkse praktijk kunnen bijdragen aan de besluitvorming over de doelmatigheid van deze middelen. Hiervoor is een nieuw studiecohort gecreëerd: de koppeling van de kankerregistratie van het IKNL Regio Zuid (www.iknlzuid.nl) aan het datanetwerk van het PHARMO Instituut (www.pharmo.nl), het IKZ-PHARMO cohort.

Dit project heeft geleid tot de uitbreiding van het IKZ-PHARMO cohort door het toevoegen van data van ziekenhuisapotheken, openbare apotheken, huisartsen en gegevens vanuit de polikliniek die bij de oncoloog worden geregistreerd (van patiënten met niet-gemetastaseerde dikkedarm- of endeldarmkanker, of niet-gemetastaseerde borstkanker ten tijde van kankerdiagnose).

Het uitgebreide IKZ-PHARMO cohort biedt nieuwe mogelijkheden voor onderzoek naar het gebruik, de effectiviteit en veiligheid van (nieuwe) (dure) geneesmiddelen voor de behandeling van kanker.

Producten

Titel: Incident cancer risk after the start of aspirin use: Results from a Dutch population-based cohort study of low dose aspirin users
Auteur: Loes M. Hollestein Myrthe P.P. van Herk-Sukel Rikje Ruiter Esther de Vries Ron H.J. Mathijssen Erik A.C. Wiemer Theo Stijnen Jan-Willem W. Coebergh Valery E.P.P. Lemmens Ron M.C. Herings Bruno H.C. Stricker Tamar Nijsten
Magazine: International Journal of Cancer
Titel: Metachronous peritoneal carcinomatosis after curative treatment of colorectal cancer
Auteur: Y.R.B.M. van Gestel I. Thomassen V.E.P.P. Lemmens J.F.M. Pruijt M.P.P. van Herk-Sukel H.J.T. Rutten G.J. Creemers I.H.J.T. de Hingh
Magazine: Surgical Oncology
Titel: Major Changes in Chemotherapy Regimens Administered to Breast Cancer Patients During 2000–2008 in the Netherlands
Auteur: Myrthe P.P. van Herk-Sukel Lonneke V. van de Poll-Franse Geert-Jan Creemers Valery E.P.P. Lemmens Paul D. van der Linden Ron M.C. Herings Jan Willem W. Coebergh Adri C. Voogd
Magazine: Breast
Titel: Prevalence and incidence of acute and chronic comorbidity in patients with squamous cell carcinoma of the head and neck
Auteur: Landis, S. H. El-Hariry, I. A. van Herk-Sukel, M. P. van den Haak, P. Janssen-Heijnen, M. L. Penning-van Beest, F. J. Herings, R. M.
Magazine: Head Neck
Titel: Patterns of metachronous metastases after curative treatment of colorectal cancer
Auteur: Yvette R.B.M. van Gestel Ignace H.J.T. de Hingh Myrthe P.P. van Herk-Sukel Felice N. van Erning Laurens V. Beerepoot Jan H. Wijsman Gerrit D. Slooterf Harm J.T. Rutten Geert-Jan M. Creemers Valery E.P.P. Lemmens
Magazine: Cancer Epidemiology
Titel: New opportunities for drug outcomes research in cancer patients: the linkage of the Eindhoven Cancer Registry and the PHARMO Record Linkage System
Auteur: van Herk-Sukel, M. P. van de Poll-Franse, L. V. Lemmens, V. E. Vreugdenhil, G. Pruijt, J. F. Coebergh, J. W. Herings, R. M.
Magazine: European Journal of Cancer
Titel: beta-Blocker use and all-cause mortality of melanoma patients:Results from a population-based Dutch cohort study
Auteur: E. Livingstone L.M. Hollestein M.P.P. van Herk-Sukel L. van de Poll-Franse T. Nijsten D. Schadendorf E. de Vries
Magazine: European Journal of Cancer
Titel: Use of Aspirin postdiagnosis improves survival for colon cancer patients
Auteur: Bastiaannet, E. Sampieri, K. Dekkers, O. M. de Craen, A. J. van Herk-Sukel, M. P. Lemmens, V. van den Broek, C. B. Coebergh, J. W. Herings, R. M. van de Velde, C. J. Fodde, R. Liefers, G. J.
Magazine: British Journal of Cancer
Titel: Aspirin use after diagnosis improves survival in older adults with colon cancer: a retrospective cohort study
Auteur: Reimers, M. S. Bastiaannet, E. van Herk-Sukel, M. P. Lemmens, V. E. van den Broek, C. B. van de Velde, C. J. de Craen, A. J. Liefers, G. J.
Magazine: Journal of the American Geriatrics Society

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Samenvatting van de aanvraag

Research on the efficiency of drugs on the list of high-cost medicines in daily practice is required by the Dutch policy for reimbursement. A large proportion of the medications listed as ‘expensive medicines’ is currently applied in the field of oncology. With the incidence rates of cancer increasing and survival rates improving, the number of prevalent cancer patients treated with anti-cancer drugs will continue to rise. While effectiveness and safety of new expensive anti-cancer drugs are thoroughly studied in randomized clinical trials, little data are available on these parameters in everyday clinical practice. Therefore, instruments should be in place that facilitate post-approval drug utilization and (cost-)effectiveness studies on expensive anti-cancer drugs. Such an instrument can be the creation of a population based cohort to be able to assess drug utilization, patters of care and exploring side effects in daily clinical practice. The methodology used in this project is the linkage of existing data sources and expansion of these data sources, to create a population-based cohort. The results of studies using the data of this cohort can then be used to assist health policy makers in deciding on the reimbursement of (expensive or orphan) anti-cancer drugs. Recently, a cohort was successfully created with the databases of the PHARMO record linkage system (PHARMO RLS) linked to the Eindhoven Cancer Registry in the ongoing ZonMw HTA-methodology project [ZonMw 80-82500-98-8227]. However, the current cohort is too small to allow effectiveness and safety studies on expensive anti-cancer treatments. Moreover, additional data is needed to be able to create the complete overview of outcomes of patients treated with expensive anti-cancer medicines including the exploration of acute, long-term and late adverse events. The goal of the current project is therefore, to optimize a population based cohort so that it can be used as a tool to assess the effectiveness and safety of expensive anti-cancer drugs in daily clinical practice most efficiently and rapidly, thereby overseeing the whole spectrum of relevant oncological practice. In this project we will focus on three additional data collections in order optimize the current ECR-PHARMO cohort: 1) linking the ECR-PHARMO cohort with general practitioner data, 2) expanding the PHARMO in-hospital and community pharmacy data in the ECR area and 3) collecting additional data on treatment complications registered during out-patient hospital visits. It will be explored whether long term effects of expensive anti-cancer drugs can be adequately studied, such as 5-year overall survival, long term treatment complications, quality of life among long term survivors, disease progression and recurrence after 3 years of diagnosis/treatment, prognosis after disease progression and recurrence, second tumours, and conditional survival. Feedback to clinicians and pharmacologists during tumour working group meetings will assure adequate interpretation of the study results. Increasingly such discussions are also held with patients’ representatives. Moreover, patient involvement will be achieved by using the PROFILES (Patient Reported Outcomes Following Initial treatment and Long term Evaluation of Survivorship) infrastructure. This infrastructure provides interaction with the patient and allows the discussion of study results. Finally, study results will be presented at congresses and published in peer-reviewed journals. In order to make the ECR-PHARMO cohort a tool that can be used by researchers to perform studies of which the results can be used by health policy makers in deciding on the reimbursement of (expensive or orphan) drugs, special attention will be given to data confidentiality, governance, privacy issues and research ethics.

Onderwerpen

Kenmerken

Projectnummer:
152001022
Looptijd: 100%
Looptijd: 100 %
2012
2015
Onderdeel van programma:
Gerelateerde subsidieronde:
Projectleider en penvoerder:
Dr. ir. M.P.P. van Herk-Sukel
Verantwoordelijke organisatie:
PHARMO Institute for Drug Outcomes Research