Principal investigator(s)
Martin Taphoorn
Leiden University Medical Center
Leiden, Netherlands
, Jaap Reijneveld
VU University Medical Center / Amsterdam Medical Center
Amsterdam, Netherlands
Project coordinator(s)
Linda Dirven
Leiden University Medical Center
Leiden, Netherlands
, Marijke Coomans
Leiden University Medical Center
Leiden, Netherlands

Project summary

The CODAGLIO project, that started in September 2016, aims to combine clinical and health-related quality of life (HRQOL) data of available randomized controlled trials in glioma (i.e., primary brain tumour) patients. The project is a collaboration between the Quality of Life Group, the Brain Tumour Group and the Quality of Life Department. We have included data of more than 6000 patients. With this large dataset we will be able to answer clinically relevant questions, such as: ‘What is the added prognostic value of HRQOL on overall survival and progression-free survival?’ and ‘Are specific symptom clusters associated with overall HRQOL?’. Ultimately, we will study the trade-off between quality and quantity of life of treatment strategies and address the question ‘Will a combined analysis of survival and HRQOL data facilitate interpretation on the net clinical benefit of a treatment strategy?’

Achievements

Since the start of the project we have been working on obtaining approval from the principal investigators or pharmaceutical companies to include the data collected in clinical trials into our database, and we are working on establishing the Data Sharing Agreements. After the agreements are in place, the statistical analyses can start.

Current status:
We are now in the process of setting up Data Transfer Agreements and constructing the database for further analyzed.
The researcher has been working on drafting the statistical analysis plans.

Future plans

Mid 2023 we hope that the database is ready for use. The remaining time of the project, we will conduct the statistical
analyses and write the manuscripts.

For patients

Patients with a glioma, the most prevalent primary malignant brain tumour, demonstrate a high symptom burden and experience many disease-specific symptoms such as cognitive dysfunction and seizures. Although patients receive treatment with surgery, radiotherapy and chemotherapy, current treatment options are not curative. Therefore, the quality of survival is for these patients at least as important as the duration of survival. Because primary brain tumours are relatively rare, and the number of trials that included assessments of health-related quality of life (HRQOL) are limited, it is essential to combine these datasets. By combining these datasets we will be able to answer clinically relevant questions that could not be answered until now. For example, we will study what specific concurrent symptoms cause a deficit in functioning, as management of these symptoms may result in an improved HRQOL. Also, we will use certain models that combine information on the impact of a treatment on both survival and HRQOL. Such information may help physicians to decide which treatment is best for a specific patient.

Publications

  • Coomans MB, Dirven L, Aaronson N, Baumert BG, van den Bent M, Bottomley A, Brandes A, Chinot O, Coens C, Gorlia T, Herrlinger U, Keime-Guibert F, Malmström A, Martinelli F, Stupp R, Talacchi A, Wick W, Reijneveld JC, and Taphoorn MJB. QLIF-27. The added value of health-related quality of life (HRQoL) as a prognostic indicator of overall survival and progression free survival in glioma patients: a meta-analysis based on individual patient data from randomized controlled trials. Neuro-Oncology, 19, issue suppl 6, Nov 2017, vi2017, DOI: 10.1093/neuonc/nox168.836
  • Coomans M, Dirven L, K Aaronson N, Baumert BG, van den Bent M, Bottomley A, Brandes AA, Chinot O, Coens C, Gorlia T, Herrlinger U, Keime-Guibert F, Malmström A, Martinelli F, Stupp R, Talacchi A, Weller M, Wick W, Reijneveld JC, Taphoorn MJB; EORTC Quality of Life Group and the EORTC Brain Tumor Group. The added value of health-related quality of life as a prognostic indicator of overall survival and progression-free survival in glioma patients: a meta-analysis based on individual patient data from randomised controlled trials. Eur J Cancer. 2019 Jul;116:190-198. doi: 10.1016/j.ejca.2019.05.012. Epub 2019 Jun 13
  • Coomans M.B., Dirven L, Bottomley A, Coens C, Gorlia T, Martinelli F, Talacchi A, Aaronson N, Baumert BG, van den Bent M, Brandes A, Chinot Herrlinger U, Keime-Guibert F, Malmström A, Stupp R, WickW, Reijneveld JC, and Taphoorn MJB. Calculating the net clinical benefit in neuro-oncology clinical trials using two methods: quality adjusted survival effect sizes (QASES) and Joint Modeling (JM). Neuro-Oncology Advances, 2(1), vdaa147.
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