The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review

Christopher P Millward; Sumirat M Keshwara; Terri S Armstrong; Heather Barrington; Sabrina Bell; Andrew R Brodbelt; Helen Bulbeck; Linda Dirven; Paul L Grundy; Abdurrahman I Islim; Mohsen Javadpour; Shelli D Koszdin; Anthony G Marson; Michael W McDermott; Torstein R Meling; Kathy Oliver; Puneet Plaha; Matthias Preusser; Thomas Santarius; Nisaharan Srikandarajah; Martin J B Taphoorn; Carole Turner; Colin Watts; Michael Weller; Paula R Williamson; Gelareh Zadeh; Amir H Zamanipoor Najafabadi; Michael D Jenkinson; EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, Brainstrust, and Brain Tumour Foundation of Canada

doi:10.1093/noajnl/vdae030

The outcomes measured and reported in intracranial meningioma clinical trials: A systematic review

Neurooncol Adv. 2024 Mar 2;6(1):vdae030. doi: 10.1093/noajnl/vdae030. eCollection 2024 Jan-Dec.

Authors

Christopher P Millward^{1

2}, Sumirat M Keshwara^{1

2}, Terri S Armstrong³, Heather Barrington⁴, Sabrina Bell⁵, Andrew R Brodbelt^{1

2}, Helen Bulbeck⁶, Linda Dirven^{7

8}, Paul L Grundy⁹, Abdurrahman I Islim^{1

2}, Mohsen Javadpour¹⁰, Shelli D Koszdin¹¹, Anthony G Marson^{1

12}, Michael W McDermott¹³, Torstein R Meling¹⁴, Kathy Oliver, Puneet Plaha¹⁵, Matthias Preusser¹⁶, Thomas Santarius¹⁷, Nisaharan Srikandarajah¹, Martin J B Taphoorn^{7

8}, Carole Turner¹⁷, Colin Watts¹⁸, Michael Weller¹⁹, Paula R Williamson⁴, Gelareh Zadeh²⁰, Amir H Zamanipoor Najafabadi²¹, Michael D Jenkinson^{1

2}; EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, Brainstrust, and Brain Tumour Foundation of Canada

Collaborators

EORTC BTG, ICOM, EANO, SNO, RANO-PRO, BNOS, SBNS, BIMS, TBTC, International Brain Tumour Alliance, Brainstrust, and Brain Tumour Foundation of Canada:
Kenneth Aldape, Abdurrahman I Islim, Karolyn Au, Jill Barnhartz-Sloan, Wenya Linda Bi, Felix Behling, Priscilla K Brastianos, Chaya Brodie, Nicholas Butowski, Carlos Carlotti, Ana Castro, Aaron Cohen-Gadol, Marta Couce, Michael D Cusimano, Francesco DiMeco, Katharine Drummond, Ian F Dunn, Craig Erker, Michelle Felicella, Daniel M Fountain, Evanthia Galanis, Norbert Galldiks, Caterina Giannini, Roland Goldbrunner, Brent Griffith, Rintaro Hashizume, C Oliver Hanemann, Christel Herold-Mende, Luke Hnenny, Craig Horbinski, Raymond Y Huang, David James, Michael D Jenkinson, Christine Jungk, Gerhard Jungwirth, Timothy J Kaufmann, Boris Krischek, Sylvia Kurz, Daniel Lachance, Christian Lafougère, Katrin Lamszus, Ian Lee, Jeff C Liu, Serge Makarenko, Tathiana Malta, Yasin Mamatjan, Alireza Mansouri, Christian Mawrin, Michael McDermott, Christopher P Millward, Jennifer Moliterno-Gunel, Andrew Morokoff, David Munoz, Farshad Nassiri, Houtan Noushmehr, Ho-Keung Ng, Arie Perry, Farhad Pirouzmand, Laila M Poisson, Bianca Pollo, Aditya Ragunathan, David R Raleigh, Mirjam Renovanz, Franz Ricklefs, Felix Sahm, Andrea Saladino, Antonio Santacroce, Thomas Santarius, Jens Schittenhelm, Christian Schichor, David Schultz, Nils O Schmidt, Warren Selman, Helen Shih, Andrew Sloan, Julian Spears, Matija Snuderl, James Snyder, Suganth Suppiah, Erik Sulman, Ghazaleh Tabatabai, Marcos Tatagiba, Marco Timmer, Daniela Tirapelli, Joerg C Tonn, Derek Tsang, Michael A Vogelbaum, Andreas von Deimling, Tobias Walbert, Simon Walling, Justin Z Wang, Patrick Y Wen, Manfred Westphal, Adriana M Workewych, Stephen Yip, Gabriel Zada, Gelareh Zadeh, Viktor Zherebitskiy

Affiliations

¹ Institute of Systems, Molecular, and Integrative Biology, University of Liverpool, UK.
² Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
³ Neuro-Oncology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland, USA.
⁴ Institute of Population Health, University of Liverpool, UK.
⁵ The Brain Tumour Charity, Hampshire, UK.
⁶ Brainstrust-The Brain Cancer People, Isle of Wight, UK.
⁷ Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.
⁸ Department of Neurology, Haaglanden Medical Center, The Hague, The Netherlands.
⁹ Department of Neurosurgery, University Hospital Southampton, Southampton, UK.
¹⁰ National Centre for Neurosurgery, Beaumont Hospital, Dublin, Ireland.
¹¹ Veterans Affairs Healthcare System, Palo Alto, California, USA.
¹² Department of Neurology, The Walton Centre NHS Foundation Trust, Liverpool, UK.
¹³ Division of Neuroscience, Florida International University, Miami, Florida, USA.
¹⁴ Department of Neurosurgery, Copenhagen University Hospital, Copenhagen, Denmark.
¹⁵ International Brain Tumour Alliance, Tadworth, UK (K.O.).; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.
¹⁶ Division of Oncology, Department of Medicine, Medical University of Vienna, Vienna, Austria.
¹⁷ Department of Neurosurgery, Addenbrooke's Hospital & University of Cambridge, Cambridge, UK.
¹⁸ Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham, UK.
¹⁹ Department of Neurology, University Hospital and University of Zurich, Zurich, Switzerland.
²⁰ Department of Surgery, University of Toronto, Toronto, Canada.
²¹ Department of Ophthalmology, Leiden University Medical Centre, Haaglanden Medical Center, Haga Teaching Hospitals, Leiden, The Netherlands.

Abstract

Background: Meningioma clinical trials have assessed interventions including surgery, radiotherapy, and pharmacotherapy. However, agreement does not exist on what, how, and when outcomes of interest should be measured. To do so would allow comparative analysis of similar trials. This systematic review aimed to summarize the outcomes measured and reported in meningioma clinical trials.

Methods: Systematic literature and trial registry searches were performed to identify published and ongoing intracranial meningioma clinical trials (PubMed, Embase, Medline, CINAHL via EBSCO, and Web of Science, completed January 22, 2022). Reported outcomes were extracted verbatim, along with an associated definition and method of measurement if provided. Verbatim outcomes were deduplicated and the resulting unique outcomes were grouped under standardized outcome terms. These were classified using the taxonomy proposed by the "Core Outcome Measures in Effectiveness Trials" (COMET) initiative.

Results: Thirty published articles and 18 ongoing studies were included, describing 47 unique clinical trials: Phase 2 n = 33, phase 3 n = 14. Common interventions included: Surgery n = 13, radiotherapy n = 8, and pharmacotherapy n = 20. In total, 659 verbatim outcomes were reported, of which 84 were defined. Following de-duplication, 415 unique verbatim outcomes remained and were grouped into 115 standardized outcome terms. These were classified using the COMET taxonomy into 29 outcome domains and 5 core areas.

Conclusions: Outcome measurement across meningioma clinical trials is heterogeneous. The standardized outcome terms identified will be prioritized through an eDelphi survey and consensus meeting of key stakeholders (including patients), in order to develop a core outcome set for use in future meningioma clinical trials.

Keywords: COMET; clinical trial; core outcome set; meningioma; outcomes.