Dobber, Lisa

Geurts, Marjolein

Van Den Bent, Martin J.

English

EUR Research Repository

EUR Research Information PortalTumor growth in recurrent glioblastoma - RANOPublished in:Neuro-OncologyPublication status and date:Published: 01/08/2024DOI (link to publisher):10.1093/neuonc/noae095Document VersionPublisher's PDF, also known as Version of recordDocument License/Available under:Article 25fa Dutch Copyright ActCitation for the published version (APA):Dobber, L., Geurts, M., & Van Den Bent, M. J. (2024). Tumor growth in recurrent glioblastoma - RANO: When to plan thebaseline scan? Neuro-Oncology, 26(8), 1536-1537. https://doi.org/10.1093/neuonc/noae095Link to publication on the EUR Research Information PortalTerms and Conditions of UseExcept as permitted by the applicable copyright law, you may not reproduce or make this material available to any third partywithout the prior written permission from the copyright holder(s). Copyright law allows the following uses of this materialwithout prior permission:            • you may download, save and print a copy of this material for your personal use only;            • you may share the EUR portal link to this material.In case the material is published with an open access license (e.g. a Creative Commons (CC) license), other uses may beallowed. Please check the terms and conditions of the specific license.Take-down policyIf you believe that this material infringes your copyright and/or any other intellectual property rights, you may request itsremoval by contacting us at the following email address: openaccess.library@eur.nl. Please provide us with all the relevantinformation, including the reasons why you believe any of your rights have been infringed. In case of a legitimate complaint,we will make the material inaccessible and/or remove it from the website.  1536 Neuro-Oncology26(8), 1536–1537, 2024 | https://doi.org/10.1093/neuonc/noae095 | Advance Access date 10 June 2024Letter to the EditorTumor growth in recurrent glioblastoma—RANO: when to plan the baseline scan?Glioblastoma is the most common primary malignant brain tumor for which no curative treatment exists. Little is known about its growth rate once disease progression occurs. This is relevant for the timing of baseline imaging for second-line treatment in clinical trials and subsequent response moni-toring. Although most trial protocols allow a 2–3-week interval between obtaining a baseline scan for study entry and therapy initiation, the 2022 revised RANO 2.0 criteria recommend an interval no greater than 14 days.1,2 To our knowledge, no ev-idence for this interval exists. If a tumor grows rapidly in the period between imaging and the start of treatment, adequate response assessment may be hindered leading to false inter-pretations of progression to the experimental treatment. We assessed whether the tumor area differs between the scan showing progressive disease (“progression scan”) and the scan for study entry (“baseline scan”) to determine the tumor growth rate.In this single-center study, adult patients at the Erasmus MC in Rotterdam, the Netherlands, with a radiologically confirmed first glioblastoma recurrence enrolled in a clinical trial be-tween 2011 and 2023 were checked for eligibility. First recur-rence (progressive disease, PD) after standard of care was established per physicians’ judgment either at Erasmus MC or the referring hospital. All studies required a 3-month in-terval between the end of radiotherapy and study enrollment. Patients were included if they had 2 available MRI scans with measurable disease made within ≤35-day interval between the progression scan and baseline scan. Patients who un-derwent re-resection were excluded. Three independent ob-servers calculated the tumor areas from the identified scans using the 2-dimensional maximal perpendicular measure on T1 contrast-enhanced axial imaging (RANO 2.0).2 Using the measurements’ mean, the percentage change in tumor area was calculated and compared to RANO’s ≥25% definition of disease progression. We chose 17 days as a landmark to eval-uate the number of patients with tumor progression consid-ering this is the maximum interval allowed by recent studies (eg, NCT01986348, NCT04910022).We included 53 out of 140 screened patients. Most were ex-cluded due to an inaccessible progression scan (n = 53). The mean age at the progression scan was 55 years (range, 19–75) and 32 patients were male. Fifty patients received standard-of-care radiotherapy and temozolomide chemotherapy. The median time between initial glioblastoma diagnosis and PD was 260 days (range, 177–1056). Dexamethasone dosage © The Author(s) 2024. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.5RANO’s threshold–40–2002040Difference in tumor area (percentage)25608010010 15 20 25 30 35Number of days between progression scan and baseline scanFigure 1. The percentage change in tumor area based on the number of days between the scan showing disease progression and the baseline scan for study entry. The dashed horizontal line at 25% difference in tumor area represents RANO’s formal progressive disease threshold. One patient with a tumor area increase of 209% was omitted from this figure for visualization purposes.Downloaded from https://academic.oup.com/neuro-oncology/article/26/8/1536/7690455 by Erasmus University Rotterdam user on 21 August 2024Neuro-Oncology1537Dobber et al.: Tumor growth in recurrent glioblastoma—RANObetween progression and baseline scan was retrospec-tively obtained from 43 patients’ charts: dosage increased in 11 patients and decreased in 2 patients.Mean time between the progression and the base-line scan was 20 days. Mean tumor areas at progression and baseline scan were 1223 mm2 (range, 128–4397) and 1405 mm2 (range, 239–4493), respectively (mean difference in tumor area of 182 mm2 [95% confidence interval {CI}, 114–249 mm2, P < .001). This corresponds to a 15% tumor area growth (CI, 9%–21%, P < .001) between scans. Most tumor areas (47/53) increased in the short time interval between imaging, with a median tumor area increase of 20% (Figure 1). Eighteen of 53 patients had formal disease progression (≥25%) within the 35-day interval. One-third of patients (7/19) with 2 scans within 17 days had ≥20% tumor area increase and 5/19 patients had a ≥25% tumor area increase. Interobserver variability (R2) ranged from 0.48 to 0.72.We demonstrate the fast growth rate of recurrent glio-blastoma. To properly assess the effect of second-line treat-ment, we emphasize the importance of baseline imaging as close as possible to starting with trial treatment: even a 17-day interval may result in misinterpretation at the first follow-up moment.3 Presently, a scan immediately before therapy initiation is often not reimbursed. An alternative for clinical trial protocols is to consider enrolling patients based on the scan demonstrating progression and per-form study baseline imaging 1–2 days prior to starting treatment.FundingThe authors declare that no funds were received during the preparation of this manuscript.Conflict of interest statementThe authors have no competing interests to declare that are rel-evant to the content of this article.Ethics approvalThis is an observational study. The study was covered by the IRB approval of the individual prospective studies.Data availabilityThe data supporting the findings of this study are available from the corresponding author upon reasonable request.Lisa Dobber, Marjolein Geurts , and  Martin J. van den BentDepartment of Neurology, Erasmus MC Cancer Center, Rotterdam, The Netherlands (L.D., M.G., M.J.B.); Department of Medical Oncology, Erasmus MC Cancer Center, Rotterdam, The Netherlands (M.G.)Corresponding Author: Martin van den Bent, Department of Neurology, Erasmus MC Cancer Center, Dr. Molewaterplein 40, 3015 GD,  Rotterdam 010-7041415, The Netherlands (mjvandenbent@neuro-oncology.nl).References1. Ellingson BM, Gerstner ER, Lassman AB, et al. Hypothetical gen-eralized framework for a new imaging endpoint of therapeutic ac-tivity in early phase clinical trials in brain tumors. Neuro-Oncology. 2022;24(8):1219–1229.2. Wen PY, van den Bent M, Youssef G, et al. RANO 2.0: Update to the re-sponse assessment in neuro-oncology criteria for high- and low-grade gliomas in adults. J Clin Oncol. 2023;41(33):5187–5199.3. Ellingson BM, Wen PY, Chang SM, et al. Objective response rate tar-gets for recurrent glioblastoma clinical trials based on the historic as-sociation between objective response rate and median overall survival. Neuro-Oncology. 2023;25(6):1017–1028.Downloaded from https://academic.oup.com/neuro-oncology/article/26/8/1536/7690455 by Erasmus University Rotterdam user on 21 August 2024

Tumor growth in recurrent glioblastoma - RANO:When to plan the baseline scan?

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Tumor growth in recurrent glioblastoma - RANO:When to plan the baseline scan?

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