Abstract
Abstract BACKGROUND In patients with glioblastoma, radiological recurrence of enhancing tissue after chemoradiotherapy can originate from progressive disease (PD) or pseudoprogression/treatment-associated changes. In earlier studies, a change of the FLAIR-signal intensity (SI) predicted PD with 18-84% sensitivity and 71-100% specificity, both with quantitative resection cavity to ventricle SI ratio of 7.3. We assessed the rate of FLAIR-signal intensity change in patients with O6-methylguanine DNA methyltransferase (MGMT) promoter-methylated or -unmethylated glioblastoma from the randomised CENTRIC and CORE studies (NCT00689221, NCT00813943). These patients were treated with chemoradiotherapy or chemoradiotherapy with cilengitide, an integrin inhibitor. METHODS Patients from both studies with a gross total resection and ≥3 follow-up MRIs were included. The outcome was determined by the modified RANO criteria of 2017. Two researchers evaluated the FLAIR-SI of the resection cavity. A positive SI change was scored qualitatively in case of a visually brighter signal intensity than on the previous MRI. Quantitative analysis was based on a ratio of SI in the resection cavity compared to SI of the ventricles. RESULTS Follow-up was available for 307 patients. Median time from RT to (preliminary) progressive disease was 6.2 months for MGMT promoter-methylated (interquartile range, (iqr)=2.5-14.7) and 6.0 for MGMT promoter-unmethylated glioblastoma (iqr=2.7-8.9). Of the 307 patients, 142 patients showed stable disease, response, or treatment-associated changes and 165 (preliminary) PD at the end of follow-up. A qualitative FLAIR-SI change was found in 61 patients (19.9%) and 44 of these developed (preliminary) PD, with a positive predictive value of 72.1% (95%-CI 59.2-82.9%); positive predictive value was 88.9% for MGMT promoter-unmethylated and 67.4% for MGMT promoter-methylated glioblastoma. We found an overall sensitivity of the FLAIR-SI-change for PD of 26.7% (95%-CI 20.1-34.1%), with ranges of 22.9 to 39.2% depending on MGMT promoter methylation status and treatment allocation; specificity ranged from 88 to 91.3%, with an overall specificity of 88.0% (95%-CI 81.5-92.9%). Median time from first FLAIR-SI to progression was 0 months (iqr=0-2.7) with a range of 0 to 13, and from the brightest signal was 0 months (iqr=0-1.0). The average signal intensity ratio was 10.2 at the time of the brightest signal; further quantitative analyses will be presented. CONCLUSION We confirmed the positive predictive value of a change in FLAIR-signal intensity of the resection cavity for concurrent or subsequent progressive disease in resected glioblastoma. Patients with such a change of the signal intensity should be worked up further on (e.g. PET imaging, biopsy, any clinical change) or else undergo another MRI closely.
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