Abstract
Background
ACRIN 6686/RTOG 0825 was a phase III trial of conventional chemoradiation plus adjuvant temozolomide with bevacizumab or without (placebo) in newly diagnosed glioblastoma. This study investigated whether changes in contrast-enhancing and FLAIR-hyperintense tumor assessed by central reading prognosticate overall survival (OS). Methods
284 patients (171 men; median age 57 years, range 19-79; 159 on bevacizumab) had MRI at post-op (baseline) and pre-cycle 4 of adjuvant temozolomide (22 weeks post- chemoradiation initiation). Four central readers measured bi-dimensional lesion enhancement (2D-T1) and FLAIR hyperintensity at both time points. Changes from baseline to pre-cycle 4 for both markers were dichotomized (increasing versus non-increasing). Cox proportional hazards model and Kaplan-Meier survival estimates were used for inference. Results
Adjusting for treatment, increasing 2D-T1 (n=262, HR=2.07 [95% CI 1.48-2.91], p<0.0001) and FLAIR (n=273, HR=1.75 [1.26-2.41], p=0.0008) significantly predicted worse OS. Median OS (days) was significantly shorter for patients with increasing versus non-increasing 2D-T1 for both bevacizumab (443 vs. 535, p=0.004) and placebo (526 vs. 887, p=0.001). Median OS was significantly shorter for patients with increasing versus non-increasing FLAIR for placebo (595 vs. 872, p=0.001), and trended similarly for bevacizumab (499 vs. 535, p=0.0935). Adjusting for 2D-T1 and treatment, increasing FLAIR represented significantly higher risk for death (HR=1.59 [1.11-2.26], p=0.01). Conclusions
Increased 2D-T1 significantly predicts worse OS in both treatment groups, implying absence of a substantial proportion of pseudoprogression 22 weeks after initiation of standard therapy. FLAIR adds value beyond 2D-T1 in predicting OS, potentially addressing the pseudoresponse effect by sub-stratifying bevacizumab-treated patients with non-increasing 2D-T1.
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