Article
Prognostic factors concerning progression-free and overall survival in primary glioblastoma – follow up results of a randomized trial
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Published: | June 18, 2018 |
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Objective: In a randomized controlled trial (RCT) the use of an intraoperative MRI (iMRI) led to improved rates of complete tumor removal. Further, tumor removal was associated with longer progression-free survival. However, overall survival (OS) was not addressed in the primary analysis.
Methods: In a prospective, randomized, parallel-group trial, we enrolled adults (≥18 years) with contrast enhancing gliomas amenable to radiologically complete resection who presented to our institution. We randomly assigned patients (1:1) to undergo intraoperative MRI-guided surgery or conventional microsurgery (control group). Analysis was done per protocol. At 5-year follow-up, we performed an analysis of survival data of patients who participated in this trial. This study is registered withClinicalTrials.gov, number NCT01394692.
Results: We analyzed 58 patients enrolled between Oct 1, 2007, and July 1, 2010. 24 (83%) of 29 patients randomly allocated to the intraoperative MRI group and 25 (86%) of 29 controls were eligible for analysis. Overall median OS was 19.2 months. The use of iMRI itself did not affect outcome (560 vs. 624 days, p=0.83). GTR (641 vs. 437 days, p=0.043),MGMTpromotor methylation status (641 vs. 500 days, p=0.028) and tumor recurrence (825 vs. 560 days, p=0.042) were associated with overall survival in a multivariate analysis. In treated for a newly diagnosed primary,MGMTpromotor methylation status (724 vs. 465 days, p=0.028) and GTR (567 vs. 402 days, p=0.045) were identified as prognosticators affecting overall survival.
Conclusion: Our secondary endpoint analysis from an RCT provides evidence that complete resection is an independent prognostic factor in high grade glioma. Use of iMRI helps to achieve a greater extent of resection and thus directly impacts patient outcome.