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Clinical Trial
. 2020 Mar 15;106(4):790-799.
doi: 10.1016/j.ijrobp.2019.11.028. Epub 2019 Nov 29.

High-risk Meningioma: Initial Outcomes From NRG Oncology/RTOG 0539

Affiliations
Clinical Trial

High-risk Meningioma: Initial Outcomes From NRG Oncology/RTOG 0539

C Leland Rogers et al. Int J Radiat Oncol Biol Phys. .

Abstract

Background: Phase 2 cooperative group meningioma trial assessing the safety and efficacy of risk-adaptive management strategies. This is the initial analysis of the high-risk cohort.

Methods and materials: High-risk patients were those with a new or recurrent World Health Organization (WHO) grade III meningioma of any resection extent, recurrent WHO grade II of any resection extent, or new WHO grade II after subtotal resection. Patients received intensity-modulated radiotherapy (IMRT) using a simultaneous integrated boost technique (60 Gy high dose and 54 Gy low dose in 30 fractions). Three-year progression-free survival (PFS) was the primary endpoint. Adverse events (AEs) were scored per NCI Common Terminology Criteria for Adverse Events version 3.

Results: Of 57 enrolled patients, 53 received protocol treatment. Median follow-up was 4.0 years (4.8 years for living patients). Two patients withdrew without progression before year 3; for the remaining 51 patients, 3-year PFS was 58.8%. Among all 53 protocol-treated patients, 3-year PFS was 59.2%. Three-year local control was 68.9%, and overall survival was 78.6%. Of 51 patients, 1 patient (1.9%) experienced a late grade-5 necrosis-related AE. All other acute (23 of 53 patients) and late (21 of 51 patients) AEs were grades 1 to 3.

Conclusions: Patients with high-risk meningioma treated with IMRT (60 Gy/30) experienced 3-year PFS of 58.8%. Combined acute and late AEs were limited to grades 1 to 3, except for a single necrosis-related grade 5 event. These results support postoperative IMRT for high-risk meningioma and invite ongoing investigations to improve outcomes further.

Trial registration: ClinicalTrials.gov NCT00895622.

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Figures

Fig. 1.
Fig. 1.
(A) Schema for the protocol and (B) CONSORT diagram for high-risk meningioma patients (group 3). Abbreviations: FU = follow-up; GTR = gross-total resection; PFS = progression-free survival; STR = subtotal resection. Figure 1A is modified from Rogers et al. Used with permission from Journal of Neurosurgery. Figure 1B is used with permission from NRG Oncology.
Fig. 2.
Fig. 2.
(A) Progression-free survival (PFS) and (B) time to progression for the 53 patients at high risk receiving protocol-specified treatment. The numbers accompanying each curve show annual actuarial values, from 1 to 5 years after study registration. For PFS, progression or death are considered events. Used with permission from NRG Oncology.
Fig. 3.
Fig. 3.
Overall survival for the 53 patients at high risk receiving protocol-specified treatment. The numbers accompanying the curve are annual actuarial results, from 1 to 5 years after study registration. Eighteen deaths were observed at the time of analysis. Used with permission from NRG Oncology.
Fig. 4.
Fig. 4.
Time to progression comparing patients with recurrent World Health Organization (WHO) grade II to those with initially diagnosed WHO grade III meningioma. The percentages accompanying the curves are annual actuarial results, from 1 to 5 years after study registration. Used with permission from NRG Oncology.
Fig. 5.
Fig. 5.
(A) Progression-free survival (PFS) comparing patients with recurrent versus newly diagnosed World Health Organization (WHO) grade III and (B) recurrent versus subtotally resected (STR), newly diagnosed WHO grade II meningioma. The percentages accompanying the curves are actuarial. For PFS, progression or death are considered events. No formal testing was performed in these subgroups because of the small sample size. Used with permission from NRG Oncology.

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