Adjuvant Radiotherapy Reduced Recurrence in Resected Atypical Meningioma

Adjuvant fractionated radiotherapy significantly improved disease-free survival (DFS) vs observation in patients with newly diagnosed World Health Organization (WHO) grade 2 atypical meningioma who had undergone complete surgical resection, according to findings from the phase 3 ROAM/EORTC-1308 trial (ISRCTN71502099) published in The Lancet. The study is the first randomized controlled trial to compare adjuvant radiotherapy with observation in this population.

What were the efficacy results from ROAM/EORTC-1308?

Among 157 randomly assigned patients, 78 of whom received radiotherapy vs 79 who underwent observation, meningioma recurrence occurred in 11 patients (14%) in the radiotherapy arm and 24 patients (30%) in the observation arm at a median follow-up of 64 months (IQR, 50-75). The 5-year DFS rate was 79.9% (95% CI, 67.6%-87.9%) with radiotherapy vs 64.3% (95% CI, 51.9%-74.2%) with observation, an absolute difference of 15.6 percentage points (95% CI, 0.6-30.5). DFS was improved in the intention-to-treat population (HR, 0.51; 95% CI, 0.27-0.97; P = .0396).

There were 13 deaths overall, 7 in the radiotherapy arm and 6 in the observation arm; no deaths were deemed to be treatment-related. No between-group difference in 5-year overall survival was observed (OR, 0.91; 95% CI, 0.27-3.05).

Fewer patients in the radiotherapy arm required second-line treatment for recurrence (10% vs 20%). The median time to second-line treatment was similar in the 2 groups, at 62.56 months (95% CI, 59.21-65.90) in the radiotherapy group and 55.3 months (95% CI, 49.69-56.92) in the observation group.

How was the ROAM/EORTC-1308 trial designed?

The open-label trial was conducted at 58 hospitals and academic centers in 11 countries. Eligible patients were 16 years or older with histologically confirmed, newly diagnosed atypical meningioma with a surgeon-assessed Simpson grade I to III gross total resection and a WHO performance status of 2 or less. Those with neurofibromatosis type 2, multiple or radiotherapy-induced meningiomas, optic nerve sheath tumors, previous intracranial tumors, or active second malignancy were excluded from trial participation.

Patients were randomly assigned 1:1 to intensity-modulated radiotherapy at a total dose of 60 Gy in 30 fractions over 6 weeks or to observation. The primary end point was DFS, defined as time from surgery to MRI-confirmed meningioma recurrence or death from any cause. Of the 78 patients assigned to radiotherapy, 12 did not receive it.

What were the safety and quality-of-life findings?

In the as-treated population, adverse events (AEs) occurred in 71% of the radiotherapy group and 46% of the observation group. In the radiotherapy group, early radiation-related AEs occurred in 45% of patients; late radiation-related AEs occurred in 26%. A total of 25 serious AEs were reported by 20% of patients in the radiotherapy group. In the observation group, 6 serious AEs were reported by 10% of patients.

Health-related quality of life was broadly similar between arms, and no clear between-group differences in neurocognitive function were detected.

What did the exploratory molecular analyses show?

Tumor tissue for molecular analysis was available for 132 patients (84%). In post hoc analyses, the DFS benefit with radiotherapy persisted after adjustments. For methylation class-benign vs methylation class-intermediate or -malignant tumors, the HR was 0.49 (95% CI, 0.25-0.95; P = .0358). When sorted by integrated molecular score of low vs intermediate or high, the HR was 0.46 (95% CI, 0.23-0.88; P = .0203).

What do the study authors conclude?

“To our knowledge, the ROAM/EORTC-1308 study is the first prospective, randomised study of patients with atypical meningioma worldwide and provides the strongest available evidence for management after surgeon-assessed complete resection,” the study authors wrote. “Adjuvant fractionated radiotherapy halves the risk of recurrence, regardless of methylation class, and with minimal late toxicity.”¹

The authors noted that a similar US randomized trial, NRG BN003 (NCT03180268), is due to complete recruitment in 2027 but will not report until the 2030s. In the interim, they wrote that decisions should be based on individual discussion with each patient.

References

Jenkinson MD, Rosala-Hallas A, Sahm F, et al. Radiotherapy versus observation following surgical resection of WHO grade 2 atypical meningioma (ROAM/EORTC-1308): an international, multicentre, open-label, phase 3, randomised controlled trial. Lancet. 2026;408(10549):1473-1484. doi:10.1016/S0140-6736(26)01804-0