CNS
Adjuvant RT vs observation after GTR of grade 2 meningioma: the trial informs the omission-vs-addition decision directly, with 8% G2-3 RT-related SAEs.
ROAM/EORTC-1308
ForNewly diagnosed WHO grade 2 atypical meningioma after Simpson I–III resection
HR 0.51
95% CI 0.27–0.97, p=0.0396
TL;DRAdjuvant IMRT 60 Gy/30 fx vs observation after complete resection of WHO grade 2 atypical meningioma: DFS HR 0.51 (0.27–0.97); 5-yr DFS 79.9% vs 64.3%.
The RT effect is probably understated: 12 of 78 assigned pts never started RT, and DFS counts out-of-field and new meningiomas that a 5–10 mm CTV was never aimed at. The planned patterns-of-failure analysis will decide whether dural margins can tighten under modern IGRT, which is the next dosimetric question once adjuvant RT is adopted.
For a newly diagnosed WHO grade 2 atypical meningioma after surgeon-assessed Simpson I–III resection, this supports adjuvant fractionated RT over observation when recurrence prevention is the priority; it does not address subtotal resection, NF2, multiple or radiation-induced meningiomas. The longer read
IMRT 60 Gy/30 fx to a 5–10 mm CTV halved the DFS hazard (HR 0.51) with no G3+ AEs among RT-related events and one G2 necrosis. The pending patterns-of-failure analysis decides whether dural margins can tighten.
Surgeon-assessed Simpson I–III resection without early postop MRI still left 30% recurrence under observation at 64 mo. GTR alone is not definitive for atypical meningioma; authors suggest observation mainly where re-resection is easy, such as convexity tumours.
10 details 1 trial watching
International open-label phase 3 RCT, 1:1, 58 hospitals in 11 countries, stratified UK vs non-UK. N=157 randomised from 990 screened; median follow-up 64 mo.
Age ≥16, newly diagnosed atypical meningioma after surgeon-assessed GTR (Simpson I–III), WHO PS ≤2, able to start RT within 12 weeks. Excluded NF2, multiple or radiation-induced meningiomas, optic nerve sheath tumours.
IMRT 60 Gy in 30 fx over 6 weeks, median 2.50 mo from surgery. CTV 5–10 mm isotropic from GTV plus 3–5 mm PTV, with prospective central plan review before treatment.
Primary: DFS, surgery to MRI-confirmed recurrence or death. Secondary: HRQoL, neurocognition (UK/Ireland), time to second-line treatment, OS, cost-effectiveness.
Early RT-related AEs in 30 (45%), all G1-2; late in 17 (26%). G2 or 3 RT-related SAEs 5 (8%), including one G2 radiation necrosis and one G2 optic neuritis; no treatment-related deaths.
Before this, evidence was retrospective series and two non-randomised phase 2 cohorts reporting 3-yr PFS 88.7% (60 Gy/30 fx) and 93.8% (54 Gy/30 fx). NRG BN003 asks the same randomised question and will be the replication test.
No central pathology review (5 pts would now be grade 3) and no mandated early postop MRI. HRQoL data fell to 38% at 5 years and neurocognition was UK/Ireland-only with ~45% missing by 24 mo, so the null QoL and cognitive findings are weak.
With 70% of observed pts recurrence-free at 5 years, the result supports offering RT rather than mandating it. Methylation class stratifies risk but did not erase the RT effect, so it cannot yet select who to observe.
| Endpoint | Radiotherapy (n=78) | Observation (n=79) | Effect |
|---|---|---|---|
| Meningioma recurrence | 11 (14%) | 24 (30%) | n/a |
| 5-yr DFS | 79.9% (67.6–87.9) | 64.3% (51.9–74.2) | Diff 15.6 pp (0.6–30.5) |
| DFS, ITT | n/a | n/a | HR 0.51 (0.27–0.97), p=0.0396 |
| DFS, as-treated | 10/66 (15%) recurred | 25/91 (27%) recurred | HR 0.54 (0.28–1.04), p=0.0642 |
| Deaths | 7 (9%) | 6 (8%) | 5-yr OS OR 0.91 (0.27–3.05) |
| Second-line treatment | 8 (10%) | 16 (20%) | n/a |
CONSORT flow
First randomised evidence and primary DFS met, but accrual closed at 41 of 46 planned events, CI upper bound 0.97, and recurrence was read locally without masking.
- Do patterns of failure support tighter dural margins?
- Can methylation class identify pts safe to observe? n=210 · primary completion 2026-03 · DNA methylation signature for recurrence after GTR
- Is adjuvant RT cost-effective vs active monitoring?