Oncology · 3 h ago
Phase 2 STEP Trial Reports High Local Control With Preoperative SRT for Brain Metastases
In the single-arm, multicenter phase 2 STEP trial, 63 adults with resectable brain metastases received three-fraction preoperative stereotactic radiotherapy (SRT) followed by surgery. Six-month local control was 100%, with a 7% one-year incidence of radiation necrosis; randomized trials are still needed to establish the approach’s role.
- Six-month local control was 100% in the treated cohort.
- One-year radiation necrosis incidence was 7%.
- No leptomeningeal disease was reported.
- Randomized trials are needed to define clinical use.
Postoperative stereotactic radiotherapy is standard after resection of brain metastases, but treatment planning can be delayed while the surgical cavity changes. The open-label, single-arm, multicenter phase 2 STEP trial evaluated preoperative SRT in adults with up to four brain metastases, including one resectable lesion no larger than 5 cm. Patients received three fractions of 7.7 Gy, followed by resection within three days of the final fraction. Of 67 eligible patients, 63 received both treatments; median age was 62 years. The primary endpoint was centrally reviewed local control at six months.
At a median follow-up of 12.7 months, six-month local control was 100% (95% CI, 95%–100%); the 12-month rate was 96.4% (95% CI, 87%–99%). No leptomeningeal disease was reported. The one-year cumulative incidence of radiation necrosis at the treated lesion was 7% (95% CI, 2%–16%). Distant intracranial failure occurred in 22 patients (35%), and 12-month overall survival was 81.2%. Postoperative complications occurred in four patients (6.3%); cognition and quality of life remained stable during protocol follow-up.
These findings support further evaluation of preoperative SRT, but the single-arm phase 2 design and limited follow-up do not establish superiority over postoperative SRT or justify changing practice. The authors note that randomized trials are ongoing.
In practice
For adults with resectable brain metastases meeting the STEP eligibility criteria, preoperative three-fraction SRT followed by surgery was associated with high local control and a low reported incidence of radiation necrosis in a phase 2 study. These results make the approach a candidate for further comparison with postoperative SRT, but the trial was single-arm, included 63 treated patients, and had a median follow-up of 12.7 months. It does not establish comparative benefit or support changing current practice; randomized trials are needed.
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Neuro-Oncology: Three-fraction preoperative stereotactic radiotherapy for resectable brain metastases: the phase 2 STEP trial ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.