Surgery and tile-based radiation therapy versus surgery and stereotactic radiation for newly diagnosed brain metastases (ROADS): a randomized, open-label, phase 3 trial.
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Weinberg Jeffrey S, Imber Brandon S, DiNapoli Vincent, Moss Nelson S, Hoang Kimberly B, Wang Fen, Mohiuddin Imran, Mistry Akshitkumar M, Garcia Michael A, Tawbi Hussein, Patel Nitesh V, Pham Huong, Ryan Robert, Wanebo John, Smith Kris, Chen Clark C, Paul Alexandra, Sloan Lindsey, Shepard Matthew J, Tatebe Ken, Shen Colette J, Brachman David G, Richardson Angela M, Evans Linton T, Biedermann Gregory B, Robin Adam, Patel Toral R, Filippidis Aristotelis, Lin Heather, Chambless Lola B, Dombrowski John, Patel Akash J, Chowdhary Sajeel, Lee K Stuart, Peach M Sean, Nowlan Adam, McCracken David J, Floyd John, Xia Fen, Rudnick Jeremy, Li Jing, Yeboa Debra Nana, Lang Frederick F, Kudchadker Rajat J, McAleer Mary Frances, Wefel Jeffrey, Ferguson Sherise Desiree, Yuan Ying, Hanft Simon, Beckham Thomas H
Аннотация
PATIENTS AND METHODS: Across 32 United States centers, patients were pre-operatively randomized 1:1 to resection R+TBRT or R+SRT. Any non-resected brain metastases received SRT post-operatively. Co-primary outcomes were time-to-surgical bed recurrence (SBR) and surgical bed recurrence-free survival (SB-RFS). Outcomes were analyzed using Cox proportional hazards models with stratification factors as covariates. Multiplicity was controlled by hierarchical testing. Analyses used the pre-specified modified intent-to-treat (mITT) population (patients who underwent surgery, had pathologic confirmation of brain metastasis, and had follow-up information).
RESULTS: From April 2021 through August 2025, 230 patients were randomized (115 per arm); 204 of whom (103 R+TBRT, 101 R+SRT) comprised the mITT population. Median follow-up was 12.9 months. Median time-to-SBR was not reached (R+TBRT) versus 17.4 months (R+SRT) (hazard ratio [HR]: 0.06; 95% confidence interval [CI]: 0.01-0.46; p=0.0070). SB-RFS was improved with R+TBRT, with a median of not reached versus 10.9 months (R+SRT) (HR: 0.48; 95% CI: 0.30-0.76; p=0.0021). Overall adverse events did not appear to differ: 83 patients (79.0%, 95% CI: 70.0-86.4) (R+TBRT) versus 67 patients (80.7%, 95% CI:70.6-88.6) (R+SRT).
CONCLUSION: For patients with newly diagnosed brain metastases requiring resection, R+TBRT significantly improved SBR and SB-RFS, demonstrating both non-inferiority and superiority.