Consolidative Thoracic Radiotherapy With Atezolizumab Maintenance in Extensive-Stage Small Cell Lung Cancer: The Phase 2 TREASURE Randomized Clinical Trial (AIO-TRK-0320)

作者：Bozorgmehr F, Chung I, Behnisch R, Weykamp F, Adeberg S, Overbeck T, El Shafie R, Maguire N, Koerber SA, Buchmeier EL, Hammer-Hellmig M, Gauler T, Pöttgen C, Wermke M, Troost EGC, Kokowski K, Röper B, Reinacher-Schick A, Consdorf NS, Ulmer M, Müller AC, Wehler T, Hey-Koch S, Alt J, Stockinger M, Kuon J, Bischof M, Lamprecht B, Geinitz H, Lerchenmüller C, Kriz J, Rauter M, Raunik W, Schmidt B, Stupavsky A, Kropf-Sanchen C, Schmidtke-Schrezenmeier G, Wiegel T, Tufman A, Manapov F, Merling M, Heussel CP, Polke M, Reck M, Al-Batran SE, Thomas M, Christopoulos P, Rieken S · 发表于：JAMA oncology · 年份：2026 · DOI：10.1001/jamaoncol.2026.2330 · 被引用次数：17

IMPORTANCE: Chemoimmunotherapy followed by immunotherapy maintenance is the standard first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), yet data regarding efficacy and safety of consolidative thoracic radiotherapy (TRT) are lacking. OBJECTIVE: To determine whether combining consolidative TRT with immunotherapy maintenance in ES-SCLC is safe and improves patients' overall survival (OS) and progression-free survival (PFS). DESIGN, SETTINGS, AND PARTICIPANTS: This was a multicenter open-label phase 2 randomized clinical trial recruiting patients from September 2020 to August 2022 in Germany and Austria, with the last follow-up visit in September 2024. Eligible patients had ES-SCLC with at least stable disease after induction chemoimmunotherapy (carboplatin-etoposide-atezolizumab). Although the database was locked in April 2025, a post hoc survival update was performed in April 2026. Data were analyzed from April 2025 to April 2026. INTERVENTIONS: Randomized (1:1) to either atezolizumab maintenance combined with consolidative TRT (30 Gy in 10 fractions) (arm A) or atezolizumab maintenance alone (arm B). MAIN OUTCOME AND MEASURE: OS (time from randomization to death due to any cause). RESULTS: Of 96 patients assessed for eligibility, 68 patients were randomized; recruitment was prematurely terminated due to safety concerns. Median OS in the combination arm was numerically shorter compared to atezolizumab only (6.7 months [95% CI, 5.1-9.0] vs 13.4 month...