Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
Dose Escalation with Intensity-Modulated Proton Therapy for Patients with High-Risk Meningiomas - Results from a Phase I Trial.
СтатьяКлиническое исследование I фазыНазвание и аннотация: Перевод в очереди
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Ehret Felix, Horick Nora K, Yeap Beow Y, Curry William T, Nahed Brian, Daartz Juliane, Johnson Jason M, Dagher Samir A, Raza Shaan M, DeMonte Franco, Yeboa Debra N, Swanson Todd A, McAleer Mary Frances, Leland Peggy, McGovern Susan L, Shih Helen A
Аннотация
PURPOSE: Outcomes for grade 2 and 3 meningiomas are poor. A few studies suggest a benefit from radiotherapy dose escalation. This trial evaluates the safety and efficacy of dose escalation with intensity-modulated proton therapy (IMPT) for grade 2 and 3 meningiomas.
PATIENTS AND METHODS: This prospective single-arm phase I trial enrolled patients with grade 2 meningioma with residual disease or recurrence or patients with grade 3 meningioma after gross total resection. Patients underwent dose-escalated IMPT to 66 Gy relative biological effectiveness [Gy(RBE)] for grade 2 gross disease and 63 Gy(RBE) for grade 3 tumor beds. The primary endpoint was acute dose-limiting toxicity (DLT). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and late toxicity.
RESULTS: Twenty-one patients with 16 grade 2 and 5 grade 3 meningiomas were enrolled and treated between 2016 and 2023. The median clinical and radiographic follow-up periods were 3.4 and 3.2 years, respectively. No DLT was observed. Five new late grade 3 toxicities occurred in four patients. Three treatment failures were observed in two grade 2 and one grade 3 tumors. Two deaths occurred in patients with grade 2 meningiomas. The 1-, 2-, and 3-year PFS rates were 100%, 95%, and 88.2%, respectively. The corresponding OS rates were 100%, 95%, and 95%, respectively.
CONCLUSIONS: This first prospective trial investigating dose-escalated IMPT for high-grade meningiomas demonstrated a favorable early safety profile and clinical outcomes. Phase II and III studies are warranted to confirm the superiority of dose escalation for high-grade meningiomas.
PATIENTS AND METHODS: This prospective single-arm phase I trial enrolled patients with grade 2 meningioma with residual disease or recurrence or patients with grade 3 meningioma after gross total resection. Patients underwent dose-escalated IMPT to 66 Gy relative biological effectiveness [Gy(RBE)] for grade 2 gross disease and 63 Gy(RBE) for grade 3 tumor beds. The primary endpoint was acute dose-limiting toxicity (DLT). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and late toxicity.
RESULTS: Twenty-one patients with 16 grade 2 and 5 grade 3 meningiomas were enrolled and treated between 2016 and 2023. The median clinical and radiographic follow-up periods were 3.4 and 3.2 years, respectively. No DLT was observed. Five new late grade 3 toxicities occurred in four patients. Three treatment failures were observed in two grade 2 and one grade 3 tumors. Two deaths occurred in patients with grade 2 meningiomas. The 1-, 2-, and 3-year PFS rates were 100%, 95%, and 88.2%, respectively. The corresponding OS rates were 100%, 95%, and 95%, respectively.
CONCLUSIONS: This first prospective trial investigating dose-escalated IMPT for high-grade meningiomas demonstrated a favorable early safety profile and clinical outcomes. Phase II and III studies are warranted to confirm the superiority of dose escalation for high-grade meningiomas.