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000285006 1001_ $$aPeyrl, Andreas$$b0
000285006 245__ $$aSustained Survival Benefit in Recurrent Medulloblastoma by a Metronomic Antiangiogenic Regimen: A Nonrandomized Controlled Trial.
000285006 260__ $$aChicago, Ill.$$bAmerican Medical Association$$c2023
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000285006 500__ $$a2023 Dec 1;9(12):1688-1695
000285006 520__ $$aMedulloblastoma recurrence in patients who have previously received irradiation has a dismal prognosis and lacks a standard salvage regimen.To evaluate the response rate of pediatric patients with medulloblastoma recurrence using an antiangiogenic metronomic combinatorial approach (Medulloblastoma European Multitarget Metronomic Anti-Angiogenic Trial [MEMMAT]).This phase 2, investigator-initiated, multicenter nonrandomized controlled trial assessed 40 patients with relapsed or refractory medulloblastoma without a ventriculoperitoneal shunt who were younger than 20 years at original diagnosis. Patients were enrolled between April 1, 2014, and March 31, 2021.Treatment consisted of daily oral thalidomide, fenofibrate, celecoxib, and alternating 21-day cycles of low-dose (metronomic) oral etoposide and cyclophosphamide, supplemented by intravenous bevacizumab and intraventricular therapy consisting of alternating etoposide and cytarabine.The primary end point was response after 6 months of antiangiogenic metronomic therapy. Secondary end points included progression-free survival (PFS), overall survival (OS), and quality of life. Adverse events were monitored to assess safety.Of the 40 patients (median [range] age at treatment start, 10 [4-17] years; 25 [62.5%] male) prospectively enrolled, 23 (57.5%) achieved disease control after 6 months of treatment, with a response detected in 18 patients (45.0%). Median OS was 25.5 months (range, 10.9-40.0 months), and median PFS was 8.5 months (range, 1.7-15.4 months). Mean (SD) PFS at both 3 and 5 years was 24.6% (7.9%), while mean (SD) OS at 3 and 5 years was 43.6% (8.5%) and 22.6% (8.8%), respectively. No significant differences in PFS or OS were evident based on molecular subgroup analysis or the number of prior recurrences. In patients demonstrating a response, mean (SD) overall 5-year PFS was 49.7% (14.3%), and for patients who remained progression free for the first 12 months of treatment, mean (SD) 5-year PFS was 66.7% (16.1%). Treatment was generally well tolerated. Grade 3 to 4 treatment-related adverse events included myelosuppression, infections, seizures, and headaches. One heavily pretreated patient with a third recurrence died of secondary acute myeloid leukemia.This feasible and well-tolerated MEMMAT combination regimen demonstrated promising activity in patients with previously irradiated recurrent medulloblastoma. Given these results, this predominantly oral, well-tolerated, and outpatient treatment warrants further evaluation.ClinicalTrials.gov Identifier: NCT01356290.
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000285006 7001_ $$aChocholous, Monika$$b1
000285006 7001_ $$aSabel, Magnus$$b2
000285006 7001_ $$aLassaletta, Alvaro$$b3
000285006 7001_ $$aSterba, Jaroslav$$b4
000285006 7001_ $$aLeblond, Pierre$$b5
000285006 7001_ $$aNysom, Karsten$$b6
000285006 7001_ $$aTorsvik, Ingrid$$b7
000285006 7001_ $$aChi, Susan N$$b8
000285006 7001_ $$aPerwein, Thomas$$b9
000285006 7001_ $$aJones, Neil$$b10
000285006 7001_ $$aHolm, Stefan$$b11
000285006 7001_ $$aNyman, Per$$b12
000285006 7001_ $$aMörse, Helena$$b13
000285006 7001_ $$aÖberg, Anders$$b14
000285006 7001_ $$aWeiler-Wichtl, Liesa$$b15
000285006 7001_ $$aLeiss, Ulrike$$b16
000285006 7001_ $$aHaberler, Christine$$b17
000285006 7001_ $$aSchmook, Maresa T$$b18
000285006 7001_ $$aMayr, Lisa$$b19
000285006 7001_ $$aDieckmann, Karin$$b20
000285006 7001_ $$0P:(DE-He78)4c28e2aade5f44d8eca9dd8e97638ec8$$aKool, Marcel$$b21$$udkfz
000285006 7001_ $$aGojo, Johannes$$b22
000285006 7001_ $$aAzizi, Amedeo A$$b23
000285006 7001_ $$aAndré, Nicolas$$b24
000285006 7001_ $$aKieran, Mark$$b25
000285006 7001_ $$aSlavc, Irene$$b26
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