Advances in radiation oncology. 2020 Oct 7. doi: 10.1016/j.adro.2020.09.018. pii: S2452-1094(20)30267-0. pmc: PMC7718550 |
Evaluation of Prognostic Factors and Role of Participation in a Randomized Trial or a Prospective Registry in Pediatric and Adolescent Nonmetastatic Medulloblastoma - A Report From the HIT 2000 Trial. |
Dietzsch S1, Placzek F2, Pietschmann K3, von Bueren AO4, Matuschek C5, Glück A6, Guckenberger M7, Budach V8, Welzel J9, Pöttgen C10, Schmidberger H11, Heinzelmann F12, Paulsen F13, Escudero MP14, Schwarz R15, Hornung D16, Martini C17, Grosu AL18, Stueben G19, Jablonska K20, Dunst J21, Stranzl-Lawatsch H22, Dieckmann K23, Timmermann B24, Pietsch T25, Warmuth-Metz M26, Bison B27, Kwiecien R28, Benesch M29, Gerber NU30, Grotzer MA31, Pfister SM32, Clifford SC33, von Hoff K34, Klagges S35, Rutkowski S36, Kortmann RD37, Mynarek M38 |
Abstract PURPOSE: We aimed to compare treatment results in and outside of a randomized trial and to confirm factors influencing outcome in a large retrospective cohort of nonmetastatic medulloblastoma treated in Austria, Switzerland and Germany. METHODS AND MATERIALS: Patients with nonmetastatic medulloblastoma (n = 382) aged 4 to 21 years and primary neurosurgical resection between 2001 and 2011 were assessed. Between 2001 and 2006, 176 of these patients (46.1%) were included in the randomized HIT SIOP PNET 4 trial. From 2001 to 2011 an additional 206 patients were registered to the HIT 2000 study center and underwent the identical central review program. Three different radiation therapy protocols were applied. Genetically defined tumor entity (former molecular subgroup) was available for 157 patients. RESULTS: Median follow-up time was 7.3 (range, 0.09-13.86) years. There was no difference between HIT SIOP PNET 4 trial patients and observational patients outside the randomized trial, with 7 years progression-free survival rates (PFS) of 79.5% ± 3.1% versus 78.7% ± 3.1% ( = .62). On univariate analysis, the time interval between surgery and irradiation (≤ 48 days vs ≥ 49 days) showed a strong trend to affect PFS (80.4% ± 2.2% vs 64.6% ± 9.1%; = .052). Furthermore, histologically and genetically defined tumor entities and the extent of postoperative residual tumor influenced PFS. On multivariate analyses, a genetically defined tumor entity wingless-related integration site-activated vs non-wingless-related integration site/non-SHH, group 3 hazard ratio, 5.49; = .014) and time interval between surgery and irradiation (hazard ratio, 2.2; = .018) were confirmed as independent risk factors. CONCLUSIONS: Using a centralized review program and risk-stratified therapy for all patients registered to the study center, outcome was identical for patients with nonmetastatic medulloblastoma treated on and off the randomized HIT SIOP PNET 4 trial. The prognostic values of prolonged time to RT and genetically defined tumor entity were confirmed. |
© 2020 The Authors. |
Publikations ID: 33305077 Quelle: öffnen |