Colin Kennedy1, Kim Bull2, Mathilde Chevignard3, David Culliford2, Helmuth G Dörr4, François Doz5, Rolf-Dieter Kortmann6, Birgitta Lannering7, Maura Massimino8, Aurora Navajas Gutiérrez9, Stefan Rutkowski10, Helen A Spoudeas11, Gabriele Calaminus12. 1. University of Southampton Faculty of Medicine and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom. Electronic address: crk1@soton.ac.uk. 2. University of Southampton Faculty of Medicine and University Hospital Southampton National Health Service Foundation Trust, Southampton, United Kingdom. 3. Hôpitaux de Saint Maurice, Saint Maurice, France; Neurophysiology, University of Pierre et Marie-Curie Paris 6, Paris, France. 4. Kinder- und Jugendklinik der Universität Erlangen, Erlangen, Germany. 5. Institut Curie and University Paris Descartes, Sorbonne Paris Cité, France. 6. Department of Radiation Therapy, University of Leipzig, Leipzig, Germany. 7. Department of Pediatrics, The Sahlgren Academy, University of Gothenburg, Gothenburg, Sweden. 8. Fondazione Istituto di Ricovero e Cura a Carattere Scientifico IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 9. Hospital Universitario Cruces, Baracaldo-Vizcaya, Spain. 10. University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 11. Center for Pediatric Endocrinology, University College London, London, United Kingdom. 12. Pediatric Oncology, University of Muenster, Muenster, Germany.
Abstract
PURPOSE: To compare quality of survival in "standard-risk" medulloblastoma after hyperfractionated radiation therapy of the central nervous system with that after standard radiation therapy, combined with a chemotherapy regimen common to both treatment arms, in the PNET4 randomised controlled trial. METHODS AND MATERIALS: Participants in the PNET4 trial and their parents/caregivers in 7 participating anonymized countries completed standardized questionnaires in their own language on executive function, health status, behavior, health-related quality of life, and medical, educational, employment, and social information. Pre- and postoperative neurologic status and serial heights and weights were also recorded. RESULTS: Data were provided by 151 of 244 eligible survivors (62%) at a median age at assessment of 15.2 years and median interval from diagnosis of 5.8 years. Compared with standard radiation therapy, hyperfractionated radiation therapy was associated with lower (ie, better) z-scores for executive function in all participants (mean intergroup difference 0.48 SDs, 95% confidence interval 0.16-0.81, P=.004), but health status, behavioral difficulties, and health-related quality of life z-scores were similar in the 2 treatment arms. Data on hearing impairment were equivocal. Hyperfractionated radiation therapy was also associated with greater decrement in height z-scores (mean intergroup difference 0.43 SDs, 95% confidence interval 0.10-0.76, P=.011). CONCLUSIONS:Hyperfractionated radiation therapy was associated with better executive function and worse growth but without accompanying change in health status, behavior, or quality of life.
RCT Entities:
PURPOSE: To compare quality of survival in "standard-risk" medulloblastoma after hyperfractionated radiation therapy of the central nervous system with that after standard radiation therapy, combined with a chemotherapy regimen common to both treatment arms, in the PNET4 randomised controlled trial. METHODS AND MATERIALS: Participants in the PNET4 trial and their parents/caregivers in 7 participating anonymized countries completed standardized questionnaires in their own language on executive function, health status, behavior, health-related quality of life, and medical, educational, employment, and social information. Pre- and postoperative neurologic status and serial heights and weights were also recorded. RESULTS: Data were provided by 151 of 244 eligible survivors (62%) at a median age at assessment of 15.2 years and median interval from diagnosis of 5.8 years. Compared with standard radiation therapy, hyperfractionated radiation therapy was associated with lower (ie, better) z-scores for executive function in all participants (mean intergroup difference 0.48 SDs, 95% confidence interval 0.16-0.81, P=.004), but health status, behavioral difficulties, and health-related quality of life z-scores were similar in the 2 treatment arms. Data on hearing impairment were equivocal. Hyperfractionated radiation therapy was also associated with greater decrement in height z-scores (mean intergroup difference 0.43 SDs, 95% confidence interval 0.10-0.76, P=.011). CONCLUSIONS: Hyperfractionated radiation therapy was associated with better executive function and worse growth but without accompanying change in health status, behavior, or quality of life.
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Authors: Vijay Ramaswamy; Marc Remke; Eric Bouffet; Simon Bailey; Steven C Clifford; Francois Doz; Marcel Kool; Christelle Dufour; Gilles Vassal; Till Milde; Olaf Witt; Katja von Hoff; Torsten Pietsch; Paul A Northcott; Amar Gajjar; Giles W Robinson; Laetitia Padovani; Nicolas André; Maura Massimino; Barry Pizer; Roger Packer; Stefan Rutkowski; Stefan M Pfister; Michael D Taylor; Scott L Pomeroy Journal: Acta Neuropathol Date: 2016-04-04 Impact factor: 17.088