Angiotensin II receptor blockers, steroids and radiotherapy in glioblastoma—a randomised multicentre trial (ASTER trial). An ANOCEF study

Autor: F. Sejalon, J.-J. Portal, M. Charissoux, D. Psimaras, R Ursu, E. Le Rhun, S Cuzzubbo, A F Carpentier, Luc Thomas, Annick Tibi, Eric Vicaut, Véronique Quillien, François Ducray, Damien Ricard, Khê Hoang-Xuan, Emmanuel Mandonnet, C. Levy-Piedbois, O. L. Chinot
Přispěvatelé: Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7), Hospices Civils de Lyon (HCL), Aix Marseille Université (AMU), Université de Lille, Sciences et Technologies, Université Montpellier 2 - Sciences et Techniques (UM2), Université de Rennes (UR), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Imagerie et Modélisation en Neurobiologie et Cancérologie (IMNC (UMR_8165)), Université Paris-Sud - Paris 11 (UP11)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Université Paris Diderot - Paris 7 (UPD7)-Centre National de la Recherche Scientifique (CNRS), Assistance Publique–Hôpitaux de Paris, Programme Hospitalier de Recherche Clinique—PHRC, BMS, Abbvie, Association Oligocyte, Association pour le développement des neurosciences à Avicenne, Ministère de la Santé, Mundipharma, Amgen, Novartis, Hoffman-la Roche, UCB Pharma, GSK, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: European Journal of Cancer
European Journal of Cancer, 2019, 109, pp.129-136. ⟨10.1016/j.ejca.2018.12.025⟩
European Journal of Cancer, Elsevier, 2019, 109, pp.129-136. ⟨10.1016/j.ejca.2018.12.025⟩
Eur.J.Cancer
Eur.J.Cancer, 2019, 109, pp.129-136. ⟨10.1016/j.ejca.2018.12.025⟩
ISSN: 0959-8049
DOI: 10.1016/j.ejca.2018.12.025⟩
Popis: Background Glioblastomas (GBMs) induce a peritumoural vasogenic oedema impairing functional status and quality of life. Steroids reduce brain tumour–related oedema but are associated with numerous side-effects. It was reported in a retrospective series that angiotensin receptor blockers might be associated with reduced peritumoural oedema. The ASTER study is a randomised, placebo-controlled trial to assess whether or not the addition of Losartan to standard of care (SOC) can reduce steroid requirement during radiotherapy (RT) in patients with newly diagnosed GBM. Patients and methods Patients with a histologically confirmed GBM after biopsy or partial surgical resection were randomised between Losartan or placebo in addition to SOC with RT and temozolomide (TMZ). The primary objective was to investigate the steroid dosage required to control brain oedema on the last day of RT in each arm. The secondary outcomes were steroids dosage 1 month after the end of RT, assessment of cerebral oedema on magnetic resonance imaging, tolerance and survival. Results Seventy-five patients were randomly assigned to receive Losartan (37 patients) or placebo (38 patients). No difference in the steroid dosage required to control brain oedema on the last day of RT, or one month after completion of RT, was seen between both arms. The incidence of adverse events was similar in both arms. Median overall survival was similar in both arms. Conclusions Losartan, although well tolerated, does not reduce the steroid requirement in newly diagnosed GBM patients treated with concomitant RT and TMZ. Trial registration number NCT01805453 with ClinicalTrials.gov.
Databáze: OpenAIRE
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