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Phase II study of irinotecan in combination with temozolomide (TEMIRI) in children with recurrent or refractory medulloblastoma: a joint ITCC and SIOPE brain tumor study

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Phase II study of irinotecan in combination with temozolomide (TEMIRI) in children with recurrent or refractory medulloblastoma: a joint ITCC and SIOPE brain tumor study

dc.contributor.author	Grill, Jacques	es_ES
dc.contributor.author	Geoerger, Birgit	es_ES
dc.contributor.author	Gesner, Lyle	es_ES
dc.contributor.author	Perek, Danuta	es_ES
dc.contributor.author	Leblond, Pierre	es_ES
dc.contributor.author	Cañete Nieto, Adela	es_ES
dc.contributor.author	Aerts, Isabelle	es_ES
dc.contributor.author	Madero, Luis	es_ES
dc.contributor.author	de Toledo Codina, Josep Sanchez	es_ES
dc.contributor.author	Verlooy, Joris	es_ES
dc.contributor.author	Estlin, Edward	es_ES
dc.contributor.author	Cisar, Laura	es_ES
dc.contributor.author	Breazna, Aurora	es_ES
dc.contributor.author	Dorman, Andrew	es_ES
dc.contributor.author	Bailey, Simon	es_ES
dc.contributor.author	Nicolin, Gary	es_ES
dc.contributor.author	Grundy, Richard G.	es_ES
dc.contributor.author	Hargrave, Darren	es_ES
dc.date.accessioned	2015-06-18T12:29:20Z
dc.date.available	2015-06-18T12:29:20Z
dc.date.issued	2013	es_ES
dc.identifier.uri	http://hdl.handle.net/10550/44467
dc.description.abstract	BackgroundThis multicenter phase II study investigated temozolomide + irinotecan (TEMIRI) treatment in children with relapsed or refractory medulloblastoma.MethodsPatients received temozolomide 100–125 mg/m2/day (days 1–5) and irinotecan 10 mg/m2/day (days 1–5 and 8–12) every 3 weeks. The primary endpoint was tumor response within the first 4 cycles confirmed ≥4 weeks and assessed by an external response review committee (ERRC). In a 2-stage Optimum Simon design, ≥6 responses in the first 15 evaluable patients were required within the first 4 cycles for continued enrollment; a total of 19 responses from the first 46 evaluable patients was considered successful.ResultsSixty-six patients were treated. Seven responses were recorded during stage 1 and 15 in the first 46 ERRC evaluated patients (2 complete responses and 13 partial responses). The objective response rate during the first 4 cycles was 32.6% (95% confidence interval [CI], 19.5%–48.0%). Median duration of response was 27.0 weeks (7.7–44.1 wk). In 63 patients evaluated by local investigators, the objective response rate was 33.3% (95% CI, 22.0%–46.3%), and 68.3% (95% CI, 55.3%–79.4%) experienced clinical benefit. Median survival was 16.7 months (95% CI, 13.3–19.8). The most common grade 3 treatment-related nonhematologic adverse event was diarrhea (7.6%). Grade 3/4 treatment-related hematologic adverse events included neutropenia (16.7%), thrombocytopenia (12.1%), anemia (9.1%), and lymphopenia (9%).ConclusionsThe planned study primary endpoint was not met. However, its tolerability makes TEMIRI a suitable candidate chemotherapy backbone for molecularly targeted agents in future trials in this setting.	es_ES
dc.subject	medulloblastoma	es_ES
dc.subject	temozolomide	es_ES
dc.subject	TEMIRI	es_ES
dc.title	Phase II study of irinotecan in combination with temozolomide (TEMIRI) in children with recurrent or refractory medulloblastoma: a joint ITCC and SIOPE brain tumor study	es_ES
dc.type	journal article	es_ES
dc.identifier.doi	10.1093/neuonc/not097	es_ES
dc.identifier.idgrec	090233	es_ES