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Titel: Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG): a phase III clinical study
VerfasserIn: Fleischhack, G.
Massimino, M.
Warmuth-Metz, M.
Khuhlaeva, E.
Janssen, G.
Graf, N.
Rutkowski, S.
Beilken, A.
Schmid, I.
Biassoni, V.
Gorelishev, S. K.
Kramm, C.
Reinhard, H.
Schlegel, P. G.
Kortmann, R.-D.
Reuter, D.
Bach, F.
Iznaga-Escobar, N. E.
Bode, U.
Sprache: Englisch
Titel: Journal of Neuro-Oncology
Bandnummer: 143
Heft: 1
Seiten: 107-113
Verlag/Plattform: Springer Nature
Erscheinungsjahr: 2019
Freie Schlagwörter: Children
DIPG
EGFR
Nimotuzumab
Radiotherapy
Diffuse midline glioma
DDC-Sachgruppe: 610 Medizin, Gesundheit
Dokumenttyp: Journalartikel / Zeitschriftenartikel
Abstract: Background Diffuse intrinsic pontine glioma (DIPG) is a devastating cancer of childhood and adolescence. Methods The study included patients between 3 and 20 years with clinically and radiologically confirmed DIPG. Primary endpoint was 6-month progression-free survival (PFS) following administration of nimotuzumab in combination with external beam radiotherapy (RT). Nimotuzumab was administered intravenously at 150 mg/m2 weekly for 12 weeks. Radiotherapy at total dose of 54 Gy was delivered between week 3 and week 9. Response was evaluated based on clinical features and MRI findings according to RECIST criteria at week 12. Thereafter, patients continued to receive nimotuzumab every alternate week until disease progression/unmanageable toxicity. Adverse events (AE) were evaluated according to Common Terminology Criteria for Adverse Events (CTC-AE) Version 3.0 (CTC-AE3). Results All 42 patients received at least one dose of nimotuzumab in outpatient settings. Two patients had partial response (4.8%), 27 had stable disease (64.3%), 10 had progressive disease (23.8%) and 3 patients (7.1%) could not be evaluated. The objective response rate (ORR) was 4.8%. Median PFS was 5.8 months and median overall survival (OS) was 9.4 months. Most common drug-related AEs were alopecia (14.3%), vomiting, headache and radiation skin injury (7.1% each). Therapy-related serious adverse events (SAEs) were intra-tumoral bleeding and acute respiratory failure, which were difficult to distinguish from effects of tumor progression. Conclusions Concomitant treatment with RT and nimotuzumab was feasible in an outpatient setting. The PFS and OS were comparable to results achieved with RT and intensive chemotherapy in hospitalized setting.
DOI der Erstveröffentlichung: 10.1007/s11060-019-03140-z
URL der Erstveröffentlichung: https://doi.org/10.1007/s11060-019-03140-z
Link zu diesem Datensatz: urn:nbn:de:bsz:291--ds-410290
hdl:20.500.11880/36821
http://dx.doi.org/10.22028/D291-41029
ISSN: 1573-7373
0167-594X
Datum des Eintrags: 10-Nov-2023
Fakultät: M - Medizinische Fakultät
Fachrichtung: M - Pädiatrie
Professur: M - Prof. Dr. Norbert Graf
Sammlung:SciDok - Der Wissenschaftsserver der Universität des Saarlandes

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