Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG): a phase III clinical study

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. und Bode, U. (2019): Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG): a phase III clinical study. In: Journal of Neuro-Oncology, Bd. 143, Nr. 1: S. 107-113

Abstract

BackgroundDiffuse intrinsic pontine glioma (DIPG) is a devastating cancer of childhood and adolescence.MethodsThe study included patients between 3 and 20years 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 150mg/m(2) weekly for 12weeks. Radiotherapy at total dose of 54Gy 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).ResultsAll 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 5.8months and median overall survival (OS) was 9.4months. 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.ConclusionsConcomitant 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.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0167-594X
• Sprache: Englisch