G Fleischhack1,2, M Massimino3, M Warmuth-Metz4, E Khuhlaeva5, G Janssen6, N Graf7, S Rutkowski8,9, A Beilken10, I Schmid11, V Biassoni3, S K Gorelishev5, C Kramm6,12, H Reinhard7,13, P G Schlegel8, R-D Kortmann14, D Reuter15, F Bach15, N E Iznaga-Escobar16, U Bode17. 1. Paediatric Haematology and Oncology, Paediatrics III, University Hospital of Essen, 45122, Essen, Germany. gudrun.fleischhack@uk-essen.de. 2. Department of Paediatric Haematology/Oncology, Children Medical Hospital, University of Bonn, 53113, Bonn, Germany. gudrun.fleischhack@uk-essen.de. 3. Paediatric Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133, Milano, Italy. 4. Department of Neuroradiology, University of Wuerzburg, 97080, Würzburg, Germany. 5. Paediatric Neurosurgical Department, Burdenko Neurosurgical Institute, Moscow, 125047, Russia. 6. Department of Paediatric Haematology/Oncology, Children's Medical Hospital, University of Duesseldorf, 40225, Düsseldorf, Germany. 7. Department of Paediatric Haematology/Oncology, Saarland University, 66421, Homburg/Saar, Germany. 8. Department of Paediatric Hematology/Oncology, University of Wuerzburg, University Children's Hospital, 97080, Wuerzburg, Germany. 9. Department of Paediatric Haematology and Oncology, University Medical Center Hamburg-Eppendorf, 20246, Hamburg, Germany. 10. Department of Paediatric Haematology/Oncology, Medical School, Children's Medical Hospital, 30625, Hannover, Germany. 11. Department of Paediatric Haematology/Oncology, Children's Medical Hospital, University of Munich, 80337, Munich, Germany. 12. Division of Paediatric Haematology and Oncology, Department of Child and Adolescent Health, University Medical Center Göttingen, 37075, Göttingen, Germany. 13. Paediatric Haematology and Oncology, Asklepios Hospital, 53757, Sankt Augustin, Germany. 14. Department of RT and Radiooncology, University of Leipzig, 04103, Leipzig, Germany. 15. Oncoscience GmbH, 22869, Schenefeld, Germany. 16. Center of Molecular Immunology, Havana, Cuba. 17. Department of Paediatric Haematology/Oncology, Children Medical Hospital, University of Bonn, 53113, Bonn, Germany.
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.
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.
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