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Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG)

Standard

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; Bode, U.

in: J NEURO-ONCOL, Jahrgang 143, Nr. 1, 05.2019, S. 107-113.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Fleischhack, G, Massimino, M, Warmuth-Metz, M, Khuhlaeva, E, Janssen, G, Graf, N, Rutkowski, S, Beilken, A, Schmid, I, Biassoni, V, Gorelishev, SK, Kramm, C, Reinhard, H, Schlegel, PG, Kortmann, R-D, Reuter, D, Bach, F, Iznaga-Escobar, NE & Bode, U 2019, 'Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG): a phase III clinical study', J NEURO-ONCOL, Jg. 143, Nr. 1, S. 107-113. https://doi.org/10.1007/s11060-019-03140-z

APA

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. (2019). Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG): a phase III clinical study. J NEURO-ONCOL, 143(1), 107-113. https://doi.org/10.1007/s11060-019-03140-z

Vancouver

Fleischhack G, Massimino M, Warmuth-Metz M, Khuhlaeva E, Janssen G, Graf N et al. Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG): a phase III clinical study. J NEURO-ONCOL. 2019 Mai;143(1):107-113. https://doi.org/10.1007/s11060-019-03140-z

Bibtex

@article{f3bfe3073ef44c7cbd64906c4ef2d15f,
title = "Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG): a phase III clinical study",
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.",
keywords = "Adolescent, Antibodies, Monoclonal, Humanized/adverse effects, Antineoplastic Agents, Immunological/adverse effects, Brain Stem Neoplasms/diagnostic imaging, Chemoradiotherapy/adverse effects, Child, Child, Preschool, Disease Progression, Female, Glioma/diagnostic imaging, Humans, Male, Pons, Survival Analysis, Treatment Outcome, Young Adult",
author = "G Fleischhack and M Massimino and M Warmuth-Metz and E Khuhlaeva and G Janssen and N Graf and S Rutkowski and A Beilken and I Schmid and V Biassoni and Gorelishev, {S K} and C Kramm and H Reinhard and Schlegel, {P G} and R-D Kortmann and D Reuter and F Bach and Iznaga-Escobar, {N E} and U Bode",
year = "2019",
month = may,
doi = "10.1007/s11060-019-03140-z",
language = "English",
volume = "143",
pages = "107--113",
journal = "J NEURO-ONCOL",
issn = "0167-594X",
publisher = "Kluwer Academic Publishers",
number = "1",

}

RIS

TY - JOUR

T1 - Nimotuzumab and radiotherapy for treatment of newly diagnosed diffuse intrinsic pontine glioma (DIPG)

T2 - a phase III clinical study

AU - Fleischhack, G

AU - Massimino, M

AU - Warmuth-Metz, M

AU - Khuhlaeva, E

AU - Janssen, G

AU - Graf, N

AU - Rutkowski, S

AU - Beilken, A

AU - Schmid, I

AU - Biassoni, V

AU - Gorelishev, S K

AU - Kramm, C

AU - Reinhard, H

AU - Schlegel, P G

AU - Kortmann, R-D

AU - Reuter, D

AU - Bach, F

AU - Iznaga-Escobar, N E

AU - Bode, U

PY - 2019/5

Y1 - 2019/5

N2 - 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.

AB - 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.

KW - Adolescent

KW - Antibodies, Monoclonal, Humanized/adverse effects

KW - Antineoplastic Agents, Immunological/adverse effects

KW - Brain Stem Neoplasms/diagnostic imaging

KW - Chemoradiotherapy/adverse effects

KW - Child

KW - Child, Preschool

KW - Disease Progression

KW - Female

KW - Glioma/diagnostic imaging

KW - Humans

KW - Male

KW - Pons

KW - Survival Analysis

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1007/s11060-019-03140-z

DO - 10.1007/s11060-019-03140-z

M3 - SCORING: Journal article

C2 - 30830679

VL - 143

SP - 107

EP - 113

JO - J NEURO-ONCOL

JF - J NEURO-ONCOL

SN - 0167-594X

IS - 1

ER -