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A phase II, randomized, study of weekly APG101+reirradiation versus reirradiation in progressive glioblastoma

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A phase II, randomized, study of weekly APG101+reirradiation versus reirradiation in progressive glioblastoma. / Wick, Wolfgang; Fricke, Harald; Junge, Klaus; Kobyakov, Grigory; Martens, Tobias; Heese, Oliver; Wiestler, Benedikt; Schliesser, Maximilian G; Pichler, Josef; Vetlova, Elena; Harting, Inga; Debus, Jürgen; Hartmann, Christian; Kunz, Claudia; Platten, Michael; Bendszus, Martin; Combs, Stephanie E.

in: CLIN CANCER RES, Jahrgang 20, Nr. 24, 15.12.2014, S. 6304-13.

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

Harvard

Wick, W, Fricke, H, Junge, K, Kobyakov, G, Martens, T, Heese, O, Wiestler, B, Schliesser, MG, Pichler, J, Vetlova, E, Harting, I, Debus, J, Hartmann, C, Kunz, C, Platten, M, Bendszus, M & Combs, SE 2014, 'A phase II, randomized, study of weekly APG101+reirradiation versus reirradiation in progressive glioblastoma', CLIN CANCER RES, Jg. 20, Nr. 24, S. 6304-13. https://doi.org/10.1158/1078-0432.CCR-14-0951-T

APA

Wick, W., Fricke, H., Junge, K., Kobyakov, G., Martens, T., Heese, O., Wiestler, B., Schliesser, M. G., Pichler, J., Vetlova, E., Harting, I., Debus, J., Hartmann, C., Kunz, C., Platten, M., Bendszus, M., & Combs, S. E. (2014). A phase II, randomized, study of weekly APG101+reirradiation versus reirradiation in progressive glioblastoma. CLIN CANCER RES, 20(24), 6304-13. https://doi.org/10.1158/1078-0432.CCR-14-0951-T

Vancouver

Wick W, Fricke H, Junge K, Kobyakov G, Martens T, Heese O et al. A phase II, randomized, study of weekly APG101+reirradiation versus reirradiation in progressive glioblastoma. CLIN CANCER RES. 2014 Dez 15;20(24):6304-13. https://doi.org/10.1158/1078-0432.CCR-14-0951-T

Bibtex

@article{38201175e8434756b1510a6986eb9688,
title = "A phase II, randomized, study of weekly APG101+reirradiation versus reirradiation in progressive glioblastoma",
abstract = "PURPOSE: Preclinical data indicate anti-invasive activity of APG101, a CD95 ligand (CD95L)-binding fusion protein, in glioblastoma.EXPERIMENTAL DESIGN: Patients (N = 91) with glioblastoma at first or second progression were randomized 1:2 between second radiotherapy (rRT; 36 Gy; five times 2 Gy per week) or rRT+APG101 (400 mg weekly i.v.). Patient characteristics [N = 84 (26 patients rRT, 58 patients rRT+APG101)] were balanced.RESULTS: Progression-free survival at 6 months (PFS-6) rates were 3.8% [95% confidence interval (CI), 0.1-19.6] for rRT and 20.7% (95% CI, 11.2-33.4) for rRT+APG101 (P = 0.048). Median PFS was 2.5 (95% CI, 2.3-3.8) months and 4.5 (95% CI, 3.7-5.4) months with a hazard ratio (HR) of 0.49 (95% CI, 0.27-0.88; P = 0.0162) adjusted for tumor size. Cox regression analysis adjusted for tumor size revealed a HR of 0.60 (95% CI, 0.36-1.01; P = 0.0559) for rRT+APG101 for death of any cause. Lower methylation levels at CpG2 in the CD95L promoter in the tumor conferred a stronger risk reduction (HR, 0.19; 95% CI, 0.06-0.58) for treatment with APG101, suggesting a potential biomarker.CONCLUSIONS: CD95 pathway inhibition in combination with rRT is an innovative concept with clinical efficacy. It warrants further clinical development. CD95L promoter methylation in the tumor may be developed as a biomarker.",
keywords = "Adult, Aged, Antigens, CD95, Antineoplastic Agents, Biomarkers, Combined Modality Therapy, Drug Administration Schedule, Female, Glioblastoma, Humans, Immunoglobulin G, Male, Middle Aged, Prognosis, Quality of Life, Recombinant Fusion Proteins, Treatment Outcome, Tumor Burden, Young Adult",
author = "Wolfgang Wick and Harald Fricke and Klaus Junge and Grigory Kobyakov and Tobias Martens and Oliver Heese and Benedikt Wiestler and Schliesser, {Maximilian G} and Josef Pichler and Elena Vetlova and Inga Harting and J{\"u}rgen Debus and Christian Hartmann and Claudia Kunz and Michael Platten and Martin Bendszus and Combs, {Stephanie E}",
note = "{\textcopyright}2014 American Association for Cancer Research.",
year = "2014",
month = dec,
day = "15",
doi = "10.1158/1078-0432.CCR-14-0951-T",
language = "English",
volume = "20",
pages = "6304--13",
journal = "CLIN CANCER RES",
issn = "1078-0432",
publisher = "American Association for Cancer Research Inc.",
number = "24",

}

RIS

TY - JOUR

T1 - A phase II, randomized, study of weekly APG101+reirradiation versus reirradiation in progressive glioblastoma

AU - Wick, Wolfgang

AU - Fricke, Harald

AU - Junge, Klaus

AU - Kobyakov, Grigory

AU - Martens, Tobias

AU - Heese, Oliver

AU - Wiestler, Benedikt

AU - Schliesser, Maximilian G

AU - Pichler, Josef

AU - Vetlova, Elena

AU - Harting, Inga

AU - Debus, Jürgen

AU - Hartmann, Christian

AU - Kunz, Claudia

AU - Platten, Michael

AU - Bendszus, Martin

AU - Combs, Stephanie E

N1 - ©2014 American Association for Cancer Research.

PY - 2014/12/15

Y1 - 2014/12/15

N2 - PURPOSE: Preclinical data indicate anti-invasive activity of APG101, a CD95 ligand (CD95L)-binding fusion protein, in glioblastoma.EXPERIMENTAL DESIGN: Patients (N = 91) with glioblastoma at first or second progression were randomized 1:2 between second radiotherapy (rRT; 36 Gy; five times 2 Gy per week) or rRT+APG101 (400 mg weekly i.v.). Patient characteristics [N = 84 (26 patients rRT, 58 patients rRT+APG101)] were balanced.RESULTS: Progression-free survival at 6 months (PFS-6) rates were 3.8% [95% confidence interval (CI), 0.1-19.6] for rRT and 20.7% (95% CI, 11.2-33.4) for rRT+APG101 (P = 0.048). Median PFS was 2.5 (95% CI, 2.3-3.8) months and 4.5 (95% CI, 3.7-5.4) months with a hazard ratio (HR) of 0.49 (95% CI, 0.27-0.88; P = 0.0162) adjusted for tumor size. Cox regression analysis adjusted for tumor size revealed a HR of 0.60 (95% CI, 0.36-1.01; P = 0.0559) for rRT+APG101 for death of any cause. Lower methylation levels at CpG2 in the CD95L promoter in the tumor conferred a stronger risk reduction (HR, 0.19; 95% CI, 0.06-0.58) for treatment with APG101, suggesting a potential biomarker.CONCLUSIONS: CD95 pathway inhibition in combination with rRT is an innovative concept with clinical efficacy. It warrants further clinical development. CD95L promoter methylation in the tumor may be developed as a biomarker.

AB - PURPOSE: Preclinical data indicate anti-invasive activity of APG101, a CD95 ligand (CD95L)-binding fusion protein, in glioblastoma.EXPERIMENTAL DESIGN: Patients (N = 91) with glioblastoma at first or second progression were randomized 1:2 between second radiotherapy (rRT; 36 Gy; five times 2 Gy per week) or rRT+APG101 (400 mg weekly i.v.). Patient characteristics [N = 84 (26 patients rRT, 58 patients rRT+APG101)] were balanced.RESULTS: Progression-free survival at 6 months (PFS-6) rates were 3.8% [95% confidence interval (CI), 0.1-19.6] for rRT and 20.7% (95% CI, 11.2-33.4) for rRT+APG101 (P = 0.048). Median PFS was 2.5 (95% CI, 2.3-3.8) months and 4.5 (95% CI, 3.7-5.4) months with a hazard ratio (HR) of 0.49 (95% CI, 0.27-0.88; P = 0.0162) adjusted for tumor size. Cox regression analysis adjusted for tumor size revealed a HR of 0.60 (95% CI, 0.36-1.01; P = 0.0559) for rRT+APG101 for death of any cause. Lower methylation levels at CpG2 in the CD95L promoter in the tumor conferred a stronger risk reduction (HR, 0.19; 95% CI, 0.06-0.58) for treatment with APG101, suggesting a potential biomarker.CONCLUSIONS: CD95 pathway inhibition in combination with rRT is an innovative concept with clinical efficacy. It warrants further clinical development. CD95L promoter methylation in the tumor may be developed as a biomarker.

KW - Adult

KW - Aged

KW - Antigens, CD95

KW - Antineoplastic Agents

KW - Biomarkers

KW - Combined Modality Therapy

KW - Drug Administration Schedule

KW - Female

KW - Glioblastoma

KW - Humans

KW - Immunoglobulin G

KW - Male

KW - Middle Aged

KW - Prognosis

KW - Quality of Life

KW - Recombinant Fusion Proteins

KW - Treatment Outcome

KW - Tumor Burden

KW - Young Adult

U2 - 10.1158/1078-0432.CCR-14-0951-T

DO - 10.1158/1078-0432.CCR-14-0951-T

M3 - SCORING: Journal article

C2 - 25338498

VL - 20

SP - 6304

EP - 6313

JO - CLIN CANCER RES

JF - CLIN CANCER RES

SN - 1078-0432

IS - 24

ER -