| Item type: | Article | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Journal or Publication Title: | Neuro-oncology | ||||||||||||||||||||||||||||||||
| Publisher: | OXFORD UNIV PRESS INC | ||||||||||||||||||||||||||||||||
| Place of Publication: | CARY | ||||||||||||||||||||||||||||||||
| Volume: | 13 | ||||||||||||||||||||||||||||||||
| Number of Issue or Book Chapter: | 1 | ||||||||||||||||||||||||||||||||
| Page Range: | pp. 132-142 | ||||||||||||||||||||||||||||||||
| Date: | 2011 | ||||||||||||||||||||||||||||||||
| Additional Information (public): | Trabedersen Glioma Study Group | ||||||||||||||||||||||||||||||||
| Institutions: | Medicine > Lehrstuhl für Neurologie | ||||||||||||||||||||||||||||||||
| Identification Number: |
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| Classification: |
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| Keywords: | RECURRENT MALIGNANT GLIOMA; GROWTH-FACTOR BETA-2; PROGNOSTIC-FACTORS; BRAIN-TUMORS; ADJUVANT TEMOZOLOMIDE; CLINICAL-TRIALS; TGF-BETA; GLIOBLASTOMA; IMMUNOSUPPRESSION; CONCOMITANT; anaplastic astrocytoma; antisense oligonucleotide; convection-enhanced delivery; glioblastoma multiforme; recurrent or refractory high-grade glioma; targeted therapy; temozolomide; trabedersen; transforming growth factor beta 2 | ||||||||||||||||||||||||||||||||
| Dewey Decimal Classification: | 600 Technology > 610 Medical sciences Medicine | ||||||||||||||||||||||||||||||||
| Status: | Published | ||||||||||||||||||||||||||||||||
| Refereed: | Yes, this version has been refereed | ||||||||||||||||||||||||||||||||
| Created at the University of Regensburg: | Unknown | ||||||||||||||||||||||||||||||||
| Item ID: | 29178 |
Web of ScienceAbstract
This randomized, open-label, active-controlled, dose-finding phase fib study evaluated the efficacy and safety of trabedersen (AP 12009) administered intratumorally by convection-enhanced delivery compared with standard chemotherapy in patients with recurrent/refractory high-grade glioma. One hundred and forty-five patients with central reference histopathology of recurrent/refractory ...
Abstract
This randomized, open-label, active-controlled, dose-finding phase fib study evaluated the efficacy and safety of trabedersen (AP 12009) administered intratumorally by convection-enhanced delivery compared with standard chemotherapy in patients with recurrent/refractory high-grade glioma. One hundred and forty-five patients with central reference histopathology of recurrent/refractory glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) were randomly assigned to receive trabedersen at doses of 10 or 80 mu M or standard chemotherapy (temozolomide or procarbazine/lomustine/ vincristine). Primary endpoint was 6-month tumor control rate, and secondary endpoints included response at further timepoints, survival, and safety. Six-month tumor control rates were not significantly different in the entire study population (AA and GBM). Prespecified AA subgroup analysis showed a significant benefit regarding the 14-month tumor control rate for 10 mu M trabedersen vs chemotherapy (p=.0032). The 2-year survival rate had a trend for superiority for 10 mu M trabedersen vs chemotherapy (p=.10). Median survival for 10 mu M trabedersen was 39.1 months compared with 35.2 months for 80 mu M trabedersen and 21.7 months for chemotherapy (not significant). In GBM patients, response and survival results were comparable among the 3 arms. Exploratory analysis on GBM patients aged <= 55 years with Karnofsky performance status >80% at baseline indicated a 3-fold survival at 2 and 3 years for 10 mu M trabedersen vs chemotherapy. The frequency of patients with related or possibly drug-related adverse events was higher with standard chemotherapy (64%) than with 80 mu M trabedersen (43%) and 10 mu M trabedersen (27%). Superior efficacy and safety for 10 mu M trabedersen over 80 mu M trabedersen and chemotherapy and positive risk-benefit assessment suggest it as the optimal dose for further clinical development in high-grade glioma.
Metadata last modified: 29 Sep 2021 07:39
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