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Hutterer, Markus ; Nowosielski, Martha ; Haybaeck, Johannes ; Embacher, Sabine ; Stockhammer, Florian ; Gotwald, Thaddäus ; Holzner, Bernhard ; Capper, David ; Preusser, Matthias ; Marosi, Christine ; Oberndorfer, Stefan ; Moik, Martin ; Buchroithner, Johanna ; Seiz, Marcel ; Tuettenberg, Jochen ; Herrlinger, Ulrich ; Wick, Antje ; Vajkoczy, Peter ; Stockhammer, Günther
| Item type: | Article | ||||
|---|---|---|---|---|---|
| Journal or Publication Title: | Neuro-Oncology | ||||
| Publisher: | Oxford Univ. Press | ||||
| Volume: | 16 | ||||
| Number of Issue or Book Chapter: | 1 | ||||
| Page Range: | pp. 92-102 | ||||
| Date: | 2014 | ||||
| Institutions: | Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Hirntumore (ZHT) | ||||
| Identification Number: |
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| Keywords: | antitumor activity and safety, glioblastoma, molecular markers, quality of life, sunitinib | ||||
| 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: | 29406 |
Abstract
Background: Due to the redundancy of molecular pathways simultaneously involved in glioblastoma growth and angiogenesis, therapeutic approaches intervening at multiple levels seem particularly appealing. Methods: This prospective, multicenter, single-arm phase II trial was designed to evaluate the antitumor activity of sunitinib, an oral small-molecule inhibitor of several receptor tyrosine ...
Abstract
Background: Due to the redundancy of molecular pathways simultaneously involved in glioblastoma growth and angiogenesis, therapeutic approaches intervening at multiple levels seem particularly appealing.
Methods: This prospective, multicenter, single-arm phase II trial was designed to evaluate the antitumor activity of sunitinib, an oral small-molecule inhibitor of several receptor tyrosine kinases, in patients with first recurrence of primary glioblastoma using a continuous once-daily dosing regimen. Patients received a starting dose of sunitinib 37.5 mg, followed by a maintenance dose between 12.5 mg and 50 mg depending on drug tolerability. The primary endpoint was a 6-month progression-free survival (PFS) rate. Secondary endpoints included median PFS, overall survival (OS), safety/toxicity, quality of life, and translational studies on the expression of sunitinib target molecules.
Results: Forty participants were included in this study, and no objective responses were detected. PFS6 was 12.5%, median PFS 2.2 months, and median OS 9.2 months. Five participants (12.5%) showed prolonged stable disease ≥6 months with a median PFS of 16.0 months (range, 6.4–41.4 mo) and a median OS of 46.9 months (range, 21.2–49.2 mo) for this subgroup. c-KIT expression in vascular endothelial cells (n = 14 participants) was associated with improved PFS. The most common toxicities were fatigue/asthenia, mucositis/dermatitis, dysesthesias, gastrointestinal symptoms, cognitive impairment, leukoctopenia, and thrombocytopenia. Two participants (5%) terminated treatment due to toxicity.
Conclusion: Continuous daily sunitinib showed minimal antiglioblastoma activity and substantial toxicity when given at higher doses. High endothelial c-KIT expression may define a subgroup of patients who will benefit from sunitinib treatment by achieving prolonged PFS.
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