Hutterer, Markus and Nowosielski, Martha and Haybaeck, Johannes and Embacher, Sabine and Stockhammer, Florian and Gotwald, Thaddaeus and Holzner, Bernhard and Capper, David and Preusser, Matthias and Marosi, Christine and Oberndorfer, Stefan and Moik, Martin and Buchroithner, Johanna and Seiz, Marcel and Tuettenberg, Jochen and Herrlinger, Ulrich and Wick, Antje and Vajkoczy, Peter and Stockhammer, Guenther (2014) A single-arm phase II Austrian/German multicenter trial on continuous daily sunitinib in primary glioblastoma at first recurrence (SURGE 01-07). NEURO-ONCOLOGY, 16 (1). pp. 92-102. ISSN 1522-8517, 1523-5866
Full text not available from this repository. (Request a copy)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. 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. 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, 6.441.4 mo) and a median OS of 46.9 months (range, 21.249.2 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. 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | QUALITY-OF-LIFE; TYROSINE KINASE INHIBITOR; ENDOTHELIAL GROWTH-FACTOR; RENAL-CELL CARCINOMA; MALIGNANT GLIOMA; CLINICAL-TRIALS; FACTOR RECEPTOR; PSEUDOPROGRESSION; BEVACIZUMAB; ANGIOGENESIS; antitumor activity and safety; glioblastoma; molecular markers; quality of life; sunitinib |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 29 Nov 2019 14:02 |
| Last Modified: | 29 Nov 2019 14:02 |
| URI: | https://pred.uni-regensburg.de/id/eprint/11096 |
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