Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Hutterer, M; Nowosielski, M; Haybaeck, J; Embacher, S; Stockhammer, F; Gotwald, T; Holzner, B; Capper, D; Preusser, M; Marosi, C; Oberndorfer, S; Moik, M; Buchroithner, J; Seiz, M; Tuettenberg, J; Herrlinger, U; Wick, A; Vajkoczy, P; Stockhammer, G.
A single-arm phase II Austrian/German multicenter trial on continuous daily sunitinib in primary glioblastoma at first recurrence (SURGE 01-07).
Neuro Oncol. 2014; 16(1):92-102
Doi: 10.1093/neuonc/not161
[OPEN ACCESS]
Web of Science
PubMed
FullText
FullText_MUG
- Co-Autor*innen der Med Uni Graz
- Haybäck Johannes
- Altmetrics:
- Dimensions Citations:
- Plum Analytics:
- Scite (citation analytics):
- Abstract:
- 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, 6.4-41.4 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. 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. ClinicalTrials.gov Identifier: NCT00535379.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Aged -
- Angiogenesis Inhibitors - therapeutic use
- Brain Neoplasms - drug therapy
- Brain Neoplasms - mortality
- Brain Neoplasms - pathology
- Drug Administration Schedule -
- Female -
- Follow-Up Studies -
- Glioblastoma - drug therapy
- Glioblastoma - mortality
- Glioblastoma - pathology
- Humans -
- Indoles - therapeutic use
- Male -
- Middle Aged -
- Neoplasm Recurrence, Local - drug therapy
- Neoplasm Recurrence, Local - mortality
- Neoplasm Recurrence, Local - pathology
- Neoplasm Staging -
- Prognosis -
- Prospective Studies -
- Pyrroles - therapeutic use
- Sunitinib -
- Survival Rate -
- Find related publications in this database (Keywords)
- antitumor activity and safety
- glioblastoma
- molecular markers
- quality of life
- sunitinib