In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 15_suppl ( 2009-05-20), p. 2016-2016
Abstract:
2016 Background: Glioblastoma multiforme (GBM) is the most common and aggressive primary brain tumor. Current standard treatment consists of fractionated radiotherapy (RT) with daily oral temozolomide (TMZ) chemotherapy followed by 6 months of adjuvant TMZ chemotherapy. Median survival is 14.3 months. Because GBM is characterized by vascular proliferation and produces high levels of vascular endothelial growth factor (VEGF), attempts to better control the disease with targeted anti-angiogenesis therapies are underway. Here, we report preliminary safety and tolerability data of bevacizumab (BV) when added to monthly TMZ chemotherapy. Methods: Subjects received standard regional RT to a dose of 60 Gy in 30 fractions with dailyconcurrent TMZ (75 mg/m2) within 3–5 weeks of diagnosis. Four weeks after RT/TMZ, subjects received 5 consecutive daily TMZ doses (150–200 mg/m2) administered every 28 days. BV (10mg/kg) was given every 14 days. Treatment continued until either disease progression or unacceptable toxicity occurred. Results: 42 of 48 planned subjects were enrolled as of 12/30/08. Twenty-three remained on study. Of these, 4 were receiving RT/TMZ, 18 were receiving TMZ/BV and 1 was delayed post-RT/TMZ due to local wound infection. Nineteen were off-study. Eleven of those off-study never received BV due to: study withdrawal (n = 2), toxicity during RT/TMZ (n = 3) and post-RT/TMZ progression (n = 6). Seven subjects progressed while receiving TMZ/BV. Twenty-six of the 42 enrolled received at least one 28-day cycle of TMZ/BV (range 1 - 16 cycles). Duration of treatment, inclusive of RT/TMZ, ranged from 27 to 523 days. Best radiographic responses of evaluable subjects, using MacDonald criteria were: 5 complete, 9 partial, 13 stable and 7 progressive disease. Of those taken off study, 13 were due to disease progression. Of those removed from study due to toxicity, none were unexpected and only 1 (a GI bleed) occurred during the TMZ/BV phase. A statistical analysis of response and survival is pending. Conclusions: The co-administration of TMZ/BV following RT/TMZ for newly diagnosed GBM is safe and well-tolerated. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2009.27.15_suppl.2016
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2009
detail.hit.zdb_id:
2005181-5
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