Phase II trial of bevacizumab (Avastin) and irinotecan (CPT-11) in recurrent malignant glioma.
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Posted on: 04/09/2007
Phase II trial of bevacizumab and irinotecan in recurrent malignant glioma.
- Vredenburgh JJ,
- Desjardins A,
- Herndon JE 2nd,
- Dowell JM,
- Reardon DA,
- Quinn JA,
- Rich JN,
- Sathornsumetee S,
- Gururangan S,
- Wagner M,
- Bigner DD,
- Friedman AH,
- Friedman HS.
The Preston Robert Tisch Brain Tumor Center and Department of Surgery, Duke University Medical Center, Durham, North Carolina 27710, USA. email@example.com
PURPOSE: Recurrent grade III-IV gliomas have a dismal prognosis with minimal improvements in survival seen following currently available salvage therapy. This study was conducted to determine if the combination of a novel antiangiogenic therapy, bevacizumab, and a cytotoxic agent, irinotecan, is safe and effective for patients with recurrent grade III-IV glioma. EXPERIMENTAL DESIGN: We conducted a phase II trial of bevacizumab and irinotecan in adults with recurrent grade III-IV glioma. Patients with evidence of intracranial hemorrhage on initial brain magnetic resonance imaging were excluded. Patients were scheduled to receive bevacizumab and irinotecan i.v. every 2 weeks of a 6-week cycle. Bevacizumab was administered at 10 mg/kg. The dose of irinotecan was determined based on antiepileptic use: patients taking enzyme-inducing antiepileptic drugs received 340 mg/m(2), whereas patients not taking enzyme-inducing antiepileptic drugs received 125 mg/m(2). Toxicity and response were assessed. RESULTS: Thirty-two patients were assessed (23 with grade IV glioma and 9 with grade III glioma). Radiographic responses were noted in 63% (20 of 32) of patients (14 of 23 grade IV patients and 6 of 9 grade III patients). The median progression-free survival was 23 weeks for all patients (95% confidence interval, 15-30 weeks; 20 weeks for grade IV patients and 30 weeks for grade III patients). The 6-month progression-free survival probability was 38% and the 6-month overall survival probability was 72%. No central nervous system hemorrhages occurred, but three patients developed deep venous thromboses or pulmonary emboli, and one patient had an arterial ischemic stroke. CONCLUSIONS: The combination of bevacizumab and irinotecan is an active regimen for recurrent grade III-IV glioma with acceptable toxicity.
PMID: 17317837 [PubMed - in process]
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