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- Title
Phase II Trial of Upfront Bevacizumab, Irinotecan, and Temozolomide for Unresectable Glioblastoma.
- Authors
Peters, Katherine B.; Lou, Emil; Desjardins, Annick; Reardon, David A.; Lipp, Eric S.; Miller, Elizabeth; Herndon, James E.; McSherry, Frances; Friedman, Henry S.; Vredenburgh, James J.
- Abstract
Background. Extent of resection remains a key prognostic factor in glioblastoma (GBM), with gross total resection providing a better prognosis than biopsy or subtotal resection. We conducted a phase II trial of upfront therapy with bevacizumab (BV), irinotecan (CPT-11), and temozolomide (TMZ) prior to chemoradiation in patients with unresectable, subtotally resected, and/or multifocal GBM. Methods. Patients received up to 4 cycles of TMZ at 200 mg/m² per day on days 1-5 (standard dosing) and BV at 10 mg/kg every 2 weeks on a 28-day cycle. CPT-11 was given every 2 weeks on a 28-day cycle at 125 mg/m² or 340 mg/m² depending on anti-epileptic drugs. Magnetic resonance imaging of the brain was done every 4 weeks, and treatment continued as long as there was no tumor progression or unmanageable toxicity. The primary endpoint was tumor response rate, with a goal of 26% or greater. Results. Forty-one patients were enrolled from December 2009 to November 2010. Radiographic responses were as follows: 9 patients (22.0%) had partial responsible, 25 (61.0%) had stable disease, and 2 (4.9%) had progression;5 patients were not assessed. Cumulative response rate was 22%. Median overall survival was 12 months (95% confidence interval: 7.2-13.5 months). Conclusion. Upfront treatment with BV, TMZ, and CPT-11 is tolerable and can lead to radiographic response in unresectable and/or subtotally resected GBM.
- Subjects
BEVACIZUMAB; IRINOTECAN; TEMOZOLOMIDE; COMBINATION drug therapy; CLINICAL trials; CONFIDENCE intervals; GLIOMAS; MAGNETIC resonance imaging; TREATMENT effectiveness; DESCRIPTIVE statistics; KARNOFSKY Performance Status; THERAPEUTICS
- Publication
Oncologist, 2015, Vol 20, Issue 7, p727
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.2015-0135