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Erschienen in: Journal of Neuro-Oncology 1/2012

01.03.2012 | Clinical Study – Patient Study

Phase II study of carboplatin, irinotecan, and bevacizumab for bevacizumab naïve, recurrent glioblastoma

verfasst von: David A. Reardon, Annick Desjardins, Katherine B. Peters, Sridharan Gururangan, John H. Sampson, Roger E. McLendon, James E. Herndon II, Anuradha Bulusu, Stevie Threatt, Allan H. Friedman, James J. Vredenburgh, Henry S. Friedman

Erschienen in: Journal of Neuro-Oncology | Ausgabe 1/2012

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Abstract

We evaluated the efficacy of carboplatin, irinotecan, and bevacizumab among bevacizumab-naïve, recurrent glioblastoma (GBM) patients in a phase 2, open-label, single arm trial. Forty eligible patients received carboplatin (area under the plasma curve [AUC] 4 mg/ml-min) on day one, while bevacizumab (10 mg/kg) and irinotecan (340 mg/m2 for patients on CYP3A-enzyme-inducing anti-epileptics [EIAEDs] and 125 mg/m2 for patients not on EIAEDs) were administered on days 1 and 14 of every 28-day cycle. Patients were evaluated after each of the first two cycles and then after every other cycle. Treatment continued until progressive disease, unacceptable toxicity, non-compliance, or voluntary withdrawal. The primary endpoint was progression-free survival at 6 months (PFS-6) and secondary endpoints included safety and median overall survival (OS). All patients had progression after standard therapy. The median age was 51 years. Sixteen patients (40%) had a KPS of 90–100, while 27 (68%) were at first progression. The median time from original diagnosis was 11.4 months. The PFS-6 rate was 46.5% (95% CI: 30.4, 61.0%) and the median OS was 8.3 months [95% confidence interval (CI): 5.9, and 10.7 months]. Grade 4 events were primarily hematologic and included neutropenia and thrombocytopenia in 20 and 10%, respectively. The most common grade 3 events were neutropenia, thrombocytopenia, fatigue, and infection in 25, 20, 13, and 10%, respectively. Eleven patients (28%) discontinued study therapy due to toxicity and 17 patients (43%) required dose modification. One patient died due to treatment-related intestinal perforation. The addition of carboplatin and irinotecan to bevacizumab significantly increases toxicity but does not improve anti-tumor activity to that achieved historically with single-agent bevacizumab among bevacizumab-naïve, recurrent GBM patients. (ClinicalTrials.gov number NCT00953121).
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Metadaten
Titel
Phase II study of carboplatin, irinotecan, and bevacizumab for bevacizumab naïve, recurrent glioblastoma
verfasst von
David A. Reardon
Annick Desjardins
Katherine B. Peters
Sridharan Gururangan
John H. Sampson
Roger E. McLendon
James E. Herndon II
Anuradha Bulusu
Stevie Threatt
Allan H. Friedman
James J. Vredenburgh
Henry S. Friedman
Publikationsdatum
01.03.2012
Verlag
Springer US
Erschienen in
Journal of Neuro-Oncology / Ausgabe 1/2012
Print ISSN: 0167-594X
Elektronische ISSN: 1573-7373
DOI
https://doi.org/10.1007/s11060-011-0722-2

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