Phase II study of Gleevec plus hydroxyurea in adults with progressive or recurrent low-grade glioma |
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Authors: | Reardon David A Desjardins Annick Vredenburgh James J Herndon James E Coan April Gururangan Sridharan Peters Katherine B McLendon Roger Sathornsumetee Sith Rich Jeremy N Lipp Eric S Janney Dorothea Friedman Henry S |
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Institution: | The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina; Department of Surgery, Duke University Medical Center, Durham, North Carolina; Department of Pediatrics, Duke University Medical Center, Durham, North Carolina. reard003@mc.duke.edu. |
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Abstract: | BACKGROUND: We evaluated the efficacy of imatinib plus hydroxyurea in patients with progressive/recurrent low‐grade glioma. METHODS: A total of 64 patients with recurrent/progressive low‐grade glioma were enrolled in this single‐center study that stratified patients into astrocytoma and oligodendroglioma cohorts. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg per day for patients not on enzyme‐inducing antiepileptic drugs (EIAEDs) and at 500 mg twice a day if on EIAEDs. The primary endpoint was progression‐free survival at 12 months (PFS‐12) and secondary endpoints were safety, median progression‐free survival, and radiographic response rate. RESULTS: Thirty‐two patients were enrolled into each cohort. Eleven patients (17%) had before radiotherapy and 24 (38%) had received before chemotherapy. The median PFS and PFS‐12 were 11 months and 39%, respectively. Outcome did not differ between the histologic cohorts. No patient achieved a radiographic response. The most common grade 3 or greater adverse events were neutropenia (11%), thrombocytopenia (3%), and diarrhea (3%). CONCLUSIONS: Imatinib plus hydroxyurea was well tolerated among recurrent/progressive LGG patients but this regimen demonstrated negligible antitumor activity. Cancer 2012. © 2012 American Cancer Society. |
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Keywords: | imatinib glioma platelet derived growth factor astrocytoma oligodendroglioma |
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