Phase II study of Gleevec plus hydroxyurea in adults with progressive or recurrent low-grade glioma
By: Reardon DA, Desjardins A, Vredenburgh JJ, Herndon JE 2nd, Coan A, Gururangan S, Peters KB, McLendon R, Sathornsumetee S, Rich JN, Lipp ES, Janney D, Friedman HS.

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.
Cancer. 2012 Feb 27. doi: 10.1002/cncr.26541.

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.

Copyright © 2012 American Cancer Society.

PMID: 22371319 [PubMed - as supplied by publisher] Source: National Library of Medicine.







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