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A phase 2 study of pegylated interferon α-2b (PEG-Intron®) in children with diffuse intrinsic pontine glioma
Article first published online: 15 NOV 2011
Copyright © 2011 American Cancer Society
Volume 118, Issue 14, pages 3607–3613, 15 July 2012
How to Cite
Warren, K., Bent, R., Wolters, P. L., Prager, A., Hanson, R., Packer, R., Shih, J. and Camphausen, K. (2012), A phase 2 study of pegylated interferon α-2b (PEG-Intron®) in children with diffuse intrinsic pontine glioma. Cancer, 118: 3607–3613. doi: 10.1002/cncr.26659
- Issue published online: 2 JUL 2012
- Article first published online: 15 NOV 2011
- Manuscript Accepted: 27 SEP 2011
- Manuscript Revised: 9 SEP 2011
- Manuscript Received: 25 JUL 2011
Interferon-α is a cytokine that has demonstrated activity in patients with supratentorial gliomas, but its ideal dose and schedule of administration is unknown. Studies suggest that low-dose, continuous exposure is more efficacious than intermittent, high doses. The authors performed a phase 2 study of recombinant interferon α-2b with monomethoxy polyethylene glycol (PEG-Intron®) in children with diffuse intrinsic pontine glioma (DIPG), a population with dismal survival despite decades of clinical investigation. The primary objective was to compare 2-year survival with a historic cohort that received radiation therapy alone.
Patients received weekly subcutaneous PEG-Intron® at a dose of 0.3 μg/kg beginning 2 to 10 weeks after the completion of radiation therapy until they developed disease progression. Patients were evaluated clinically and radiographically at regular intervals. Serum and urine were assayed for biomarkers before each cycle. Quality-of-life (QOL) evaluations were administered at baseline and before every other cycle of therapy to the parents of patients ages 6 to 18 years.
Thirty-two patients (median age, 5.3 years; range, 1.8-14.8 years) were enrolled and received a median of 7 cycles of therapy (range, from 1 cycle to ≥70 cycles). PEG-Intron® was well tolerated, and no decrease in QOL scores was noted in the subset of patients tested. The 2-year survival rate was 14%, which was not significantly improved compared with the historic cohort. However, the median time to progression was 7.8 months, which compared favorably with recent trials reporting a time to progression of 5 months in a similar population.
Although low-dose PEG-Intron® therapy did not significantly improve 2-year survival in children with DIPG compared with an historic control population, it did delay the time to progression. Cancer 2012;3607–3613. © 2011 American Cancer Society.