A phase 2 study of pegylated interferon α-2b (PEG-Intron(®)) in children with diffuse intrinsic pontine glioma.

A phase 2 study of pegylated interferon α-2b (PEG-Intron(®)) in children with diffuse intrinsic pontine glioma.
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DOI:
10.1002/cncr.26659
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发表时间:
2012-07-15
期刊:
影响因子:
6.2
通讯作者:
Camphausen K
Camphausen K
中科院分区:
医学1区
文献类型:
--
作者:
Warren K;Bent R;Wolters PL;Prager A;Hanson R;Packer R;Shih J;Camphausen K

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Interferon-alpha is a cytokine with demonstrated activity in patients with supratentorial gliomas, but the ideal dose and schedule of administration is unknown. Studies suggest low-dose continuous exposure is more efficacious than intermittent high doses. We performed a Phase II study of PEG-Intron® in children with DIPG, a population with dismal survival despite decades of clinical investigation. The primary objective was to compare 2-year survival to a historical cohort treated with radiation therapy alone. Patients received weekly subcutaneous PEG-Intron® at a dose of 0.3 μg/kg beginning 2–10 weeks after completing radiation therapy until disease progression. Patients were evaluated clinically and radiographically at regular intervals. Serum and urine were assayed for biomarkers prior to each cycle. Quality of life (QOL) evaluations were administered at baseline and prior to every other cycle of therapy to parents of patients ages 6–18 years. Thirty-two patients (median age 5.3 years, range 1.8–14.8) enrolled and received a median of 7 cycles of therapy (range 1–70+). PEG-Intron® was well tolerated and no decrease in QOL scores was noted in the subset of patients tested. The two-year survival rate was 14%, which was not significantly improved compared to our historical cohort. However, median time to progression (TTP) was 7.8 months, which favorably compares to recent trials reporting TTP 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 to a historical control population, it may delay time to progression.
DOI: 10.1016/0166-3542(94)90058-2
发表时间: 1994-07-01
期刊: ANTIVIRAL RESEARCH
影响因子: 7.6
作者:
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