| Title |
A phase I/II study of gemcitabine during radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma
|
|---|---|
| Published in |
Journal of Neuro-Oncology, July 2017
|
| DOI | 10.1007/s11060-017-2575-9 |
| Pubmed ID | |
| Authors |
Sophie E. M. Veldhuijzen van Zanten, Fatma E. El-Khouly, Marc H. A. Jansen, Dewi P. Bakker, Esther Sanchez Aliaga, Cornelis J. A. Haasbeek, Nicole I. Wolf, C. Michel Zwaan, W. Peter Vandertop, Dannis G. van Vuurden, Gertjan J. L. Kaspers |
| Abstract |
The purpose of this phase I/II, open-label, single-arm trial is to investigate the safety, tolerability, maximum tolerated dose and preliminary efficacy of the potential radiosensitizer gemcitabine, administered concomitantly to radiotherapy, in children with newly diagnosed diffuse intrinsic pontine glioma (DIPG). Six doses of weekly gemcitabine were administered intravenously, concomitantly to 6 weeks of hyperfractionated radiotherapy. Successive cohorts received increasing doses of 140, 175 and 200 mg/m(2) gemcitabine, respectively, following a 3 + 3 dose-escalation schedule without expansion cohort. Dose-limiting toxicities (DLT) were monitored during treatment period. Clinical response was assessed using predefined case report forms and radiological response was assessed using the modified RANO criteria. Quality of life (QoL) was assessed using PedsQL questionnaires. Between June 2012 and December 2016, nine patients were enrolled. Treatment was well tolerated, and no DLTs were observed up to the maximum dose of 200 mg/m(2). All patients experienced reduction of tumor-related symptoms. QoL tended to improve during treatment. PFS and MOS were 4.8 months (95% CI 4.0-5.7) and 8.7 months (95% CI 7.0-10.4). Classifying patients according to the recently developed DIPG survival prediction model, intermediate risk patients (n = 4), showed a PFS and MOS of 6.4 and 12.4 months, respectively, versus a PFS and MOS of 4.5 and 8.1 months, respectively, in high risk patient (n = 5). Gemcitabine up to 200 mg/m(2)/once weekly, added to radiotherapy, is safe and well tolerated in children with newly diagnosed DIPG. PFS and MOS were not significantly different from literature. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 64 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 64 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 9 | 14% |
| Researcher | 7 | 11% |
| Other | 5 | 8% |
| Student > Ph. D. Student | 5 | 8% |
| Student > Bachelor | 3 | 5% |
| Other | 9 | 14% |
| Unknown | 26 | 41% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 14 | 22% |
| Biochemistry, Genetics and Molecular Biology | 5 | 8% |
| Neuroscience | 5 | 8% |
| Computer Science | 5 | 8% |
| Nursing and Health Professions | 3 | 5% |
| Other | 5 | 8% |
| Unknown | 27 | 42% |
Attention Score in Context
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#20,438,227
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Outputs from Journal of Neuro-Oncology
#2,587
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Outputs of similar age from Journal of Neuro-Oncology
#43
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