Difference between revisions of "High-grade glioma, pediatric"

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[[#top|Back to Top]]
 
[[#top|Back to Top]]
 
</div>
 
</div>
{{#lst:Section editor transclusions|peds-neuro}}
+
{{#lst:Editorial board transclusions|peds-neuro}}
<big>''This page contains studies that are specific to pediatric populations. For the more general high-grade glioma category page, follow [[:Category:High-grade_gliomas|this link]].</big>
+
''This page contains studies that are specific to pediatric populations.  
 +
*For the more general '''high-grade glioma''' category page, follow '''[[:Category:High-grade_gliomas|this link]]'''.
 +
*For '''pediatric low-grade glioma (pLGG)''', follow '''[[Low-grade glioma, pediatric|this link]]'''.
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
|-
 
|-
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|}
 
|}
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
 
+
=Guidelines=
 +
'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
 +
==NCCN==
 +
*[https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1509 NCCN Guidelines - Pediatric Central Nervous System Cancers]
 
=Adjuvant therapy=
 
=Adjuvant therapy=
==Lomustine, Vincristine, Prednisone {{#subobject:f7dcb5|Regimen=1}}==
+
==Temozolomide & RT {{#subobject:5fe805|Regimen=1}}==
 +
Temozolomide & RT: Temozolomide & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:2a87ef|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://doi.org/10.1200/JCO.2017.76.0611 Grill et al. 2018 (HERBY)]
 +
|2011-2015
 +
| style="background-color:#1a9851" |Randomized Phase 2 (C)
 +
|[[#Temozolomide.2C_Bevacizumab.2C_RT_999|Temozolomide, Bevacizumab, RT]]
 +
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*[[Surgery#CNS_cancer_surgery|Surgical biopsy, partial resection, or total resection]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Temozolomide (Temodar)]] as follows:
 +
**Cycle 1 (chemoradiation): 75 mg/m<sup>2</sup> PO or IV once per day on days 1 to 42
 +
**Cycles 2 to 13: 150 to 200 mg/m<sup>2</sup> PO once per day on days 1 to 5
 +
====Radiotherapy====
 +
*Concurrent [[External_beam_radiotherapy|radiation therapy]] as follows:
 +
**Cycle 1: 180 cGy fractions x 30 fractions, for a total dose of 5400 cGy
 +
'''10-week course, then 28-day cycle for up to 12 cycles'''
 +
</div></div>
 +
===References===
 +
#'''HERBY:''' Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Cañete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, open-label, randomized, multicenter trial (HERBY) of bevacizumab in pediatric patients with newly diagnosed high-grade glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. Epub 2018 Feb 7. [https://doi.org/10.1200/JCO.2017.76.0611 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29412784/ PubMed] [https://clinicaltrials.gov/study/NCT01390948 NCT01390948]
  
 +
==VCP {{#subobject:f7dcb5|Regimen=1}}==
 +
VCP: '''<u>V</u>'''incristine, '''<u>C</u>'''CNU (Lomustine), '''<u>P</u>'''rednisone
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:251b74|Variant=1}}===
 
===Regimen {{#subobject:251b74|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
|[https://doi.org/10.1200/JCO.1995.13.1.112 Finlay et al. 1995]
+
|[https://doi.org/10.1200/JCO.1995.13.1.112 Finlay et al. 1995 (CCG-945)]
 
|1985-1990
 
|1985-1990
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
Line 30: Line 71:
 
|-
 
|-
 
|}
 
|}
 +
''Note: the exact schedule of vincristine is impossible to discern from Figure 1.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
+
*[[Surgery#CNS_cancer_surgery|Surgery]], then adjuvant [[#Vincristine_.26_RT|Vincristine & RT]]
*[[Surgery#CNS_cancer_surgery|Surgery]], then Vincristine & RT
+
</div>
 
+
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
+
*[[Lomustine (CCNU)]] 100 mg/m<sup>2</sup> IV once on day 1
*[[Lomustine (CCNU)]]
+
*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
*[[Vincristine (Oncovin)]]
 
 
====Glucocorticoid therapy====
 
====Glucocorticoid therapy====
*[[Prednisone (Sterapred)]]
+
*[[Prednisone (Sterapred)]] 40 mg/m<sup>2</sup> PO once per day on days 1 to 14
 
+
'''42-day cycle for 8 cycles'''
 +
</div></div>
 
===References===
 
===References===
 
+
#'''CCG-945:''' Finlay JL, Boyett JM, Yates AJ, Wisoff JH, Milstein JM, Geyer JR, Bertolone SJ, McGuire P, Cherlow JM, Tefft M, Turski PA, Wara WM, Edwards M, Sutton LN, Berger MS, Epstein F, Ayers G, Allen JC, Packer RJ; Children's Cancer Group. Randomized phase III trial in childhood high-grade astrocytoma comparing vincristine, lomustine, and prednisone with the eight-drugs-in-1-day regimen. J Clin Oncol. 1995 Jan;13(1):112-23. [https://doi.org/10.1200/JCO.1995.13.1.112 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/7799011/ PubMed]
#'''CCG-945:''' Finlay JL, Boyett JM, Yates AJ, Wisoff JH, Milstein JM, Geyer JR, Bertolone SJ, McGuire P, Cherlow JM, Tefft M, Turski PA, Wara WM, Edwards M, Sutton LN, Berger MS, Epstein F, Ayers G, Allen JC, Packer RJ; Children's Cancer Group. Randomized phase III trial in childhood high-grade astrocytoma comparing vincristine, lomustine, and prednisone with the eight-drugs-in-1-day regimen. J Clin Oncol. 1995 Jan;13(1):112-23. [https://doi.org/10.1200/JCO.1995.13.1.112 link to original article] [https://pubmed.ncbi.nlm.nih.gov/7799011 PubMed]
+
==Vincristine & RT {{#subobject:f7drt5|Regimen=1}}==
 
+
Vincristine & RT: Vincristine & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
==Temozolomide & RT {{#subobject:5fe805|Regimen=1}}==
+
<div class="toccolours" style="background-color:#eeeeee">
 
+
===Regimen {{#subobject:rt1b74|Variant=1}}===
Temozolomide & RT: Temozolomide & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 
===Regimen {{#subobject:2a87ef|Variant=1}}===
 
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
!style="width: 20%"|Years of enrollment
+
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
|[https://doi.org/10.1200/JCO.2017.76.0611 Grill et al. 2018 (HERBY)]
+
|[https://doi.org/10.1200/JCO.1995.13.1.112 Finlay et al. 1995 (CCG-945)]
|2011-2015
+
|1985-1990
| style="background-color:#1a9851" |Randomized Phase 2 (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
|[[#Temozolomide.2C_Bevacizumab.2C_RT_99|Temozolomide, Bevacizumab, RT]]
+
|8-drug regimen
| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS
+
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
+
*[[Surgery#CNS_cancer_surgery|Surgery]]
*[[Surgery#CNS_cancer_surgery|Surgical biopsy, partial resection, or total resection]]
+
</div>
 
+
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
+
*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64
*[[Temozolomide (Temodar)]] as follows:
 
**Cycle 1: 75 mg/m<sup>2</sup> PO or IV once per day
 
**Cycles 2 to 13: 150 to 200 mg/m<sup>2</sup> PO once per day on days 1 to 5
 
 
 
 
====Radiotherapy====
 
====Radiotherapy====
 
+
*Concurrent [[External_beam_radiotherapy|radiation therapy]]
*Concurrent [[External_beam_radiotherapy|radiation therapy]] as follows:
+
'''70-day course'''
**Cycle 1: 1.8 Gy fractions x 30 fractions, for a total dose of 54 Gy
+
</div>
 
+
<div class="toccolours" style="background-color:#cbd5e8">
'''6-week course, then 4-week break, then 28-day cycle for up to 12 cycles'''
+
====Subsequent treatment====
 +
*Adjuvant [[#VCP|VCP]]
 +
</div></div>
  
 
===References===
 
===References===
#'''HERBY:''' Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Cañete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, open-label, randomized, multicenter trial (HERBY) of bevacizumab in pediatric patients with newly diagnosed high-grade glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. Epub 2018 Feb 7. [https://doi.org/10.1200/JCO.2017.76.0611 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29412784 PubMed] NCT01390948
+
#'''CCG-945:''' Finlay JL, Boyett JM, Yates AJ, Wisoff JH, Milstein JM, Geyer JR, Bertolone SJ, McGuire P, Cherlow JM, Tefft M, Turski PA, Wara WM, Edwards M, Sutton LN, Berger MS, Epstein F, Ayers G, Allen JC, Packer RJ; Children's Cancer Group. Randomized phase III trial in childhood high-grade astrocytoma comparing vincristine, lomustine, and prednisone with the eight-drugs-in-1-day regimen. J Clin Oncol. 1995 Jan;13(1):112-23. [https://doi.org/10.1200/JCO.1995.13.1.112 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/7799011/ PubMed]
  
 
=Recurrent disease, non-curative therapy, non-randomized or retrospective data=
 
=Recurrent disease, non-curative therapy, non-randomized or retrospective data=
 
 
==Temozolomide monotherapy {{#subobject:e73a18|Regimen=1}}==
 
==Temozolomide monotherapy {{#subobject:e73a18|Regimen=1}}==
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #1, no radiation history {{#subobject:f06af9|Variant=1}}===
 
===Regimen variant #1, no radiation history {{#subobject:f06af9|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
!style="width: 33%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
Line 98: Line 137:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
 
*[[Temozolomide (Temodar)]] 150 to 200 mg/m<sup>2</sup> PO once per day on days 1 to 5
 
*[[Temozolomide (Temodar)]] 150 to 200 mg/m<sup>2</sup> PO once per day on days 1 to 5
 
**Patients who previously received craniospinal irradiation (CSI) instead received 180 mg/m<sup>2</sup> PO once per day on days 1 to 5
 
**Patients who previously received craniospinal irradiation (CSI) instead received 180 mg/m<sup>2</sup> PO once per day on days 1 to 5
 
 
'''28-day cycle for up to 11 cycles'''
 
'''28-day cycle for up to 11 cycles'''
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #2, previous craniospinal irradiation (CSI) {{#subobject:f06tf5|Variant=1}}===
 
===Regimen variant #2, previous craniospinal irradiation (CSI) {{#subobject:f06tf5|Variant=1}}===
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
!style="width: 33%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
Line 116: Line 155:
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
 
*[[Temozolomide (Temodar)]] 180 mg/m<sup>2</sup> PO once per day on days 1 to 5
 
*[[Temozolomide (Temodar)]] 180 mg/m<sup>2</sup> PO once per day on days 1 to 5
 
 
'''28-day cycle for up to 11 cycles'''
 
'''28-day cycle for up to 11 cycles'''
 
+
</div></div>
 
===References===
 
===References===
#Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH; Children's Oncology Group. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. [https://doi.org/10.1002/cncr.22961 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17705175 PubMed]
+
#Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH; Children's Oncology Group. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. [https://doi.org/10.1002/cncr.22961 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17705175/ PubMed]
 
 
=Investigational agents=
 
*[[G207]]
 
  
 
[[Category:High-grade glioma regimens]]
 
[[Category:High-grade glioma regimens]]

Latest revision as of 00:25, 4 July 2024

Section editor
Nwood.jpeg
Nicole M. Wood, DO
University of Missouri
Kansas City, MO, USA

LinkedIn

This page contains studies that are specific to pediatric populations.

  • For the more general high-grade glioma category page, follow this link.
  • For pediatric low-grade glioma (pLGG), follow this link.
4 regimens on this page
5 variants on this page


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

NCCN

Adjuvant therapy

Temozolomide & RT

Temozolomide & RT: Temozolomide & Radiation Therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Grill et al. 2018 (HERBY) 2011-2015 Randomized Phase 2 (C) Temozolomide, Bevacizumab, RT Did not meet primary endpoint of EFS

Chemotherapy

  • Temozolomide (Temodar) as follows:
    • Cycle 1 (chemoradiation): 75 mg/m2 PO or IV once per day on days 1 to 42
    • Cycles 2 to 13: 150 to 200 mg/m2 PO once per day on days 1 to 5

Radiotherapy

  • Concurrent radiation therapy as follows:
    • Cycle 1: 180 cGy fractions x 30 fractions, for a total dose of 5400 cGy

10-week course, then 28-day cycle for up to 12 cycles

References

  1. HERBY: Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Cañete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, open-label, randomized, multicenter trial (HERBY) of bevacizumab in pediatric patients with newly diagnosed high-grade glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. Epub 2018 Feb 7. link to original article contains dosing details in manuscript PubMed NCT01390948

VCP

VCP: Vincristine, CCNU (Lomustine), Prednisone

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Finlay et al. 1995 (CCG-945) 1985-1990 Phase 3 (C) 8-drug regimen Did not meet primary endpoint of OS

Note: the exact schedule of vincristine is impossible to discern from Figure 1.

Preceding treatment

Chemotherapy

Glucocorticoid therapy

42-day cycle for 8 cycles

References

  1. CCG-945: Finlay JL, Boyett JM, Yates AJ, Wisoff JH, Milstein JM, Geyer JR, Bertolone SJ, McGuire P, Cherlow JM, Tefft M, Turski PA, Wara WM, Edwards M, Sutton LN, Berger MS, Epstein F, Ayers G, Allen JC, Packer RJ; Children's Cancer Group. Randomized phase III trial in childhood high-grade astrocytoma comparing vincristine, lomustine, and prednisone with the eight-drugs-in-1-day regimen. J Clin Oncol. 1995 Jan;13(1):112-23. link to original article contains dosing details in manuscript PubMed

Vincristine & RT

Vincristine & RT: Vincristine & Radiation Therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Finlay et al. 1995 (CCG-945) 1985-1990 Phase 3 (C) 8-drug regimen Did not meet primary endpoint of OS

Preceding treatment

Chemotherapy

Radiotherapy

70-day course

Subsequent treatment

References

  1. CCG-945: Finlay JL, Boyett JM, Yates AJ, Wisoff JH, Milstein JM, Geyer JR, Bertolone SJ, McGuire P, Cherlow JM, Tefft M, Turski PA, Wara WM, Edwards M, Sutton LN, Berger MS, Epstein F, Ayers G, Allen JC, Packer RJ; Children's Cancer Group. Randomized phase III trial in childhood high-grade astrocytoma comparing vincristine, lomustine, and prednisone with the eight-drugs-in-1-day regimen. J Clin Oncol. 1995 Jan;13(1):112-23. link to original article contains dosing details in manuscript PubMed

Recurrent disease, non-curative therapy, non-randomized or retrospective data

Temozolomide monotherapy

Regimen variant #1, no radiation history

Study Dates of enrollment Evidence
Nicholson et al. 2007 1998-1999 Non-randomized

Chemotherapy

  • Temozolomide (Temodar) 150 to 200 mg/m2 PO once per day on days 1 to 5
    • Patients who previously received craniospinal irradiation (CSI) instead received 180 mg/m2 PO once per day on days 1 to 5

28-day cycle for up to 11 cycles


Regimen variant #2, previous craniospinal irradiation (CSI)

Study Dates of enrollment Evidence
Nicholson et al. 2007 1998-1999 Non-randomized

Chemotherapy

28-day cycle for up to 11 cycles

References

  1. Nicholson HS, Kretschmar CS, Krailo M, Bernstein M, Kadota R, Fort D, Friedman H, Harris MB, Tedeschi-Blok N, Mazewski C, Sato J, Reaman GH; Children's Oncology Group. Phase 2 study of temozolomide in children and adolescents with recurrent central nervous system tumors: a report from the Children's Oncology Group. Cancer. 2007 Oct 1;110(7):1542-50. link to original article contains dosing details in manuscript PubMed