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

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{| class="wikitable" style="text-align:center; width:50%;"
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<span id="BackToTop"></span>
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! colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c" |'''Section editor'''
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<div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px">
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|-
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[[#top|Back to Top]]
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| style="background-color:#F0F0F0" |[[File:SeemaNagpal.jpg|frameless|upright=0.3|center]]
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</div>
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|<big>[[User:Seemanagpal|Seema Nagpal, MD]]<br>Stanford University<br>Palo Alto, CA</big>
+
{{#lst:Editorial board transclusions|peds-neuro}}
−
|-
+
''This page contains studies that are specific to pediatric populations.  
−
|}
+
*For the more general '''low-grade glioma''' category page, follow '''[[Low-grade_glioma|this link]]'''.
−
<big>''This page contains studies that are specific to pediatric populations. For the more general low-grade glioma category page, follow [[Low-grade_glioma|this link]].</big>
+
*For '''pediatric high-grade glioma (pHGG)''', follow '''[[High-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=
 
==Carboplatin & Vincristine {{#subobject:056d2c|Regimen=1}}==
 
==Carboplatin & Vincristine {{#subobject:056d2c|Regimen=1}}==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
CV: '''<u>C</u>'''arboplatin & '''<u>V</u>'''incristine
 
CV: '''<u>C</u>'''arboplatin & '''<u>V</u>'''incristine
 
<br>VC: '''<u>V</u>'''incristine & '''<u>C</u>'''arboplatin
 
<br>VC: '''<u>V</u>'''incristine & '''<u>C</u>'''arboplatin
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #1, 175/1.5 (capped vincristine) {{#subobject:caa541|Variant=1}}===
 
===Regimen variant #1, 175/1.5 (capped vincristine) {{#subobject:caa541|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
Line 31: Line 31:
 
|-
 
|-
 
|[https://doi.org/10.1200/JCO.1993.11.5.850 Packer et al. 1993]
 
|[https://doi.org/10.1200/JCO.1993.11.5.850 Packer et al. 1993]
−
|NR
+
|Not reported
 
| style="background-color:#91cf61" |Non-randomized
 
| style="background-color:#91cf61" |Non-randomized
 
| style="background-color:#d3d3d3" |
 
| style="background-color:#d3d3d3" |
Line 38: Line 38:
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3413276/ Ater et al. 2012 (COG A9952)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3413276/ Ater et al. 2012 (COG A9952)]
 
|1997-2005
 
|1997-2005
−
| style="background-color:#1a9851" |Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
 
|[[Stub#TPCV|TPCV]]
 
|[[Stub#TPCV|TPCV]]
−
| style="background-color:#ffffbf" |Did not meet primary endpoints of EFS/OS
+
| style="background-color:#ffffbf" |Did not meet co-primary endpoints of EFS/OS
 
|-
 
|-
 
|}
 
|}
−
''Note that the cycle begins on day 0.''
+
''Note: The course begins on day 0.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*[[Surgery#CNS_cancer_surgery|Biopsy or incomplete resection]]
 
*[[Surgery#CNS_cancer_surgery|Biopsy or incomplete resection]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Carboplatin (Paraplatin)]] 175 mg/m<sup>2</sup> IV once per day on days 0, 7, 14, 21, 42, 49, 56, 63
 
*[[Carboplatin (Paraplatin)]] 175 mg/m<sup>2</sup> IV once per day on days 0, 7, 14, 21, 42, 49, 56, 63
 
*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63
 
*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63
−
 
 
'''10-week course'''
 
'''10-week course'''
−
 
+
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 
====Subsequent treatment====
 
====Subsequent treatment====
−
*CV maintenance
+
*[[#Carboplatin_.26_Vincristine_2|CV]] consolidation
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #2, 550/1.5 (uncapped vincristine) {{#subobject:31a2e6|Variant=1}}===
 
===Regimen variant #2, 550/1.5 (uncapped vincristine) {{#subobject:31a2e6|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
Line 65: Line 69:
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5517338/ Gnekow et al. 2017 (SIOP-LCG 2004)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5517338/ Gnekow et al. 2017 (SIOP-LCG 2004)]
 
|2004-2012
 
|2004-2012
−
| style="background-color:#1a9851" |Phase III (C)
+
| style="background-color:#1a9851" |Phase 3 (C)
 
|[[Stub#VCE|VCE]]
 
|[[Stub#VCE|VCE]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
 
*[[Surgery#CNS_cancer_surgery|Biopsy or incomplete resection]]
 
*[[Surgery#CNS_cancer_surgery|Biopsy or incomplete resection]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Carboplatin (Paraplatin)]] 550 mg/m<sup>2</sup> IV over 60 minutes once on day 1
+
*[[Carboplatin (Paraplatin)]] as follows:
 +
**Cycles 1 to 4: 550 mg/m<sup>2</sup> IV over 60 minutes once on day 1
 +
**Cycles 5 to 7: 550 mg/m<sup>2</sup> IV over 60 minutes once on day 1
 
*[[Vincristine (Oncovin)]] as follows:
 
*[[Vincristine (Oncovin)]] as follows:
 
**Cycles 1 to 4: 1.5 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
**Cycles 1 to 4: 1.5 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 
**Cycles 5 to 7: 1.5 mg/m<sup>2</sup> IV once on day 1
 
**Cycles 5 to 7: 1.5 mg/m<sup>2</sup> IV once on day 1
−
 
 
'''21-day cycle for 4 cycles, then 28-day cycle for 3 cycles'''
 
'''21-day cycle for 4 cycles, then 28-day cycle for 3 cycles'''
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
 +
====Subsequent treatment====
 +
*[[#Carboplatin_.26_Vincristine_2|CV]] consolidation
 +
</div></div>
  
−
====Subsequent treatment====
+
===References===
−
*VC consolidation
+
# Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, Phillips PC, Ryan J, Boyett JM, Geyer R, Finlay J. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. [https://doi.org/10.1200/JCO.1993.11.5.850 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/8487049/ PubMed]
 +
# '''COG A9952:''' Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. Epub 2012 Jun 4. [https://doi.org/10.1200/JCO.2011.36.6054 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3413276/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/22665535/ PubMed] [https://clinicaltrials.gov/study/NCT00002944 NCT00002944]
 +
# '''SIOP-LGG 2004:''' Gnekow AK, Walker DA, Kandels D, Picton S, Perilongo G, Grill J, Stokland T, Sandstrom PE, Warmuth-Metz M, Pietsch T, Giangaspero F, Schmidt R, Faldum A, Kilmartin D, De Paoli A, De Salvo GL; of the Low Grade Glioma Consortium and the participating centers. A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (≤16 years) low grade glioma - a final report. Eur J Cancer. 2017 Aug;81:206-225. Epub 2017 Jun 22. Erratum in: Eur J Cancer. 2017 Dec 13;:. [https://doi.org/10.1016/j.ejca.2017.04.019 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5517338/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/28649001/ PubMed] EudraCT 2005-005377-29
 +
# '''LOGGIC/​FIREFLY-2:''' [https://clinicaltrials.gov/study/NCT05566795 NCT05566795]
  
 +
=Consolidation after adjuvant therapy=
 +
==Carboplatin & Vincristine {{#subobject:05jcn4|Regimen=1}}==
 +
CV: '''<u>C</u>'''arboplatin & '''<u>V</u>'''incristine
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #1, 8 cycles {{#subobject:38uve6|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 +
!style="width: 33%"|Study
 +
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3413276/ Ater et al. 2012 (COG A9952)]
 +
|1997-2005
 +
| style="background-color:#91cf61" |Non-randomized part of phase 3 RCT
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*Adjuvant [[#Carboplatin_.26_Vincristine|CV]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Carboplatin (Paraplatin)]] 175 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22
 +
*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 1, 8, 15
 +
'''42-day cycle for 8 cycles'''
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #2, 10 cycles {{#subobject:3yrwe6|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 +
!style="width: 33%"|Study
 +
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5517338/ Gnekow et al. 2017 (SIOP-LCG 2004)]
 +
|2004-2012
 +
| style="background-color:#91cf61" |Non-randomized part of phase 3 RCT
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*Adjuvant [[#Carboplatin_.26_Vincristine|CV]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Carboplatin (Paraplatin)]] 550 mg/m<sup>2</sup> IV once on day 1
 +
*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> IV once per day on days 1, 8, 15
 +
'''42-day cycle for 10 cycles'''
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #3, 12 cycles {{#subobject:38uv12|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 +
!style="width: 33%"|Study
 +
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://doi.org/10.1200/JCO.1993.11.5.850 Packer et al. 1993]
 +
|Not reported
 +
| style="background-color:#91cf61" |Non-randomized
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*Adjuvant [[#Carboplatin_.26_Vincristine|CV]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Carboplatin (Paraplatin)]] 175 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22
 +
*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 1, 8, 15
 +
'''42-day cycle for 12 cycles'''
 +
</div></div>
 
===References===
 
===References===
−
# Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, Phillips PC, Ryan J, Boyett JM, Geyer R, Finlay J. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. [https://doi.org/10.1200/JCO.1993.11.5.850 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/8487049 PubMed]
+
# Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, Phillips PC, Ryan J, Boyett JM, Geyer R, Finlay J. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. [https://doi.org/10.1200/JCO.1993.11.5.850 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/8487049/ PubMed]
−
# '''COG A9952:''' Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. Epub 2012 Jun 4. [https://doi.org/10.1200/JCO.2011.36.6054 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3413276/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/22665535 PubMed]
+
# '''COG A9952:''' Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. Epub 2012 Jun 4. [https://doi.org/10.1200/JCO.2011.36.6054 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3413276/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/22665535/ PubMed] [https://clinicaltrials.gov/study/NCT00002944 NCT00002944]
−
# '''SIOP-LGG 2004:''' Gnekow AK, Walker DA, Kandels D, Picton S, Perilongo G, Grill J, Stokland T, Sandstrom PE, Warmuth-Metz M, Pietsch T, Giangaspero F, Schmidt R, Faldum A, Kilmartin D, De Paoli A, De Salvo GL; of the Low Grade Glioma Consortium and the participating centers. A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (≤16 years) low grade glioma - a final report. Eur J Cancer. 2017 Aug;81:206-225. Epub 2017 Jun 22. Erratum in: Eur J Cancer. 2017 Dec 13;:. [https://www.ejcancer.com/article/S0959-8049(17)30921-8/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5517338/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28649001 PubMed]
+
# '''SIOP-LGG 2004:''' Gnekow AK, Walker DA, Kandels D, Picton S, Perilongo G, Grill J, Stokland T, Sandstrom PE, Warmuth-Metz M, Pietsch T, Giangaspero F, Schmidt R, Faldum A, Kilmartin D, De Paoli A, De Salvo GL; of the Low Grade Glioma Consortium and the participating centers. A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (≤16 years) low grade glioma - a final report. Eur J Cancer. 2017 Aug;81:206-225. Epub 2017 Jun 22. Erratum in: Eur J Cancer. 2017 Dec 13;:. [https://doi.org/10.1016/j.ejca.2017.04.019 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5517338/ link to PMC article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/28649001/ PubMed]
  
 
=Recurrent or progressive, non-curative therapy=
 
=Recurrent or progressive, non-curative therapy=
−
==Cisplatin & Etoposide (EP) {{#subobject:3a5f3f|Regimen=1}}==
+
==Carboplatin & Vincristine {{#subobject:0jjd2c|Regimen=1}}==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:cuhh41|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/10.1056/nejmoa2303815 Bouffet et al. 2023 (TADPOLE)]
 +
|2017-2021
 +
| style="background-color:#1a9851" |Randomized Phase 2 (C)
 +
|[[#Dabrafenib_.26_Trametinib|Dabrafenib & Trametinib]]
 +
| style="background-color:#d73027" |Inferior ORR
 
|-
 
|-
−
|[[#top|back to top]]
 
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#fdcdac">
 +
====Biomarker eligibility criteria====
 +
*BRAF V600 mutation
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Carboplatin (Paraplatin)]] 175 mg/m<sup>2</sup> IV once per day on days 0, 7, 14, 21, 42, 49, 56, 63
 +
*[[Vincristine (Oncovin)]] 1.5 mg/m<sup>2</sup> (maximum dose of 2 mg) IV once per day on days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63
 +
'''10-week course'''
 +
</div></div>
 +
===References===
 +
#'''TADPOLE:''' Bouffet E, Hansford JR, Garrè ML, Hara J, Plant-Fox A, Aerts I, Locatelli F, van der Lugt J, Papusha L, Sahm F, Tabori U, Cohen KJ, Packer RJ, Witt O, Sandalic L, Bento Pereira da Silva A, Russo M, Hargrave DR. Dabrafenib plus Trametinib in Pediatric Glioma with BRAF V600 Mutations. N Engl J Med. 2023 Sep 21;389(12):1108-1120. [https://doi.org/10.1056/nejmoa2303815 link to original article] '''does not contain dosing details in manuscript; refers to COG A9952''' [https://pubmed.ncbi.nlm.nih.gov/37733309/ PubMed] [https://clinicaltrials.gov/study/NCT02684058 NCT02684058]
 +
 +
==Cisplatin & Etoposide (EP) {{#subobject:3a5f3f|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:55de5f|Variant=1}}===
 
===Regimen {{#subobject:55de5f|Variant=1}}===
−
{| class="wikitable" style="width: 50%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
 
|[https://doi.org/10.1007/s11060-010-0136-6 Massimino et al. 2010]
 
|[https://doi.org/10.1007/s11060-010-0136-6 Massimino et al. 2010]
 +
|2001-11 to 2007-12
 
|style="background-color:#91cf61"|Non-randomized
 
|style="background-color:#91cf61"|Non-randomized
 
|-
 
|-
 
|}
 
|}
 
''Note: In children less than 1 year old or less than 10 kg, "doses were adjusted to their weight"--reference does not say exactly how doses are adjusted.''
 
''Note: In children less than 1 year old or less than 10 kg, "doses were adjusted to their weight"--reference does not say exactly how doses are adjusted.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 to 3, '''given first'''
 
*[[Cisplatin (Platinol)]] 25 mg/m<sup>2</sup> IV over 2 hours once per day on days 1 to 3, '''given first'''
 
*[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 3, '''given second'''
 
*[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 3, '''given second'''
−
 
+
====Supportive therapy====
−
====Supportive medications====
 
 
*Hydration for 2 hours before chemotherapy, and for 2 hours after chemotherapy
 
*Hydration for 2 hours before chemotherapy, and for 2 hours after chemotherapy
 +
'''28-day cycle for 4 cycles, then 35-day cycle for 3 cycles, then 42-day cycle for 3 cycles'''
 +
</div></div>
 +
===References===
 +
# Massimino M, Spreafico F, Riva D, Biassoni V, Poggi G, Solero C, Gandola L, Genitori L, Modena P, Simonetti F, Potepan P, Casanova M, Meazza C, Clerici CA, Catania S, Sardi I, Giangaspero F. A lower-dose, lower-toxicity cisplatin-etoposide regimen for childhood progressive low-grade glioma. J Neurooncol. 2010 Oct;100(1):65-71. Epub 2010 Feb 12. [https://doi.org/10.1007/s11060-010-0136-6 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/20151174/ PubMed]
  
−
'''28-day cycle for 4 cycles, then 35-day cycle for 3 cycles, then 42-day cycle for 3 cycles'''
+
==Dabrafenib & Trametinib {{#subobject:7d3694|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:23212f|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/10.1056/nejmoa2303815 Bouffet et al. 2023 (TADPOLE)]
 +
|2017-2021
 +
| style="background-color:#1a9851" |Randomized Phase 2 (E-RT-switch-ooc)
 +
|[[#Carboplatin_.26_Vincristine_3|Carboplatin & Vincristine]]
 +
| style="background-color:#1a9850" |Superior ORR (primary endpoint)<br>ORR: 47% vs 11%<br>(RR 4.31, 95% CI 1.7-11.2)
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#fdcdac">
 +
====Biomarker eligibility criteria====
 +
*BRAF V600 mutation
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted therapy====
 +
*[[Dabrafenib (Tafinlar)]] by the following age-based criteria:
 +
**Less than 12 years old: 2.625 mg/kg PO twice per day
 +
**12 years or older: 2.25 mg/kg PO twice per day
 +
*[[Trametinib (Mekinist)]] by the following age-based criteria:
 +
**Less than 6 years old: 0.032 mg/kg PO once per day
 +
**6 years or older: 0.025 mg/kg PO once per day
 +
'''Continued indefinitely'''
 +
</div></div>
  
 
===References===
 
===References===
−
# Massimino M, Spreafico F, Riva D, Biassoni V, Poggi G, Solero C, Gandola L, Genitori L, Modena P, Simonetti F, Potepan P, Casanova M, Meazza C, Clerici CA, Catania S, Sardi I, Giangaspero F. A lower-dose, lower-toxicity cisplatin-etoposide regimen for childhood progressive low-grade glioma. J Neurooncol. 2010 Oct;100(1):65-71. Epub 2010 Feb 12. [https://doi.org/10.1007/s11060-010-0136-6 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/20151174 PubMed]
+
#'''TADPOLE:''' Bouffet E, Hansford JR, Garrè ML, Hara J, Plant-Fox A, Aerts I, Locatelli F, van der Lugt J, Papusha L, Sahm F, Tabori U, Cohen KJ, Packer RJ, Witt O, Sandalic L, Bento Pereira da Silva A, Russo M, Hargrave DR. Dabrafenib plus Trametinib in Pediatric Glioma with BRAF V600 Mutations. N Engl J Med. 2023 Sep 21;389(12):1108-1120. [https://doi.org/10.1056/nejmoa2303815 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/37733309/ PubMed] [https://clinicaltrials.gov/study/NCT02684058 NCT02684058]
  
 
==Temozolomide monotherapy {{#subobject:7b66b|Regimen=1}}==
 
==Temozolomide monotherapy {{#subobject:7b66b|Regimen=1}}==
−
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#eeeeee">
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
 
===Regimen variant #1 {{#subobject:4fe4rl|Variant=1}}===
 
===Regimen variant #1 {{#subobject:4fe4rl|Variant=1}}===
−
{| class="wikitable" style="width: 50%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
−
!style="width: 25%"|Study
+
!style="width: 33%"|Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://onlinelibrary.wiley.com/doi/10.1002/cncr.22961/full Nicholson et al. 2007]
+
|[https://doi.org/10.1002/cncr.22961 Nicholson et al. 2007]
 +
|1998-1999
 
|style="background-color:#91cf61"|Non-randomized
 
|style="background-color:#91cf61"|Non-randomized
 
|-
 
|-
 
|}
 
|}
 
''Note: This dosing is for patients who previously received craniospinal irradiation (CSI).''
 
''Note: This dosing is for patients who previously received craniospinal irradiation (CSI).''
 +
<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 11 cycles'''
 
'''28-day cycle for 11 cycles'''
−
 
+
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #2 {{#subobject:4fe632|Variant=1}}===
 
===Regimen variant #2 {{#subobject:4fe632|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]]
 
|-
 
|-
−
|[https://onlinelibrary.wiley.com/doi/10.1002/cncr.22961/full Nicholson et al. 2007]
+
|[https://doi.org/10.1002/cncr.22961 Nicholson et al. 2007]
 
|1998-1999
 
|1998-1999
 
|style="background-color:#91cf61"|Non-randomized
 
|style="background-color:#91cf61"|Non-randomized
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Temozolomide (Temodar)]] 200 mg/m<sup>2</sup> PO once per day on days 1 to 5
 
*[[Temozolomide (Temodar)]] 200 mg/m<sup>2</sup> PO once per day on days 1 to 5
 +
'''28-day cycle for 11 cycles'''
 +
</div></div>
 +
===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] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/17705175/ PubMed]
  
−
'''28-day cycle for 11 cycles'''
+
==Tovorafenib monotherapy {{#subobject:7toc23b|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:boc4rl|Variant=1}}===
 +
{| class="wikitable" style="color:white; background-color:#404040"
 +
|<small>'''FDA-recommended dose'''</small>
 +
|-
 +
|}
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 +
!style="width: 33%"|Study
 +
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://clinicaltrials.gov/study/NCT04775485 Awaiting publication (FIREFLY-1)]
 +
|2021-2022
 +
|style="background-color:#91cf61"|Phase 2 (RT)
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#fdcdac">
 +
====Biomarker eligibility criteria====
 +
*BRAF alteration
 +
====Prior treatment criteria====
 +
*At least one line of prior systemic therapy
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted therapy====
 +
*[[Tovorafenib (Ojemda)]] 380 mg/m<sup>2</sup> (maximum dose of 600 mg) PO once on day 1
 +
'''7-day 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://onlinelibrary.wiley.com/doi/10.1002/cncr.22961/full link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/17705175 PubMed]
+
#'''FIREFLY-1:''' [https://clinicaltrials.gov/study/NCT04775485 NCT04775485]
  
 
[[Category:Low-grade glioma regimens]]
 
[[Category:Low-grade glioma regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Low-grade gliomas]]
 
[[Category:Low-grade gliomas]]
−
[[Category:Pediatric cancers]]
+
[[Category:Pediatric neurologic neoplasms]]

Latest revision as of 23:49, 20 July 2024

Back to Top

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 low-grade glioma category page, follow this link.
  • For pediatric high-grade glioma (pHGG), follow this link.
7 regimens on this page
11 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

Carboplatin & Vincristine

CV: Carboplatin & Vincristine
VC: Vincristine & Carboplatin

Regimen variant #1, 175/1.5 (capped vincristine)

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Packer et al. 1993 Not reported Non-randomized
Ater et al. 2012 (COG A9952) 1997-2005 Phase 3 (C) TPCV Did not meet co-primary endpoints of EFS/OS

Note: The course begins on day 0.

Preceding treatment

Chemotherapy

10-week course

Subsequent treatment

  • CV consolidation


Regimen variant #2, 550/1.5 (uncapped vincristine)

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Gnekow et al. 2017 (SIOP-LCG 2004) 2004-2012 Phase 3 (C) VCE Did not meet primary endpoint of PFS

Preceding treatment

Chemotherapy

  • Carboplatin (Paraplatin) as follows:
    • Cycles 1 to 4: 550 mg/m2 IV over 60 minutes once on day 1
    • Cycles 5 to 7: 550 mg/m2 IV over 60 minutes once on day 1
  • Vincristine (Oncovin) as follows:
    • Cycles 1 to 4: 1.5 mg/m2 IV once per day on days 1, 8, 15
    • Cycles 5 to 7: 1.5 mg/m2 IV once on day 1

21-day cycle for 4 cycles, then 28-day cycle for 3 cycles

Subsequent treatment

  • CV consolidation

References

  1. Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, Phillips PC, Ryan J, Boyett JM, Geyer R, Finlay J. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. link to original article dosing details in manuscript have been reviewed by our editors PubMed
  2. COG A9952: Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. Epub 2012 Jun 4. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT00002944
  3. SIOP-LGG 2004: Gnekow AK, Walker DA, Kandels D, Picton S, Perilongo G, Grill J, Stokland T, Sandstrom PE, Warmuth-Metz M, Pietsch T, Giangaspero F, Schmidt R, Faldum A, Kilmartin D, De Paoli A, De Salvo GL; of the Low Grade Glioma Consortium and the participating centers. A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (≤16 years) low grade glioma - a final report. Eur J Cancer. 2017 Aug;81:206-225. Epub 2017 Jun 22. Erratum in: Eur J Cancer. 2017 Dec 13;:. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed EudraCT 2005-005377-29
  4. LOGGIC/​FIREFLY-2: NCT05566795

Consolidation after adjuvant therapy

Carboplatin & Vincristine

CV: Carboplatin & Vincristine

Regimen variant #1, 8 cycles

Study Dates of enrollment Evidence
Ater et al. 2012 (COG A9952) 1997-2005 Non-randomized part of phase 3 RCT

Preceding treatment

  • Adjuvant CV

Chemotherapy

42-day cycle for 8 cycles


Regimen variant #2, 10 cycles

Study Dates of enrollment Evidence
Gnekow et al. 2017 (SIOP-LCG 2004) 2004-2012 Non-randomized part of phase 3 RCT

Preceding treatment

  • Adjuvant CV

Chemotherapy

42-day cycle for 10 cycles


Regimen variant #3, 12 cycles

Study Dates of enrollment Evidence
Packer et al. 1993 Not reported Non-randomized

Preceding treatment

  • Adjuvant CV

Chemotherapy

42-day cycle for 12 cycles

References

  1. Packer RJ, Lange B, Ater J, Nicholson HS, Allen J, Walker R, Prados M, Jakacki R, Reaman G, Needles MN, Phillips PC, Ryan J, Boyett JM, Geyer R, Finlay J. Carboplatin and vincristine for recurrent and newly diagnosed low-grade gliomas of childhood. J Clin Oncol. 1993 May;11(5):850-6. link to original article dosing details in manuscript have been reviewed by our editors PubMed
  2. COG A9952: Ater JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. Epub 2012 Jun 4. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT00002944
  3. SIOP-LGG 2004: Gnekow AK, Walker DA, Kandels D, Picton S, Perilongo G, Grill J, Stokland T, Sandstrom PE, Warmuth-Metz M, Pietsch T, Giangaspero F, Schmidt R, Faldum A, Kilmartin D, De Paoli A, De Salvo GL; of the Low Grade Glioma Consortium and the participating centers. A European randomised controlled trial of the addition of etoposide to standard vincristine and carboplatin induction as part of an 18-month treatment programme for childhood (≤16 years) low grade glioma - a final report. Eur J Cancer. 2017 Aug;81:206-225. Epub 2017 Jun 22. Erratum in: Eur J Cancer. 2017 Dec 13;:. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed

Recurrent or progressive, non-curative therapy

Carboplatin & Vincristine

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Bouffet et al. 2023 (TADPOLE) 2017-2021 Randomized Phase 2 (C) Dabrafenib & Trametinib Inferior ORR

Biomarker eligibility criteria

  • BRAF V600 mutation

Chemotherapy

10-week course

References

  1. TADPOLE: Bouffet E, Hansford JR, Garrè ML, Hara J, Plant-Fox A, Aerts I, Locatelli F, van der Lugt J, Papusha L, Sahm F, Tabori U, Cohen KJ, Packer RJ, Witt O, Sandalic L, Bento Pereira da Silva A, Russo M, Hargrave DR. Dabrafenib plus Trametinib in Pediatric Glioma with BRAF V600 Mutations. N Engl J Med. 2023 Sep 21;389(12):1108-1120. link to original article does not contain dosing details in manuscript; refers to COG A9952 PubMed NCT02684058

Cisplatin & Etoposide (EP)

Regimen

Study Dates of enrollment Evidence
Massimino et al. 2010 2001-11 to 2007-12 Non-randomized

Note: In children less than 1 year old or less than 10 kg, "doses were adjusted to their weight"--reference does not say exactly how doses are adjusted.

Chemotherapy

Supportive therapy

  • Hydration for 2 hours before chemotherapy, and for 2 hours after chemotherapy

28-day cycle for 4 cycles, then 35-day cycle for 3 cycles, then 42-day cycle for 3 cycles

References

  1. Massimino M, Spreafico F, Riva D, Biassoni V, Poggi G, Solero C, Gandola L, Genitori L, Modena P, Simonetti F, Potepan P, Casanova M, Meazza C, Clerici CA, Catania S, Sardi I, Giangaspero F. A lower-dose, lower-toxicity cisplatin-etoposide regimen for childhood progressive low-grade glioma. J Neurooncol. 2010 Oct;100(1):65-71. Epub 2010 Feb 12. link to original article dosing details in manuscript have been reviewed by our editors PubMed

Dabrafenib & Trametinib

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Bouffet et al. 2023 (TADPOLE) 2017-2021 Randomized Phase 2 (E-RT-switch-ooc) Carboplatin & Vincristine Superior ORR (primary endpoint)
ORR: 47% vs 11%
(RR 4.31, 95% CI 1.7-11.2)

Biomarker eligibility criteria

  • BRAF V600 mutation

Targeted therapy

  • Dabrafenib (Tafinlar) by the following age-based criteria:
    • Less than 12 years old: 2.625 mg/kg PO twice per day
    • 12 years or older: 2.25 mg/kg PO twice per day
  • Trametinib (Mekinist) by the following age-based criteria:
    • Less than 6 years old: 0.032 mg/kg PO once per day
    • 6 years or older: 0.025 mg/kg PO once per day

Continued indefinitely

References

  1. TADPOLE: Bouffet E, Hansford JR, Garrè ML, Hara J, Plant-Fox A, Aerts I, Locatelli F, van der Lugt J, Papusha L, Sahm F, Tabori U, Cohen KJ, Packer RJ, Witt O, Sandalic L, Bento Pereira da Silva A, Russo M, Hargrave DR. Dabrafenib plus Trametinib in Pediatric Glioma with BRAF V600 Mutations. N Engl J Med. 2023 Sep 21;389(12):1108-1120. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT02684058

Temozolomide monotherapy

Regimen variant #1

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

Note: This dosing is for patients who previously received craniospinal irradiation (CSI).

Chemotherapy

28-day cycle for 11 cycles


Regimen variant #2

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

Chemotherapy

28-day cycle for 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 dosing details in manuscript have been reviewed by our editors PubMed

Tovorafenib monotherapy

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence
Awaiting publication (FIREFLY-1) 2021-2022 Phase 2 (RT)

Biomarker eligibility criteria

  • BRAF alteration

Prior treatment criteria

  • At least one line of prior systemic therapy

Targeted therapy

7-day cycles

References

  1. FIREFLY-1: NCT04775485
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