Difference between revisions of "Neuroblastoma - historical"
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− | {{#lst: | + | {{#lst:Editorial board transclusions|peds-neuro}} |
− | + | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the [[Neuroblastoma|main neuroblastoma page]] for current regimens. | |
− | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only | ||
− | |||
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− | + | =High-risk, upfront therapy= | |
− | =High | ||
==COG ANBL0532 Regimen A== | ==COG ANBL0532 Regimen A== | ||
− | ===Induction | + | <div class="toccolours" style="background-color:#c8a2c8"> |
− | + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | |
− | ====Chemotherapy, | + | !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://www.ncbi.nlm.nih.gov/pmc/articles/pmc6714031/ Park et al. 2019 (COG ANBL0532)] | ||
+ | | | ||
+ | | style="background-color:#1a9851" |Phase 3 (C) | ||
+ | |[[Neuroblastoma#COG_ANBL0532_Regimen_B|COG ANBL0532 Regimen B]] | ||
+ | | style="background-color:#d73027" |Inferior EFS | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Induction=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy, CPM + TOPO portion (cycles 1 & 2)==== | ||
+ | *[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | ||
+ | **12 kg or less: 13.3 mg/kg iV over 30 to 60 minutes once per day on days 1 to 5 | ||
+ | **More than 12 kg: 400 mg/m<sup>2</sup> IV over 30 to 60 minutes once per day on days 1 to 5 | ||
+ | *[[Topotecan (Hycamtin)]] 1.2 mg/m<sup>2</sup> IV over 30 minutes once per day on days 1 to 5 | ||
+ | ====Supportive therapy, CPM + TOPO portion (cycles 1 & 2)==== | ||
+ | *[[Filgrastim (Neupogen)]] as follows: | ||
+ | **Cycle 1: 5 mcg/kg SC or IV once per day, beginning 24 hours after completion of chemotherapy and continuing until ANC greater than 1000/μL | ||
+ | **Cycle 2: 5 mcg/kg SC or IV once per day, beginning 24 hours after completion of chemotherapy and continuing until ANC greater than 1000/μL, then 10 mcg/kg SC or IV once per day until PBSC harvest is complete | ||
+ | ***PBSC harvest on day 14 | ||
+ | ====Chemotherapy, EP portion (cycles 3 & 5)==== | ||
+ | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
+ | **12 kg or less: 1.66 mg/kg IV over 1 hour once per day on days 1 to 4 | ||
+ | **More than 12 kg: 50 mg/m<sup>2</sup> IV over 1 hour once per day on days 1 to 4 | ||
+ | *[[Etoposide (Vepesid)]] by the following weight-based criteria: | ||
+ | **12 kg or less: 6.67 mg/kg IV over 1 hour once per day on days 1 to 3 | ||
+ | **More than 12 kg: 200 mg/m<sup>2</sup> IV over 1 hour once per day on days 1 to 3 | ||
+ | ====Chemotherapy, CAV portion (cycles 4 & 6)==== | ||
*[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 70 mg/kg iV over 6 hours once per day on days 1 to 2 |
− | **> 12 kg: | + | **More than 12 kg: 2100 mg/m<sup>2</sup> IV over 6 hours once per day on days 1 to 2 |
− | + | *[[Vincristine (Oncovin)]] by the following age- and weight-based criteria: | |
− | *[[ | + | **Younger than 12 months old: 0.017 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 1 to 3, given prior to doxorubicin (infusion time per institutional policy) |
− | + | **12 months old or older AND more than 12 kg: 0.097 mg/m<sup>2</sup> or 0.022 mg/kg (choose lower dose) (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 1 to 3, given prior to doxorubicin (infusion time per institutional policy) | |
− | ''' | + | **12 months old or older AND 12 kg or less: 0.022 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 1 to 3, given prior to doxorubicin (infusion time per institutional policy) |
− | + | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | |
− | ====Chemotherapy | + | **12 kg or less: 0.83 mg/kg iV over 24 hours once per day on days 1 to 3 |
+ | **More than 12 kg: 25 mg/m<sup>2</sup> IV over 24 hours once per day on days 1 to 3 | ||
+ | ====Supportive therapy, CAV portion (cycles 4 & 6)==== | ||
+ | *[[Mesna (Mesnex)]] by the following weight-based criteria: | ||
+ | **12 kg or less: 14 mg/kg IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion | ||
+ | **More than 12 kg: 420 mg/m<sup>2</sup> IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion | ||
+ | '''21-day cycle for 6 cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Consolidation, single autologous HSCT=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Melphalan (Alkeran)]] by the following laboratory- and weight-based criteria: | ||
+ | **12 kg or less AND GFR 100 mL/min or more: 2.3 mg/kg IV over 15 to 30 minutes once per day on days -7, -6, -5 | ||
+ | **More than 12 kg and GFR 100 mL/min or more: 70 mg/m<sup>2</sup> IV over 15 to 30 minutes once per day on days -7, -6, -5 | ||
+ | **12 kg or less and GFR 60 up to 100 mL/min: 2 mg/kg IV over 15 to 30 minutes once per day on days -7, -6, -5 | ||
+ | **More than 12 kg and GFR 60 up to 100 mL/min: 60 mg/m<sup>2</sup> IV over 15 to 30 minutes once per day on days -7, -6, -5 | ||
+ | *[[Etoposide (Vepesid)]] by the following laboratory- and weight-based criteria: | ||
+ | **12 kg or less AND GFR 100 mL/min or more: 11.3 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **More than 12 kg and GFR 100 mL/min or more: 338 mg/m<sup>2</sup> IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **12 kg or less and GFR 60 up to 100 mL/min: 6.7 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **More than 12 kg and GFR 60 up to 100 mL/min: 200 mg/m<sup>2</sup> IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | *[[Carboplatin (Paraplatin)]] by the following laboratory- and weight-based criteria: | ||
+ | **12 kg or less AND GFR 100 mL/min or more: 14.2 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **More than 12 kg and GFR 100 mL/min or more: 425 mg/m<sup>2</sup> IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **12 kg or less and GFR 60 up to 100 mL/min: 4.1 AUC using Calvert Formula (Max Dose = 300 mg/m<sup>2</sup>) IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **More than 12 kg and GFR 60 up to 100 mL/min: Use the lowest of either 4.1 AUC using Calvert Formula or 10 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | *PBSC on day 0 | ||
+ | ====Supportive therapy,==== | ||
+ | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV once per day starting on day 0 and continuing until post-nadir ANC greater than 2000/μL for 3 consecutive days | ||
+ | '''36-day course''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Maintenance=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Isotretinoin (Accutane)]] by the following weight-based criteria: | ||
+ | **12 kg or less: 5.33 mg/kg (Round dose to nearest 10 mg) PO twice per day on days 1 to 14 | ||
+ | **More than 12 kg: 160 mg/m<sup>2</sup> (Round dose to nearest 10 mg) PO twice per day on days 1 to 14 | ||
+ | '''28-day cycle for 6 cycles''' | ||
+ | </div></div></div> | ||
+ | ===References=== | ||
+ | #'''COG ANBL0532:''' Park JR, Kreissman SG, London WB, Naranjo A, Cohn SL, Hogarty MD, Tenney SC, Haas-Kogan D, Shaw PJ, Kraveka JM, Roberts SS, Geiger JD, Doski JJ, Voss SD, Maris JM, Grupp SA, Diller L. Effect of Tandem Autologous Stem Cell Transplant vs Single Transplant on Event-Free Survival in Patients With High-Risk Neuroblastoma: A Randomized Clinical Trial. JAMA. 2019 Aug 27;322(8):746-755. [https://doi.org/10.1001/jama.2019.11642 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6714031/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/31454045/ PubMed] [https://clinicaltrials.gov/study/NCT00567567 NCT00567567] | ||
+ | ==COG ANBL 0032 Regimen A== | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Post-consolidation, Study Phase=== | ||
+ | {| 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/PMC3086629/ Yu et al. 2010 (COG ANBL0032)] | ||
+ | |2001-2009 | ||
+ | | style="background-color:#91cf61" |Non-randomized part of phase 3 RCT | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Isotretinoin (Accutane)]] by the following weight-based criteria: | ||
+ | **More than 12 kg: 80 mg/m<sup>2</sup> (round to nearest 10 mg) PO twice per day on days 11 to 24 | ||
+ | **12 kg or less: 2.67 mg/kg (round to nearest 10 mg) PO twice per day on days 11 to 24 | ||
+ | '''25-day cycle for 6 cycles''' | ||
+ | </div></div> | ||
+ | ===References=== | ||
+ | # '''COG ANBL0032:''' Yu AL, Gilman AL, Ozkaynak MF, London WB, Kreissman SG, Chen HX, Smith M, Anderson B, Villablanca JG, Matthay KK, Shimada H, Grupp SA, Seeger R, Reynolds CP, Buxton A, Reisfeld RA, Gillies SD, Cohn SL, Maris JM, Sondel PM; Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1324-34. [https://doi.org/10.1056/NEJMoa0911123 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3086629/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20879881/ PubMed] [https://clinicaltrials.gov/study/NCT00026312 NCT00026312] | ||
+ | ##'''Update:''' Yu AL, Gilman AL, Ozkaynak MF, Naranjo A, Diccianni MB, Gan J, Hank JA, Batova A, London WB, Tenney SC, Smith M, Shulkin BL, Parisi M, Matthay KK, Cohn SL, Maris JM, Bagatell R, Park JR, Sondel PM. Long-Term Follow-up of a Phase III Study of ch14.18 (Dinutuximab) + Cytokine Immunotherapy in Children with High-Risk Neuroblastoma: COG Study ANBL0032. Clin Cancer Res. 2021 Apr 15;27(8):2179-2189. Epub 2021 Jan 27. [https://doi.org/10.1158/1078-0432.ccr-20-3909 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8046731/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33504555/ PubMed] | ||
+ | ==COG A3973 with Myeloablative Therapy== | ||
+ | <div class="toccolours" style="background-color:#c8a2c8"> | ||
+ | {| 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/PMC3963485/ Kreissman et al. 2013 (COG A3973)] | ||
+ | |2001-2006 | ||
+ | | style="background-color:#91cf61" |Non-randomized part of phase 3 RCT | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: PBSC Harvest occurs on Week 6 of treatment (cycle 2).'' | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Induction=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy, CAV portion (cycles 1, 2, 4, 6)==== | ||
+ | *[[Vincristine (Oncovin)]] by the following age- and weight-based criteria: | ||
+ | **Younger than 12 months old: 0.017 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy) | ||
+ | **12 months old or older AND more than 12 kg: 0.67 mg/m<sup>2</sup> or 0.022 mg/kg (choose lower dose) (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy) | ||
+ | **12 months old or older AND 12 kg or less: 0.022 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy) | ||
*[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 70 mg/kg IV over 6 hours once per day on days 0, 1 |
− | ** | + | **More than 12 kg: 2100 mg/m<sup>2</sup> IV over 6 hours once per day on days 0, 1 |
− | + | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | |
− | *[[ | + | **12 kg or less: 0.83 mg/kg IV over 24 hours once per day on days 0 to 2 |
− | + | **More than 12 kg: 25 mg/m<sup>2</sup> IV over 24 hours once per day on days 0 to 2 | |
− | + | ====Supportive therapy, CAV portion (cycles 1, 2, 4, 6)==== | |
− | + | *[[Mesna (Mesnex)]] by the following weight-based criteria: | |
− | ====Supportive | + | **12 kg or less: 10 mg/kg IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion on days 0, 1 |
− | + | **More than 12 kg: 420 mg/m<sup>2</sup> IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 3, 6, and 9 hours after each cyclophosphamide infusion on days 0, 1 | |
− | *[[ | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV once per day starting on day 3 and continuing until post-nadir ANC greater than 1500/μL |
− | + | ====Chemotherapy, EP portion (cycles 3 & 5)==== | |
− | *[[Filgrastim (Neupogen)]] | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | ====Chemotherapy, | ||
− | |||
*[[Cisplatin (Platinol)]] by the following weight-based criteria: | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 1.66 mg/kg IV over 1 hour once per day on days 0 to 3 |
− | ** | + | **More than 12 kg: 50 mg/m<sup>2</sup> IV over 1 hour once per day on days 0 to 3 |
− | |||
*[[Etoposide (Vepesid)]] by the following weight-based criteria: | *[[Etoposide (Vepesid)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 6.67 mg/kg IV over 2 hours once per day on days 0 to 2 |
− | **> 12 kg: 200 mg/m<sup>2</sup> IV over 1 | + | **More than 12 kg: 200 mg/m<sup>2</sup> IV over 2 hours once per day on days 0 to 2 |
+ | ====Supportive therapy, EP portion (cycles 3 & 5)==== | ||
+ | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV once per day starting on day 4 and continuing until post-nadir ANC greater than 1500/μL | ||
+ | '''21-day cycle for 6 cycles''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Consolidation=== | ||
+ | CEM: '''<u>C</u>'''arboplatin, '''<u>E</u>'''toposide, '''<u>M</u>'''elphalan | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Carboplatin (Paraplatin)]] by the following laboratory- and weight-based criteria: | ||
+ | **12 kg or less AND GFR 100 mL/min or more: 14.2 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **More than 12 kg and GFR 100 mL/min or more: 425 mg/m<sup>2</sup> IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **12 kg or less and GFR 60 up to 100 mL/min: Use the lowest of either 4.1 AUC using Calvert Formula or 10 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **More than 12 kg and GFR 60 up to 100 mL/min: 4.1 AUC using Calvert Formula (Max Dose = 300 mg/m<sup>2</sup>) IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | *[[Etoposide (Vepesid)]] by the following laboratory- and weight-based criteria: | ||
+ | **12 kg or less AND GFR 100 mL/min or more: 11.3 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **More than 12 kg and GFR 100 mL/min or more: 338 mg/m<sup>2</sup> IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **12 kg or less and GFR 60 up to 100 mL/min: 6.7 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | **More than 12 kg and GFR 60 up to 100 mL/min: 200 mg/m<sup>2</sup> IV over 24 hours once per day on days -7, -6, -5, -4 | ||
+ | *[[Melphalan (Alkeran)]] by the following laboratory- and weight-based criteria: | ||
+ | **12 kg or less AND GFR 100 mL/min or more: 2.3 mg/kg IV over 15 to 30 minutes once per day on days -7, -6, -5 | ||
+ | **More than 12 kg and GFR 100 mL/min or more: 70 mg/m<sup>2</sup> IV over 15 to 30 minutes once per day on days -7, -6, -5 | ||
+ | **12 kg or less and GFR 60 up to 100 mL/min: 2 mg/kg IV over 15 to 30 minutes once per day on days -7, -6, -5 | ||
+ | **More than 12 kg and GFR 60 up to 100 mL/min: 60 mg/m<sup>2</sup> IV over 15 to 30 minutes once per day on days -7, -6, -5 | ||
+ | '''Stem cells re-infused on day 0''' | ||
+ | </div></div><br> | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Maintenance, "Post Consolidation" Isotretinoin=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Isotretinoin (Accutane)]] by the following weight-based criteria: | ||
+ | **12 kg or less: 5.33 mg/kg (Round dose to nearest 10 mg) PO twice per day on days 1 to 14 | ||
+ | **More than 12 kg: 160 mg/m<sup>2</sup> (Round dose to nearest 10 mg) PO twice per day on days 1 to 14 | ||
+ | '''28-day cycle for 6 cycles''' | ||
+ | </div></div></div> | ||
+ | ===References=== | ||
+ | # '''COG A3973:''' Kreissman SG, Seeger RC, Matthay KK, London WB, Sposto R, Grupp SA, Haas-Kogan DA, Laquaglia MP, Yu AL, Diller L, Buxton A, Park JR, Cohn SL, Maris JM, Reynolds CP, Villablanca JG. Purged versus non-purged peripheral blood stem-cell transplantation for high-risk neuroblastoma (COG A3973): a randomised phase 3 trial. Lancet Oncol. 2013 Sep;14(10):999-1008. Epub 2013 Jul 25. [https://doi.org/10.1016%2FS1470-2045(13)70309-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3963485/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23890779/ PubMed] [https://clinicaltrials.gov/study/NCT00004188 NCT00004188] | ||
+ | ## '''Subgroup analysis:''' von Allmen D, Davidoff AM, London WB, Van Ryn C, Haas-Kogan DA, Kreissman SG, Khanna G, Rosen N, Park JR, La Quaglia MP. Impact of Extent of Resection on Local Control and Survival in Patients from the COG A3973 Study with High-Risk Neuroblastoma. J Clin Oncol. 2017 Jan 35;2:208-216. Epub 2016 Nov 21. [https://doi.org/10.1200/jco.2016.67.2642 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5455676/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27870572/ link to PubMed] | ||
− | ====Chemotherapy, | + | ==COG A3973 without Myeloablative Therapy== |
+ | <div class="toccolours" style="background-color:#c8a2c8"> | ||
+ | {| 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/PMC3963485/ Kreissman et al. 2013 (COG A3973)] | ||
+ | |2001-2006 | ||
+ | | style="background-color:#91cf61" |Non-randomized part of phase 3 RCT | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Induction=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy, Cycles 1, 2, 4, and 6==== | ||
+ | *[[Vincristine (Oncovin)]] by the following age- and weight-based criteria: | ||
+ | **Younger than 12 months old: 0.017 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy) | ||
+ | **12 months old or older AND 12 kg or less: 0.022 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy) | ||
+ | **12 months old or older AND more than 12 kg: 0.67 mg/m<sup>2</sup> or 0.022 mg/kg (choose lower dose) (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy) | ||
*[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 70 mg/kg IV over 6 hours once per day on days 0, 1 |
− | ** | + | **More than 12 kg: 2100 mg/m<sup>2</sup> IV over 6 hours once per day on days 0, 1 |
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
*[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | *[[Doxorubicin (Adriamycin)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 0.83 mg/kg IV over 24 hours once per day on days 0 to 2 |
− | ** | + | **More than 12 kg: 25 mg/m<sup>2</sup> IV over 24 hours once per day on days 0 to 2 |
− | + | '''21-day cycles''' | |
− | '''21 | + | '''PBSC Harvest occurs on Week 6 of treatment (cycle 2)''' |
− | + | ====Supportive therapy, Cycle 1, 2, 4, and 6==== | |
− | ====Supportive | ||
− | |||
*[[Mesna (Mesnex)]] by the following weight-based criteria: | *[[Mesna (Mesnex)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 10 mg/kg IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion on days 0, 1 |
− | ** | + | **More than 12 kg: 420 mg/m<sup>2</sup> IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 3, 6, and 9 hours after each cyclophosphamide infusion on days 0, 1 |
− | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV once per day starting on day 3 and continuing until post-nadir ANC greater than 1500/μL | |
− | '''21 | + | '''21-day cycles''' |
− | + | ====Chemotherapy, Cycles 3 and 5==== | |
− | ====Chemotherapy, | ||
− | |||
*[[Cisplatin (Platinol)]] by the following weight-based criteria: | *[[Cisplatin (Platinol)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 1.66 mg/kg IV over 1 hour once per day on days 0 to 3 |
− | ** | + | **More than 12 kg: 50 mg/m<sup>2</sup> IV over 1 hour once per day on days 0 to 3 |
− | |||
*[[Etoposide (Vepesid)]] by the following weight-based criteria: | *[[Etoposide (Vepesid)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 6.67 mg/kg IV over 2 hours once per day on days 0 to 2 |
− | ** | + | **More than 12 kg: 200 mg/m<sup>2</sup> IV over 2 hours once per day on days 0 to 2 |
− | + | '''21-day cycles''' | |
− | '''21 | + | ====Supportive therapy, Cycles 3 and 5==== |
− | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV once per day starting on day 4 and continuing until post-nadir ANC greater than 1500/μL | |
− | ====Chemotherapy, | + | '''21-day cycles''' |
− | + | </div></div><br> | |
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Maintenance, Cyclophosphamide and Topotecan=== | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy, 3 cycles==== | ||
*[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | *[[Cyclophosphamide (Cytoxan)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 8.33 mg/kg IV over 30 minutes once per day on days 0 to 4 |
− | + | **More than 12 kg: 250 mg/m<sup>2</sup> IV over 30 minutes once per day on days 0 to 4 | |
− | + | *[[Topotecan (Hycamtin)]] by the following weight-based criteria: | |
− | + | **12 kg or less: 0.025 mg/kg IV over 30 minutes once per day on days 0 to 4 | |
− | + | **More than 12 kg: 0.75 mg/m<sup>2</sup> IV over 30 minutes once per day on days 0 to 4 | |
− | ** | + | '''21-day cycle''' |
− | + | ====Supportive therapy, 3 cycles==== | |
− | |||
− | *[[ | ||
− | ** | ||
− | ** | ||
− | |||
− | '''21 | ||
− | |||
− | ====Supportive | ||
− | |||
*[[Mesna (Mesnex)]] by the following weight-based criteria: | *[[Mesna (Mesnex)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 1.7 mg/kg IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion on days 0, 1 |
− | ** | + | **More than 12 kg: 50 mg/m<sup>2</sup> IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again 3 hours after each cyclophosphamide infusion on days 0, 1 |
− | + | *[[Filgrastim (Neupogen)]] 5 mcg/kg SC or IV once per day starting on day 5 and continuing until post-nadir ANC greater than 1500/μL | |
− | + | '''21-day cycles''' | |
− | + | </div></div><br> | |
− | + | <div class="toccolours" style="background-color:#ee6b6e"> | |
− | + | ===Maintenance, "Post Maintenance" Isotretinoin=== | |
− | + | <div class="toccolours" style="background-color:#b3e2cd"> | |
− | + | ====Chemotherapy, 6 cycles==== | |
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | *[[Filgrastim (Neupogen)]] 5 | ||
− | |||
− | ''' | ||
− | |||
− | ===Maintenance, | ||
− | ====Chemotherapy,==== | ||
*[[Isotretinoin (Accutane)]] by the following weight-based criteria: | *[[Isotretinoin (Accutane)]] by the following weight-based criteria: | ||
− | ** | + | **12 kg or less: 5.33 mg/kg (Round dose to nearest 10 mg) PO twice per day on days 1 to 14 |
− | ** | + | **More than 12 kg: 160 mg/m<sup>2</sup> (Round dose to nearest 10 mg) PO twice per day on days 1 to 14 |
− | + | '''28-day cycle''' | |
− | ''' | + | </div></div></div> |
+ | ===References=== | ||
+ | # '''COG A3973:''' Kreissman SG, Seeger RC, Matthay KK, London WB, Sposto R, Grupp SA, Haas-Kogan DA, Laquaglia MP, Yu AL, Diller L, Buxton A, Park JR, Cohn SL, Maris JM, Reynolds CP, Villablanca JG. Purged versus non-purged peripheral blood stem-cell transplantation for high-risk neuroblastoma (COG A3973): a randomised phase 3 trial. Lancet Oncol. 2013 Sep;14(10):999-1008. Epub 2013 Jul 25. [https://doi.org/10.1016%2FS1470-2045(13)70309-7 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3963485/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23890779/ PubMed] [https://clinicaltrials.gov/study/NCT00004188 NCT00004188] | ||
+ | ## '''Subgroup analysis:''' von Allmen D, Davidoff AM, London WB, Van Ryn C, Haas-Kogan DA, Kreissman SG, Khanna G, Rosen N, Park JR, La Quaglia MP. Impact of Extent of Resection on Local Control and Survival in Patients from the COG A3973 Study with High-Risk Neuroblastoma. J Clin Oncol. 2017 Jan 35;2:208-216. Epub 2016 Nov 21. [https://doi.org/10.1200/jco.2016.67.2642 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5455676/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27870572/ link to PubMed] | ||
+ | =Relapsed or refractory= | ||
+ | ==Cyclophosphamide monotherapy {{#subobject:ea894c|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen {{#subobject:9134b2|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/10.1056/NEJM196406182702503 Thurman et al. 1964] | ||
+ | |NR | ||
+ | | style="background-color:#91cf61" |Non-randomized | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cyclophosphamide (Cytoxan)]] 5 mg/kg IV once per day on days 1 to 10 | ||
+ | '''10-day course''' | ||
+ | </div></div> | ||
===References=== | ===References=== | ||
− | # | + | # Thurman WG, Fernbach DJ, Sullivan MP. Cyclophosphamide therapy in childhood neuroblastoma. N Engl J Med. 1964 Jun 18;270:1336-40. [https://doi.org/10.1056/NEJM196406182702503 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14140265/ PubMed] |
− | == | + | ==Cyclophosphamide & Vincristine {{#subobject:f725b0|Regimen=1}}== |
− | === | + | <div class="toccolours" style="background-color:#ee6b6e"> |
− | + | ===Regimen {{#subobject:fecc86|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/10.1001/jama.1969.03150200091010 Evans et al. 1969] | ||
+ | |NR | ||
+ | | style="background-color:#91cf61" |Non-randomized | ||
+ | |- | ||
+ | |} | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[ | + | *[[Cyclophosphamide (Cytoxan)]] 10 mg/kg IV once on day 8 |
− | * | + | *[[Vincristine (Oncovin)]] 0.05 mg/kg IV once on day 1 |
− | + | '''14-day cycle for at least 6 cycles''' | |
− | + | </div></div> | |
− | ''' | + | ===References=== |
+ | # Evans AE, Heyn RM, Newton WA Jr, Leikin SL. Vincristine sulfate and cyclophosphamide for children with metastatic neuroblastoma. JAMA. 1969 Feb 17;207(7):1325-7. [https://doi.org/10.1001/jama.1969.03150200091010 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/5818324/ PubMed] | ||
+ | [[Category:Neuroblastoma regimens]] | ||
+ | [[Category:Historical regimens]] | ||
+ | [[Category:Disease-specific pages]] | ||
+ | [[Category:Pediatric solid tumors]] |
Latest revision as of 21:08, 29 June 2024
Section editor | |
---|---|
Nicole M. Wood, DO University of Missouri Kansas City, MO, USA |
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main neuroblastoma page for current regimens.
2 regimens on this page
2 variants on this page
|
High-risk, upfront therapy
COG ANBL0532 Regimen A
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Park et al. 2019 (COG ANBL0532) | Phase 3 (C) | COG ANBL0532 Regimen B | Inferior EFS |
Induction
Chemotherapy, CPM + TOPO portion (cycles 1 & 2)
- Cyclophosphamide (Cytoxan) by the following weight-based criteria:
- 12 kg or less: 13.3 mg/kg iV over 30 to 60 minutes once per day on days 1 to 5
- More than 12 kg: 400 mg/m2 IV over 30 to 60 minutes once per day on days 1 to 5
- Topotecan (Hycamtin) 1.2 mg/m2 IV over 30 minutes once per day on days 1 to 5
Supportive therapy, CPM + TOPO portion (cycles 1 & 2)
- Filgrastim (Neupogen) as follows:
- Cycle 1: 5 mcg/kg SC or IV once per day, beginning 24 hours after completion of chemotherapy and continuing until ANC greater than 1000/μL
- Cycle 2: 5 mcg/kg SC or IV once per day, beginning 24 hours after completion of chemotherapy and continuing until ANC greater than 1000/μL, then 10 mcg/kg SC or IV once per day until PBSC harvest is complete
- PBSC harvest on day 14
Chemotherapy, EP portion (cycles 3 & 5)
- Cisplatin (Platinol) by the following weight-based criteria:
- 12 kg or less: 1.66 mg/kg IV over 1 hour once per day on days 1 to 4
- More than 12 kg: 50 mg/m2 IV over 1 hour once per day on days 1 to 4
- Etoposide (Vepesid) by the following weight-based criteria:
- 12 kg or less: 6.67 mg/kg IV over 1 hour once per day on days 1 to 3
- More than 12 kg: 200 mg/m2 IV over 1 hour once per day on days 1 to 3
Chemotherapy, CAV portion (cycles 4 & 6)
- Cyclophosphamide (Cytoxan) by the following weight-based criteria:
- 12 kg or less: 70 mg/kg iV over 6 hours once per day on days 1 to 2
- More than 12 kg: 2100 mg/m2 IV over 6 hours once per day on days 1 to 2
- Vincristine (Oncovin) by the following age- and weight-based criteria:
- Younger than 12 months old: 0.017 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 1 to 3, given prior to doxorubicin (infusion time per institutional policy)
- 12 months old or older AND more than 12 kg: 0.097 mg/m2 or 0.022 mg/kg (choose lower dose) (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 1 to 3, given prior to doxorubicin (infusion time per institutional policy)
- 12 months old or older AND 12 kg or less: 0.022 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 1 to 3, given prior to doxorubicin (infusion time per institutional policy)
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- 12 kg or less: 0.83 mg/kg iV over 24 hours once per day on days 1 to 3
- More than 12 kg: 25 mg/m2 IV over 24 hours once per day on days 1 to 3
Supportive therapy, CAV portion (cycles 4 & 6)
- Mesna (Mesnex) by the following weight-based criteria:
- 12 kg or less: 14 mg/kg IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion
- More than 12 kg: 420 mg/m2 IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion
21-day cycle for 6 cycles
Consolidation, single autologous HSCT
Chemotherapy
- Melphalan (Alkeran) by the following laboratory- and weight-based criteria:
- 12 kg or less AND GFR 100 mL/min or more: 2.3 mg/kg IV over 15 to 30 minutes once per day on days -7, -6, -5
- More than 12 kg and GFR 100 mL/min or more: 70 mg/m2 IV over 15 to 30 minutes once per day on days -7, -6, -5
- 12 kg or less and GFR 60 up to 100 mL/min: 2 mg/kg IV over 15 to 30 minutes once per day on days -7, -6, -5
- More than 12 kg and GFR 60 up to 100 mL/min: 60 mg/m2 IV over 15 to 30 minutes once per day on days -7, -6, -5
- Etoposide (Vepesid) by the following laboratory- and weight-based criteria:
- 12 kg or less AND GFR 100 mL/min or more: 11.3 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4
- More than 12 kg and GFR 100 mL/min or more: 338 mg/m2 IV over 24 hours once per day on days -7, -6, -5, -4
- 12 kg or less and GFR 60 up to 100 mL/min: 6.7 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4
- More than 12 kg and GFR 60 up to 100 mL/min: 200 mg/m2 IV over 24 hours once per day on days -7, -6, -5, -4
- Carboplatin (Paraplatin) by the following laboratory- and weight-based criteria:
- 12 kg or less AND GFR 100 mL/min or more: 14.2 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4
- More than 12 kg and GFR 100 mL/min or more: 425 mg/m2 IV over 24 hours once per day on days -7, -6, -5, -4
- 12 kg or less and GFR 60 up to 100 mL/min: 4.1 AUC using Calvert Formula (Max Dose = 300 mg/m2) IV over 24 hours once per day on days -7, -6, -5, -4
- More than 12 kg and GFR 60 up to 100 mL/min: Use the lowest of either 4.1 AUC using Calvert Formula or 10 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4
- PBSC on day 0
Supportive therapy,
- Filgrastim (Neupogen) 5 mcg/kg SC or IV once per day starting on day 0 and continuing until post-nadir ANC greater than 2000/μL for 3 consecutive days
36-day course
Maintenance
Chemotherapy
- Isotretinoin (Accutane) by the following weight-based criteria:
- 12 kg or less: 5.33 mg/kg (Round dose to nearest 10 mg) PO twice per day on days 1 to 14
- More than 12 kg: 160 mg/m2 (Round dose to nearest 10 mg) PO twice per day on days 1 to 14
28-day cycle for 6 cycles
References
- COG ANBL0532: Park JR, Kreissman SG, London WB, Naranjo A, Cohn SL, Hogarty MD, Tenney SC, Haas-Kogan D, Shaw PJ, Kraveka JM, Roberts SS, Geiger JD, Doski JJ, Voss SD, Maris JM, Grupp SA, Diller L. Effect of Tandem Autologous Stem Cell Transplant vs Single Transplant on Event-Free Survival in Patients With High-Risk Neuroblastoma: A Randomized Clinical Trial. JAMA. 2019 Aug 27;322(8):746-755. link to original article link to PMC article PubMed NCT00567567
COG ANBL 0032 Regimen A
Post-consolidation, Study Phase
Study | Dates of enrollment | Evidence |
---|---|---|
Yu et al. 2010 (COG ANBL0032) | 2001-2009 | Non-randomized part of phase 3 RCT |
Chemotherapy
- Isotretinoin (Accutane) by the following weight-based criteria:
- More than 12 kg: 80 mg/m2 (round to nearest 10 mg) PO twice per day on days 11 to 24
- 12 kg or less: 2.67 mg/kg (round to nearest 10 mg) PO twice per day on days 11 to 24
25-day cycle for 6 cycles
References
- COG ANBL0032: Yu AL, Gilman AL, Ozkaynak MF, London WB, Kreissman SG, Chen HX, Smith M, Anderson B, Villablanca JG, Matthay KK, Shimada H, Grupp SA, Seeger R, Reynolds CP, Buxton A, Reisfeld RA, Gillies SD, Cohn SL, Maris JM, Sondel PM; Children's Oncology Group. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1324-34. link to original article link to PMC article PubMed NCT00026312
- Update: Yu AL, Gilman AL, Ozkaynak MF, Naranjo A, Diccianni MB, Gan J, Hank JA, Batova A, London WB, Tenney SC, Smith M, Shulkin BL, Parisi M, Matthay KK, Cohn SL, Maris JM, Bagatell R, Park JR, Sondel PM. Long-Term Follow-up of a Phase III Study of ch14.18 (Dinutuximab) + Cytokine Immunotherapy in Children with High-Risk Neuroblastoma: COG Study ANBL0032. Clin Cancer Res. 2021 Apr 15;27(8):2179-2189. Epub 2021 Jan 27. link to original article link to PMC article PubMed
COG A3973 with Myeloablative Therapy
Study | Dates of enrollment | Evidence |
---|---|---|
Kreissman et al. 2013 (COG A3973) | 2001-2006 | Non-randomized part of phase 3 RCT |
Note: PBSC Harvest occurs on Week 6 of treatment (cycle 2).
Induction
Chemotherapy, CAV portion (cycles 1, 2, 4, 6)
- Vincristine (Oncovin) by the following age- and weight-based criteria:
- Younger than 12 months old: 0.017 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy)
- 12 months old or older AND more than 12 kg: 0.67 mg/m2 or 0.022 mg/kg (choose lower dose) (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy)
- 12 months old or older AND 12 kg or less: 0.022 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy)
- Cyclophosphamide (Cytoxan) by the following weight-based criteria:
- 12 kg or less: 70 mg/kg IV over 6 hours once per day on days 0, 1
- More than 12 kg: 2100 mg/m2 IV over 6 hours once per day on days 0, 1
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- 12 kg or less: 0.83 mg/kg IV over 24 hours once per day on days 0 to 2
- More than 12 kg: 25 mg/m2 IV over 24 hours once per day on days 0 to 2
Supportive therapy, CAV portion (cycles 1, 2, 4, 6)
- Mesna (Mesnex) by the following weight-based criteria:
- 12 kg or less: 10 mg/kg IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion on days 0, 1
- More than 12 kg: 420 mg/m2 IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 3, 6, and 9 hours after each cyclophosphamide infusion on days 0, 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV once per day starting on day 3 and continuing until post-nadir ANC greater than 1500/μL
Chemotherapy, EP portion (cycles 3 & 5)
- Cisplatin (Platinol) by the following weight-based criteria:
- 12 kg or less: 1.66 mg/kg IV over 1 hour once per day on days 0 to 3
- More than 12 kg: 50 mg/m2 IV over 1 hour once per day on days 0 to 3
- Etoposide (Vepesid) by the following weight-based criteria:
- 12 kg or less: 6.67 mg/kg IV over 2 hours once per day on days 0 to 2
- More than 12 kg: 200 mg/m2 IV over 2 hours once per day on days 0 to 2
Supportive therapy, EP portion (cycles 3 & 5)
- Filgrastim (Neupogen) 5 mcg/kg SC or IV once per day starting on day 4 and continuing until post-nadir ANC greater than 1500/μL
21-day cycle for 6 cycles
Consolidation
CEM: Carboplatin, Etoposide, Melphalan
Chemotherapy
- Carboplatin (Paraplatin) by the following laboratory- and weight-based criteria:
- 12 kg or less AND GFR 100 mL/min or more: 14.2 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4
- More than 12 kg and GFR 100 mL/min or more: 425 mg/m2 IV over 24 hours once per day on days -7, -6, -5, -4
- 12 kg or less and GFR 60 up to 100 mL/min: Use the lowest of either 4.1 AUC using Calvert Formula or 10 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4
- More than 12 kg and GFR 60 up to 100 mL/min: 4.1 AUC using Calvert Formula (Max Dose = 300 mg/m2) IV over 24 hours once per day on days -7, -6, -5, -4
- Etoposide (Vepesid) by the following laboratory- and weight-based criteria:
- 12 kg or less AND GFR 100 mL/min or more: 11.3 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4
- More than 12 kg and GFR 100 mL/min or more: 338 mg/m2 IV over 24 hours once per day on days -7, -6, -5, -4
- 12 kg or less and GFR 60 up to 100 mL/min: 6.7 mg/kg IV over 24 hours once per day on days -7, -6, -5, -4
- More than 12 kg and GFR 60 up to 100 mL/min: 200 mg/m2 IV over 24 hours once per day on days -7, -6, -5, -4
- Melphalan (Alkeran) by the following laboratory- and weight-based criteria:
- 12 kg or less AND GFR 100 mL/min or more: 2.3 mg/kg IV over 15 to 30 minutes once per day on days -7, -6, -5
- More than 12 kg and GFR 100 mL/min or more: 70 mg/m2 IV over 15 to 30 minutes once per day on days -7, -6, -5
- 12 kg or less and GFR 60 up to 100 mL/min: 2 mg/kg IV over 15 to 30 minutes once per day on days -7, -6, -5
- More than 12 kg and GFR 60 up to 100 mL/min: 60 mg/m2 IV over 15 to 30 minutes once per day on days -7, -6, -5
Stem cells re-infused on day 0
Maintenance, "Post Consolidation" Isotretinoin
Chemotherapy
- Isotretinoin (Accutane) by the following weight-based criteria:
- 12 kg or less: 5.33 mg/kg (Round dose to nearest 10 mg) PO twice per day on days 1 to 14
- More than 12 kg: 160 mg/m2 (Round dose to nearest 10 mg) PO twice per day on days 1 to 14
28-day cycle for 6 cycles
References
- COG A3973: Kreissman SG, Seeger RC, Matthay KK, London WB, Sposto R, Grupp SA, Haas-Kogan DA, Laquaglia MP, Yu AL, Diller L, Buxton A, Park JR, Cohn SL, Maris JM, Reynolds CP, Villablanca JG. Purged versus non-purged peripheral blood stem-cell transplantation for high-risk neuroblastoma (COG A3973): a randomised phase 3 trial. Lancet Oncol. 2013 Sep;14(10):999-1008. Epub 2013 Jul 25. link to original article link to PMC article PubMed NCT00004188
- Subgroup analysis: von Allmen D, Davidoff AM, London WB, Van Ryn C, Haas-Kogan DA, Kreissman SG, Khanna G, Rosen N, Park JR, La Quaglia MP. Impact of Extent of Resection on Local Control and Survival in Patients from the COG A3973 Study with High-Risk Neuroblastoma. J Clin Oncol. 2017 Jan 35;2:208-216. Epub 2016 Nov 21. link to original article link to PMC article link to PubMed
COG A3973 without Myeloablative Therapy
Study | Dates of enrollment | Evidence |
---|---|---|
Kreissman et al. 2013 (COG A3973) | 2001-2006 | Non-randomized part of phase 3 RCT |
Induction
Chemotherapy, Cycles 1, 2, 4, and 6
- Vincristine (Oncovin) by the following age- and weight-based criteria:
- Younger than 12 months old: 0.017 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy)
- 12 months old or older AND 12 kg or less: 0.022 mg/kg (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy)
- 12 months old or older AND more than 12 kg: 0.67 mg/m2 or 0.022 mg/kg (choose lower dose) (maximum dose of 2 mg in 72 hours) IV over 1 minute or infusion once per day on days 0 to 2, given prior to doxorubicin (infusion time per institutional policy)
- Cyclophosphamide (Cytoxan) by the following weight-based criteria:
- 12 kg or less: 70 mg/kg IV over 6 hours once per day on days 0, 1
- More than 12 kg: 2100 mg/m2 IV over 6 hours once per day on days 0, 1
- Doxorubicin (Adriamycin) by the following weight-based criteria:
- 12 kg or less: 0.83 mg/kg IV over 24 hours once per day on days 0 to 2
- More than 12 kg: 25 mg/m2 IV over 24 hours once per day on days 0 to 2
21-day cycles PBSC Harvest occurs on Week 6 of treatment (cycle 2)
Supportive therapy, Cycle 1, 2, 4, and 6
- Mesna (Mesnex) by the following weight-based criteria:
- 12 kg or less: 10 mg/kg IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion on days 0, 1
- More than 12 kg: 420 mg/m2 IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 3, 6, and 9 hours after each cyclophosphamide infusion on days 0, 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV once per day starting on day 3 and continuing until post-nadir ANC greater than 1500/μL
21-day cycles
Chemotherapy, Cycles 3 and 5
- Cisplatin (Platinol) by the following weight-based criteria:
- 12 kg or less: 1.66 mg/kg IV over 1 hour once per day on days 0 to 3
- More than 12 kg: 50 mg/m2 IV over 1 hour once per day on days 0 to 3
- Etoposide (Vepesid) by the following weight-based criteria:
- 12 kg or less: 6.67 mg/kg IV over 2 hours once per day on days 0 to 2
- More than 12 kg: 200 mg/m2 IV over 2 hours once per day on days 0 to 2
21-day cycles
Supportive therapy, Cycles 3 and 5
- Filgrastim (Neupogen) 5 mcg/kg SC or IV once per day starting on day 4 and continuing until post-nadir ANC greater than 1500/μL
21-day cycles
Maintenance, Cyclophosphamide and Topotecan
Chemotherapy, 3 cycles
- Cyclophosphamide (Cytoxan) by the following weight-based criteria:
- 12 kg or less: 8.33 mg/kg IV over 30 minutes once per day on days 0 to 4
- More than 12 kg: 250 mg/m2 IV over 30 minutes once per day on days 0 to 4
- Topotecan (Hycamtin) by the following weight-based criteria:
- 12 kg or less: 0.025 mg/kg IV over 30 minutes once per day on days 0 to 4
- More than 12 kg: 0.75 mg/m2 IV over 30 minutes once per day on days 0 to 4
21-day cycle
Supportive therapy, 3 cycles
- Mesna (Mesnex) by the following weight-based criteria:
- 12 kg or less: 1.7 mg/kg IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again at 4 and 8 hours after each cyclophosphamide infusion on days 0, 1
- More than 12 kg: 50 mg/m2 IV over 15 minutes, given immediately prior to each cyclophosphamide dose and again 3 hours after each cyclophosphamide infusion on days 0, 1
- Filgrastim (Neupogen) 5 mcg/kg SC or IV once per day starting on day 5 and continuing until post-nadir ANC greater than 1500/μL
21-day cycles
Maintenance, "Post Maintenance" Isotretinoin
Chemotherapy, 6 cycles
- Isotretinoin (Accutane) by the following weight-based criteria:
- 12 kg or less: 5.33 mg/kg (Round dose to nearest 10 mg) PO twice per day on days 1 to 14
- More than 12 kg: 160 mg/m2 (Round dose to nearest 10 mg) PO twice per day on days 1 to 14
28-day cycle
References
- COG A3973: Kreissman SG, Seeger RC, Matthay KK, London WB, Sposto R, Grupp SA, Haas-Kogan DA, Laquaglia MP, Yu AL, Diller L, Buxton A, Park JR, Cohn SL, Maris JM, Reynolds CP, Villablanca JG. Purged versus non-purged peripheral blood stem-cell transplantation for high-risk neuroblastoma (COG A3973): a randomised phase 3 trial. Lancet Oncol. 2013 Sep;14(10):999-1008. Epub 2013 Jul 25. link to original article link to PMC article PubMed NCT00004188
- Subgroup analysis: von Allmen D, Davidoff AM, London WB, Van Ryn C, Haas-Kogan DA, Kreissman SG, Khanna G, Rosen N, Park JR, La Quaglia MP. Impact of Extent of Resection on Local Control and Survival in Patients from the COG A3973 Study with High-Risk Neuroblastoma. J Clin Oncol. 2017 Jan 35;2:208-216. Epub 2016 Nov 21. link to original article link to PMC article link to PubMed
Relapsed or refractory
Cyclophosphamide monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Thurman et al. 1964 | NR | Non-randomized |
References
- Thurman WG, Fernbach DJ, Sullivan MP. Cyclophosphamide therapy in childhood neuroblastoma. N Engl J Med. 1964 Jun 18;270:1336-40. link to original article contains dosing details in manuscript PubMed
Cyclophosphamide & Vincristine
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Evans et al. 1969 | NR | Non-randomized |
Chemotherapy
- Cyclophosphamide (Cytoxan) 10 mg/kg IV once on day 8
- Vincristine (Oncovin) 0.05 mg/kg IV once on day 1
14-day cycle for at least 6 cycles
References
- Evans AE, Heyn RM, Newton WA Jr, Leikin SL. Vincristine sulfate and cyclophosphamide for children with metastatic neuroblastoma. JAMA. 1969 Feb 17;207(7):1325-7. link to original article contains dosing details in manuscript PubMed