Neuroblastoma

Carboplatin & Paclitaxel (CP)

CP: Carboplatin & Paclitaxel

Regimen

Study	Dates of enrollment	Evidence	Comparator	Comparative Efficacy
Forde et al. 2022 (CheckMate 816)	2017-2019	Phase 3 (C)	1a. CP & Nivolumab 1b. CVb & Nivolumab 1c. DC & Nivolumab	Inferior EFS

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details. This study was conducted in the United States. The reason for the study was that an unanswered question at the time was whether adding an immune checkpoint inhibitor would improve outcomes.

Biomarker eligibility criteria

• CheckMate 816: No sensitizing EGFR or ALK mutations

Chemotherapy

• Carboplatin (Paraplatin) AUC 5 or 6 IV once on day 1
• Paclitaxel (Taxol) 175 or 200 mg/m² IV once on day 1

21-day cycle for 3 cycles

Subsequent treatment

• Complete resection

References

1. CheckMate 816: Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. link to original article contains dosing details in manuscript PubMed NCT02998528

Start of hidden/commented information for virtual editor End of hidden/commented information for virtual editor

Start of comment inserted by visual editor(edited again by visual editor)

(edited again by visual editor end)End of comment inserted by visual editor
Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer. If this is your first time visiting, we suggest you read the tutorial.

Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.

14 regimens on this page 15 variants on this page

Neuroblastoma is a rare cancer but is the most common malignancy of infancy. Most of our contributors are adult oncologists, please consider expanding this page!

High-risk, consolidation

Dinutuximab, GM-CSF, IL-2, Isotretinoin

Regimen

Study	Evidence	Comparator	Efficacy
Yu et al. 2010 (COG ANBL0032)	Phase III	Isotretinoin	Seems to have superior OS

Note: in distinction from most chemotherapy regimens, the first day of a cycle is day 0 and the last day of a 28-day cycle is day 27.

Immunotherapy

• Dinutuximab (Unituxin) as follows:
  • Cycles 1, 3, 5: 25 mg/m² IV once per day on days 3 to 6
  • Cycles 2 & 4: 25 mg/m² IV once per day on days 7 to 10
• Sargramostim (Leukine) as follows:
  • Cycles 1, 3, 5: 250 mcg/m² SC once per day on days 0 to 13
• Aldesleukin (Proleukin) as follows:
  • Cycles 2 & 4: 3.0 x 10⁶ IU/m²/day IV continuous infusion on days 0 to 3, then 4.5 x 10⁶ IU/m²/day IV continuous infusion on days 7 to 10
• Isotretinoin (Accutane) 160 mg/m²/day PO on days 14 to 27

28-day cycle for 6 cycles

References

1. 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 contains verified protocol PubMed

Isotretinoin monotherapy

Regimen

Study	Evidence	Comparator	Efficacy
Yu et al. 2010 (COG ANBL0032)	Phase III	Dinutuximab, GM-CSF, IL-2, Isotretinoin	Seems to have inferior OS

Chemotherapy

• Isotretinoin (Accutane) 80 mg/m² BID on days 1 to 14

28-day cycle for 6 cycles

References

1. 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 contains verified protocol PubMed

Relapsed or refractory

Irinotecan, Temozolomide, Dinutuximab

Regimen

Study	Evidence	Comparator	Efficacy
Mody et al. 2017 (COG ANBL1221)	Randomized phase II, <20 pts	Irinotecan, Temozolomide, Temsirolimus	Superior ORR

Note: this dinutuximab dose is based on a mid-protocol revision.

Chemoimmunotherapy

• Irinotecan (Camptosar) 50 mg/m² IV over 90 minutes once per day on days 1 to 5
• Temozolomide (Temodar) 100 mg/m² PO once per day on days 1 to 5
• Dinutuximab (Unituxin) 17.5 mg/m² IV over 10 hours once per day on days 2 to 5
  • Infusion time could be extended to 20 hours "if patients experienced pain, fever, tachycardia, tachypnea, or hypotension unresponsive to supportive measures."

Supportive medications

• Sargramostim (Leukine) 250 mcg/m² SC once per day on days 6 to 12

21-day cycle for up to 17 cycles

References

1. Mody R, Naranjo A, Van Ryn C, Yu AL, London WB, Shulkin BL, Parisi MT, Servaes SE, Diccianni MB, Sondel PM, Bender JG, Maris JM, Park JR, Bagatell R. Irinotecan-temozolomide with temsirolimus or dinutuximab in children with refractory or relapsed neuroblastoma (COG ANBL1221): an open-label, randomised, phase 2 trial. Lancet Oncol. 2017 Jul;18(7):946-957. Epub 2017 May 23. link to original article link to PMC article contains verified protocol PubMed