Neuroblastoma

Archetype F 14 regimens (Main Regimens) neuroblastoma

Low, intermediate, and high-risk neuroblastoma

DefinitionClick to collapse

Neuroblastoma is a cancer originating from the developing sympathetic nervous system and is the most common extracranial solid tumor in children [1,2]. It is a primitive neoplasm of neuroectodermal origin composed of neuroblasts (immature nerve cells) arising from the embryonic neural crest [5,54]. These tumors may occur anywhere in the sympathoadrenal neuroendocrine system, including the adrenal gland, connective/soft tissue, retroperitoneum, and mediastinum [5,54]. Neuroblastoma, ganglioneuroblastoma, and ganglioneuroma are collectively referred to as neuroblastic tumors, all with similar imaging appearance [1,2,54]. The tumor arises from the sympathetic nervous system and local extension mainly consists of vascular encasement, infiltration of adjacent soft tissues and organs (most commonly kidneys and liver), and infiltration of the foramina and epidural space of the spinal canal when the primary tumor arises from a paraspinal sympathetic chain [55]. Approximately 50% of patients present with localized or regional disease, and approximately 35% have regional lymph node spread at diagnosis [4,67]. The International Neuroblastoma Risk Group (INRG) Staging System (INRGSS) classifies tumors as L1 (localized, no image-defined risk factors [IDRFs]), L2 (locoregional with one or more IDRFs), M (distant metastatic disease except MS), and MS (metastatic disease in children <18 months confined to skin, liver, and/or bone marrow with <10% involvement) [55]. Risk classification is assigned based on age, INRG stage, MYCN amplification status, histopathology (favorable/unfavorable), segmental chromosomal aberrations (SCAs), and ploidy, with 5-year EFS rates of 90.7% for low-risk, 85.1% for intermediate-risk, and 51.2% for high-risk disease [47].

EpidemiologyClick to collapse

Neuroblastoma is the most common extracranial solid tumor in children, with an estimated 600 to 800 patients diagnosed annually in the United States [1,3]. The prevalence is approximately 1 per 7000 live births [2]. The average age at diagnosis is between 1 and 2 years, and the vast majority of individuals are <5 years of age at diagnosis [3,4]. Approximately 50% of patients present with localized or regional disease, and approximately 35% have regional lymph node spread at time of diagnosis [67]. Racial and ethnic disparities exist: a recent study found that 5-year survival was higher for white (80.7%) and Hispanic (80.8%) patients compared with Black patients (72.6%) [7,9]. Overall survival by risk group, based on the revised COG risk classification: low-risk 5-year OS 97.9% (±0.5%), intermediate-risk 5-year OS 95.8% (±0.8%), high-risk 5-year OS 62.5% (±1.3%) [47]. Five-year event-free survival rates are 90.7% for low-risk, 85.1% for intermediate-risk, and 51.2% for high-risk [47]. Outcomes have improved over time with increasingly intensive multimodal therapy, but high-risk disease remains challenging. Paraneoplastic syndromes occur in a small subgroup: opsoclonus-myoclonus-ataxia syndrome (OMAS) occurs in approximately 2% of patients, and vasoactive intestinal peptide tumor (VIPoma) syndrome occurs in <1% [29,24]. Familial neuroblastoma is rare, estimated at 1–2% of all cases [12]. The incidence of neuroblastoma is stable but outcomes vary by race/ethnicity and socioeconomic status [6,8].

SubtypesClick to collapse

Most common neuroblastic tumor; exact frequency not specified in source.
Neuroblastoma (Schwannian stroma-poor)

The most common type of peripheral neuroblastic tumor, composed of neuroblasts with variable Schwannian stroma. Subtyped by degree of neuroblastic differentiation: undifferentiated, poorly differentiated, or differentiating. Further classified by mitosis-karyorrhexis index (MKI): low (<100/5000 cells), intermediate (100–200/5000), or high (≥200/5000).

Less common than neuroblastoma; exact frequency not specified.
Ganglioneuroblastoma, nodular (composite, Schwannian stroma-rich/stroma-dominant and stroma-poor)

Tumor composed of at least two distinct histologies: one is neuroblastoma (forming discrete nodules) and the other is ganglioneuroblastoma, intermixed or ganglioneuroma. The neuroblastoma component dictates clinical behavior. Prognostic group (FH/UH) determined by age-dependent morphologic features (grade of neuroblastic differentiation and MKI) applied to the neuroblastoma component.

Uncommon; exact frequency not specified.
Ganglioneuroblastoma, intermixed (Schwannian stroma-rich)

Tumor with abundant Schwannian stroma and scattered neuroblastic cells. Typically diagnosed in older children. Classified into FH group; expected excellent prognosis. Biopsy diagnosis should include comment 'Favorable histology based on review of limited material' due to risk of missing a neuroblastoma nodule.

Least common; exact frequency not specified.
Ganglioneuroma (Schwannian stroma-dominant)

Mature, benign tumor composed of ganglion cells and Schwannian stroma. Classified into FH group; excellent prognosis. Biopsy diagnosis with caution regarding sampling.

Approximately 50% of newly diagnosed patients have non-high-risk disease; high-risk disease accounts for approximately 50% [85,86].
Molecular subtypes based on biomarker profiling

Risk stratification depends on MYCN amplification status, SCA status (segmental losses at 1p, 11q, 3p, 4p and gains at 17q, 1q, 2p), and ploidy (DNA index). MYCN amplification is the strongest independent prognostic factor. Favorable histology group includes poorly differentiated or differentiating subtype with low/intermediate MKI ≤547 days old, or differentiating with low MKI ≤1824 days old. Unfavorable histology includes undifferentiated at any age, high MKI at any age, poorly differentiated with any MKI ≥548 days old, differentiating with intermediate MKI ≥548 days, or differentiating with any MKI ≥1825 days.

Molecular PathogenesisClick to collapse

Neuroblastoma is driven by a combination of genomic events that influence prognosis and therapy. The strongest independent prognostic risk factor is amplification of the MYCN oncogene, which is associated with aggressive disease and is assessed in all neuroblastomas and ganglioneuroblastoma nodular tumors [57,58]. MYCN amplification is defined by FISH as >8 copies per cell or ≥4-fold increase, and can exceed 30-fold [9]. Segmental chromosomal aberrations (SCAs) are also prognostically important, with the most extensively studied including loss at 1p, 11q, 3p, and 4p, and gain at 17q, 1q, and 2p. The presence of SCAs in conjunction with other factors contributes to risk classification [10,11,59,81]. Ploidy status (DNA index) is another key factor: a DI of 1 (diploid) is less favorable than DI>1 (hyperdiploid), particularly in infants [60]. Germline alterations in ALK (gain-of-function mutations) and PHOX2B (loss-of-function mutations) are causative in familial neuroblastoma, which accounts for 1–2% of all cases [14,15,16]. Somatic ALK mutations and amplifications are also found in sporadic disease and predict response to ALK inhibitors in relapsed/refractory disease [63,64,65]. At relapse, tumors frequently acquire RAS-MAPK pathway mutations, which contribute to treatment resistance [51]. Additional germline variants in BARD1, SMARCA4, and RAS pathway genes (Costello syndrome, Noonan syndrome, neurofibromatosis) have been associated with neuroblastoma predisposition [13,17,18]. The genetic landscape also includes alterations in other neuroblastoma-associated genes identified through next-generation sequencing [62]. Overall, the genomic pattern (numerical vs. segmental alterations) is a predictor of outcome, with segmental patterns conferring worse prognosis [80]. These molecular features are integrated into the COG risk classification system to guide treatment [47].

Risk FactorsClick to collapse

Familial neuroblastoma and germline mutations

Familial neuroblastoma accounts for approximately 1–2% of all cases. Germline gain-of-function mutations in ALK and loss-of-function mutations in PHOX2B have been identified as causative factors [12,14,15,16]. Other germline pathogenic variants in BARD1, SMARCA4 are enriched and predict worse survival [17,18].

Associated genetic syndromes

Li-Fraumeni syndrome (TP53 mutations), Costello syndrome, Noonan syndrome, and neurofibromatosis (RAS pathway mutations) are associated with neuroblastoma [13].

Race/ethnicity and socioeconomic disparities

Limited data suggest health disparities exist. A recent study found 5-year survival was higher for white (80.7%) or Hispanic (80.8%) patients compared with Black patients (72.6%) [7,9]. Poverty has been associated with inferior survival in high-risk neuroblastoma clinical trials [8].

Other genetic susceptibility loci

Common genetic variants likely contribute to sporadic neuroblastoma predisposition, but additional validation studies are needed [12].

Clinical FeaturesClick to collapse

Typical Presentation

Neuroblastoma is a cancer of the developing sympathetic nervous system and the most common extracranial solid tumor in children, with an estimated 600–800 cases per year in the United States and a prevalence of approximately 1 per 7000 live births [1,2]. The average age at diagnosis is between 1 and 2 years, and the vast majority of patients are <5 years old [3,4]. Patients most commonly present with an abdominal mass or abdominal distension [2,5]. Other common presenting symptoms include loss of appetite, weight loss, irritability, constipation, fever, hypertension, anemia, and bone pain [5]. Paraneoplastic syndromes occur in a small subgroup and do not imply metastatic or incurable disease [6]. Opsoclonus-myoclonus-ataxia syndrome (OMAS) occurs in approximately 2% of patients, presenting with irregular multidirectional eye movements, myoclonic jerking of limbs, ataxia, and disordered mood/behavior [7,8]. Vasoactive intestinal peptide tumor (VIPoma) syndrome occurs in <1% of patients, causing chronic watery diarrhea, weight loss, and electrolyte abnormalities [9]. Lambert-Eaton myasthenic syndrome may rarely occur with proximal lower extremity weakness, loss of reflexes, and dysautonomia [10].

Symptoms

Most patients
Abdominal mass/distension

Most common presenting feature; often found by caregiver or during routine exam

Common in high-risk disease
Bone pain

Often due to metastatic disease; may cause limping or refusal to bear weight

Less common
Periorbital ecchymosis (raccoon eyes)

Caused by orbital metastases; may be accompanied by proptosis

Variable
Fever, weight loss, irritability

Constitutional symptoms may indicate advanced disease

2% of patients [7]
Opsoclonus-myoclonus-ataxia

Irregular eye movements, myoclonic jerking, ataxia, mood/behavior changes

<1% [9]
Chronic watery diarrhea

Due to VIP secretion; associated with weight loss and electrolyte disturbances

Rare but critical
Spinal cord compression symptoms

Back pain, weakness, bowel/bladder dysfunction

Occasional
Hypertension

May result from renal artery compression or catecholamine secretion

Signs

Most patients
Abdominal mass

Palpable, firm, often nontender; may cross midline

Common in MS
Hepatomegaly

Common in infants with stage MS disease; can cause respiratory compromise

Less common
Periorbital ecchymosis

Bilateral 'raccoon eyes' from metastatic deposits

Infants with MS
Subcutaneous nodules

Bluish nodules on skin, especially in infants

Uncommon
Horner syndrome

Ptosis, miosis, anhidrosis; may be post-surgical or from thoracic tumor

Rare but serious
Neurologic deficits

Motor or sensory deficits from spinal cord compression or paraspinal involvement

Red FlagsClick to collapse

InvestigationsClick to collapse

Diagnostic

Tissue sampling (surgical resection or biopsy)

Definitive diagnosis requires tumor tissue for histology and molecular profiling

Hematoxylin and eosin (H&E) staining

Primary histologic diagnosis; determines tumor category and differentiation

Immunohistochemistry (IHC)

Aids diagnosis in small samples or undifferentiated tumors

Urine homovanillic acid (HVA) and vanillylmandelic acid (VMA)

Required for diagnosis if only diagnostic tissue is bone marrow

Bilateral bone marrow aspirates and trephine biopsies

Assess metastatic involvement; can be diagnostic if marrow is only source

Complete blood count (CBC) with differential

Baseline assessment; detect bone marrow suppression or blood loss

Comprehensive metabolic panel

Evaluate organ function, electrolytes, LDH

Lactate dehydrogenase (LDH)

Prognostic value; higher levels associated with worse outcome

Ferritin

Prognostic value; higher levels associated with worse outcome

Prothrombin time (PT)/INR

Useful if liver involved or concern for bleeding

Audiogram

Baseline if platinum-containing chemotherapy planned

Echocardiogram and ECG

Baseline if anthracycline-containing chemotherapy planned

Pregnancy test

For patients of childbearing potential

Fertility preservation referral

For patients likely to receive extensive alkylator therapy

Paraneoplastic syndrome testing

If clinical suspicion for OMAS (check anti-Hu/ANNA1, CSF studies) or VIPoma (serum VIP)

Staging

Cross-sectional imaging (CT with contrast or MRI with/without contrast)

Evaluate soft tissue disease; assess IDRFs for INRG staging

MRI of spine with/without contrast

Assess intraspinal extension, nerve root or spinal cord involvement

MRI of brain with/without contrast or CT skull/orbits with contrast

Evaluate intracranial extension, orbital metastases

I-123 MIBG scintigraphy with SPECT or SPECT/CT

Gold standard for detecting metastatic disease; identify MIBG-avid disease

FDG-PET/CT or PET/MRI

Alternative for MIBG non-avid or mixed-avidity tumors

Bilateral bone marrow aspirates and trephine biopsies

Assess marrow involvement; required for staging and risk classification

Ultrasound

Initial screening for abdominal/pelvic mass; low interobserver reproducibility

Biomarkers

MYCN amplification

Strong prognostic factor; associated with aggressive disease; determines risk group

Segmental chromosomal aberrations (SCAs)

Prognostic; presence of SCAs may be associated with aggressive disease depending on other factors

Ploidy (DNA index, DI)

DI=1 may be associated with aggressive disease depending on age and other factors

ALK amplification and sequence variants

Predict response to ALK inhibitors in relapsed/refractory disease

Next-generation sequencing (NGS)

Simultaneous evaluation of MYCN, SCAs, ALK, and other neuroblastoma-associated genes

Germline testing

Identify familial neuroblastoma (ALK, PHOX2B) or other predisposition syndromes (Li-Fraumeni, RASopathies)

StagingClick to collapse

International Neuroblastoma Risk Group (INRG) Staging System (INRGSS) [34]

T Categories

StageDescription
L1 (Localized)Localized tumor not involving vital structures as defined by the list of image-defined risk factors (IDRFs) and confined to one body compartment [34].
L2 (Locoregional)Locoregional tumor with presence of one or more IDRFs [34].

N Categories

StageDescription
N (Regional lymph nodes)The INRGSS does not include a separate N category. Regional lymph node involvement is integrated into L1/L2 staging: L1 implies no IDRFs; L2 includes IDRFs that may reflect nodal involvement (e.g., encasement of vessels) but not separately staged [34].

M Categories

StageDescription
M (Distant metastatic)Distant metastatic disease (except stage MS) [34].
MS (Metastatic special)Metastatic disease in children younger than 18 months, with metastases confined to skin, liver, and/or bone marrow (<10% involvement) [34].

Stage Groupings

GroupCriteriaClinical MeaningFive Yr SurvivalTreatment Intent
L1Localized tumor with no IDRFs, confined to one body compartment.Surgically resectable with low risk of complications; low to intermediate risk depending on age and biology.Not reported by stage alone; survival by risk group: low risk 97.9%, intermediate 95.8%, high 62.5% [35].Curative; often surgery alone, observation (select infants), or surgery + chemotherapy for intermediate risk.
L2Locoregional tumor with one or more IDRFs.Higher surgical risk; neoadjuvant chemotherapy often used; risk group depends on age, MYCN, histology, ploidy.Variable by risk group, see above.Curative; chemotherapy + surgery, with possible RT in high-risk cases.
MDistant metastatic disease (excluding MS).High-risk disease in most cases (≥18 months) or intermediate-risk in select infants <12 months with favorable biology.High risk: 5-year OS 62.5% [35].Curative but intensive: induction chemo, surgery, high-dose chemo + stem cell rescue, RT, post-consolidation immunotherapy.
MSChildren <18 months, metastases confined to skin, liver, and/or bone marrow (<10% involvement).Favorable biology often leads to spontaneous regression; requires close observation unless symptomatic.Low risk: excellent (>95%); intermediate-risk: ~95% [35].Observation if asymptomatic with favorable biology; low-intensity chemotherapy if symptomatic or unfavorable biology; RT rarely needed.

Staging Pearls

  • The INRGSS replaced the older INSS to allow pretreatment staging based on imaging (IDRFs), not surgical findings [34].
  • IDRFs are defined by consensus and include vascular encasement, tracheal compression, intraspinal extension, infiltration of adjacent organs, and others (see NEUROB-B 3 of 4) [36].
  • MIBG avidity is present in up to 90% of tumors; MIBG scan is essential for M and MS staging [21].
  • Bilateral bone marrow aspirates and biopsies are mandatory for detecting marrow involvement, which defines M or MS stage.
  • MS stage is only applicable to children <18 months; patients ≥18 months with limited metastases are staged as M.
  • The INRGSS stage is a key factor in the COG risk classification system, along with MYCN, histology, ploidy, SCAs, and age [35].
  • FDG-PET is used as an alternative if MIBG non-avid; however, MIBG remains the preferred tracer for staging.
  • Risk group assignment determines treatment intensity; not all patients with stage M are high-risk (e.g., infants <12 months with favorable biology).

Management PrinciplesClick to collapse

Neuroblastoma is a heterogeneous disease of the developing sympathetic nervous system, the most common extracranial solid tumor in children, with an estimated 600–800 new cases annually in the United States (prevalence ~1 per 7000 live births). The average age at diagnosis is between 1 and 2 years, with the vast majority of patients <5 years old. Treatment is multimodal and risk-adapted, stratified into low-, intermediate-, and high-risk groups based on age, INRG stage, MYCN amplification status, histopathology (International Neuroblastoma Pathology Classification [INPC] favorable or unfavorable), presence of segmental chromosomal aberrations (SCAs), and DNA index (DI). The goal for low- and intermediate-risk disease is cure with minimal toxicity, using surgery and moderate-intensity chemotherapy; for high-risk disease, intensive multimodality therapy divided into induction, consolidation, and post-consolidation phases has improved outcomes, with 5-year overall survival (OS) now approximately 62.5% ± 1.3% [Irwin 2021]. Treatment decisions must incorporate multidisciplinary evaluation including diagnostic and interventional radiology, nuclear medicine, surgery, pathology, radiation oncology, and pediatric oncology.

Curative with observation alone

Low-risk: infants <6 months with isolated adrenal masses ≤3.1 cm solid or ≤5 cm with ≥25% cystic component; also asymptomatic stage MS with favorable biology (<12 months, FH, DI>1, SCA-negative, MYCN non-amplified)

Observation with serial ultrasound; no biopsy or chemotherapy required.

Curative with surgery ± chemotherapy

Low-risk L1 tumors not meeting observation criteria; also some intermediate-risk localized tumors with favorable biology after chemotherapy

Surgical resection if safe; if incomplete resection and MYCN amplification is detected, reclassify as high-risk.

Curative with chemotherapy + surgery

Intermediate-risk: localized L2, stage M <18 months with favorable biology, stage MS symptomatic or with unfavorable biology

Response-adapted chemotherapy (2–8 cycles) based on age, stage, and biology; gross total resection may be performed after chemotherapy; surveillance after achieving target response.

Curative with intensive multimodality therapy

High-risk: all patients with MYCN amplification (except L1 completely resected), stage M ≥18 months, L2 ≥18 months with unfavorable histology or undifferentiated/poorly differentiated, and other subsets as defined by risk classification

Induction multiagent chemotherapy (5–6 cycles) + primary site resection; consolidation with high-dose chemotherapy and autologous stem cell rescue (tandem transplant preferred, category 1) + radiotherapy; post-consolidation with anti-GD2 antibody (dinutuximab) + sargramostim + isotretinoin (category 1); optional continuation therapy with eflornithine (category 2B).

Palliative or disease control

Relapsed/refractory high-risk neuroblastoma

Individualized, strongly encourage clinical trial; chemoimmunotherapy (e.g., irinotecan/temozolomide + anti-GD2 antibody) or I-131 MIBG or targeted agents (ALK inhibitors if ALK aberration).

A multidisciplinary team is essential for neuroblastoma management, including diagnostic radiologists, nuclear medicine physicians, interventional radiologists, surgeons (pediatric surgical oncologists), anatomic and molecular pathologists, radiation oncologists, and pediatric oncologists. Multidisciplinary discussion is required for optimal timing of surgery (at diagnosis vs. after neoadjuvant chemotherapy), assessment of image-defined risk factors (IDRFs), determination of resectability, and iterative decision-making during intermediate-risk therapy regarding additional chemotherapy vs. surgery. The Panel recommends coordinated diagnostic sampling including pathologists, oncologists, surgeons, and radiologists.

Management PathwaysClick to collapse

Low-Risk Neuroblastoma – Observation

Branching: Age <6 months, Adrenal mass size (≤3.1 cm solid or ≤5 cm cystic), No IDRFs, Stage MS asymptomatic with favorable biology (<12 months, FH, DI>1, SCA-, MYCN non-amplified)

Infants <6 months with isolated adrenal masses <5 cm diameter (as defined) OR asymptomatic MS with favorable biology
Observation (Preferred)
Low-Risk Neuroblastoma – Surgical Resection

Branching: L1 stage, No MYCN amplification (or MYCN amplified but completely resected then low-risk), Presence of IDRFs (L1 vs. L2) – if L2, reassess risk group

L1 tumors not meeting observation criteria
Surgical resection (Preferred)
New baseline imaging ≥1 month post-op, then surveillance with ultrasound if possible. See NEUROB-3 and NEUROB-F.
Intermediate-Risk Neuroblastoma – Localized Tumors (L1/L2 non-high-risk)

Branching: Age, INPC histology (FH/UH), DI (diploid/hyperdiploid), SCA status, MYCN non-amplified

Favorable biology (FH, DI>1, no SCA) regardless of age; OR age <365 days with UH, DI>1, no SCA; OR age <365 days with FH, DI=1, no SCA; OR age <365 days with UH, DI=1, no SCA; OR age <365 days with FH, DI>1, SCA+; OR ≥365 days with FH and SCA
2 cycles of chemotherapy (COG ANBL0531 regimen) (Preferred)
Treatment endpoint: ≥50% reduction in primary tumor volume (or by RECIST). If achieved, surveillance. If not, consider surgery or additional 2–4 cycles, then reassess. If 8 cycles given and still unresectable, consider second-line chemotherapy per Twist et al. [Twist 2019].
Age 365 to <547 days with UH; OR age <365 days with SCA (either UH or DI=1)
4 cycles of chemotherapy (Preferred)
May require 8 cycles total if target not met at 4 cycles. See above for additional cycles and second-line options.
Intermediate-Risk Neuroblastoma – Stage M (age <18 months, favorable biology subsets)

Branching: Age (<365 vs. 365–<547 days), Biologic features (FH, DI, SCA)

Age <365 days with all favorable biology (FH, DI>1, no SCA)
4 cycles of chemotherapy (Preferred)
If
Age <365 days with ≥1 unfavorable biologic feature; OR age 365 to <547 days with FH, DI>1, no SCA
8 cycles of chemotherapy (Preferred)
Additional cycles or second-line chemotherapy may be considered if target not met.
Intermediate-Risk Neuroblastoma – Stage MS

Branching: Age (<3 months), Symptoms (hepatomegaly, respiratory compromise), Biologic features (FH, DI, SCA, MYCN), Ability to biopsy

Symptomatic (Hsu score ≥2) or <3 months with evolving hepatomegaly; all favorable biology (biopsy deferred until safe)
2 cycles of chemotherapy (Preferred)
If inadequate response, consider 2–4 additional cycles. RT may be considered for symptomatic patients with inadequate response. Once stable, biopsy and reassign risk.
Symptomatic with unfavorable biology (after biopsy confirms UH, DI=1, or SCA+)
4 cycles of chemotherapy (Preferred)
If
High-Risk Neuroblastoma – Induction Therapy

Branching: Risk classification (MYCN amplified, stage M ≥18 months, L2 ≥18 months UH, etc.), End-induction response (CR, PR, MR, SD, PD)

Newly diagnosed high-risk
Multiagent chemotherapy (5–6 cycles) (Preferred); Resection of primary tumor and locoregional disease (Preferred)
High-Risk Neuroblastoma – Post-Induction Response-Based Decision

Branching: End-induction response: CR, PR, MR/SD, PD

CR or PR to induction
Proceed to consolidation: high-dose chemotherapy with autologous stem cell rescue (Preferred)
MR or SD at end of induction
Bridging therapy (chemoimmunotherapy) or clinical trial (Preferred)
PD during or at end of induction
Chemoimmunotherapy or clinical trial (Preferred)
High-Risk Neuroblastoma – Consolidation Therapy

Branching: Risk subgroup (common vs. special), End-induction residual disease

Common high-risk groups (all others, including MYCN amplified, stage M ≥18 months, etc.)
Tandem high-dose chemotherapy with autologous stem cell rescue (category 1) (Preferred); RT to primary site and sites of residual metastatic disease (Preferred)
Special high-risk groups: Stage L2, ≥18 months, MYCN non-amplified, UH; OR Stage M, 12 to <18 months, MYCN non-amplified, with UH/diploid/SCA+
Single high-dose chemotherapy with autologous stem cell rescue (Preferred)
Same RT approach as common high-risk groups.
High-Risk Neuroblastoma – Post-Consolidation Therapy

Branching: Disease status after consolidation (no progression vs. PD)

No disease progression after consolidation
Anti-GD2 antibody with isotretinoin and sargramostim (category 1) (Preferred); Continuation therapy: eflornithine (category 2B) (Useful in certain circumstances)
Progressive disease after consolidation
Chemoimmunotherapy or clinical trial (Preferred)
Relapsed/Refractory Neuroblastoma

Branching: Timing of relapse, Extent of disease, MIBG avidity, Prior treatments, Organ function, Molecular features

First relapse or first declaration of refractory disease
Chemoimmunotherapy with anti-GD2 antibody + chemotherapy (Preferred); I-131 MIBG therapy (Other recommended); Targeted agents for actionable aberrations (Useful in certain circumstances)
Second or greater relapse
Rechallenge with prior effective chemoimmunotherapy or new regimen (Other recommended)

Pretreatment EvaluationClick to collapse

Tissue Sampling
Surgical resection for localized disease without IDRFs; biopsy (open or core) if resection not indicated. Fine-needle aspiration not recommended.
Category 2A
Multiple core biopsies (≥10 cores, 20–30 mm length, 16-gauge needle) for histology and biomarker testing. Review frozen section for viability.
Category 2A
Bilateral bone marrow aspirates and trephine biopsies (may be sole diagnostic source).
Category 2A
Biopsy may be delayed in patients <2 months with hepatomegaly or infants with safety concerns (coagulopathy, organ failure). Perform when safe.
Category 2A
Infants <6 months with L1 adrenal mass ≤3.1 cm solid or ≤5 cm cystic do not require biopsy.
Category 2A
History and Physical
Complete history and physical with attention to abdominal mass, organomegaly, neurologic exam.
Essential
Family history of neuroblastoma or other childhood cancers.
Essential
Assessment for paraneoplastic syndromes (OMAS, VIPoma, Lambert-Eaton).
Useful
Laboratory Studies
CBC with differential, comprehensive metabolic panel.
Essential
Urine HVA/VMA: required for diagnosis only if marrow is sole diagnostic tissue.
Essential if diagnosis from marrow
PT/INR if liver involvement or bleeding concern.
Useful in selected cases
LDH, ferritin (prognostic but not part of risk classification).
Useful in selected cases
Pregnancy test for patients of childbearing potential.
Useful in selected cases
Audiogram if platinum-containing chemotherapy indicated.
Conditional
Echocardiogram and ECG if anthracycline-containing chemotherapy indicated.
Conditional
Fertility referral for patients likely to receive extensive alkylator therapy.
Conditional
Imaging
Cross-sectional imaging (MRI or CT with contrast) of primary site to evaluate soft tissue disease and IDRFs.
Essential
MRI spine with/without contrast for paraspinal disease or concern for nerve root/spinal cord involvement.
Essential if paraspinal
MRI brain with contrast or CT skull/orbits if neurologic symptoms or clinically indicated.
Conditional
I-123 MIBG scan with SPECT/CT (if available) to assess metastatic disease. Obtain prior to primary resection if possible. Not required in infants <6 months with L1 adrenal mass ≤3.1/5 cm.
Essential
FDG-PET/CT or PET/MRI for MIBG non-avid or mixed-avidity disease.
Conditional
Pathology and Biomarker Testing
Histologic classification per INPC (FH vs. UH) using pre-treatment sample.
Essential
MYCN amplification assessment (FISH, microarray, or NGS) on all neuroblastomas and ganglioneuroblastoma nodular nodules.
Essential
SCAs assessment (1p, 11q, 17q, 3p, 4p, 1q, 2p) using microarray or NGS.
Essential for risk classification
Ploidy (DI) by flow cytometry or NGS; if missing, assign risk based on other factors.
Essential for risk classification
ALK mutation and amplification testing by NGS (recommended simultaneously with MYCN and SCA).
Recommended for therapy selection if relapsed/refractory

SurgeryClick to collapse

Surgery plays a critical role in diagnosis (biopsy), local control (resection of primary tumor and locoregional disease), and management of complications (e.g., silo placement for abdominal compartment syndrome). The extent and timing of surgery depend on risk group, presence of IDRFs, and response to neoadjuvant chemotherapy. Multidisciplinary discussion is essential to balance morbidity and oncologic outcomes.

Evaluate primary tumor resectability using cross-sectional imaging (CT or MRI) and IDRF assessment.

Multidisciplinary discussion of risks/benefits and optimal timing should include surgeons, diagnostic and interventional radiologists, medical oncologists, radiation oncologists, pathologists, and dieticians as needed.

For intermediate-risk disease, if more than minimal surgical risk, neoadjuvant chemotherapy should be given first.

For high-risk disease, neoadjuvant chemotherapy is nearly always indicated prior to resection.

Surgical approach should limit morbidity, avoid resection of vital structures, and preserve organ function.

Gross total resection is optimal for high-risk; subtotal resection if gross total would jeopardize vital organs, major nerves, or vessels.

Nephrectomy should be avoided. Resection of adjacent organs (kidney, pancreas, intestine) is not recommended.

Resection of nodal disease adherent to primary tumor is recommended; distant lymph node resection not required.

En bloc resection is not required; tumors may be resected in multiple segments.

Procedures

Biopsy

When upfront resection not possible or recommended (metastatic disease, L2 tumors, infants with MS disease at high risk for complications).

Resection – Low-Risk L1

L1 tumors not meeting observation criteria; completely resectable with minimal morbidity.

Resection – Intermediate-Risk Localized

Localized tumors after chemotherapy if target volume reduction not achieved; or if initial surgery safe without neoadjuvant therapy.

Resection – High-Risk Primary Tumor

All high-risk patients after initial cytoreductive chemotherapy.

Silo placement (laparotomy with silo)

Extreme situations: infants with abdominal compartment syndrome, severe respiratory compromise, or life-threatening hepatomegaly due to MS disease.

Cervical and cervicothoracic resection

Primary tumors in neck or cervicothoracic junction.

Thoracic cavity resection

Primary thoracic neuroblastoma.

Abdominal/adrenal/retroperitoneal/pelvic resection

Primary tumors in abdomen, adrenal, retroperitoneum, or pelvis.

Paraspinal tumor management

Intraspinal extension of paraspinal tumor.

Radiation TherapyClick to collapse

Radiation therapy (RT) is indicated for nearly all cases of high-risk neuroblastoma and in exceedingly rare circumstances for non-high-risk disease (e.g., symptomatic stage MS with inadequate response to chemotherapy). RT is delivered after recovery from high-dose chemotherapy with stem cell rescue unless emergent. The primary site is always irradiated; metastatic sites are irradiated if there is concern for active disease after induction chemotherapy (MIBG/FDG uptake and/or persistent soft tissue >1 cm³).

Principles

  • RT is delivered after recovery from high-dose chemotherapy with stem cell rescue unless emergent indication.
  • IMRT or proton therapy are recommended to reduce side effects.
  • Primary site always irradiated. Metastatic sites only if active disease at end-induction.
  • Metastatic sites should be irradiated concurrently with primary site if indicated.
  • Repeat imaging after transplant and before RT is not routine but may aid decision-making in select cases.
  • Simulation: supine with immobilization; 4D-CT recommended for targets subject to respiratory motion; consider MRI simulation for paraspinal sites.
  • Target volume definitions: GTV includes postoperative tumor bed, residual disease, initially involved regional lymph nodes (based on post-induction/pre-surgery volume). CTV = GTV + 1 cm confined to anatomic borders. ITV if respiratory motion. PTV = CTV + 0.3–0.5 cm.
  • If primary tumor resected prior to induction, GTV based on tumor volume at diagnosis.
  • For metastatic sites: mGTV defined by post-induction volume; mCTV = mGTV + 1 cm; mPTV = mCTV + 0.3–0.5 cm.

Dose Frameworks

NameTotal DoseDose Per FractionFractionsScheduleIndication
Standard dose to primary and metastatic sites21.6 Gy1.8 Gy12Daily fractions, typically 5 days per week.Primary site and all sites of residual metastatic disease at end-induction.
Emergent RT4.5 Gy1.5 Gy3Daily or twice daily as needed for emergent decompression.Hepatomegaly leading to respiratory distress; orbital/optic pathway disease leading to vision loss.

Approaches

NameDose FractionationConcurrent ChemotherapyIndicationKey TrialToxicities
Post-consolidation RT to primary and metastatic sites21.6 Gy in 1.8 Gy fractionsNone; delivered after recovery from transplant, before or concurrent with post-consolidation immunotherapy (but not concurrent with high-dose chemotherapy).All high-risk patients after consolidation therapy.COG ANBL0532: dose escalation to 36 Gy (boost of 14.4 Gy) did not improve local control or EFS [Liu 2020]. COG A3973: extended field to uninvolved nodal stations did not improve outcomes [Braunstein 2019].Renal (contralateral kidney V18 Gy <25%, mean ≤14.4 Gy; ipsilateral kidney V18 Gy <75%, mean ≤18 Gy), hepatic (mean <18 Gy), pulmonary (bilateral V20 Gy <30%, contralateral V20 Gy <10%), vertebral (minimum 18 Gy to prevent asymmetrical growth), ototoxicity, second malignancies.

Systemic TherapyClick to collapse

Systemic therapy for neuroblastoma is risk-adapted and multimodal. For low-risk disease, treatment is primarily surgical, with observation for select infants. Intermediate-risk disease uses moderate-intensity multiagent chemotherapy (carboplatin, cyclophosphamide, doxorubicin, etoposide) with response-adapted duration (2–8 cycles). High-risk disease requires intensive induction chemotherapy (topotecan/cyclophosphamide, cisplatin/etoposide, and vincristine/doxorubicin/cyclophosphamide), consolidation with high-dose chemotherapy and autologous stem cell rescue, post-consolidation immunotherapy (anti-GD2 antibody + sargramostim + isotretinoin), and optional continuation therapy with eflornithine. For relapsed/refractory disease, chemoimmunotherapy (irinotecan/temozolomide + anti-GD2 antibody) or targeted radiopharmaceuticals (I-131 MIBG) or targeted agents (ALK inhibitors) are used, with clinical trial participation strongly encouraged.

Intermediate-risk (low- and intermediate-risk non-high-risk)
Based on ANBL0531 which demonstrated excellent outcomes with reduced therapy for favorable biology. Duration determined by age, stage, and biologic features.
Preferred: Carboplatin/cyclophosphamide/doxorubicin/etoposide (COG ANBL0531 regimen) or SIOPEN regimen (carboplatin/etoposide alternating with cyclophosphamide/doxorubicin/vincristine).
High-risk induction
End-induction response rates ~80% PR or better; similar across regimens. 5-cycle regimen reduces exposure to nephrotoxic and cardiotoxic agents.
Preferred: 5-cycle induction: Topotecan/cyclophosphamide (cycles 1–2), cisplatin/etoposide (cycle 3), vincristine/doxorubicin/cyclophosphamide (cycle 4), cisplatin/etoposide (cycle 5). Regimens: ANBL12P1 or ANBL1531.
High-risk consolidation
ANBL0532: 3-year EFS 61.6% for tandem vs. 48.4% for single transplant [Park 2019].
Preferred: Tandem transplant: thiotepa/cyclophosphamide followed 6–10 weeks later by dose-reduced CEM (carboplatin/etoposide/melphalan) (category 1).
High-risk post-consolidation
ANBL0032: 2-year EFS from start of post-consolidation 66% vs. 46% for isotretinoin alone [Yu 2010, 2021]. SIOPEN HR-NBL1 showed no benefit and increased toxicity with IL-2 [Ladenstein 2018].
Preferred: Isotretinoin/sargramostim + dinutuximab (6 cycles; no interleukin-2). Category 1.
High-risk continuation therapy
Study 3b: EFS HR 0.48 (95% CI 0.27–0.85) and OS HR 0.32 (95% CI 0.15–0.70) vs. external control [Oesterheld 2024]. FDA approved December 2023.
Preferred: Eflornithine (category 2B) for patients in remission and with ≥PR after completion of anti-GD2 immunotherapy.
Relapsed/refractory - first relapse
Objective response rates ~40% in multiple studies [Mody 2020, Munoz 2023, Lerman 2023, Gray 2026]. Naxitamab approved for bone/bone marrow disease.
Preferred: Irinotecan/temozolomide + dinutuximab + GM-CSF (COG ANBL1221 regimen) or naxitamab-gqgk + irinotecan/temozolomide + GM-CSF (HITS regimen).

Key Regimens

COG ANBL0531 Intermediate-Risk Chemotherapy (8-cycle alternating regimen)
Carboplatin 560 mg/m² >12 kg or 18.6 mg/kg ≤12 kg IV Day 1 (cycles 1,2,4,6,7) + Etoposide 120 mg/m² >12 kg or 4 mg/kg ≤12 kg IV Days 1–3 (cycles 1,3,4,7,8) + Cyclophosphamide 1000 mg/m² >12 kg or 33.3 mg/kg ≤12 kg IV Day 1 (cycles 2,3,5,6,8) + Doxorubicin 30 mg/m² >12 kg or 1 mg/kg ≤12 kg IV Day 1 (cycles 2,4,6,8)
High-Risk Induction Regimen (5-cycle, ANBL12P1/ANBL1531-like)
Topotecan 1.2 mg/m²/dose IV Days 1–5 (cycles 1 and 2) + Cyclophosphamide 400 mg/m²/dose IV Days 1–5 (cycles 1 and 2) + Cisplatin 50 mg/m²/dose IV Days 1–4 (cycles 3 and 5) + Etoposide 200 mg/m²/dose IV Days 1–3 (cycles 3 and 5) + Vincristine Age-, weight-, and BSA-based dosing IV Days 1 and 3 (cycle 4); Days 1–3 (cycle 6 if used) + Doxorubicin 25 mg/m²/dose IV Days 1–3 (cycle 4) + Cyclophosphamide 2100 mg/m²/dose IV Days 1–2 (cycle 4)
Tandem Transplant Conditioning (ANBL0532)
Thiotepa 300 mg/m²/dose IV Days -7 to -5 (first transplant) + Cyclophosphamide 1500 mg/m²/dose IV Days -5 to -2 (first transplant) + Carboplatin Age-, BSA-, GFR-based dosing IV Days -7 to -4 (second transplant) + Etoposide 300 mg/m²/dose (if GFR ≥100) IV Days -7 to -4 (second transplant) + Melphalan 60 mg/m²/dose IV Days -7 to -5 (second transplant)
Post-Consolidation Immunotherapy (ANBL0032-based)
Sargramostim 250 µg/m²/dose SQ Days 1–14 (cycles 1,3,5) + Dinutuximab 17.5 mg/m²/dose IV Days 4–7 (cycles 1,3,5) + Isotretinoin 80 mg/m²/dose PO twice daily PO Days 11–24 (all 6 cycles)
Continuation Therapy: Eflornithine
Eflornithine BSA-based: >1.5: 768 mg; 0.75-≤1.5: 576 mg; 0.5-<0.75: 384 mg; 0.25-<0.5: 192 mg PO Twice daily for up to 2 years
Chemoimmunotherapy for Relapsed/Refractory (ANBL1221/HITS)
Temozolomide 100 mg/m²/dose (ANBL1221) or 150 mg/m²/dose (HITS) PO Days 1–5 + Irinotecan 50 mg/m²/dose IV over 90 min Days 1–5 + Dinutuximab 17.5 mg/m²/dose IV Days 2–5 + Sargramostim 250 µg/m²/dose SQ Days 6–12 (ANBL1221) or Days 6–10 (HITS)

Treatment Response AssessmentClick to collapse

Title

Response Assessment

Timing

Response assessment is performed at protocol-specified timepoints that differ by risk group. For high-risk disease: full disease evaluation (anatomic imaging of primary site, I-123 MIBG scan [or FDG-PET if MIBG non-avid], bilateral bone marrow aspirates and biopsies) is recommended at end of induction, start of post-consolidation, and end of therapy. Midpoint I-123 MIBG scan recommended after first 3 cycles of post-consolidation. For intermediate-risk disease: evaluate after assigned number of chemotherapy cycles; if target response achieved, obtain MIBG as part of end-of-therapy evaluation.

Response Logic
  • Primary site response: CR (<10 mm residual soft tissue, complete resolution of MIBG/FDG uptake), PR (≥30% decrease in longest diameter, MIBG/FDG stable/improved/resolved), SD (neither PR nor PD), PD (>20% increase and ≥5 mm absolute increase; note: fluctuating MIBG avidity alone is insufficient for PD).

  • Metastatic bone/soft tissue response: CR (non-primary lesions <10 mm, lymph nodes short axis <10 mm, complete resolution of MIBG/FDG uptake), PR (≥30% decrease in sum of diameters, no new lesions, ≥50% reduction in MIBG absolute bone score [relative score 0.1-0.5] or ≥50% reduction in FDG-PET-avid bone lesions), SD, PD (any new soft tissue lesion MIBG-avid or histologically confirmed; new MIBG-avid bone site; FDG-PET-avid bone site with CT/MRI or histologic confirmation; >20% increase in sum of diameters; relative MIBG bone score ≥1.2).

  • Bone marrow response: CR (no tumor infiltration), MD (≤5% tumor infiltration), SD (>5% tumor infiltration that does not meet CR/MD/PD), PD (marrow without infiltration becomes >5%; or >2-fold increase to >20%).

  • Overall response: CR (all components CR), PR (PR in at least one component, all others CR/MD/PR or not involved), MR (PR or CR in at least one component but at least one other SD; no PD), SD (SD in one component, no better than SD in others; no PD), PD (any component PD).

Imaging Recommendations
  • Primary site: RECIST 1.1 (single longest dimension) on CT or MRI; functional imaging (MIBG or FDG-PET) for assessment of avidity.

  • Metastatic bone/soft tissue: MIBG scan with semiquantitative scoring (modified Curie score in North America or SIOPEN score). FDG-PET for MIBG non-avid tumors.

  • Bone marrow: bilateral aspirates and trephine biopsies evaluated per Burchill criteria (immunocytology/immunohistochemistry for tumor cells; >5% viable tumor recommended as reliable level for detecting response).

  • Urine catecholamines (HVA/VMA) and technetium-99m scintigraphy are no longer used for response assessment per revised INRC [Park 2017].

  • Novel radiotracers are in development but insufficient data for routine incorporation into INRC.

Biopsy Or Salvage Logic
  • For intermediate-risk patients who do not achieve target response after 8 cycles of chemotherapy, consider biopsy of residual mass to assess histologic differentiation; if differentiated, observation may be appropriate. If undifferentiated viable tumor remains, consider second-line chemotherapy (cyclophosphamide/topotecan) per Twist et al. [Twist 2019].

  • For high-risk patients with less than PR at end of induction: bridging therapy may be offered to improve response before proceeding to consolidation [Desai 2022]. Patients with PD should receive non-myeloablative chemoimmunotherapy or enroll in clinical trial.

  • For relapsed/refractory disease: repeat tumor biomarker profiling on a current sample is strongly recommended to identify actionable aberrations (e.g., ALK mutations) and guide therapy selection.