title: Dinutuximab for maintenance therapy in pediatric neuroblastoma.
abstract: OBJECTIVE
  The pharmacology, clinical efficacy, safety, dosage and administration, and role in therapy of dinutuximab for the treatment of high-risk pediatric neuroblastoma are reviewed.
  
  
  CONCLUSIONS
  Dinutuximab (Unituxin, United Therapeutics) is a novel monoclonal antibody recently approved for use in combination with granulocyte- macrophage colony-stimulating factor, interleukin-2, and isotretinoin for the treatment of pediatric patients with high-risk neuroblastoma. Its approval has led to the first major change in standard recommended first-line maintenance therapy for high-risk pediatric neuroblastoma in over a decade. Dinutuximab causes antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity by binding to GD2, a tumor-associated antigen. The recommended dosage of dinutuximab is 17.5 mg/m2/day for 4 consecutive days of each 24- or 32-day cycle, for a maximum of 5 cycles. In a Phase III trial, patients who received dinutuximab as part of combination immunotherapy in addition to standard maintenance therapy had significantly improved 2-year event-free survival relative to those who received standard maintenance therapy alone (66% versus 46%,p< 0.01). Dinutuximab has a unique adverse-effect profile that includes infusion reactions, neuropathic pain, and electrolyte abnormalities; the most common adverse effects observed with dinutuximab use in clinical trials were pain, pyrexia, myelosuppression, infusion reactions, and electrolyte abnormalities.
  
  
  CONCLUSIONS
  Dinutuximab is a novel monoclonal antibody that is efficacious as part of combination immunotherapy in pediatric patients with high-risk neuroblastoma.
authors.affiliation: University of Wisconsin Health, Madison, WI.
authors.forename: Lauren
authors.initials: L
authors.lastname: McGinty
authors.affiliation: College of Pharmacy, University of Kentucky, Lexington, KY jill.kolesar@uky.edu.|Early Phase Clinical Trials Center, Markey Cancer Center, Lexington, KY. jill.kolesar@uky.edu.
authors.forename: Jill
authors.initials: J
authors.lastname: Kolesar
mesh_terms: D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use*; D000951:Antigens, Neoplasm / Q000276:immunology; D000074322:Antineoplastic Agents, Immunological / Q000494:pharmacology / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000494:pharmacology / Q000627:therapeutic use*; D002648:Child; D018572:Disease-Free Survival; D005732:Gangliosides / Q000037:antagonists & inhibitors / Q000276:immunology; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000037:antagonists & inhibitors / Q000276:immunology; D006801:Humans; D007167:Immunotherapy / Q000379:methods; D007376:Interleukin-2 / Q000494:pharmacology / Q000627:therapeutic use; D015474:Isotretinoin / Q000494:pharmacology / Q000627:therapeutic use; D060046:Maintenance Chemotherapy / Q000379:methods*; D009447:Neuroblastoma / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality
chemical_list: D000911:Antibodies, Monoclonal; D000951:Antigens, Neoplasm; D000074322:Antineoplastic Agents, Immunological; D005732:Gangliosides; D007376:Interleukin-2; C019403:ganglioside, GD2; C112746:dinutuximab; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D015474:Isotretinoin
keywords: dinutuximab; neuroblastoma