title: Infants with stage 4 neuroblastoma: the impact of the chimeric anti-GD2-antibody ch14.18 consolidation therapy.
abstract: BACKGROUND
  Antibody treatment is considered tolerable and potentially effective in the therapy of neuroblastoma. We have analyzed the clinical data of infants < 1 year with stage 4 neuroblastoma with regard to the consolidation treatment.
  
  
  METHODS
  Infants < 1 year with stage 4 neuroblastoma who completed initial treatment (6-8 chemotherapy cycles followed either by 4 cycles low dose oral chemotherapy or high dose chemotherapy with stem cell transplantation) without event were eligible for this trial. Consolidation therapy consisted of 6 cycles of antibody ch14.18 (20 mg/m(2) x d ch14.18 for 5 days every 2 months) or 12 months oral maintenance chemotherapy (MT).
  
  
  RESULTS
  Of 59 evaluable patients, 31 received a total of 159 ch14.18 cycles, 16 received MT instead, and 12 had no further treatment. Fever (47 % of cycles), abnormal CRP without infection (25 %), rash (23 %), cough (16 %), and pain (8 %) were the main side effects. Univariate analysis found no difference in event free survival (3-year-EFS 80.5 +/- 7.1 %, 87.5 +/- 8.3 %, and 75.0 +/- 12.5 % for patients treated with antibody ch14.18, MT, and no further therapy, p = 0.433) and overall survival (3-year-OS 90.1 +/- 5.4 %, 93.8 +/- 6.0 %, and 91.7 +/- 8.0 % for patients treated with antibody ch14.18, MT, and no further therapy, p = 0.931). Multivariate analysis failed to demonstrate an advantage of antibody treatment.
  
  
  CONCLUSIONS
  The outcome of infants with stage 4 neuroblastoma is good. Consolidation treatment with ch14.18 was tolerable but associated with fever, elevated CRP, rash, cough, and pain as side effects. Compared to oral maintenance chemotherapy and no consolidation treatment, ch14.18 treatment had no impact on the patients' outcome which confirms the results found in children > 1 year.
authors.affiliation: Children's Hospital, University of Cologne, Germany. thorsten.simon@uk-koeln.de
authors.forename: T
authors.initials: T
authors.lastname: Simon
authors.forename: B
authors.initials: B
authors.lastname: Hero
authors.forename: A
authors.initials: A
authors.lastname: Faldum
authors.forename: R
authors.initials: R
authors.lastname: Handgretinger
authors.forename: M
authors.initials: M
authors.lastname: Schrappe
authors.forename: D
authors.initials: D
authors.lastname: Niethammer
authors.forename: F
authors.initials: F
authors.lastname: Berthold
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007167:Immunotherapy; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D015999:Multivariate Analysis; D009447:Neuroblastoma / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D012189:Retrospective Studies; D033581:Stem Cell Transplantation; D016019:Survival Analysis; D016896:Treatment Outcome; D014212:Tretinoin / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D014212:Tretinoin; C112746:dinutuximab