title: Ocular abnormalities in patients treated with a novel anti-GD2 monoclonal antibody, hu14.18K322A.
abstract: OBJECTIVE
  To determine the incidence of and factors associated with the development of mydriasis and impaired accommodation in patients with refractory or recurrent neuroblastoma receiving the anti-GD2 antibody hu14.18K322A.
  
  
  METHODS
  The medical records of eligible patients with refractory or recurrent neuroblastoma who received escalating doses of hu14.18K322A, ranging from 2 to 70 mg/m(2)/dose for 4 consecutive days every 28 days, were retrospectively reviewed to identify ocular abnormalities arising during the treatment period.
  
  
  RESULTS
  A total of 38 patients (median age, 7 years; 23 males) were included. All patients underwent comprehensive eye examinations prior to each course of therapy. Mydriasis was seen in 13 patients (34%), and impaired accommodation was seen in 9 (24%), indicating a dose-related effect between hu14.18K322A and both mydriasis (P = 0.021) and impaired accommodation (P = 0.029). Age and sex were not associated with ocular abnormalities. Ocular symptoms resolved in the majority of patients after the drug was discontinued.
  
  
  CONCLUSIONS
  Side effects of mydriasis and impaired accommodation have a dose-dependent relationship with hu14.18K322A. These side effects do not warrant discontinuation of treatment, as they usually resolve after completion of therapy. Management of ocular side effects should focus on treating symptoms with manifest refraction, bifocals, or tinted spectacles.
authors.affiliation: Department of Ophthalmology, Hamilton Eye Institute, University of Tennessee Health Science Center, Memphis, Tennessee; Department of Surgery, Division of Ophthalmology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Brian C
authors.initials: BC
authors.lastname: Tse
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee; Department of Pediatrics, College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee.
authors.forename: Fariba
authors.initials: F
authors.lastname: Navid
authors.affiliation: Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Billups
authors.affiliation: Department of Ophthalmology, Hamilton Eye Institute, University of Tennessee Health Science Center, Memphis, Tennessee; Department of Surgery, Division of Ophthalmology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Thomas
authors.initials: T
authors.lastname: O'Donnell
authors.affiliation: Department of Ophthalmology, Hamilton Eye Institute, University of Tennessee Health Science Center, Memphis, Tennessee; Department of Surgery, Division of Ophthalmology, St. Jude Children's Research Hospital, Memphis, Tennessee; Department of Pediatrics, College of Medicine, University of Tennessee Health Science Center, Memphis, Tennessee. Electronic address: mhoehn@uthsc.edu.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Hoehn
mesh_terms: D000065:Accommodation, Ocular / Q000187:drug effects*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D001932:Brain Neoplasms / Q000188:drug therapy*; D002648:Child; D004305:Dose-Response Relationship, Drug; D005260:Female; D005732:Gangliosides / Q000276:immunology*; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D008297:Male; D015878:Mydriasis / Q000139:chemically induced* / Q000175:diagnosis / Q000503:physiopathology; D009364:Neoplasm Recurrence, Local; D009447:Neuroblastoma / Q000188:drug therapy*; D012189:Retrospective Studies; D012307:Risk Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D005732:Gangliosides; C019403:ganglioside, GD2
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