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Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma.

Publication ,  Journal Article
Yu, AL; Gilman, AL; Ozkaynak, MF; London, WB; Kreissman, SG; Chen, HX; Smith, M; Anderson, B; Villablanca, JG; Matthay, KK; Shimada, H ...
Published in: N Engl J Med
September 30, 2010

BACKGROUND: Preclinical and preliminary clinical data indicate that ch14.18, a monoclonal antibody against the tumor-associated disialoganglioside GD2, has activity against neuroblastoma and that such activity is enhanced when ch14.18 is combined with granulocyte-macrophage colony-stimulating factor (GM-CSF) or interleukin-2. We conducted a study to determine whether adding ch14.18, GM-CSF, and interleukin-2 to standard isotretinoin therapy after intensive multimodal therapy would improve outcomes in high-risk neuroblastoma. METHODS: Patients with high-risk neuroblastoma who had a response to induction therapy and stem-cell transplantation were randomly assigned, in a 1:1 ratio, to receive standard therapy (six cycles of isotretinoin) or immunotherapy (six cycles of isotretinoin and five concomitant cycles of ch14.18 in combination with alternating GM-CSF and interleukin-2). Event-free survival and overall survival were compared between the immunotherapy group and the standard-therapy group, on an intention-to-treat basis. RESULTS: A total of 226 eligible patients were randomly assigned to a treatment group. In the immunotherapy group, a total of 52% of patients had pain of grade 3, 4, or 5, and 23% and 25% of patients had capillary leak syndrome and hypersensitivity reactions, respectively. With 61% of the number of expected events observed, the study met the criteria for early stopping owing to efficacy. The median duration of follow-up was 2.1 years. Immunotherapy was superior to standard therapy with regard to rates of event-free survival (66±5% vs. 46±5% at 2 years, P=0.01) and overall survival (86±4% vs. 75±5% at 2 years, P=0.02 without adjustment for interim analyses). CONCLUSIONS: Immunotherapy with ch14.18, GM-CSF, and interleukin-2 was associated with a significantly improved outcome as compared with standard therapy in patients with high-risk neuroblastoma. (Funded by the National Institutes of Health and the Food and Drug Administration; ClinicalTrials.gov number, NCT00026312.)

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 30, 2010

Volume

363

Issue

14

Start / End Page

1324 / 1334

Location

United States

Related Subject Headings

  • Survival Analysis
  • Stem Cell Transplantation
  • Neuroblastoma
  • Isotretinoin
  • Interleukin-2
  • Intention to Treat Analysis
  • Infant
  • Immunotherapy
  • Humans
  • Granulocyte-Macrophage Colony-Stimulating Factor
 

Citation

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ICMJE
MLA
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Yu, A. L., Gilman, A. L., Ozkaynak, M. F., London, W. B., Kreissman, S. G., Chen, H. X., … Children’s Oncology Group, . (2010). Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med, 363(14), 1324–1334. https://doi.org/10.1056/NEJMoa0911123
Yu, Alice L., Andrew L. Gilman, M Fevzi Ozkaynak, Wendy B. London, Susan G. Kreissman, Helen X. Chen, Malcolm Smith, et al. “Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma.N Engl J Med 363, no. 14 (September 30, 2010): 1324–34. https://doi.org/10.1056/NEJMoa0911123.
Yu AL, Gilman AL, Ozkaynak MF, London WB, Kreissman SG, Chen HX, et al. Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma. N Engl J Med. 2010 Sep 30;363(14):1324–34.
Yu, Alice L., et al. “Anti-GD2 antibody with GM-CSF, interleukin-2, and isotretinoin for neuroblastoma.N Engl J Med, vol. 363, no. 14, Sept. 2010, pp. 1324–34. Pubmed, doi:10.1056/NEJMoa0911123.
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):1324–1334.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

September 30, 2010

Volume

363

Issue

14

Start / End Page

1324 / 1334

Location

United States

Related Subject Headings

  • Survival Analysis
  • Stem Cell Transplantation
  • Neuroblastoma
  • Isotretinoin
  • Interleukin-2
  • Intention to Treat Analysis
  • Infant
  • Immunotherapy
  • Humans
  • Granulocyte-Macrophage Colony-Stimulating Factor