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Furman WL, McCarville B, Shulkin BL, et al. Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. J Clin Oncol. 2021;JCO2101375doi: 10.1200/JCO.21.01375.
Furman, W. L., McCarville, B., Shulkin, B. L., Davidoff, A., Krasin, M., Hsu, C. W., Pan, H., Wu, J., Brennan, R., Bishop, M. W., Helmig, S., Stewart, E., Navid, F., Triplett, B., Santana, V., Santiago, T., Hank, J. A., Gillies, S. D., Yu, A., Sondel, P. M., Leung, W. H., Pappo, A., & Federico, S. M. (2021). Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, JCO2101375. https://doi.org/10.1200/JCO.21.01375
Furman, Wayne L, et al. "Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A." Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. (2021): JCO2101375. doi: https://doi.org/10.1200/JCO.21.01375
Furman WL, McCarville B, Shulkin BL, Davidoff A, Krasin M, Hsu CW, Pan H, Wu J, Brennan R, Bishop MW, Helmig S, Stewart E, Navid F, Triplett B, Santana V, Santiago T, Hank JA, Gillies SD, Yu A, Sondel PM, Leung WH, Pappo A, Federico SM. Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A. J Clin Oncol. 2021 Dec 06;JCO2101375. doi: 10.1200/JCO.21.01375. Epub 2021 Dec 06. PMID: 34871104.
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J Clin Oncol. 2021 Dec 06;JCO2101375. doi: 10.1200/JCO.21.01375. Epub 2021 Dec 06.

Improved Outcome in Children With Newly Diagnosed High-Risk Neuroblastoma Treated With Chemoimmunotherapy: Updated Results of a Phase II Study Using hu14.18K322A.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Wayne L Furman, Beth McCarville, Barry L Shulkin, Andrew Davidoff, Matthew Krasin, Chia-Wei Hsu, Haitao Pan, Jianrong Wu, Rachel Brennan, Michael W Bishop, Sara Helmig, Elizabeth Stewart, Fariba Navid, Brandon Triplett, Victor Santana, Teresa Santiago, Jacquelyn A Hank, Stephen D Gillies, Alice Yu, Paul M Sondel, Wing H Leung, Alberto Pappo, Sara M Federico

Affiliations

  1. Department of Oncology, St Jude Children's Research Hospital, Memphis, TN.
  2. St Jude Children's Research Hospital, Memphis, TN.
  3. University of Kentucky, Lexington, KY.
  4. Department of Pediatrics, Children's Hospital Los Angeles, University of Southern California, Los Angeles, CA.
  5. Departments of Pediatrics and Human Oncology, University of Wisconsin, Madison, WI.
  6. Provenance Biopharmaceuticals, Carlisle, MA.
  7. University of California San Diego, San Diego, CA.
  8. Institute of Stem Cell and Translational Cancer Research, Chang Gung Memorial Hospital at Linkou and Chang Gung University, Taiwan.
  9. Department of Pediatrics, University of Hong Kong, Hong Kong.

PMID: 34871104 DOI: 10.1200/JCO.21.01375

Abstract

PURPOSE: We evaluated whether combining a humanized antidisialoganglioside monoclonal antibody (hu14.18K322A) throughout therapy improves early response and outcomes in children with newly diagnosed high-risk neuroblastoma.

PATIENTS AND METHODS: We conducted a prospective, single-arm, three-stage, phase II clinical trial. Six cycles of induction chemotherapy were coadministered with hu14.18K322A, granulocyte-macrophage colony-stimulating factor (GM-CSF), and low-dose interleukin-2 (IL-2). The consolidation regimen included busulfan and melphalan. When available, an additional cycle of parent-derived natural killer cells with hu14.18K322A was administered during consolidation (n = 31). Radiation therapy was administered at the end of consolidation. Postconsolidation treatment included hu14.18K322A, GM-CSF, IL-2, and isotretinoin. Early response was assessed after the first two cycles of induction therapy. End-of-induction response, event-free survival (EFS), and overall survival (OS) were evaluated.

RESULTS: Sixty-four patients received hu14.18K322A with induction chemotherapy. This regimen was well tolerated, with continuous infusion narcotics. Partial responses (PRs) or better after the first two chemoimmunotherapy cycles occurred in 42 of 63 evaluable patients (66.7%; 95% CI, 55.0 to 78.3). Primary tumor volume decreased by a median of 75% (range, 100% [complete disappearance]-5% growth). Median peak hu14.18K322A serum levels in cycle one correlated with early response to therapy (

CONCLUSION: Adding hu14.18K322A to induction chemotherapy improved early objective responses, significantly reduced tumor volumes in most patients, improved end-of-induction response rates, and yielded an encouraging 3-year EFS. These results, if validated in a larger study, may be practice changing.

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