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Immunotherapy plus standard treatment increased EFS, OS in neuroblastoma
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2009 ASCO Annual Meeting
Chimeric anti-GD2 antibody ch14.18, an antibody-based immunotherapy, reduced the risk for relapse and improved OS by 20% in patients with high-risk neuroblastoma, according to data from a phase-3 Children’s Oncology Group study. Results were presented ahead of the 2009 ASCO Annual Meeting.
“High-risk neuroblastoma often returns and most
patients do not survive,” Alice L. Yu, MD,
PhD, research professor of pediatrics in the Hematologic Malignancies
Program at The University of California at San Diego, said during her
presentation. “So with that, we know that a new modality of treatment is
needed to prevent relapse for high-risk neuroblastoma.” 
Click
here to hear Dr. Yu speak about the results.
The study included 226 high-risk patients who had a complete or partial response to induction therapy and myeloablative consolidation with stem cell rescue. Patients were randomly assigned to six cycles of standard therapy (13-cis-retinoic acid) with or without five concomitant cycles of immunotherapy (ch14.18 plus GM-CSF or IL2 in alternating cycles). Yu and colleagues also conducted a randomized comparison of event-free survival and OS.
Event-free survival was 66% in the immunotherapy group compared with 46% in the standard treatment group after two years. Similarly, OS was 86% in the immunotherapy group compared with 75% in the standard treatment group after two years. Pain, vascular leak syndrome and allergic reactions were the most common adverse effects in the immunotherapy group.
“The 20% increase in children alive over two years or two years without cancer who received experimental immunotherapy after stem cell transplant makes this immunotherapy the new standard of care,” Yu said. – by Stacey L. Adams
This is a very exciting result that will alter the standard of care for high-risk neuroblastoma. The study, conducted by the Children’s Oncology Group, exemplifies the power of cooperative group research involving tight collaborations between scientists, clinical researchers and clinicians. The result raises provocative scientific and logistical questions. How much did the cytokine component (IL-2 and GM-CSF) of the anti-GD2 therapy arm contribute to the improvement in clinical outcomes? Can a similar result be achieved without cytokines or with other methods of cytokine delivery? What clinical or biological features determined which patients benefited from immunotherapy? Because immunotherapy lengthened duration of therapy and was associated with toxicity, is it possible to preselect patients who would benefit from such an approach? A logistical issue is that worldwide demand for the anti-GD2 antibody is certain to increase. Will the antibody become available outside the context of clinical trials? Are other anti-GD2 antibodies equivalent? The pediatric oncology community will watch with great interest to see how this story evolves in the coming months and years.
– Jeffrey S. Dome, MD
Chief, Division of Oncology,
Center for Cancer and
Blood Disorders, Children's National Medical Center
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