Alice L. Yu, M.D colchicine ., Ph.D., Andrew L. Gilman, M.D., M. Fevzi Ozkaynak, M.D., Wendy B. London, Ph.D., Susan G. Kreissman, M.D., Helen X. Chen, M.D., Malcolm Smith, M.D., Ph.D., Barry Anderson, M.D., Judith G. Villablanca, M.D., Katherine K. Matthay, M.D., Hiro Shimada, M.D., Stephan A. Grupp, M.D., Ph.D., Robert Seeger, M.D., C. Patrick Reynolds, M.D., Ph.D., Allen Buxton, M.S., Ralph A. Reisfeld, Ph.D., Steven D. Gillies, Ph.D., Susan L. Cohn, M.D., John M. Maris, M.D., and Paul M. Sondel, M.D., Ph.D. For the Children’s Oncology Group: Anti-GD2 Antibody with GM-CSF, Interleukin-2, and Isotretinoin for Neuroblastoma Neuroblastoma, a tumor of the sympathetic nervous system in charge of 12 percent of deaths associated with cancer in kids under 15 years,1 is a heterogeneous disease, with nearly 50 percent of patients having a high-risk phenotype characterized by widespread dissemination of the cancers and poor long-term survival, even if intensive multimodal treatments are used.2 The initial results of the last randomized, controlled trial displaying a significant improvement in outcomes were published over a decade ago3,4 and established the typical therapy for high-risk neuroblastoma: myeloablative therapy with stem-cell rescue, followed by the treatment of minimal residual disease with isotretinoin.
Adverse Events All sufferers had at least 1 adverse event . Self-limited infections, upper respiratory illness primarily, accounted for the majority, but stomatitis was common also. These events are in keeping with the known basic safety profile of everolimus and were generally quality 1 or quality 2 events. Events rated as severe adverse events were reported in 10 individuals, and one grade 4 event occurred in one patient. Four patients had serious adverse events. One patient with a history of reactive airway disease was hospitalized after recurrent top respiratory infection developed, with sinusitis and cough that exacerbated breathing difficulties and was connected with leukopenia.