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    Neuroblastoma Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Treatment of High-Risk Neuroblastoma

    Table 8. Children's Oncology Group (COG) Neuroblastoma High-Risk Group Assignment Schema continued...

    Local control (surgery and radiation therapy)

    The potential benefit of aggressive surgical approaches in high-risk patients with metastatic disease to achieve complete tumor resection, either at the time of diagnosis or following chemotherapy, has not been unequivocally demonstrated.

    • Several studies have reported that complete resection of the primary tumor at diagnosis improved survival; however, the outcome in these patients may be more dependent on the biology of the tumor, which itself may determine resectability, than on the extent of surgical resection.[19,20,21,22,23,24]
    • Radiation therapy to consolidate local control after surgical resection is often given.[25]; [26][Level of evidence: 3iiA]
    • In stage 4 patients older than 18 months, it is controversial as to whether there is any advantage to gross-total resection of the primary tumor mass after chemotherapy.[21,22,23,24]

    Treatment Options Under Clinical Evaluation

    The following are examples of national and/or institutional clinical trials that are currently being conducted. Information about ongoing clinical trials is available from the NCI Web site.

    • COG-ANBL12P1 (NCT01798004) (Busulfan, Melphalan, and SCT After Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma): Because busulfan/melphalan has not been used with the COG induction regimen, the primary objective of this study is to examine the toxicity profile of busulfan/melphalan in the context of COG therapy, with specific focus on the incidence and severity of pulmonary and hepatic toxicity. The outcome of this trial will influence the choice of preparative regimens used in the upcoming COG high-risk neuroblastoma trials.
    • COG-ANBL09P1 (NCT01175356) (Induction Therapy Including 131 I-Metaiodobenzylguanidine [mIBG] and Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma Undergoing SCT, Radiation Therapy, and Maintenance Therapy With Isotretinoin): This pilot study will evaluate the tolerability and feasibility of an induction chemotherapy regimen containing five cycles of multiagent chemotherapy and a block of 131 I-mIBG followed by a consolidation regimen of busulfan/melphalan with autologous stem cell rescue and external-beam radiation therapy. The study has been amended to omit vincristine and irinotecan as radiation sensitizers, and the period from transplant to the start of radiation was extended to 42 days because of toxicity.
    • COG-ANBL0032 (Isotretinoin With Monoclonal Antibody, Interleukin-2, and Sargramostim Following SCT in Treating Patients With Neuroblastoma): The COG is studying, now in a nonrandomized fashion, the use of monoclonal antibody therapy with GM-CSF and interleukin-2 combined with isotretinoin following chemotherapy.[16]
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