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The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.
The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.
The mAb was approved in combination with the cytokines granulocyte macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2), and the oral retinoid isotretinoin (RA). The approval was based on a pivotal, phase 3, multicenter, open-label, randomized trial conducted by the Children’s Oncology Group between October 2001 and January 2009 that was stopped early after the combination demonstrated superiority over standard therapy with respect to event-free survival (EFS).2
Two hundred and twenty-six patients (mostly pediatric patients, though age up to 31 years at diagnosis was allowed) with high-risk neuroblastoma were enrolled based on the following criteria: age of ≤31 years at diagnosis; completion of induction therapy, autologous stem-cell transplant (SCT), and radiation therapy, with autologous SCT performed within 9 months of initiation of induction therapy; achievement of at least partial response prior to autologous SCT; enrollment between 50-100 days after final autologous SCT; absence of progressive disease; adequate organ function; life expectancy of at least 2 months; and prior enrollment in the COG biology study (ANBL00B1). An additional 25 patients with biopsy-proven residual disease after autologous SCT were also enrolled, but were nonrandomly assigned to the immunotherapy arm and were excluded from the primary outcome analysis. Patients with systemic infections or a requirement for concomitant systemic corticosteroids or immunosuppressant usage were ineligible.
Click on the PDF icon at the top of this introduction to read the full article.