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Background <p>Granulocyte–macrophage colony-stimulating factor (GM-CSF), aldesleukin and isotretinoin are unavailable in Japan, necessitating alternative cytokines for dinutuximab immunotherapy. We compared the efficacy of a regimen containing granulocyte colony-stimulating factor (G-CSF)/teceleukin (regimen A) to that with GM-CSF/aldesleukin/isotretinoin (regimen B) in children with newly diagnosed high-risk neuroblastoma.</p> Methods <p>After completing initial therapy including high-dose chemotherapy followed by autologous stem cell transplantation and radiotherapy, children with non-progressive disease were randomized to regimen A or B. Regimen B was identical to the immunotherapy regimen tested in ANBL0032 (six cycles of isotretinoin and five concomitant cycles of dinutuximab alternating with GM-CSF and aldesleukin). Regimen A consisted of six cycles of dinutuximab alternating with G-CSF and teceleukin. Event-free survival (EFS) and overall survival (OS) were compared between two regimens.</p> Results <p>In total, 35 patients (16 receiving regimen A and 19 receiving regimen B) were enrolled. The 2-year EFS was 80.8% for patients receiving regimen A and 62.3% for those receiving regimen B, and their OS rates were 93.8% and 100.0%, respectively. The hazard ratio of regimen A compared to regimen B for EFS was 0.494 (upper limit of one-sided 70% confidence interval: 0.710), suggesting comparable efficacy of the two regimens. Frequently recorded grade 3/4 adverse events were fever, infection, and hematologic toxicity with no obvious difference in incidence between the regimens.</p> Conclusions <p>Our results suggest that the efficacy of the alternative regimen containing G-CSF is comparable to that of the ANBL0032 regimen, providing a rationale for further evaluation in a phase III trial.</p>

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Efficacy of anti-GD2 antibody immunotherapy with filgrastim and teceleukin versus standard treatment with sargramostim, aldesleukin and isotretinoin in children with high-risk neuroblastoma

  • 期刊论文

  • 发表日期：

    2026年7月23日

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  • Chika Nitani,
  • Junichi Hara,
  • Hiroshi Kawamoto,
  • Tomoaki Taguchi,
  • Yuki Yuza,
  • Shuhei Karakawa,
  • Kimikazu Matsumoto,
  • Toshimi Kimura,
  • Kenichi Yoshimura,
  • Kiyoshi Yoshimura,
  • Akinobu Hamada

摘要

Background

Granulocyte–macrophage colony-stimulating factor (GM-CSF), aldesleukin and isotretinoin are unavailable in Japan, necessitating alternative cytokines for dinutuximab immunotherapy. We compared the efficacy of a regimen containing granulocyte colony-stimulating factor (G-CSF)/teceleukin (regimen A) to that with GM-CSF/aldesleukin/isotretinoin (regimen B) in children with newly diagnosed high-risk neuroblastoma.

Methods

After completing initial therapy including high-dose chemotherapy followed by autologous stem cell transplantation and radiotherapy, children with non-progressive disease were randomized to regimen A or B. Regimen B was identical to the immunotherapy regimen tested in ANBL0032 (six cycles of isotretinoin and five concomitant cycles of dinutuximab alternating with GM-CSF and aldesleukin). Regimen A consisted of six cycles of dinutuximab alternating with G-CSF and teceleukin. Event-free survival (EFS) and overall survival (OS) were compared between two regimens.

Results

In total, 35 patients (16 receiving regimen A and 19 receiving regimen B) were enrolled. The 2-year EFS was 80.8% for patients receiving regimen A and 62.3% for those receiving regimen B, and their OS rates were 93.8% and 100.0%, respectively. The hazard ratio of regimen A compared to regimen B for EFS was 0.494 (upper limit of one-sided 70% confidence interval: 0.710), suggesting comparable efficacy of the two regimens. Frequently recorded grade 3/4 adverse events were fever, infection, and hematologic toxicity with no obvious difference in incidence between the regimens.

Conclusions

Our results suggest that the efficacy of the alternative regimen containing G-CSF is comparable to that of the ANBL0032 regimen, providing a rationale for further evaluation in a phase III trial.