DINUTUXIMAB BETA-BASED CHEMO-IMMUNOTHERAPY FOR RELAPSED/REFRACTORY HIGH-RISK NEUROBLASTOMA: PRELIMINARY RESULTS


Olgun H. N., Çeçen R. E., İnce D., Kızmazoğlu D., Baysal B., Önal A., ...More

The 54th Congress of the International Society of Paediatric Oncology, Barcelona, Spain, 28 September - 01 October 2022, vol.167, no.1786, pp.225

  • Publication Type: Conference Paper / Summary Text
  • Volume: 167
  • City: Barcelona
  • Country: Spain
  • Page Numbers: pp.225
  • Dokuz Eylül University Affiliated: Yes

Abstract

Background and Aims

Relapsed or refractory (R/R) high-risk (HR) neuroblastoma (NB) has a dismal prognosis. Anti-GD2-mediated chemo-immunotherapy has a considerable anti-tumor activity in patients with R/R HR-NB. In the present study, we purposed to investigate the impacts and adverse effects of the combination of immunotherapy with dinutuximab beta (DB) and chemotherapy in patients with R/R HR-NB.

Methods

Patients of over 12 months with documentation of a HR-NB diagnosis were eligible at relapse or designation of refractory disease status. Inclusion criteria were as follows: relapsed or refractory, measurable by contrast-enhanced magnetic resonance imaging (MRI) and/or computed tomography (CT) or metaiodobenzylguanidine (MIBG)/ fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT evaluable disease and/or demonstrated by bone marrow aspiration and biopsy. Chemotherapy scheme was irinotecan (IV, 50 mg/m² per dose, on Days 0-4) and temozolomide (PO, 100 mg/m² per dose, on days 0-4). Dinutuximab beta was administered intravenously for 10 days through continuous infusion with 10 mg/m2 per day (on Days 1-10). The patients received 2 to 12 successive cycles with duration of 28 days each. Disease assessment was performed after cycles 2, 4, and 6 and every 2 to 3 cycles thereafter.

Results

Between January 2020 and January 2022, nineteen (n=19) patients received a total of 116 cycles of DB+CT. Objective (complete or partial) responses were achieved in 12/19 (63%) patients, including complete remission (CR) in 6/19 and partial response (PR) in 6/19. Stable disease was observed in two patients. The remaining five patients developed bone/bone marrow and soft tissue progression after 2-4 cycles of treatment. The most common side effect was fever, which was more common in the first cycles of treatment. Grade ≥3 toxicities were leukopenia (62%), thrombocytopenia (27%), hypertransaminasemia (25%), fever (14%), and rash/itching (11%), respectively.

Conclusions

DB-based chemo-immunotherapy is suitable leading to an encouraging response rate in patients with R/R HR-NB