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. 2024 May:202:114001.
doi: 10.1016/j.ejca.2024.114001. Epub 2024 Mar 11.

Chemo-immunotherapy with dinutuximab beta in patients with relapsed/progressive high-risk neuroblastoma: does chemotherapy backbone matter?

Patricia Raiser  1 , Gudrun Schleiermacher  2 , Marion Gambart  3 , Benoit Dumont  4 , Anne-Sophie Defachelles  5 , Estelle Thebaud  6 , Julie Tandonnet  7 , Claudia Pasqualini  1 , Stéphanie Proust  8 , Natacha Entz-Werle  9 , Isabelle Aerts  2 , Lee A Ndounga-Diakou  10 , Arnaud Petit  11 , Chloe Puiseux  12 , Camille Khanfar  13 , Jeremie Rouger  14 , Ludovic Mansuy  15 , Joy Benadiba  16 , Frédéric Millot  17 , Claire Pluchart  18 , Salim Laghouati  10 , Birgit Geoerger  19 , Gilles Vassal  1 , Dominique Valteau-Couanet  1 , Pablo Berlanga  20
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Free article

Chemo-immunotherapy with dinutuximab beta in patients with relapsed/progressive high-risk neuroblastoma: does chemotherapy backbone matter?

Patricia Raiser et al. Eur J Cancer. 2024 May.
Free article

Abstract

Background: Addition of anti-GD2 antibodies to temozolomide-based chemotherapy has demonstrated increased antitumor activity and progression-free survival in patients with relapsed/progressive high-risk neuroblastoma. However, chemo-immunotherapy is not yet approved for this indication. This study presents the chemo-immunotherapy experience in patients with relapsed/progressive high-risk neuroblastoma treated within the off-label use program of the Neuroblastoma Committee of the French Society of Pediatric Oncology (SFCE).

Methods: Dinutuximab beta (dB) was administered alongside temozolomide-topotecan (TOTEM) or temozolomide-irinotecan (TEMIRI) at first disease relapse/progression or topotecan-cyclophosphamide (TopoCyclo) at further relapse/progression. Real-world data on demographics, treatment, antitumor activity and safety was collected from all patients after inclusion in SACHA-France (NCT04477681), a prospective national registry, which documents safety and efficacy data on innovative anticancer therapies prescribed to patients ≤ 25 years old as compassionate or off-label use.

Results: Between February 2021 and July 2023, 39 patients with confirmed relapsed/progressive high-risk neuroblastoma (median age 6 years, range 1-24) were treated with dB+TopoCyclo (n = 24) or dB+TOTEM/TEMIRI (n = 15) across 17 centers. In total, 163 chemo-immunotherapy cycles were administered, main toxicities were mild or moderate, with higher incidence of hematological adverse drug reactions with dB+TopoCyclo than dB+TOTEM/TEMIRI. Objective response rate was 42% for dB+TopoCyclo (CI95% 22-63%) and 40% for dB+TOTEM/TEMIRI (CI95% 16-68%).

Conclusion: Similar objective response rates for dB+TopoCyclo and dB+TOTEM/TEMIRI in patients with relapsed/progressive high-risk neuroblastoma emphasize the importance of chemo-immunotherapy, irrespective of the chemotherapy backbone.

Keywords: Chemotherapy; Dinutuximab beta; Immunotherapy; Neuroblastoma; Real-world data; Relapse.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Pablo Berlanga reported an advisory role (institutional funding) for EUSA Pharma and grants and drugs for trials from Bayer outside the submitted work. No other disclosures were reported.

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