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  3. Dinutuximab Beta Added to Temozolomide-Based Chemotherapy for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON Immuno Phase II Trial.

Dinutuximab Beta Added to Temozolomide-Based Chemotherapy for Children With Relapsed and Refractory Neuroblastoma: Results of the ITCC-SIOPEN BEACON Immuno Phase II Trial.

Fecha de publicación: Fecha Ahead of Print:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Gray JC
  • Weston R
  • Owens C
  • Gambart M
  • De Wilde B
  • Nysom K
  • van Eijkelenburg N
  • Ladenstein R
  • Castellano A
  • Gerber NU
  • Marshall LV
  • Barone G
  • Rubio-San-Simon A
  • Ng A
  • Vaidya S
  • Gallego S
  • Makin G
  • Burke GAA
  • McCarthy A
  • Murphy D
  • Zwaan CM
  • López-Almaraz R
  • Jannier S
  • Thebaud E
  • Corradini N
  • Yeomanson D
  • Howell L
  • Tweddle DA
  • Elliott M
  • Hobin D
  • Valteau-Couanet D
  • Schleiermacher G
  • Chastagner P
  • Defachelles AS
  • Brichard B
  • George S
  • Chesler L
  • Laidler J
  • Firth C
  • Holt G
  • Moroz V
  • Pearson ADJ
  • Gates S
  • Wheatley K
  • Kearns P

Grupos

Abstract

PURPOSE: Outcomes for children with relapsed and refractory high-risk neuroblastoma (RR-HR-NBL) remain dismal. Here, we investigate addition of the anti-GD2 monoclonal antibody, dinutuximab beta (dB), to temozolomide (T)-based chemotherapy. MATERIALS AND METHODS: Patients with RR-HR-NBL were randomly assigned in a 1:2 ratio to receive chemotherapy alone or chemotherapy with dB, given concurrently as a 7-day infusion (10 mg/m(2)/24 h). The trial had a factorial design, with some patients also randomly assigned between chemotherapy regimens (T v T-topotecan [TTo]). Crossover to dB with To/cyclophosphamide was allowed for patients randomly assigned to chemotherapy alone with disease progression (PD). The primary outcome was best objective response (complete or partial) rate (overall response rate [ORR]) during six cycles of treatment. Progression-free (PFS), overall survival (OS), and safety were secondary outcomes. RESULTS: Sixty-five patients were randomly assigned to chemotherapy alone (3 T, 19 TTo) or with dB (6 dBT, 37 dBTTo). The median age was 4 years; 28 and 37 patients had refractory and relapsed diseases, respectively. Baseline characteristics were balanced between arms. The ORR was 30.2% (13 of 43) and 18.2% (4 of 22) in dB and non-dB arms, the median PFS was 11.1 months (95% CI, 4.3 to 15.5) for dB patients and 3.8 months (95% CI, 1.9 to 7.9) for non-dB patients, respectively. The median OS was 25.7 months (95% CI, 11.4 to not reached [NR]) for dB patients and 17.1 months (95% CI, 7.6 to 54.6) for non-dB patients (upper 95% CI, NR in dB arm). Thirteen of 22 patients in the non-dB arm crossed over to dB with cyclophosphamide/To because of PD. Neurotoxicity was more common in the dB arm (grade 1 and 2: 26% v 9%, grade 3: 2.3% v 4.5%), but other toxicities were similar. CONCLUSION: Within a randomized phase II setting, results observed with addition of dB to T-based chemotherapy in RR-HR-NB warrant further evaluation.

Datos de la publicación

ISSN/ISSNe:
0732-183X, 1527-7755

JOURNAL OF CLINICAL ONCOLOGY  LIPPINCOTT WILLIAMS & WILKINS

Tipo:
Article
Páginas:
176-187
PubMed:
41385757
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
9,378 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 7

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Keywords

  • Adolescent; Antibodies, Monoclonal; Antineoplastic Combined Chemotherapy Protocols; Child; Child, Preschool; Female; Humans; Infant; Male; Neoplasm Recurrence, Local; Neuroblastoma; Progression-Free Survival; Temozolomide; antineoplastic agent; dinutuximab; monoclonal antibody; temozolomide; adolescent; child; clinical trial; controlled study; drug therapy; female; human; infant; male; mortality; multicenter study; neuroblastoma; pathology; phase 2 clinical trial; preschool child; progression free survival; randomized controlled trial; tumor recurrence

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