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Phase II, Open-Label, Randomized, Multicenter Trial (HERBY) of Bevacizumab in Pediatric Patients With Newly Diagnosed High-Grade Glioma

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Grill, J
  • Massimino, M
  • Bouffet, E
  • Azizi, AA
  • McCowage, G
  • Saran, F
  • Le Deley, MC
  • Varlet, P
  • Morgan, PS
  • Jaspan, T
  • Jones, C
  • Giangaspero, F
  • Smith, H
  • Garcia, J
  • Elze, MC
  • Rousseau, RF
  • Abrey, L
  • Hargrave, D
  • Vassal, G

Grupos

Abstract

PurposeBevacizumab (BEV) is approved in more than 60 countries for use in adults with recurrent glioblastoma. We evaluated the addition of BEV to radiotherapy plus temozolomide (RT+TMZ) in pediatric patients with newly diagnosed high-grade glioma (HGG).MethodsThe randomized, parallel group, multicenter, open-label HERBY trial (ClinicalTrials.gov identifier: NCT01390948) enrolled patients age 3 years to 18 years with localized, centrally neuropathology-confirmed, nonbrainstem HGG. Eligible patients were randomly assigned to receive RT + TMZ (RT: 1.8 Gy, 5 days per week, and TMZ: 75 mg/m(2) per day for 6 weeks; 4-week treatment break; then up to 12 x 28-day cycles of TMZ [cycle 1: 150 mg/m(2) per day, days 1 to 5; cycles 2 to 12: 200 mg/m(2) per day, days 1 to 5]) with or without BEV (10 mg/kg every 2 weeks). The primary end point was event-free survival (EFS) as assessed by a central radiology review committee that was blinded to treatment. We report findings of EFS at 12 months after the enrollment of the last patient.ResultsOne hundred twenty-one patients were enrolled (RT+TMZ [n = 59]; BEV plus RT+TMZ [n = 62]). Central radiology review committee-assessed median EFS did not differ significantly between treatment groups (RT+TMZ, 11.8 months; 95% CI, 7.9 to 16.4 months; BEV plus RT+TMZ, 8.2 months; 95% CI, 7.8 to 12.7 months; hazard ratio, 1.44; P = .13 [stratified log-rank test]). In the overall survival analysis, the addition of BEV did not reduce the risk of death (hazard ratio, 1.23; 95% CI, 0.72 to 2.09). More patients in the BEV plus RT+TMZ group versus the RT+TMZ group experienced one or more serious adverse events (n = 35 [58%] v n = 27 [48%]), and more patients who received BEV discontinued study treatment as a result of adverse events (n = 13 [22%] v n = 3 [5%]).ConclusionAdding BEV to RT+TMZ did not improve EFS in pediatric patients with newly diagnosed HGG. Our findings were not comparable to those of previous adult trials, which highlights the importance of performing pediatric-specific studies. (C) 2018 by American Society of Clinical Oncology

Datos de la publicación

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

JOURNAL OF CLINICAL ONCOLOGY  LIPPINCOTT WILLIAMS & WILKINS

Tipo:
Article
Páginas:
951-958
PubMed:
29412784
Factor de Impacto:
11,754 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 111

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Keywords

  • CHILDRENS ONCOLOGY GROUP; RESPONSE ASSESSMENT; GLIOBLASTOMA; TEMOZOLOMIDE; PATTERNS; RADIOTHERAPY; PROGRESSION; MUTATIONS; EFFICACY; CRITERIA

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