• Jacques Grill, Maura Massimino, Eric Bouffet, Amedeo A Azizi, Geoffrey McCowage, Adela Cañete, Frank Saran, Le DeleyMarie-CécileMCJacques Grill, Marie-Cécile Le Deley, and Gilles Vassal, Institut Gustave-Roussy, Villejuif; Marie-Cécile Le Deley, Paris-Saclay and Paris-Sud Universities, CESP, Institut National de la Santé et de la Recherche Médicale, Orsay; Pasc, Pascale Varlet, Paul S Morgan, Tim Jaspan, Chris Jones, Felice Giangaspero, Helen Smith, Josep Garcia, Markus C Elze, Raphaël F Rousseau, Lauren Abrey, Darren Hargrave, and Gilles Vassal.
• Jacques Grill, Marie-Cécile Le Deley, and Gilles Vassal, Institut Gustave-Roussy, Villejuif; Marie-Cécile Le Deley, Paris-Saclay and Paris-Sud Universities, CESP, Institut National de la Santé et de la Recherche Médicale, Orsay; Pascale Varlet, Sainte-Anne Hospital, Paris, France; Maura Massimino, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale dei Tumori, Milan; Felice Giangaspero, Sapienza University, Rome; Felice Giangaspero, IRCCS Neuromed, Pozzilli, Italy; Eric Bouffet, Hospital for Sick Children, Toronto, Ontario, Canada; Amedeo A. Azizi, Medical University of Vienna, Vienna, Austria; Geoffrey McCowage, Australasian Children's Cancer Trials, Clayton, Victoria, Australia; Adela Cañete, Hospital La Fe, Valencia, Spain; Frank Saran, The Royal Marsden Hospital; Chris Jones, The Institute of Cancer Research; Darren Hargrave, Great Ormond Street Hospital, London; Paul S. Morgan and Tim Jaspan, Nottingham University Hospitals, Queen's Medical Centre, Nottingham, United Kingdom; Helen Smith, Josep Garcia, Markus C. Elze, and Lauren Abrey, F. Hoffmann-La Roche Ltd, Basel, Switzerland; and Raphaël F. Rousseau, Gritstone Oncology, Emeryville, CA.
• J. Clin. Oncol. 2018 Apr 1; 36 (10): 951-958.

AbstractPurpose Bevacizumab (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). Methods The 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/m2 per day for 6 weeks; 4-week treatment break; then up to 12 × 28-day cycles of TMZ [cycle 1: 150 mg/m2 per day, days 1 to 5; cycles 2 to 12: 200 mg/m2 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. Results One 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%]). Conclusion Adding 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.

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