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

Al's Comment:

 This trial shows why we need to test treatments in kids and not just assume that they will work the same as in adults.  This trial compares the standard of radiation and temodar with and without Avastin,  for newly diagnosed high grade glioma.  In previously reported trials on adults, there was a pretty good increase in progression free survival with just about no increase in overall survival.  In this study with children, they found that adding Avastin decreased both the progression free survival and overall survival, and there were more side effects in the Avastin group.

[Disclosure: Genetech is a sponsor of our organization]

Posted on: 02/08/2018

J Clin Oncol. 2018 Feb 7:JCO2017760611. doi: 10.1200/JCO.2017.76.0611. [Epub ahead of print]
Phase II, Open-Label, Randomized, Multicenter Trial (HERBY) of Bevacizumab in Pediatric Patients With Newly Diagnosed High-Grade Glioma.
Grill J1, Massimino M1, Bouffet E1, Azizi AA1, McCowage G1, Cañete A1, Saran F1, Le Deley MC1, Varlet P1, Morgan PS1, Jaspan T1, Jones C1, Giangaspero F1, Smith H1, Garcia J1, Elze MC1, Rousseau RF1, Abrey L1, Hargrave D1, Vassal G1.
Author information:
    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.
Purpose 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 ( 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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