medwireNews: Adding bevacizumab to radiotherapy plus temozolomide does not improve event-free survival in children with newly diagnosed high-grade glioma (HGG), trial findings show.
“These results are not fully consistent with adult studies and highlight the biologic differences between adult and childhood HGG, as well as the importance of performing pediatric-specific studies,” say Jacques Grill (Institut Gustave-Roussy, Villejuif, France) and co-workers in the Journal of Clinical Oncology.
The phase II HERBY investigators say that their findings differed from those in adult patients, where bevacizumab has been shown to delay radiologic progression.
In a commentary accompanying the report, Paul Graham Fisher (Stanford University, Palo Alto, California, USA) says: “Grill et al should be congratulated for publishing this negative study and for providing the final chapter, we hope, in pediatric cancer trials that do not recognize the distinct biology and clinical behavior of [pediatric] HGGs compared with adult [HGGs].
“The important take-home message from the study by Grill et al is that we have continued to ignore the fact that children are not little adults.”
The open-label, multicenter trial enrolled patients, aged between 3 and 18 years, with localized, centrally neuropathology-confirmed, nonbrainstem HGG.
All 121 participants received both 1.8 Gy radiotherapy 5 days/week and daily temozolomide 75 mg/m2 for 6 weeks followed by a minimum 4-week treatment break. Patients then received up to 12 28-day cycles of temozolomide, with cycle one at 150 mg/m2 per day on days 1 to 5 and cycles two to 12 at 200 mg/m2 on days 1 to 5.
Participants were also randomly assigned to receive no bevacizumab (n=59) or bevacizumab 10 mg/kg every 2 weeks (n=62).
The primary endpoint of event-free survival did not differ significantly between the groups, at 11.8 months without bevacizumab and 8.2 months with bevacizumab.
The addition of bevacizumab also did not significantly affect the risk for death overall. However, more patients receiving bevacizumab experienced one or more serious adverse events, at 58%, and discontinued treatment due to adverse events, at 22%, than did those not treated with bevacizumab, at 48% and 5%, respectively.
The researchers conclude: “These results […] highlight the biologic differences between adult and childhood HGG.”
Addressing what needs to happen next, Fisher comments: “We must pursue strategies that may differ sharply from those used in the treatment of adult cancer.”
By Anita Chakraverty
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