Phase III trial of nimotuzumab for the treatment of newly diagnosed diffuse intrinsic pontine gliomas in children and adolescents

Treatment of children with high grade glioma with nimotuzumab: A 5-y institutional experience

“…This antibody has an excellent safety profile that is unique in its class. 22,23 Because the antibody has intermediate affinity for EGFR, it preferentially accumulates in malignant tumors that overexpress EGFR, avoiding the severe skin rash, hypomagnesemia or diarrhea usually seen with cetuximab, panitumumab, erlotinib or gefitinib. 26,27 Other monoclonal antibodies such as bevacizumab, an anti-VEGF molecule, have been used in the treatment of children with brain tumors at significantly lower cumulative doses.…”

“…19 Nimotuzumab itself, labeled with the same radioisotope, accumulated in the brain tumors of patients with persistent glioblastoma multiforme or anaplastic astrocytomas after treatment with irradiation and nimotuzumab. 20 The objective responses (complete and partial responses) seen after treating relapsing glioma patients with ior egf/r3 21 or nimotuzumab alone, 22 indicates antibody penetration and effect at the tumor site.…”

“…Median overall survival was extended for responders (10 mo) compared with non-responders (4 mo). 22 Children with newly diagnosed DIPG have also been treated with nimotuzumab in combination with radiotherapy or radiotherapy/vinorelbine. A Phase 3 open-label, single-arm trial was done to assess the safety and efficacy of nimotuzumab in newlydiagnosed DIPG patients in combination with radiotherapy.…”

“…The median overall survival was 9.6 mo. 23 In another study, Massimino et al treated DIPG patients with nimotuzumab, vinorelbine and radiation, followed by consolidation courses of the antibody every 2 weeks. Preliminary results for 12 children, age range 3-13 y were recently reported.…”

Treatment of high-grade glioma in children

“…EGFR-insan R-3 monoklonal antikoru olan nimotuzumab, 47 nüks YDG ve BSKli hastanın takip edildiği faz II ça-lışmada kullanılmış, 22 BGG'li çocuğun 10'unda stabil hastalık ve kısmi cevap alınmıştır. [36] Yeni tanılı BSG'li hastalarda da kullanılmaktadır. Gefitinib, intratumoral kanamaya neden olduğundan 250 mg/m 2 doz ile kullanılmış ve 1 yıllık OS %48 bulunmuştur.…”