Nimotuzumab and vinorelbine concomitantly to radiation and as maintenance for diffuse pontine glioma in childhood: Results from a series of 12 patients.

Abstract

9557 Background: Childhood MRI diagnosed diffuse pontine glioma have a universally known awful prognosis. After joining a previous trial with nimotuzumab and radiation, reported also at ASCO (2008), and continuing for a total of 37 patients from January 2006-June 2009 according to this new combination, we obtained median PFS 7 months, median OS 11 months, thus entirely consistent with best literature data and those previously reported by ourselves (Massimino 2008). All treatment was given on an outpatient basis, without any side effects correlated with the use of nimotuzumab. Two of 37 children were alive without tumor progression 17 and 27 months after diagnosis. Methods: In a subsequent mono-institutional experience, exploring add-on strategies, we began a pilot protocol on a compassionate case-by-case basis, using nimotuzumab together with vinorelbine, combined with radiation, adopting consolidation courses with the same timing as in the previous international radiation plus nimotuzumab protocol. Vinorelbine was at a dose of 20 mg/sqm/weekly together with nimotuzumab at the standard dose of 150 mg/sqm during the 6 weeks of radiotherapy, and 25 mg/sqm in any other week, with the same dose of nimotuzumab during the consolidation courses, planned until tumor progression or for a duration of two years. Results: We have so far treated 12 children, 7 males and 5 females, age range 3-13 years, enrolled according to the standard MRI inclusion criteria. After a mean follow-up of 10 months, 10/12 were alive, their PFS at 9 months was 69 ± 21% and their OS at 12 months was 81.5 ± 12 %. According to MRI evaluation, in 10/12 children evaluable for response, 7 had partial remission and 3 stable disease with 100% symptom amelioration. The nimotuzumab/vinorelbine combination was very well tolerated, with no acute side-effects. As in the case of nimotuzumab alone, all children were treated on an outpatient basis. Conclusions: The observation time for this new series is long enough to give the impression that this combination has promise, with statistically significant differences with previous reported experiences.