Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma
The Lancet Oncology Sep 01, 2017
Weller M et al. - In the current study it was shown that rindopepimut did not increase survival in patients with newly diagnosed glioblastoma.
Methods
745 patients aged 18 years and older from 165 hospitals in 22 countries with glioblastoma expressing EGFRvIII who had undergone maximal surgical resection and completed standard chemoradiation without progression were recruited.
The patients were randomized to receive rindopepimut (500 ug admixed with 150 ug GM-CSF) or control (100 ug keyhole limpet haemocyanin) via monthly intradermal injection until progression or intolerance, concurrent with standard oral temozolomide (150–200 mg/m2 for 5 of 28 days) for 6–12 cycles or longer.
Results
The study was terminated for futility after a preplanned interim analysis.
There was no significant difference in overall survival for patients with minimal residual disease (median overall survival = 20·1 months in the rindopepimut group versus 20·0 months in the control group (HR = 1·01).
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