Escalating temozolomide dose regimen beyond that used in standard therapy, termed the dose dense regimen, has been proposed as a means to functional deplete MGMT and improve temozolomide efficacy in the management of glioblastoma. This randomized control trial evaluated 883 patients with glioblastoma who underwent standard radiation and were randomized to concurrent standard dose temozolomide (150-200 mg/m2 on days 1-5 every 28 days, n=411) versus dose dense temozolomide (75-100 mg/m2 on days 1-21 every 28 days, n=422). While patients with MGMT promoter methylation survived longer than those without promoter methylation (overall survival of 21.2 months versus 14 months; and median survival of 8.7 months versus 5.7 months, p<0.001), there was no difference between standard and dose dense temozolomide (16.6 versus 14.9 months, respectively.) The study concludes that dose dense temozolomide therapy is not associated with improved efficacy relative to the current standard of care.
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