Many studies have compared 6 cycles of monthly temzolomide to extended temozolomide for newly diagnosed GBM. However, all of those studies have been retrospective in nature (they were not designed as prospective clinical trials randomizing patients to either 6 or 12 months of monthly TMZ).
A small (20 patients in each arm), but randomized trial was published recently by an Indian group. The result was a 4 month increase in median progression-free survival in the 12 month arm, and a >8 month increase in median overall survival (15.4 months versus 23.8 months), measured from diagnosis.
Patients in this trial were between the ages of 18 and 65, with KPS equal to or over 70. Unfortunately, there was no information (and consequently no stratification by) MGMT status, which limits the significance of the study, as the authors readily admit. "One limitation of our study is the small sample size of patients
and lack of information on MGMT methylation status of patients." However, this is the first randomized trial for newly diagnosed GBM comparing 6 cycles to 12 cycles of monthly temozolomide treatment.
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