Comment: The quality of the evidence is downgraded by study quality (inadequate or unclear allocation concealment, no blinding) and indirectness (differences in patients, all trials enrolled highly selected patients with good prognostic features that are not entirely representative of all patients with GBM).
A Cochrane review [Abstract] 1 included 3 studies with a total of 745 subjects with primary glioblastoma multiforme (GBM). They investigated temozolomide in combination with radiotherapy vs. radiotherapy alone. Temozolomide increased overall survival (OS, HR 0.60, 95% CI 0.46 to 0.79) and increased progression free survival (PFS, HR 0.63, 95% CI 0.43 to 0.92), when compared with radiotherapy alone, although these benefits only appear to emerge when therapy is given in both concomitant and adjuvant phases of treatment. A single RCT found that temozolomide did not have a statistically significant effect on QoL. Risk of haematological complications, fatigue and infections were increased with temozolomide.
In recurrent high-grade glioma, two RCTs (n=672) found that temozolomide did not increase OS compared to standard chemotherapy (HR 0.9, 95% CI 0.76 to 1.06) but it did increase PFS in a subgroup analysis of grade IV GBM tumours (HR 0.68, 95% CI 0.51 to 0.90; n=225). Adverse events were similar between arms. In the elderly, 2 RCTs (n=664) found that OS and PFS were similar with temozolomide alone vs. radiotherapy alone.
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