Wednesday, April 29, 2009

5 year results of Temozolomide + RT for GBM

The EORTC-NCIC trial examining temozolomide + RT for GBM is updated in the Lancet Oncology this week with 5 year results.

To review this is a randomized phase III trial examining 60 Gy RT vs 60 Gy + concurrent temozolomide and 6 months adjuvant temozolomide (TMZ). This was the first real advance in GBMs for decades and was initially presented with a 2 year OS benefit in the NEJM 2005.

To review the final 5 year results: OS was 27.2% (95% CI 22.2—32.5) at 2 years, 16.0% (12.0—20.6) at 3 years, 12.1% (8.5—16.4) at 4 years, and 9.8% (6.4—14.0) at 5 years with RT+TMZ, versus 10.9% (7.6—14.8), 4·4% (2.4—7.2), 3.0% (1.4—5.7), and 1.9% (0.6—4.4) for RT alone (HR 0.6, 95% CI 0.5—0.7; p<0·00001).

All subgroups benefited, including those >60 years of age. Methylation of the MGMT promoter predicted for the most benefit.

10% long term survival may not seem like much, but the tail on this curve supports the hypothesis that GBM (at least with MGMT methylation), is a curable disease with RT + TMZ.

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