EF-14 Study : Efficacy of alternating electrical fields combined with Temozolomide vs Temozolomide alone in patients with newly diagnosed GBM
Andreas Hottinger, Centre hospitalier universitaire vaudois, Lausanne, Switzerland
Alternating electric fields (tumor treating fields, TTF) present a new therapeutic modality that can be applied locoregionally. These electric fields interact with cell division and the assembly of organelles.
In this phase III trial, patients suffering from newly diagnosed glioblastoma were randomized (1 :2) following treatment with RT and temozolomide to recieve maintenance temozolomide either alone or in combination with TTF. Progression-free survival was the primary endpoint. TTF were applied continuously (>18 hours/day) by 4 transducer arrays placed on the shaved scalp connected to a portable electric field generator.
Between 2009 and 2014, 700 patients with newly diagnosed GBM patients were randomized. The patient characteristics were well balanced between the 2 groups including for age, extent of resection, sex, and MGMT methylation status. Median time from diagnosis to enrollment was 3.8 and 3.7 months respectively. Median progression free survival was 7.1 months for the TMZ/TTF group vs 4.2 months for the TMZ group (HR : 0.694 (CI95% : 0.558-0.863 ; log rank p =0.0010). Median overall survival was 19.4 months vs 16.6 months (HR : 0.754 (0.595-0.955), p = 0.0222). This translates to a 2 year survival of 43% (CI 36-50%) vs. 29% (CI 21-38%). No significant difference of toxicity was observed between the groups. Quality of life and cognitive functions were similar between the 2 groups.
The addition of TTF to standard first line treatment significantly improves the outcome of GBM patients without increasing side effects. Maintenance Temozolomide treatment with TTF should be considered as a new standard for patients with newly diagnosed GBM.Format: Oral communication