LTBK-01: PROSPECTIVE, MULTI-CENTER PHASE III TRIAL OF TUMOR TREATING FIELDS TOGETHER WITH TEMOZOLOMIDE COMPARED TO TEMOZOLOMIDE ALONE IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA

BACKGROUND: Tumor Treating Fields (TTFields) is an established, frequency-tuned, anti-mitotic, physical treatment modality that acts in metaphase, anaphase and telophase. TTFields are delivered to the brain by a patient operated, portable medical device (Optune™, Novocure Ltd.). An international, multicenter, prospective, randomized phase 3 trial (EF-14) was initiated in 2009 to test the efficacy and safety of combining TTFields with temozlomide (TMZ) compared to TMZ alone following radiation therapy with adjuvant TMZ in patients with newly diagnosed GBM. Results of a protocol pre-specified successful interim analysis on the first 315 patients randomized has been reported (Stupp et al. JAMA 2015). Here we report the main outcomes of all 695 patients enrolled with a mature minimum follow-up of 18 month (median follow-up 36 months) for all patients (Range 19–80 months).