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Glioblastoma is the most devastating primary malignancy of the central nervous system in adults Most patients die within 1 to 2 years of diagnosis Tumor-treating fields TTFields are a locoregionally delivered antimitotic treatment that interferes with cell division and organelle assembly To evaluate the efficacy and safety of TTFields used in combination with temozolomide maintenance treatment after chemoradiation therapy for patients with glioblastoma After completion of chemoradiotherapy patients with glioblastoma were randomized 2 1 to receive maintenance treatment with either TTFields plus temozolomide n 466 or temozolomide alone n 229 median time from diagnosis to randomization 3 8 months in both groups The study enrolled 695 of the planned 700 patients between July 2009 and November 2014 at 83 centers in the United States Canada Europe Israel and South Korea The trial was terminated based on the results of this planned interim analysis Treatment with TTFields was delivered continuously 18 hours day via 4 transducer arrays placed on the shaved scalp and connected to a portable medical device Temozolomide 150-200 mg m2 d was given for 5 days of each 28-day cycle The primary end point was progression-free survival in the intent-to-treat population significance threshold of 01 with overall survival in the per-protocol population n 280 as a powered secondary end point significance threshold of 006 This prespecified interim analysis was to be conducted on the first 315 patients after at least 18 months of follow-up The interim analysis included 210 patients randomized to TTFields plus temozolomide and 105 randomized to temozolomide alone and was conducted at a median follow-up of 38 months range 18-60 months Median progression-free survival in the intent-to-treat population was 7 1 months 95 CI 5 9-8 2 months in the TTFields plus temozolomide group and 4 0 months 95 CI 3 3-5 2 months in the temozolomide alone group hazard ratio HR 0 62 98 7 CI 0 43-0 89 P 001 Median overall survival in the per-protocol population was 20 5 months 95 CI 16 7-25 0 months in the TTFields plus temozolomide group n 196 and 15 6 months 95 CI 13 3-19 1 months in the temozolomide alone group n 84 HR 0 64 99 4 CI 0 42-0 98 P 004 In this interim analysis of 315 patients with glioblastoma who had completed standard chemoradiation therapy adding TTFields to maintenance temozolomide chemotherapy significantly prolonged progression-free and overall survival clinicaltrials gov Identifier NCT00916409

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Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Cl...