Randomized trial terminated early based on benefit shown for TTFields added to maintenance chemo
WEDNESDAY, Dec. 16, 2015 (HealthDay News) — For patients with glioblastoma, addition of tumor-treating fields (TTFields) to maintenance chemotherapy is associated with significantly prolonged survival, according to a study published in the Dec. 15 issue of the Journal of the American Medical Association.
Roger Stupp, M.D., from the University Hospital Zurich, and colleagues examined the efficacy and safety of TTFields used in combination with temozolomide maintenance treatment after chemoradiation therapy. Patients with glioblastoma were randomized after completion of chemoradiotherapy to maintenance treatment with TTFields plus temozolomide (466 patients) or temozolomide alone (229 patients).
The trial was terminated based on the results of this planned interim analysis after randomization of 210 patients to TTFields plus temozolomide and 105 to temozolomide alone and median follow-up of 38 months. The researchers found that median progression-free survival was 7.1 months in the TTFields plus temozolomide group and 4.0 months in the temozolomide alone group in the intent-to-treat population (hazard ratio, 0.62; P = 0.001). The median overall survival was 20.5 months in the TTFields plus temozolomide group and 15.6 months in the temozolomide alone group in the per-protocol population (hazard ratio, 0.64; P = 0.004).
“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,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry and to Novocure, which developed the TTFields device and funded the study.
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