Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma
Authors: Martin J. B. Taphoorn, Linda Dirven, Andrew A. Kanner, Gitit Lavy-Shahaf, Uri Weinberg, Sophie Taillibert, Steven A. Toms, Jerome Honnorat, Thomas C. Chen, Jan Sroubek, Carlos David, Ahmed Idbaih, Jacob C. Easaw, Chae-Yong Kim, Jordi Bruna, Andreas F. Hottinger, Yvonne Kew, Patrick Roth, Rajiv Desai, John L. Villano, Eilon D. Kirson, Zvi Ram, Roger Stupp
Journal: JAMA Oncology (2018)

<h3>Importance</h3> Tumor-treating fields (TTFields) therapy improves both progression-free and overall survival in patients with glioblastoma. There is a need to assess the influence of TTFields on patients’ health-related quality of life (HRQoL). <h3>Objective</h3> To examine the association of TTFields therapy with progression-free survival and HRQoL among patients with glioblastoma. <h3>Design, Setting, and Participants</h3> This secondary analysis of EF-14, a phase 3 randomized clinical trial, compares TTFields and temozolomide or temozolomide alone in 695 patients with glioblastoma after completion of radiochemotherapy. Patients with glioblastoma were randomized 2:1 to combined treatment with TTFields and temozolomide or temozolomide alone. The study was conducted from July 2009 until November 2014, and patients were followed up through December 2016. <h3>Interventions</h3> Temozolomide, 150 to 200 mg/m<sup>2</sup>/d, was given for 5 days during each 28-day cycle. TTFields were delivered continuously via 4 transducer arrays placed on the shaved scalp of patients and were connected to a portable medical device. <h3>Main Outcomes and Measures</h3> Primary study end point was progression-free survival; HRQoL was a predefined secondary end point, measured with questionnaires at baseline and every 3 months thereafter. Mean changes from baseline scores were evaluated, as well as scores over time. Deterioration-free survival and time to deterioration were assessed for each of 9 preselected scales and items. <h3>Results</h3> Of the 695 patients in the study, 639 (91.9%) completed the baseline HRQoL questionnaire. Of these patients, 437 (68.4%) were men; mean (SD) age, 54.8 (11.5) years. Health-related quality of life did not differ significantly between treatment arms except for itchy skin. Deterioration-free survival was significantly longer with TTFields for global health (4.8 vs 3.3 months;<i>P</i> &lt; .01); physical (5.1 vs 3.7 months;<i>P</i> &lt; .01) and emotional functioning (5.3 vs 3.9 months;<i>P</i> &lt; .01); pain (5.6 vs 3.6 months;<i>P</i> &lt; .01); and leg weakness (5.6 vs 3.9 months;<i>P</i> &lt; .01), likely related to improved progression-free survival. Time to deterioration, reflecting the influence of treatment, did not differ significantly except for itchy skin (TTFields worse; 8.2 vs 14.4 months;<i>P</i> &lt; .001) and pain (TTFields improved; 13.4 vs 12.1 months;<i>P</i> &lt; .01). Role, social, and physical functioning were not affected by TTFields. <h3>Conclusions and Relevance</h3> The addition of TTFields to standard treatment with temozolomide for patients with glioblastoma results in improved survival without a negative influence on HRQoL except for more itchy skin, an expected consequence from the transducer arrays. <h3>Trial Registration</h3> clinicaltrials.gov Identifier:NCT00916409