Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed Glioblastoma: A Secondary Analysis of a Randomized Clinical Trial.

Document Type

Article

Publication Date

4-2018

Institution/Department

Neurology and Neuroscience

Journal Title

JAMA Oncology

MeSH Headings

Electromagnetic Fields; Combined Modality Therapy; Temozolomide Administration and Dosage; Glioma Therapy; Human; Male; Female; Temozolomide Pharmacodynamics; Treatment Outcomes; Adverse Health Care Event; Survival Analysis; Quality of Life; P-Value; Descriptive Statistics; Chi Square Test; T-Tests; Mann-Whitney U Test; Questionnaires; Funding Source; Male; Female

Abstract

P <.01); physical (5.1 vs 3.7 months; P <.01) and emotional functioning (5.3 vs 3.9 months; P <.01); pain (5.6 vs 3.6 months; P <.01); and leg weakness (5.6 vs 3.9 months; P <.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; P <.001) and pain (TTFields improved; 13.4 vs 12.1 months; P <.01). Role, social, and physical functioning were not affected by TTFields. Conclusions and Relevance: 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. Trial Registration: clinicaltrials.gov Identifier: NCT00916409This secondary analysis of a randomized clinical trial examines the association between therapy with tumor-treating fields plus temozolomide and survival and health-related quality of life in patients with glioblastoma after completion of chemoradiotherapy."}" data-sheets-userformat="{"2":33569153,"3":{"1":0,"3":1},"10":0,"11":4,"14":[null,2,0],"15":"Calibri","16":11,"28":1}">Key Points: Question: What is the influence of adding tumor-treating fields to the standard treatment on health-related quality of life in patients with glioblastoma? Findings: In this secondary analysis of the EF-14 randomized clinical trial, the addition of tumor-treating fields did not negatively influence health-related quality of life except for itchy skin, an expected consequence from the transducer arrays. Meaning: Tumor-treating field therapy has previously been shown to prolong both progression-free and overall survival. When considering the net clinical benefit, improved survival without a negative influence on health-related quality of life supports the addition of tumor-treating fields to standard treatment in patients with glioblastoma.Importance: 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). Objective: To examine the association of TTFields therapy with progression-free survival and HRQoL among patients with glioblastoma. Design, Setting, and Participants: 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. Interventions: Temozolomide, 150 to 200 mg/m2/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. Main Outcomes and Measures: 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. Results: 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; P <.01); physical (5.1 vs 3.7 months; P <.01) and emotional functioning (5.3 vs 3.9 months; P <.01); pain (5.6 vs 3.6 months; P <.01); and leg weakness (5.6 vs 3.9 months; P <.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; P <.001) and pain (TTFields improved; 13.4 vs 12.1 months; P <.01). Role, social, and physical functioning were not affected by TTFields. Conclusions and Relevance: 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. Trial Registration: clinicaltrials.gov Identifier: NCT00916409This secondary analysis of a randomized clinical trial examines the association between therapy with tumor-treating fields plus temozolomide and survival and health-related quality of life in patients with glioblastoma after completion of chemoradiotherapy.

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