Tumor treating fields (TTFields) on healthrelated quality of life (HRQoL) in ndGBM: An exploratory analysis of the EF-14 phase I-II trial
Walbert T, Lavy-Shahaf G, Toms SA, and Kesari S. Tumor treating fields (TTFields) on healthrelated quality of life (HRQoL) in ndGBM: An exploratory analysis of the EF-14 phase I-II trial. Cancer Res 2018; 78(13).
TTFields are a novel treatment modality based on homeuse medical device which continuously delivers alternating electric fields to the region of the tumor. These fields selectively interfere with a number of cellular processes during the mitotic cycle, such as the assembly of the mitotic spindle, leading to apoptosis. In the EF-14 phase I-II study in newly diagnosed glioblastoma, TTFields added to maintenance temozolomide led to a significant increase in overall survival, as well as in the 5-year survival rate compared to patients treated with temozolomide alone. It was previously reported that the addition of TTFields to maintenance temozolomide did not negatively impact nine prespecified HRQoL scales except for an expected increase in itchy skin, and in addition resulted in a significant delay in the increase of HRQoL pain assessment. Here we present an exploratory analysis of the remaining EORTC QLQ C30 and BN-20 HRQoL scales. Methods HRQoL was a predefined secondary endpoint in the EF-14 study, measured by collecting the EORTC QLQ-C30 and BN-20 questionnaires at baseline and every 3 months thereafter. HRQoL was assessed for the remaining HRQoL scales except for the prespecified and previously reported nine preselected scales: global health, physical, cognitive, role, social and emotional functioning, itchy skin, pain, and leg weakness. Mean changes from baseline scores were evaluated, as well as significant changes in scores over time (>10 points) using a repeated measures test. Moreover, deterioration-free survival and time to deterioration in HRQoL were assessed for each scale, as well as the percentage of patients with stable/improved HRQoL compared to baseline. Results No statistically or clinically significant decline in any of the exploratory HRQoL scales was seen in the repeated measures analysis or in time to deterioration. A significantly larger proportion of patients treated with TTFields compared to control patients reported stable/improved bladder control (63.6% Vs. 46.8%, p=0.001) and diarrhea (60.6% vs. 43.7%, p=0.001) compared to baseline. The deterioration-free survival for diarrhea, future uncertainty and headaches was significantly delayed in TTFields/temozolomide treated patients compared to those treated with temozolomide alone (HR 0.68, 0.71 and 0.67, respectively, p<0.001). Conclusions The delay in deterioration free survival and increase in percentage of patients with stable/improved HRQoL in several of the additional HRQoL scales may be attributed in part to the longer progression-free survival observed in TTFields/temozolomide treated patients on the EF-14 trial. No negative impact of HRQoL was seen in any of the exploratory analysis. These results further support the addition of TTFields to standard therapy in newly diagnosed glioblastoma patients.