Patient Reported Outcome (PRO) Among High-Grade Glioma Patients Receiving TTFields Treatment: A Two Center Observational Study

Julia Onken, Ute Goerling, Marcel Heinrich, Stephanie Pleissner, Dietmar Krex, Peter Vajkoczy, Martin Misch, Julia Onken, Ute Goerling, Marcel Heinrich, Stephanie Pleissner, Dietmar Krex, Peter Vajkoczy, Martin Misch

Abstract

Study design: A two center, observational study. Introduction: Patient reported outcome (PRO) plays an increasingly important role in the evaluation of novel therapies for tumor patients. It has been shown that tumor treating fields (TTFields) in combination with standard therapy prolong survival in high-grade glioma (hgG) patients. But critics claim that TTFields significantly impacts patients' everyday life due to side effects and average daily time on therapy (18 h) in a patient population with very limited life expectancy and high symptom burden. However, very limited data exist on PRO for TTFields treatment. Methods: This two center, observational study describes PRO of 30 hgG patients receiving TTFields in combination with chemotherapy. We introduced a device-specific questionnaire (DSQ) addressing device-specific restrictions and impact on daily live after 2 months of therapy. Additionally following questionnaires were used: EORTC (European Organization for Research and Treatment of Cancer), QLQ-30 (Quality of life of cancer patients), QLQ BN20 (Quality of life brain cancer module), QLQ FA13 (Cancer-related fatigue), and SSUK-8 (social support). Results: Surveys have been completed by 91% of enrolled patients. EORTC QLQ-30 revealed better physical, emotional, and cognitive function than social and role function of study cohort. TTFields users reported frequently on positive social support and a low level of detrimental interactions. Seventy one percent of patients felt affected in daily life due to TTFields at least 2-3 times per week up to several times per day while maintaining high therapy compliance. Most frequent device-specific restrictions were duration of therapy (74%), size (66%), and weight (70%) of the device and changing time and bonding of the transducer arrays (66%, mean duration: 43.6 min). Restrictions on exercise of hobbies/work (63%/61%), body care (71%), and sexuality/relationship (64%) were most relevant. Seventy percent would recommend TTFields to others and 67% would reuse TTFields treatment again based on their current experience. Conclusion: The study shows that although TTFields treatment frequently affects everyday life in all aspects, therapy compliance was high and 67% of patients would reconsider TTFields for themselves. We propose that findings of PRO be taken into account for medical consultation about TTFields and in future device development to deliver high-value patient-centered care.

Keywords: TTFields treatment; glioblastoma; patient reported outcome (PRO); quality of life (QoL); therapy compliance.

Copyright © 2019 Onken, Goerling, Heinrich, Pleissner, Krex, Vajkoczy and Misch.

Figures

Figure 1
Figure 1
Results of EORTC QLQ-C30, EORTC QLQ-BN20, and EORTC QLQ-FA13 assessed at 2 month of TTFields treatment. Mean scores (X-axis) range from 0 to 100%, which are proportional to the degree of function or symptom load. In the function scales higher scores represent a better level of functioning while in the case of symptom scales/items higher scores mark a higher level of symptomatology or problems. (A) Health related quality of life (HRQoL) and functional scales items from EORTC QLQ-C30 2 months after TTFields start. (B) EORTC QLQ-C30 symptom scale 2 months after TTFields start. (C) EORTC QLQ-BN20 2 months after TTFields start. (D) Presence of fatigue assessed with EORTC QLQ-FA13 2 months after TTFields start. (E) Social support and detrimental interaction assessed with SSUK-8 2 months after TTFields start. EORTC, European Organization for Research and Treatment of Cancer; QLQ-BN20, Quality of life brain cancer module; QLQ-C30, Quality of life of cancer patients; QLQ-FA13, cancer-related fatigue.
Figure 2
Figure 2
PROMs using a device-specific questionnaire completed 2 months after TTFields initiation addressing device-specific complains. PROMs, patient-reported outcome measures.
Figure 3
Figure 3
Impact of TTFields on everyday life assessed with a device-specific questionnaire completed 2 months after therapy initiation.

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