CTNI-71. TTFIELDS IN ROUTINE CLINICAL CARE OF NEWLY DIAGNOSED GBM PATIENTS IN GERMANY – FIRST REPORT ON THE FULLY ENROLLED TIGER STUDY POPULATION

Abstract OBJECTIVE Glioblastoma (GBM) is widely treated with surgery, chemoradiation and TTFields in combination with chemotherapy. Since the introduction of TTFields to first-line GBM treatment, prescribing physicians in Germany are interested to gain additional knowledge on the use in clinical practice. The TIGER study was designed to assess the therapy decision making process, safety and efficacy of TTFields in clinical routine, as well as evaluating quality of life (QoL) within 4 months after start of therapy, treatment compliance and duration. METHODS This multi-center prospective non-interventional study in Germany (NCT03258021) included newly diagnosed GBM patients eligible for TTFields therapy. Within the study, after receiving introduction to TTFields therapy, patients could decide for or against receiving TTFields. The study was designed to recruit 500 patients for each group, with and without TTFields. Demographic data, QoL and reasons for therapy decision 2–4 months after treatment start are assessed using the EORTC-QLQ-C30/BN-20 and a TTFields questionnaire, respectively, with 18 months follow-up. RESULTS At the last data cut-off (31st March, 2020), the median follow-up was 11 months (range: 0–28 months) and 581 (82%) of the 710 recruited patients in the trial had decided for TTFields therapy. According to preliminary analysis, this patient population represents a typical GBM population regarding median age (59 years, range: 19.0–85.0), gender (37 % female), median KPS (90, range: 40–100) and MGMT promoter methylation status (44% methylated). In this population 49 % received complete resection, 33 % partial resection and 19 % biopsy. CONCLUSION The TIGER study allows prospective and systematic analysis of TTFields treatment decision making and use of typical GBM patient population in routine clinical care. In addition, the study allows the evaluation of compliance and treatment duration. Here, we will present an updated analysis of the TIGER study.

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QOLP-31. QUALITY OF LIFE OF PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA DURING TTFIELDS THERAPY IN ROUTINE CLINICAL CARE: FIRST RESULTS OF THE TIGER STUDY

Neuro-Oncology ◽

10.1093/neuonc/noab196.751 ◽

2021 ◽

Vol 23 (Supplement_6) ◽

pp. vi189-vi190

Author(s):

Oliver Bähr ◽

Ghazaleh Tabatabai ◽

Rainer Fietkau ◽

Roland Goldbrunner ◽

Martin Glas

Keyword(s):

Quality Of Life ◽

Clinical Care ◽

Demographic Data ◽

Treatment Compliance ◽

Additional Treatment ◽

Phase Iii ◽

Interdisciplinary Treatment ◽

Routine Clinical Care

Abstract OBJECTIVE Current interdisciplinary treatment strategies for glioblastoma (GBM) outside clinical trials include maximally safe resection, followed by radiation and chemotherapy. The results of the positive phase III trial EF-14, adding Tumor Treating Fields (TTFields) to temozolomide (TMZ) maintenance therapy, brought an additional treatment method to clinical routine. The TIGER (TTFields In GErmany in Routine Clinical Care) study documents the use of TTFields in routine clinical care with a focus on health-related quality of life (HRQoL) within 4 months after starting therapy, treatment compliance and duration. METHODS This multi-center, prospective, non-interventional study in Germany (NCT03258021) included ndGBM patients eligible for TTFields therapy. Following their consent, patients received a comprehensive introduction to the therapy and baseline demographic data were collected. Information on TTFields therapy decision was evaluated based on a dedicated TTFields questionnaire at baseline in both arms; follow-up information on how patients handle the therapy was collected two months after TTFields treatment start. HRQoL was assessed in patients deciding for TTFields therapy at baseline and at 2 and 4 months using the EORTC-QLQ-C30/BN-20 questionnaires. RESULTS Between August 2017 and November 2019, 710 patients (259 female/451 male) were enrolled at 81 participating centers. The mean age was 58.5 years (range: 19.0-85.0; Cut-off: August 31, 2020). The overall baseline characteristics of the study group reflects a typical GBM population. Of these, 582 (82%) decided to start TTFields; 128 (18%) refused TTFields treatment. HRQoL did not decline during TTFields therapy except for itchy skin, comparable to the EF-14 trial. A detailed analysis of the cohort as well as their reported QoL will be presented. CONCLUSION The TIGER study is the largest non-interventional trial on the use of TTFields in routine clinical care. The use of TTFields in patients with ndGBM did not impair HRQoL during the follow-up period, except for more itchy skin.

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P14.63 The use of TTFields for newly diagnosed GBM patients in Germany in routine clinical care (TIGER: TTFields in Germany in routine clinical care)

Neuro-Oncology ◽

10.1093/neuonc/noz126.298 ◽

2019 ◽

Vol 21 (Supplement_3) ◽

pp. iii82-iii82

Author(s):

O Bähr ◽

G Tabatabai ◽

R Fietkau ◽

R Goldbrunner ◽

M G Glas

Keyword(s):

Electric Fields ◽

Treatment Duration ◽

Clinical Care ◽

Demographic Data ◽

Intermediate Frequency ◽

Newly Diagnosed ◽

Phase 3 ◽

Term Survival ◽

Routine Clinical Care ◽

Therapy Decision

Abstract BACKGROUND Despite various clinical phase 3 trials, survival for the most common brain tumour, glioblastoma (GBM), has not improved since 2005. Alternating electric fields with low-intensity and intermediate frequency, known as tumor treating fields (TTFields) were shown to inhibit cancer cell division. In the EF-14 phase 3 trial, the addition of TTFields to adjuvant temozolomide (TMZ) chemotherapy demonstrated significant extension of median overall, progression-free and long-term survival in newly diagnosed GBM (ndGBM) patients. As there is very high interest among prescribing physicians from all disciplines in Germany to further evaluate these effects in routine clinical care, the aim of the TIGER study is to assess safety and efficacy of TTFields in routine clinical care as well as reasons for patients refusing TTFields treatment, changes in quality of life within 4 months after start of therapy, treatment duration and compliance. METHODS The TIGER study is a multi-centre, prospective, non-interventional study in Germany (NCT03258021). All ndGBM patients who are eligible for TTFields therapy are asked for consent for study participation and comprehensively introduced to the therapy to allow them to make a conscious positive or negative therapy decision. At baseline and 2–4 months after treatment start, demographic data as well as the QoL and reasons for therapy decision are evaluated applying the EORTC-QLQ-C30/BN-20 and TTFields questionnaire, respectively. A number of about 1000 patient is planned (500 in each arm with positive and negative treatment decision, respectively) with a follow-up period of 18 months. RESULTS At the time point of the last data cut-off (March 2019), more than 460 patients in the trial have made a decision for or against treatment with TTFields. Within this population, more than 80% of patients agreed to undergo TTFields therapy. The median age of patients included in the trial is actually 58.4 years (range 19–85). In this population 47 % received complete resection, 32 % partial resection and 22 % biopsy. CONCLUSION Systematic and prospective data analysis for the use of TTFields in routine clinical care including patient’s therapy decision can be assessed in the TIGER trial. Additionally, the study supports the evaluation of treatment duration and usage rate, which could drive future analysis of TTFields treatment duration. Most recent data will be presented at the EANO annual meeting.

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ACTR-31. THE USE OF TTFIELDS FOR NEWLY DIAGNOSED GBM PATIENTS IN GERMANY IN ROUTINE CLINICAL CARE (TIGER: TTFIELDS IN GERMANY IN ROUTINE CLINICAL CARE)

Neuro-Oncology ◽

10.1093/neuonc/noz175.074 ◽

2019 ◽

Vol 21 (Supplement_6) ◽

pp. vi20-vi20

Author(s):

Oliver Bähr ◽

Ghazaleh Tabatabai ◽

Rainer Fietkau ◽

Roland Goldbrunner ◽

Martin Glas

Keyword(s):

Treatment Duration ◽

Clinical Care ◽

Treatment Success ◽

Treatment Decision ◽

Treatment Quality ◽

Newly Diagnosed ◽

Phase 3 ◽

Term Survival ◽

Routine Clinical Care ◽

Therapy Decision

Abstract OBJECTIVE Survival for the most common brain tumor, glioblastoma (GBM), has not improved since 2005, despite numerous phase 3 trials. The phase 3 EF-14 trial demonstrated significantly improved overall, progression-free and long-term survival in newly diagnosed GBM (ndGBM) patients by addition of TTFields to adjuvant temozolomide chemotherapy. As there is very high interest among prescribing physicians from all disciplines to further evaluate these effects in routine clinical care, the aim of the TIGER study is to assess safety and efficacy of TTFields in routine care and reasons for patients refusing TTFields treatment, quality of life, treatment duration and compliance. METHODS The TIGER study is a multi-centre, prospective, non-interventional study in Germany (NCT03258021). All ndGBM patients who are eligible for TTFields therapy are asked for consent for study-participation and comprehensively introduced to the therapy to allow them to make a conscious positive or negative therapy decision. At baseline and 2–4 months after treatment start, demographic data, the QoL and reasons for therapy decision are evaluated utilizing the EORTC-QLQ-C30/BN-20 and TTFields questionnaire. Inclusion of 1000 patients is planned (500 with positive/negative treatment decision, respectively) with a follow-up period of 18 months. RESULTS At the last data cut-off (May 2019), 497 patients have made a decision regarding treatment with TTFields. Within this population, 84% of patients decided to undergo TTFields therapy. The median age of patients included in the trial is currently 58.3 years (19–85). 91% of patients report that the prospect of treatment success considerably or strongly affects treatment decision. Most recent data will be presented at the meeting. CONCLUSION Systematic and prospective data assessment for using TTFields in routine clinical care including patient’s therapy decision can be evaluated in TIGER. Additionally, the study supports the analysis of treatment duration and usage rate, which could drive future assessment of TTFields treatment duration.

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P14.20 Quality of life of patients with newly diagnosed glioblastoma during TTFields therapy in routine clinical care: first results of the TIGER study

Neuro-Oncology ◽

10.1093/neuonc/noab180.143 ◽

2021 ◽

Vol 23 (Supplement_2) ◽

pp. ii41-ii42

Author(s):

O Bähr ◽

G Tabatabai ◽

R Fietkau ◽

R Goldbrunner ◽

M Glas

Keyword(s):

Quality Of Life ◽

Clinical Care ◽

Treatment Compliance ◽

Phase Iii ◽

Interdisciplinary Treatment ◽

Interventional Study ◽

Routine Clinical Care ◽

Health Related

Abstract BACKGROUND Glioblastoma (GBM) is an aggressive primary tumor of the central nervous system. Current interdisciplinary treatment strategies outside clinical trials include maximal safe resection, followed by treatment with radiation and an alkylating chemotherapy. Based on the results of the positive phase III trial EF-14, the addition of Tumor Treating Fields (TTFields) to temozolomide (TMZ) maintenance therapy brought an additional treatment method to clinical routine. The prospective non-interventional study TIGER (TTFields In GErmany in Routine Clinical Care) documents the use of TTFields in routine clinical care with a particular focus on health-related quality of life (HRQoL) within 4 months after starting therapy, treatment compliance and duration. MATERIAL AND METHODS This multi-center prospective non-interventional study in Germany (NCT03258021) included ndGBM patients eligible for TTFields therapy. Following their consent to participate in the study, patients received a comprehensive introduction to the therapy and their baseline demographic data were collected. Information on TTFields therapy decision is evaluated based on a dedicated TTFields questionnaire at baseline in both arms, follow-up information on how patients cope with the therapy is collected two months after TTFields treatment start, if applicable. HRQoL was assessed in patients deciding for TTFields therapy at baseline as well as at 2 months and 4 months thereafter using the EORTC-QLQ-C30/BN-20 questionnaires. RESULTS Between August 2017 and November 2019, 710 patients (259 female/451 male) were enrolled at 81 participating centers. The mean age was 58.5 years (range: 19.0–85.0; Cut-off: August 31, 2020). The overall baseline characteristics of the study group reflects a typical GBM population. Of these, 582 (82%) decided to start TTFields and 128 (18%) refused TTFields treatment. Health-related QoL did not decline during TTFields therapy except for itchy skin, comparable to the results of the EF-14 phase 3 trial. A detailed analysis of the cohort as well as their reported QoL will be presented. CONCLUSION The TIGER study is the largest non-interventional trial on the use of TTFields in routine clinical care. The use of TTFields in patients with ndGBM did not impair HRQoL during the follow-up period, except for more itchy skin.

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A framework for the evaluation of patients with congenital facial weakness

Orphanet Journal of Rare Diseases ◽

10.1186/s13023-021-01736-1 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Bryn D. Webb ◽

Irini Manoli ◽

Elizabeth C. Engle ◽

Ethylin W. Jabs

Keyword(s):

Genetic Counseling ◽

Genetic Testing ◽

Patient Population ◽

Clinical Care ◽

Diagnostic Algorithm ◽

Accurate Diagnosis ◽

Facial Weakness ◽

The Core ◽

Follow Up Studies

AbstractThere is a broad differential for patients presenting with congenital facial weakness, and initial misdiagnosis unfortunately is common for this phenotypic presentation. Here we present a framework to guide evaluation of patients with congenital facial weakness disorders to enable accurate diagnosis. The core categories of causes of congenital facial weakness include: neurogenic, neuromuscular junction, myopathic, and other. This diagnostic algorithm is presented, and physical exam considerations, additional follow-up studies and/or consultations, and appropriate genetic testing are discussed in detail. This framework should enable clinical geneticists, neurologists, and other rare disease specialists to feel prepared when encountering this patient population and guide diagnosis, genetic counseling, and clinical care.

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Abstract P494: Long-term Outcomes of a Cluster-randomized Trial Testing the Effects Blood Pressure Telemonitoring and Pharmacist Management

Hypertension ◽

10.1161/hyp.70.suppl_1.p494 ◽

2017 ◽

Vol 70 (suppl_1) ◽

Author(s):

Karen L Margolis ◽

Stephen E Asche ◽

Anna R Bergdall ◽

Steven P Dehmer ◽

Beverly B Green ◽

...

Keyword(s):

Blood Pressure ◽

Randomized Trial ◽

Clinical Care ◽

Cluster Randomized Trial ◽

Home Blood Pressure ◽

Uncontrolled Hypertension ◽

Routine Clinical Care ◽

Differential Reduction ◽

Cluster Randomized

Background/Aims: Hypertension is a common condition and leading cause of cardiovascular disease. We previously reported results of a cluster-randomized trial evaluating a home blood pressure (BP) telemonitoring and pharmacist management intervention, with significant reductions in BP favoring the intervention arm over 18 months. This analysis examined the durability of the intervention effect on BP through 54 months of follow-up and compared BP measurements performed in the research clinic and in routine clinical care. Methods: The Hyperlink trial randomized 16 primary care clinics having 450 study-enrolled patients with uncontrolled hypertension to either Telemonitoring Intervention (TI) or usual care (UC) study arms. BP was measured as the mean of 3 measurements obtained at each research clinic visit. General linear mixed models utilizing a direct likelihood-based ignorable approach for missing data were used to examine change from baseline to 54 months in systolic and diastolic BP (SBP and DBP). Results: Research clinic BP measurements were obtained from 326 (72%) study patients at the 54 month follow-up visit. Routine clinical care BP measurements were obtained from 444 (99%) of study patients from 7025 visits during the follow-up period. For TI patients, based on research clinic measurements baseline SBP was 148.2 mm Hg and 54 month follow-up was 131.2 mm Hg (-17.0 mm Hg, p<.001). For UC patients, baseline SBP was 147.7 mm Hg and 54 month follow-up was 131.7 mm Hg ( -16.0 mm Hg, p<.001). The differential reduction by study arm in SBP from baseline to 54 months was -1.0 mm Hg (95% CI: -5.4 to 3.4, p=0.63). For TI patients, baseline DBP was 84.4 mm Hg and 54 month follow-up was 77.8 (-6.6 mm Hg, p<.001). For UC patients, baseline DBP was 85.1 mm Hg and 54 month follow-up was 79.1 mm Hg (-6.0 mm Hg, p<.001). The differential reduction by study arm in DBP from baseline to 54 months was -0.6 mm Hg (95% CI: -3.5 to 2.4, p=0.67). SBP and DBP results from routine clinical measurements closely approximated the pattern of results from research clinic measurements. Conclusion: Significant BP reductions in the TI arm relative to UC were no longer seen at 54 month follow-up. To maintain intervention benefits over a longer period of time additional intervention is needed.

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Treatment Compliance as a Major Barrier to Optimal Cervical Cancer Treatment in Guatemala

Journal of Global Oncology ◽

10.1200/jgo.18.00243 ◽

2019 ◽

pp. 1-5 ◽

Cited By ~ 1

Author(s):

Abigail S. Zamorano ◽

Joaquin Barnoya ◽

Eduardo Gharzouzi ◽

Camaryn Chrisman Robbins ◽

Emperatriz Orozco ◽

...

Keyword(s):

Cervical Cancer ◽

Access To Care ◽

Cancer Treatment ◽

Patient Population ◽

Treatment Compliance ◽

External Beam Radiation ◽

Cervical Cancer Patient ◽

Beam Radiation ◽

Lost To Follow Up

PURPOSE Despite being the only hospital to provide comprehensive cervical cancer treatment to many medically underserved Guatemalan women, no assessment of the cervical cancer patient population at the Guatemala Cancer Institute has been performed. To understand the demographics of the patient population, their treatment outcomes, and access to care, we sought to assess treatment compliance of patients with cervical cancer at the Guatemala Cancer Institute and its effects on patient outcomes. METHODS A retrospective chart review was conducted of patients with cervical cancer between 2005 and 2007 and assessed for follow-up through December 2015. Demographics and clinical characteristics were tabulated. A Kaplan-Meier curve to model compliance was generated. RESULTS Ninety-two patients with invasive cancer were analyzed. Most presented with squamous cell carcinoma (73%) and at locally advanced stages (IIB, 51%; IIIB, 33%). Most (75 of 92, 81.5%) initiated treatment after diagnosis, but 18.5% (17 of 92) were lost to follow-up before treatment initiation. For treatment, 97% received external beam radiation, 84% brachytherapy, and 4% concomitant chemotherapy. Nearly 20% of patients were lost to follow-up in the first 6 months and 65% in the first 5 years. Of the 67 patients who completed treatment, only 15 (16% of the initial cohort) were diagnosed with a recurrence. No deaths were recorded. CONCLUSION The low recurrence rate and no documented deaths suggest a correlation with the low compliance rate and poor follow-up. This finding highlights the need to examine more fully the barriers to compliance and access to care among this population to optimize the treatment of cervical cancer.

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Immuno-Imaging to Predict Treatment Response in Infection, Inflammation and Oncology

Journal of Clinical Medicine ◽

10.3390/jcm8050681 ◽

2019 ◽

Vol 8 (5) ◽

pp. 681 ◽

Cited By ~ 5

Author(s):

Alberto Signore ◽

Chiara Lauri ◽

Sveva Auletta ◽

Kelly Anzola ◽

Filippo Galli ◽

...

Keyword(s):

Decision Making ◽

Nuclear Medicine ◽

Treatment Response ◽

Fungal Infections ◽

Inflammatory Diseases ◽

Imaging Techniques ◽

Nuclear Medicine Imaging ◽

Tumour Immunology ◽

Therapy Decision

Background: Molecular nuclear medicine plays a pivotal role for diagnosis in a preclinical phase, in genetically susceptible patients, for radio-guided surgery, for disease relapse evaluation, and for therapy decision-making and follow-up. This is possible thanks to the development of new radiopharmaceuticals to target specific biomarkers of infection, inflammation and tumour immunology. Methods: In this review, we describe the use of specific radiopharmaceuticals for infectious and inflammatory diseases with the aim of fast and accurate diagnosis and treatment follow-up. Furthermore, we focus on specific oncological indications with an emphasis on tumour immunology and visualizing the tumour environment. Results: Molecular nuclear medicine imaging techniques get a foothold in the diagnosis of a variety of infectious and inflammatory diseases, such as bacterial and fungal infections, rheumatoid arthritis, and large vessel vasculitis, but also for treatment response in cancer immunotherapy. Conclusion: Several specific radiopharmaceuticals can be used to improve diagnosis and staging, but also for therapy decision-making and follow-up in infectious, inflammatory and oncological diseases where immune cells are involved. The identification of these cell subpopulations by nuclear medicine techniques would provide personalized medicine for these patients, avoiding side effects and improving therapeutic approaches.

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Nivolumab in pre-treated advanced non-small cell lung cancer: long term follow up data from the Dutch expanded access program and routine clinical care

Translational Lung Cancer Research ◽

10.21037/tlcr-19-698 ◽

2020 ◽

Vol 9 (5) ◽

pp. 1736-1748

Author(s):

Robert D. Schouten ◽

Lucie Egberink ◽

Mirte Muller ◽

Cornedine J. De Gooijer ◽

Erik van Werkhoven ◽

...

Keyword(s):

Lung Cancer ◽

Clinical Care ◽

Small Cell ◽

Small Cell Lung ◽

Routine Clinical Care ◽

Expanded Access Program ◽

Long Term Follow Up ◽

Access Program

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Health-related quality of life measures in routine clinical care: Can FACT-Fatigue help to assess the management of fatigue in cancer patients?

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462309090126 ◽

2009 ◽

Vol 25 (01) ◽

pp. 90-96 ◽

Cited By ~ 12

Author(s):

Maria-Jose Santana ◽

Heather-Jane Au ◽

Melina Dharma-Wardene ◽

Joanne D. Hewitt ◽

David Dupere ◽

...

Keyword(s):

Quality Of Life ◽

Cancer Patients ◽

Clinical Care ◽

Health Related Quality ◽

Routine Clinical Care ◽

Study Results ◽

Related Quality ◽

Health Related

Objectives:Fatigue is the most common symptom reported by cancer patients. The inclusion of health-related quality of life (HRQL) measures in routine clinical care of cancer patients may improve the management of fatigue. The primary objective of this study is to provide evidence on the magnitude of change in fatigue subscale scores using the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) that is clinically important.Methods:Consecutive patients with advanced primary lung cancer attending a Canadian tertiary care cancer and, prior to undergoing palliative chemotherapy, were enrolled in the study. Patients completed a battery of questionnaires [FACT-F, Qualitative Patients Self-report of Fatigue Level (QPSRF)] at baseline, follow-up and 2 weeks after their final cycle of chemotherapy. Clinicians assessed the patients using the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale at baseline and each follow-up visit. FACT-F change scores were computed as the mean change in score (end of study score minus baseline score).Results:A total of 43 patients with mean age of 59 years were enrolled in the study. Results revealed a mean change in FACT-F subscale score of 5.0 (SE 1.06) for those who rated themselves as more tired, 1.28 (SE 1.00) for those who rated themselves as the same (no change), and −1.52 (SE 0.84) for those patients who rated themselves as less tired.Conclusions:We provide evidence on the magnitude of change in FACT-F score that is associated with the perception by patients of improvement in fatigue and magnitude of change in score that is associated with worsening in fatigue.

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