scholarly journals Correction to: Global post‑marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high‑grade glioma in clinical practice

2021 ◽  
Author(s):  
Wenyin Shi ◽  
Deborah T. Blumenthal ◽  
Nancy Ann Oberheim Bush ◽  
Sied Kebir ◽  
Rimas V. Lukas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Online Publication ◽  
High Grade Glioma ◽  
High Grade ◽  
Tumor Treating Fields ◽  
Safety Surveillance ◽  
Post Marketing

The graphic abstract was missing in the original online publication. The original article has been corrected.

scholarly journals Global Post-Marketing Safety Surveillance of Tumor Treating Fields (TTFields) in Patients With High-Grade Glioma in Clinical Practice

2020 ◽  
Vol 108 (3) ◽  
pp. e697
Author(s):  
W. Shi ◽  
D. Blumenthal ◽  
N.A. Oberheim ◽  
S. Kebir ◽  
R.V. Lukas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
High Grade Glioma ◽  
High Grade ◽  
Tumor Treating Fields ◽  
Safety Surveillance ◽  
Post Marketing

Abstract LB-167: Post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice

2020 ◽  
Author(s):  
Wenyin Shi ◽  
Deborah T. Blumenthal ◽  
Nancy Ann Oberheim Bush ◽  
Sied Kebir ◽  
Rimas V. Lukas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
High Grade Glioma ◽  
High Grade ◽  
Tumor Treating Fields ◽  
Safety Surveillance ◽  
Post Marketing

scholarly journals Global post-marketing safety surveillance of Tumor Treating Fields (TTFields) in patients with high-grade glioma in clinical practice

2020 ◽  
Vol 148 (3) ◽  
pp. 489-500 ◽  
Author(s):  
Wenyin Shi ◽  
Deborah T. Blumenthal ◽  
Nancy Ann Oberheim Bush ◽  
Sied Kebir ◽  
Rimas V. Lukas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Brain Tumors ◽  
Elderly Patients ◽  
Safety Profile ◽  
Anaplastic Astrocytoma ◽  
Female Ratio ◽  
Tumor Treating Fields ◽  
Safety Surveillance ◽  
Post Marketing Surveillance ◽  
Post Marketing

Abstract Introduction Tumor Treating Fields (TTFields; antimitotic treatment) delivers low-intensity, intermediate-frequency, alternating electric fields through skin-applied transducer arrays. TTFields (200 kHz) was FDA-approved in glioblastoma (GBM), based on the phase 3 EF-11 (recurrent GBM, rGBM) and EF-14 (newly diagnosed GBM, ndGBM) trials. The most common TTFields-related adverse event (AE) in both trials was array-associated skin irritation. We now report on TTFields-related AEs in the real-world, clinical practice setting. Methods Unsolicited, post-marketing surveillance data from TTFields-treated patients (October 2011–February 2019) were retrospectively analyzed using MedDRA v21.1 preferred terms, stratified by region (US, EMEA [Europe, Middle East, Africa], Japan), diagnosis (ndGBM, rGBM, anaplastic astrocytoma/oligodendroglioma, other brain tumors), and age (< 18 [pediatric], 18–64 [adults], ≥ 65 [elderly]; years of age). Results Of 11,029 patients, 53% were diagnosed with ndGBM and 39% were diagnosed with rGBM at any line of disease recurrence. Most were adults (73%), 26% were elderly, and the male-to-female ratio was ~ 2:1 (close to published ratios of typical GBM populations). The most commonly reported TTFields-related AE was array-associated skin reaction, occurring in patients with ndGBM (38%), rGBM (29%), anaplastic astrocytoma/oligodendroglioma (38%), and other brain tumors (31%); as well as 37% of pediatric, 34% of adult, and 36% of elderly patients. Most skin AEs were mild/moderate and manageable. Other TTFields-related AEs in patients with ndGBM/rGBM included under-array heat sensation (warmth; 11%, 10%, respectively) and electric sensation (tingling; 11%, 9%, respectively), and headache (7%, 6%, respectively). Conclusions This TTFields safety surveillance analysis in > 11,000 patients revealed no new safety concerns, with a favorable safety profile comparable with published TTFields/GBM trials. The safety profile remained consistent among subgroups, suggesting feasibility in multiple populations, including elderly patients. Graphic abstract

Immunotherapy for high grade glioma: current clinical practice for patients with (relapsed) GBM

2012 ◽  
Vol 224 (06) ◽  
Author(s):  
S Van Gool ◽  
F Pauwels ◽  
S De Vleeschouwer
Keyword(s):  
Clinical Practice ◽  
High Grade Glioma ◽  
High Grade ◽  
Current Clinical Practice

NCOG-14. REAL-WORLD RETROSPECTIVE ANALYSIS OF TUMOR TREATING FIELDS IN THE TREATMENT OF HIGH-GRADE GLIOMA BASED ON CHINESE POPULATION

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi154-vi155
Author(s):  
Lingchao Chen ◽  
Junrui Chen ◽  
Kun Song ◽  
Jingtao Nie ◽  
Dongxiao Zhuang ◽  
...  
Keyword(s):  
Retrospective Analysis ◽  
Real World ◽  
Chinese Population ◽  
Adverse Reactions ◽  
High Grade Glioma ◽  
High Grade ◽  
Newly Diagnosed ◽  
Efficacy Data ◽  
Tumor Treating Fields ◽  
Recurrent Gbm

Abstract OBJECTIVES Tumor Treating Fields (TTFields) has been approved for the treatment of newly diagnosed and relapsed glioblastoma（GBM）in China in 2020. Only few TTFields data in Asia patients were reported. This retrospective analysis is aimed at investigating the efficacy, safety and the potential relationship with biomarkers of TTFields treatment in the real-world clinical practice of the Chinese glioma population. METHODS High-grade glioma patients who were under TTFields treatment from May 2019 to May 2021 in Shanghai Huashan Hospital were analyzed, including baseline data, efficacy data and incidence of adverse events. RESULTS Eighty-two patients (median age 51.0 [26.0 - 47.0] years) with high-grade glioma were enrolled, including 60 newly diagnosed GBM, 16 recurrent GBM, and 6 WHO grade III gliomas. The median time was 9.9 (4.6-15.7) months for follow-ups, median time for TTFields treatment was 4.3(1.1-20.35) months. The median compliance rate was 90% (40%-97%). For newly diagnosed GBM (n=60) and recurrent GBM (n=16), the 6-month PFS rate were 78.4% (95%CI: 63.9-87.6) and 46.7% (95%CI: 21.2- 67.8) respectively. The 10-month OS rate were 86.3% (95%CI: 69.6- 94.2) and 60.0% (95%CI: 12.6- 88.2) respectively. The 6-month PFS rate in the IDHw/TERTm population was 69.9% (95%CI: 45.9-84.9) and 78.3% (95%CI: 46.5-92.5) in the IDHw/TERTw patients with newly diagnosed GBM. 59(72%) patients had skin-related adverse reactions, and majority are grade 1-2 (grade 1-2, 69.5%; grade 3, 2.5%). CONCLUSIONS This is the 1st retrospective analysis done using TTFields in the treatment of high-grade gliomas in the Chinese population with the largest sample size. From our short follow up, TTFields appears good efficacy among GBM patients. The incidence of skin adverse reactions is higher comparable to published data, but mainly consisted of grade1-2. Long-term efficacy data need to be further followed-up.

Abstract LB-155: Adherence to tumor treating fields (TTFields) in high-grade glioma patients - a single center experience

2019 ◽  
Author(s):  
Carsten Hagemann ◽  
Judith Weiland ◽  
Nadine Lilla ◽  
Thomas Linsenmann ◽  
Ralf-Ingo Ernestus ◽  
...  
Keyword(s):  
High Grade Glioma ◽  
High Grade ◽  
Single Center ◽  
Tumor Treating Fields ◽  
Single Center Experience

Abstract LB-155: Adherence to tumor treating fields (TTFields) in high-grade glioma patients - a single center experience

2019 ◽  
Author(s):  
Carsten Hagemann ◽  
Judith Weiland ◽  
Nadine Lilla ◽  
Thomas Linsenmann ◽  
Ralf-Ingo Ernestus ◽  
...  
Keyword(s):  
High Grade Glioma ◽  
High Grade ◽  
Single Center ◽  
Tumor Treating Fields ◽  
Single Center Experience

scholarly journals P14.60 FET PET response upon radiochemotherapy followed by Tumor Treating Fields (TTFields) in a patient with progressive high-grade glioma

2019 ◽  
Vol 21 (Supplement_3) ◽  
pp. iii81-iii81
Author(s):  
A F Keßler ◽  
J Weiland ◽  
T Linsenmann ◽  
R Ernestus ◽  
C Hagemann ◽  
...  
Keyword(s):  
Tumor Progression ◽  
Treatment Response ◽  
High Grade Glioma ◽  
High Grade ◽  
Who Grade ◽  
Fet Pet ◽  
Tumor Treating Fields ◽  
Grade Ii ◽  
The Right ◽  
Pet Scans

Abstract BACKGROUND The addition of Tumor Treating Fields (TTFields) to the first-line therapy in glioblastoma (GBM) demonstrated significantly improved progression free survival, overall survival and longterm survival rates in the EF-14 phase 3 trial. However, responder analysis of patients with recurrent GBM (rGBM) treated with TTFields monotherapy (in the EF-11 trial) revealed delayed response monitored by MRI analysis. More recent data suggests that O-(2-18F-fluoroethyl)-L-tyrosine (FET) PET may add valuable information for monitoring therapy response of glioblastoma patients treated with TTFields. Here, we report on FET PET response in a patient with progressive anaplastic astrocytoma WHO grade III (AA) treated with TTFields in combination with temozolomide (TMZ) chemotherapy. METHODS We present a 38-year old patient with an initial diagnosis of a diffuse astrocytoma WHO grade II in 2011, and malignisation to an AA on progression. The treatment regimen included initially radio-chemotherapy (RCT) with TMZ. On further progression of the AA in 2017, TTFields were added to another 6 cycles of TMZ. Several FET PET scans for differentiation of tumor progression from treatment-related changes were performed over time. The definitive diagnosis (tumor progression and grading) was confirmed by histopathology after stereotactic biopsy (SB). RESULTS In 2012, the patient was first diagnosed with a low grade astrocytoma WHO grade II of the right frontal, temporal and parietal lobe including infiltration of thalamus and corpus was confirmed by SB, followed by irradiation. On progression in 2015, a FET PET Scan showed FET avidity in all tumor affected regions of the brain. SB confirmed an AA, while FET PET scans showed only a mild response in the temporoparietal region after 6 cycles of TMZ. In 2017, the next progression without further malignisation was confirmed by SB and treated RCT with 41.4 Gy and TMZ chemotherapy, followed by application of TTFields with an average usage rate of 85.7 % over 6 months. Thus, the TTFields adherence was well above the independent prognostic threshold of 75 %. No additional adverse events due to the combined therapy of TTFields and TMZ were observed. Due to a new contrast enhancing lesion in the right frontal lobe (10x7mm), another FET PET scan was performed 1.5 years later. In this scan, obtained after combined TTFields and RCT therapy a strong response regarding FET avidity was observed. CONCLUSION In summary, FET PET is able to add important additional information for evaluation of treatment response in high grade glioma patients, in particular for TTFields treated patients, while adding TTFields to radiochemotherapy might even enhance treatment response of high grade glioma. Further studies might elucidate the role of FET PET imaging for therapy monitoring in high grade glioma patients treated with TTFields.

Post-marketing safety surveillance of tumor treating fields (TTFields) in patients with high-grade glioma in clinical practice.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2542-2542
Author(s):  
Wenyin Shi ◽  
Deborah T. Blumenthal ◽  
Nancy Ann Oberheim Bush ◽  
Seid Kebir ◽  
Rimas Vincas Lukas ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Brain Tumors ◽  
Elderly Patients ◽  
Skin Reaction ◽  
Anaplastic Astrocytoma ◽  
Phase Iii ◽  
Local Skin ◽  
Tumor Treating Fields ◽  
Safety Surveillance ◽  
Local Skin Reaction

2542 Background: Tumor Treating Fields (TTFields) are an antineoplastic treatment delivering low intensity, intermediate frequency, alternating electric fields through two pairs of transducer arrays locoregionally applied to tumor bed. TTFields are FDA-approved for glioblastoma (GBM; 200 kHz) and mesothelioma (150 kHz). Safety and effectiveness were demonstrated in the phase III EF-11 and EF-14 trials in recurrent GBM (rGBM) and in newly diagnosed GBM (ndGBM), respectively. The main TTFields-related adverse event (AE) was array-associated manageable skin irritation. We report AEs from TTFields-treated patients in the real-world, clinical practice setting. Methods: Unsolicited, global, post-market surveillance data from TTFields-treated patients (October 2011–February 2019) were retrospectively analyzed using MedDRA v21.1, stratified by region (US, EMEA [Europe, Middle East, Africa], or Japan), diagnosis (ndGBM, rGBM, anaplastic astrocytoma and anaplastic oligodendroglioma, or other brain tumors that includes brain metastases from different cancer types), and years of age (<18, pediatric; 18 to 64, adults; or ≥65, elderly). Results: Of 11,029 patients, 53% had ndGBM, 39% had rGBM (at any line of recurrence), 6% had anaplastic astrocytoma/oligodendroglioma, and 1% had other brain tumors. Most were adults (73%) and 26% were elderly (≥65 years of age). The majority of patients were males (66.3%) compared to females (33.7%), with a ratio representative of a typical GBM population. The most reported TTFields-related AE was array-associated local skin reaction, with an incidence of 38% in ndGBM, 29% in rGBM, 38% in anaplastic astrocytoma/oligodendroglioma, 31% in other brain tumors, 37% in pediatric, 34% in adults, and 36% in elderly patients. Most skin AEs were mild to moderate and resolved with no treatment or over the counter topical ointments. Incidence of other TTFields-related AEs in patients with ndGBM and rGBM, respectively, included heat sensation (under-array warmth; 11%, 10%), electric sensation (under-array tingling; 11%, 9%), and headache (7%, 6%). Conclusions: This retrospective, global, TTFields safety surveillance analysis revealed no new safety signals, with favorable safety and tolerability comparable to published TTFields/GBM trials. The most common TTFields-related AE was array-associated local skin reaction. The safety profile remained consistent among subgroups (diagnosis, age, or region) and total cohort, indicating feasibility in multiple subpopulations, including elderly patients.

INNV-10. TUMOR TREATING FIELDS (TTF) AS MAINTENANCE THERAPY FOR AN OLIGODENDROGLIOMA CASE AND LONG-TERM FOLLOW-UP

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi107-vi107
Author(s):  
Uvin Ko ◽  
Steven Du ◽  
Matthew Moldenhauer ◽  
Xiao-Tang Kong
Keyword(s):  
Maintenance Therapy ◽  
Tumor Progression ◽  
Brain Mri ◽  
High Grade Glioma ◽  
Residual Tumor ◽  
Potential Effect ◽  
Distribution Area ◽  
High Grade ◽  
Initial Image ◽  
Tumor Treating Fields

Abstract INTRODUCTION Recurrence of low- and high-grade gliomas is observed often after radiation and chemotherapy. Despite continued research on glioma management, there is limited knowledge regarding maintenance treatment after standard care. Tumor Treating Fields as maintenance therapy after radiation and chemotherapy may potentially help prevent recurrence. CASE REPORT In 2011, a 35-year-old male reported headaches to a local ED. A non-enhancing mass was detected on his brain MRI. Observation was advised by his local surgeon. The patient presented with seizures in early 2014, and his brain MRI found the mass developed new enhancement. In late 2014, the patient had multiple seizures, and significant progression of the tumor was discovered. The patient underwent craniotomy and biopsy in the middle cerebral artery distribution area in early 2015. Pathology reported grade II oligodendroglioma; however, the patient only underwent a biopsy, which might have missed the high-grade glioma region. His brain MRI showed a significant enhancing lesion with rapid growth, which was clinically more consistent with grade III oligodendroglioma. Radiation therapy was conducted followed by 6 cycles of PCV chemotherapy throughout 11 months. Post-radiation-chemotherapy brain MRI was stable with a moderate size residual tumor at the right insula region. Following patient wishes, NovoTTF-100A, or Optune, was administered 6 weeks after completion of chemotherapy as maintenance therapy for 2 years to prevent tumor progression. Now, after 3 years being off Optune, the patient is stable without new neurological symptoms or tumor progression. DISCUSSION: Our case highlights the potential effect of Tumor Treating Fields as maintenance therapy after initial radiation and chemotherapy for low- and high-grade oligodendrogliomas. The patient had rapid tumor progression prior to diagnosis and only underwent a biopsy without resection, yet uncommonly, has survived since initial image diagnosis 10 years ago and tissue diagnosis 6 years ago and is fully functional currently.

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