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

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.

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

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.

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

Real-world longitudinal data of peginterferon beta-1a from a Swedish national post-marketing surveillance study (IMSE 6) - efficacy and safety profile

2018 ◽  
Author(s):  
Stina Kågström ◽  
Anna Fält ◽  
Selin Safer Demirbüker ◽  
Anne-Marie Landtblom ◽  
Peter Sundström ◽  
...  
Keyword(s):  
Longitudinal Data ◽  
Real World ◽  
Safety Profile ◽  
Surveillance Study ◽  
Efficacy And Safety ◽  
Post Marketing Surveillance ◽  
Post Marketing

scholarly journals ES-1 Clinical results of tumor treating fields in patients with glioblastoma in Japan, compared with global surveillance

2020 ◽  
Vol 2 (Supplement_3) ◽  
pp. ii3-ii3
Author(s):  
Yoshihiro Muragaki ◽  
Masayuki Nitta ◽  
Taiichi Saito ◽  
Shunichi Tutsuki ◽  
Atsushi Fukui ◽  
...  
Keyword(s):  
Side Effects ◽  
Insurance Coverage ◽  
Intermediate Frequency ◽  
Clinical Results ◽  
Tumor Treating Fields ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
Us Fda ◽  
Medical University

Abstract INTRODUCTION: The tumor treatment field induces apoptosis of tumor cells by providing a low intensity, intermediate frequency, alternating current electric field via a transducer array. TTFields is based on Phase 3 EF-11 and EF-14 trials for glioblastoma in the US FDA and Japan PMDA. Therefore, I will report the statistics of TTFields use in Japan along with recent papers. METHODS: 410 patients were treated with TTFields in Japan (December 2017-), of which 17 were at Tokyo Women’s Medical University. We also referred to papers about global post-marketing surveillance and recent studies. RESULTS: Of the 410 patients, 409 (99.8%) were diagnosed with ndGBM(male: female, 66.8%: 33.2%). As of June 2020, 222 patients (54.1%) were on treatment and 188 (45.9%) were discontinued. In 17 cases at TWMU, the average age was 46.3 years. The average treatment period was 218 days, with 6 patients (35%) continuing treatment, 6 patients (35%) discontinuing due to patient wishes, and 5 patients (30%) discontinuing treatment due to recurrence. Side effects were contact dermatitis under the array in 9 patients (57%) and mild malaise in 7 patients (43%). We experienced long-term progression-free cases with TTF use of 25 months (survival 30 months after surgery) with a glioma partially resected and 21 months (survival 27 months after surgery) with a biopsied glioma. In the biopsy case, bevacizumab was used in combination during the treatment. Conclusion: In global surveillance, use for rGBM accounts for 39%, but Japan is limited to use for ndGBM due to insurance coverage. In terms of side effects, it showed a good safety profile comparable to previous trials. Long-term progression-free cases have been observed, and it is necessary to examine the characteristics of patients who respond to treatment and the effect of concomitant use with bevacizumab by prospective studies

scholarly journals AB0249 SAFETY OF BARICITINIB IN JAPANESE PATIENTS WITH RHEUMATOID ARTHRITIS (RA): THE 2020 INTERIM REPORT FROM ALL-CASE POST MARKETING SURVEILLANCE IN CLINICAL PRACTICE

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1150.1-1150
Author(s):  
T. Fujii ◽  
T. Atsumi ◽  
N. Okamoto ◽  
N. Takahashi ◽  
N. Tamura ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Aspiration Pneumonia ◽  
Japanese Patients ◽  
Research Support ◽  
Serious Adverse Events ◽  
Chugai Pharmaceutical ◽  
Post Marketing Surveillance ◽  
Otsuka Pharmaceutical ◽  
Post Marketing

Background:An all-case post marketing surveillance (PMS) of baricitinib (Bari), that started in Sep 2017, collects safety and effectiveness for the first 24 wks of treatment and continues to collect serious adverse events (SAEs) for 3 yrs.Objectives:To evaluate Bari safety in RA patients (pt) in clinical practice.Methods:We report pt baseline demographics and adverse events (AEs) up to 24 wks for pts whose case report files for 24-wk data were completed as of Jun 2020.Results:Data from 3445 pts were analyzed (females=80%, mean age=64yr, mean RA duration 12yr). Bari dose regimen was as follows: 4mg, 60%, 2mg, 27%, 4mg→2mg, 5%, 2mg→4mg, 5%, and others, 2%. Concomitant use of MTX and glucocorticoid was 65% and 48%, respectively. 74% continued treatment for 24 wks. AE and SAE were recognized in 887 (26%) and 122 pts (4%), respectively. 6 pts died of pneumonia, aspiration pneumonia, bacterial pneumonia, cerebral infarction/ILD/aspiration pneumonia, adenocarcinoma, and colorectal cancer. Major AEs were as follows: herpes zoster=3%, liver dysfunction=3%, serious infection=1%, anemia=1%, hyperlipidemia=1%, malignancy=0.3%, interstitial pneumonia=0.2%, MACE=0.1%, and VTE=0.1%.Conclusion:Data do not show new safety concerns and encourage guideline-compliant use of Bari.Disclosure of Interests:Takao Fujii Speakers bureau: Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; Ono Pharmaceutical Co. Ltd., Consultant of: Asahikasei Pharma Corp, Grant/research support from: Asahikasei Pharma Corp; AbbVie Japan GK; Chugai Pharmaceutical Co. Ltd., Eisai Co. Ltd; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Ono Pharmaceutical Co., Ltd., Tatsuya Atsumi Speakers bureau: AbbVie Japan GK; Astellas Pharma Inc.; Bristol-Myers Squibb Co. Ltd; Chugai Pharmaceutical Co. Ltd.; Daiichi Sankyo Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., UCB Japan Co. Ltd., Consultant of: AbbVie Japan GK; AstraZeneca plc.; Boehringer Ingelheim Co. Ltd.; Medical & Biological Laboratories Co. Ltd.; Novartis Pharma K.K.; Ono Pharmaceutical Co. Ltd.; Pfizer Japan Inc., Grant/research support from: Astellas Pharma Inc., Alexion Inc.; Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co., Ltd.Pfizer Japan Inc.; Takeda Pharmaceutical Co. Ltd., Nami Okamoto Speakers bureau: AbbVie Japan GK; Asahikasei Pharma Co.; AYUMI Pharmaceutical Co.Eisai Co. Ltd; Bristol-Myers Squibb Co. Ltd.; Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Co.; Pfizer Japan Inc.Sanofi K.K.; Chugai Pharmaceutical Co. Ltd.; Novartis Pharma Co.; Teijin Pharma Ltd.; Torii Pharmaceutical Co., Ltd., Nobunori Takahashi Speakers bureau: AbbVie Japan GK; Eisai Co. Ltd.; Mitsubishi Tanabe Pharma Co.; Pfizer Japan Inc.; Chugai Pharmaceutical Co., Ltd.; Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K.; UCB Japan Co. Ltd.; Astellas Pharma Inc.; Bristol Myers Squibb Co. Ltd., Grant/research support from: Bristol Myers Squibb Co. Ltd., Naoto Tamura Speakers bureau: AbbVie Japan GK; Bristol Myers Squibb Co. Ltd.; Chugai Pharmaceutical Co. Ltd.; Eisai Co. Ltd.; Eli Lilly Japan K.K.; Glaxo Smith Kline K.K.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co., Atsuo Nakajima: None declared, Ayako Nakajima Speakers bureau: AbbVie Japan GK; Actelion Pharmaceuticals Japan Ltd., Asahi Kasei Pharma Co., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd.,Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Eli Lilly Japan K.K., Glaxo Smith Kline K.K., Hisamitsu Pharmaceutical Co. Inc., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Teijin Pharma Ltd., Grant/research support from: Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Co., Pfizer Japan Inc., Hiroaki Matsuno Speakers bureau: Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Consultant of: Mochida Pharmaceutical Co., Ltd., Grant/research support from: Astellas Pharma Inc., Eli Lilly Japan K.K.; Janssen Pharmaceutical K.K, Naoto Tsujimoto Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Atsushi Nishikawa Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Taeko Ishii Shareholder of: Eli Lilly, Employee of: Eli Lilly Japan K.K., Tsutomu Takeuchi Speakers bureau: AbbVie Japan GK, Ayumi Pharmaceutical Co., Bristol Myers Squibb Co., Ltd., Chugai Pharmaceutical Co, Ltd. Daiichi Sankyo Co., Ltd. Eisai Co., Ltd. Eli Lilly Japan K.K.; Gilead Sciences, Inc. Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Co.; Novartis Pharma Co.; Pfizer Japan Inc.; Sanofi K.K.; UCB Japan Co., Ltd., Consultant of: AbbVie Japan GK, Astellas Pharma, Inc.; Chugai Pharmaceutical Co, Ltd.; Eli Lilly Japan K.K.; Eisai Co., Ltd.; Gilead Sciences, Inc.; Janssen Pharmaceutical K.K.; Mitsubishi-Tanabe Pharma Corp., Pfizer Japan Inc., Grant/research support from: AbbVie Japan GK, Asahikasei Pharma Corp., Chugai Pharmaceutical Co, Ltd., DNA Chip Research Inc.; Eisai Co., Ltd., Eli Lilly Japan K.K.; Mitsubishi-Tanabe Pharma Corp., UCB Japan Co., Ltd., Masataka Kuwana Speakers bureau: AbbVie Japan GK, Astellas Pharma Inc., Asahi Kasei Pharma Co., Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Janssen Pharmaceutical K.K., Medical &Biological Laboratories Co., Ltd.; Mitsubishi Tanabe Pharma Co.; Mochida Pharmaceutical Co., Ltd., Nippon Shinyaku Co., Ltd.; Ono Pharmaceutical Co., Ltd.; Pfizer Japan Inc., Consultant of: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Corbus Pharmaceuticals Holdings, Inc.; Medical &Biological Laboratories Co., Ltd.; Mochida Pharmaceutical Co., Ltd., Grant/research support from: Boehringer-Ingelheim, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Medical &Biological Laboratories Co., Ltd; Mitsubishi Tanabe Pharma Co., Ono Pharmaceutical Co., Ltd., Michiaki Takagi Speakers bureau: Yes, but sponsored lectures without COI in the academic meetings, only.

scholarly journals 0471 24-Month Post Marketing Safety Surveillance Data of a Novel Continuous Release and Absorption Melatonin (CRA-Melatonin) Delivery System, Confirms Favorable Safety Profile

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A180-A181
Author(s):  
D Brodner ◽  
P Corsino
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Call Center ◽  
First Generation ◽  
Surveillance Period ◽  
Continuous Release ◽  
Safety Surveillance ◽  
Post Marketing ◽  
Favorable Safety ◽  
Reporting Rates

Abstract Introduction The awareness of sleep disorders having negative health consequences, including hypertension, diabetes, obesity, depression, heart attack and stroke, has sharply escalated in recent years. Traditional treatments, including benzodiazepenes, non-benzodiazepenes, anti-depressants and non-prescription first-generation antihistamines, come with limitations in efficacy, safety and tolerability. The search for non-drug alternatives continues. The novel, well tolerated CRA-melatonin was shown in a randomized, crossover, pharmacokinetic (PK) study versus the leading marketed melatonin to achieve quick uptake and then continuous release and absorption for up to 7 hours. No safety or tolerability issues were observed. The Remfresh Safety Update at 24 months (REMSU24), a real-world safety surveillance study was conducted to confirm the previously observed safety profile of CRA-melatonin. Methods An independent call center with pharmacovigilance-trained health care personnel in accordance with FDA guidelines on properly reporting events, was retained to receive and record customer questions, product issues and adverse events (AEs). The study was conducted from March 9, 2017 to March 9, 2019. Results An estimated 320,255 patients used CRA-melatonin during the surveillance period. There were no serious AEs. The self-reporting rates of non-serious AEs were low with only 51 events recorded, a 0.016% event rate. The two most frequent AEs, headaches and nightmares are known comorbidities of insomnia. As background, there had been no treatment emergent adverse events for CRA-melatonin in the PK trial. Conclusion CRA-melatonin’s extended 7-hour PK profile may be an effective and well-tolerated baseline therapy to improve sleep. These results confirm the favorable safety and tolerability trend observed in the PK study. In REMSU24, the scatter of reported adverse events could not be separated from what could be expected in the untreated general population. Support This study was supported by Physician’s Seal LLC

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