SURG-06. THE SAFETY PROFILE OF TUMOR TREATING FIELDS (TTFIELDS; 200 KHZ) CONCOMITANT WITH VENTRICULO-PERITONEAL SHUNTS IN PATIENTS WITH GLIOBLASTOMA AND HYDROCEPHALUS

2021 ◽  
Vol 23 (Supplement_6) ◽  
pp. vi196-vi196
Author(s):  
Nancy Ann Oberheim-Bush ◽  
Wenyin Shi ◽  
Michael McDermott ◽  
Alexander Grote ◽  
Julia Stindl ◽  
...  
Keyword(s):  
Real World ◽  
Clinical Setting ◽  
Safety Profile ◽  
The United States ◽  
Adult Patients ◽  
High Risk Population ◽  
Skin Reactions ◽  
Vp Shunt ◽  
The Real ◽  
Tumor Treating Fields

Abstract INTRODUCTION Hydrocephalus is a common development in patients with glioblastoma (GBM) requiring treatment with ventriculo-peritoneal (VP)-shunts (programmable/non-programmable). To maximize outcomes in this high-risk population, evaluation of VP-shunt usage concomitant with GBM treatments is necessary. Tumor Treating Fields (TTFields; 200 kHz; anti-mitotic, loco-regional cancer modality) non-invasively delivers continuous, alternating electrical fields per scalp-placed arrays. TTFields treatment has obtained FDA-approval/CE-mark in adult patients with newly-diagnosed GBM (ndGBM) and recurrent GBM (rGBM). Due to insufficient TTFields/VP-shunt usage data, label does not currently advise concurrent use. We report on safety data from adult patients utilizing TTFields/VP-shunts in the real-world, clinical-setting. METHODS This retrospective, post-marketing, safety surveillance analysis evaluated unsolicited data from adult patients with GBM/hydrocephalus who were TTFields-treated in the presence of a VP-shunt. Available data from >18,000 patients with GBM prescribed TTFields (November 1, 2012 to April 15, 2021 [cut-off date]) were screened for eligibility. Included were 156 adult patients (≥ 18 years of age) with confirmed GBM/hydrocephalus and TTFields/VP-shunt (46 programmable; 110 non-programmable/unknown) usage. Patients were further analyzed by diagnosis (ndGBM, n=92; rGBM, n=64). RESULTS Of 156 TTFields/VP-shunt-treated patients (median age 52), 66% were male and 81% from the United States (19%; Europe/Middle-east/Africa). Overall, no TTFields-related shunt-failures or differences by GBM diagnosis in shunt-type and TTFields-related AEs were observed. Commonly-reported TTFields-related adverse events (AEs) >10% were beneath-array skin reactions (∼43%), electric sensations (∼14%; tingling), headache (∼13%), fatigue/malaise (∼12%), and heat sensation (∼11%; warmth); headache and fatigue/malaise are also associated with other concomitant treatments/disease burden. There were 5 serious AEs (all skin AEs) potentially-related to TTFields at the shunt-site (2 events, wound dehiscence; 3 events, skin erosion). CONCLUSIONS Adult patients with GBM/hydrocephalus treated with TTFields (200 kHz)/VP-shunts in the real-world, clinical-setting suggests feasibility and a tolerable safety profile; with no evidence of disrupted VP-shunt effectiveness. TTFields safety profile was consistent with prior-studies.

scholarly journals 1247. Dalbavancin in Osteomyelitis and Joint Infections: An Analysis From an Observational, Multicenter, Retrospective Cohort Study of the Real-World Use in Adult Patients

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S641-S642
Author(s):  
Julia Garcia Diaz ◽  
Jennifer McGregor ◽  
Anathakrishnan Ramani ◽  
John Lock ◽  
Yoav Golan ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Outcome ◽  
Real World ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Joint Infection ◽  
The United States ◽  
Adult Patients ◽  
The Real ◽  
Staphylococcus Spp

Abstract Background Dalbavancin (DAL) is approved in the United States (US) and Europe for acute bacterial skin and skin structure infections and exhibits broad spectrum activity against clinically important Gram-positive pathogens including methicillin-sensitive and methicillin-resistant Staphylococcus aureus, and Streptococcus spp. We describe the use of DAL in patients with osteomyelitis or joint infection from a phase 4 observational, multicenter, retrospective cohort study of the real-world use of DAL in adult patients across the US: Dalvance Utilization Registry Investigating Value and Efficacy (DRIVE). Methods Data were collected between 03/25/2017 and 11/27/2018 and included demographics, disease and pathogen characteristics, antibiotic use, clinical outcome, and safety. Patients with a determinate clinical outcome (success/failure) were included in the evaluable population. Results Data for 96 patients with osteomyelitis and 33 patients with joint infection (safety population) were entered into this subanalysis. Patient demographics and medical history were broadly similar for patients with osteomyelitis or joint infection. The majority (80.4–100%) of patients received DAL as concurrent therapy and clinical success, defined qualitatively, was achieved in 64.7-87.5% of patients (Fig. 1). Most patients received 1 or 2 IV DAL doses (osteomyelitis, 33.3% and 34.6%, respectively; joint infection, 37.5% and 31.3%, respectively); 11.5% and 6.3% of patients with osteomyelitis or joint infection, respectively received >4 doses (Fig. 2). Staphylococcus spp. was the most frequently isolated organism at baseline (Fig. 3); 61.1% and 35.7% of osteomyelitis and joint infection isolates tested, respectively were resistant to oxacillin. At 60 days post-DAL treatment, numbers of Staphylococcus spp. isolated from both groups decreased (Fig. 3), confirming microbiological cure. The rate of serious adverse events was low (16 events in 7 [7.3%] patients with osteomyelitis, 2 events in 2 [6.1%] patients with joint infection) and consistent with the safety profile of DAL. Fig. 1 Fig. 2 Fig. 3 Conclusion In this real-world study in patients with Staphylococcal osteomyelitis and joint infection, DAL resulted in high rates of clinical and microbiological success. Disclosures Jennifer McGregor, RPh, AbbVie (Employee) Anathakrishnan Ramani, MD, FACP, AAHIVS, CIC, Allergan (prior to its acquisition by AbbVie) (Speaker’s Bureau) John Lock, PharmD, BCPS, AQ-ID, AbbVie (Employee) Pedro Gonzalez, MD, MT, AbbVie (Employee)

scholarly journals Safety profile of chimeric antigen receptor T-cell immunotherapies (CAR-T) in clinical practice

2021 ◽  
Author(s):  
Giulia Bonaldo ◽  
Nicola Montanaro ◽  
AlbertoVaccheri ◽  
Domenico Motola
Keyword(s):  
T Cell ◽  
Chimeric Antigen Receptor ◽  
Clinical Setting ◽  
Safety Profile ◽  
Antigen Receptor ◽  
The United States ◽  
Reporting Odds Ratio ◽  
Cytokine Release ◽  
Car T ◽  
Age Range

Abstract Purpose Two chimeric antigen receptor T-cell (CAR-T) therapies have been approved in the United States (USA) in 2017 and Europe (EU) in 2018: axicabtagene ciloleucel and tisagenlecleucel. They contain the patient’s own T cells, which are extracted, genetically modified, and reinfused. Alongside the good efficacy results, the assessment of safety profile of these new therapies represents a great challenge. Our aim was to analyze the reports of the adverse drug reactions (ADR) after CAR-T administration as occurred in the real clinical setting. Methods We performed a retrospective observational study, collecting all the reports in EU (EudraVigilance, EV) and US (FAERS) databases of ADRs regarding axicabtagene ciloleucel and tisagenlecleucel. Both descriptive and statistical analyses were performed, the latter by using Reporting Odds Ratio (ROR). Results A total number of 1426 reports of suspected ADRs were retrieved in EudraVigilance and FAERS. Patients’ reported age reflected the age range for which the drugs are approved (18–64 years for axicabtagene ciloleucel and patients aged under 25 years for tisagenlecleucel). The most reported event was cytokine release syndrome (CRS), 185 events for tisagenlecleucel and 462 for axicabtagene ciloleucel in FAERS and 137 and 498, respectively, in EudraVigilance. A disproportionality was found comparing axicabtagene ciloleucel with tisagenlecleucel for the above-mentioned event: EV ROR 2.47, 95% CI 2.22–2.74, FAERS 1.89, 1.70–2.10. Conclusion CRS represents the major problem with the administration of CAR-T therapies. Our analysis has not revealed new ADRs; however, it supports the safety profile of CAR-T with new data from real clinical setting.

scholarly journals Neither a New Cold War nor a New Peloponnesian War: The Emerging Cyber-narrative Competition at the Heart of Sino-American Relations

2021 ◽  
Vol 21 (2) ◽  
pp. 252-264
Author(s):  
Nicholas Ross Smith ◽  
Ruairidh J. Brown
Keyword(s):  
United States ◽  
Cold War ◽  
Real World ◽  
The United States ◽  
Peloponnesian War ◽  
The Real ◽  
Current State ◽  
Thucydides Trap ◽  
The Relationship ◽  
Industrial Revolutions

There is much pessimism as to the current state of Sino-American relations, especially since the onset of the COVID-19 pandemic in January 2020. Such pessimism has led to some scholars and commentators asserting that the Sino-American relationship is on the cusp of either a new Cold War or, even more alarmingly, something akin to the Peloponnesian War (via a Thucydides Trap) whereby the United States might take pre-emptive measures against China. This article rejects such analogizing and argues that, due to important technological advancements found at the intersection of the digital and fourth industrial revolutions, most of the real competition in the relationship is now occurring in cyberspace, especially with regards to the aim of asserting narratives of truth. Two key narrative battlegrounds that have raged since the onset of the COVID-19 pandemic are examined: where was the origin of the COVID-19 pandemic? and who has had the most successful response to the COVID-19 pandemic?. This article shows that Sino-American competition in cyberspace over asserting their narratives of truth (related to the COVID-19 pandemic) is fierce and unhinged. Part of what is driving this competition is the challenging domestic settings politicians and officials find themselves in both China and the United States, thus, the competing narratives being asserted by both sides are predominately for domestic audiences. However, given that cyberspace connects states with foreign publics more intimately, the international aspect of this competition is also important and could result in further damage to the already fragile Sino-American relationship. Yet, whether this competition will bleed into the real world is far from certain and, because of this, doomsaying via historical analogies should be avoided.

Prospects for Social Reporting in the United States: A Receding Horizon

1987 ◽  
Vol 8 (x) ◽  
pp. 251-261
Author(s):  
Richard C. Rockwell
Keyword(s):  
Social Sciences ◽  
United States ◽  
Real World ◽  
The United States ◽  
Social Reporting ◽  
Social Scientists ◽  
Scientific Advance ◽  
The Real ◽  
Incomplete Model ◽  
The Social

This essay sets forth the thesis that social reporting in the United States has suffered from an excess of modesty among social scientists. This modesty might be traceable to an incomplete model of scientific advance. one that has an aversion to engagement with the real world. The prospects for social reporting in the United States would be brighter if reasonable allowances were to be made for the probable scientific yield of the social reporting enterprise itself. This yield could support and improve not only social reporting but also many unrelated aspects of the social sciences.

The Fissioning of the Modern Family in Utopia- The Real- World Consequences of Political Illusions

2018 ◽  
Vol 1 (1) ◽  
pp. 98-112
Author(s):  
Bryce Christensen
Keyword(s):  
United States ◽  
20Th Century ◽  
Real World ◽  
Family Life ◽  
The United States ◽  
The Real ◽  
The Family ◽  
Modern Family

Since the mid-20th century, the United States-, like many Europeancountries, -has witnessed dramatic changes in family life, resulting inremarkably low rates for marriage and fertility, remarkably high rates fordivorce, cohabitation, and out-of-wedlock births. To understand these changes the article presents, on the example of literature, ideologies, philosophical trends, and intellectual opinions, which in a particularly destructive way influenced the contemporary condition of the family.

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