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Article ; Online: Exoskeletal solutions to enable mobility with a lower leg fracture in austere environments.

Johnson, W Brett / Young, Aaron / Goldman, Stephen / Wilson, Jon / Alderete, Joseph F / Childers, W Lee

Wearable technologies

2023 Volume 4, Page(s) e5

Abstract: The treatment and evacuation of people with lower limb fractures in austere environments presents unique challenges that assistive exoskeletal devices could address. In these dangerous situations, independent mobility for the injured can preserve their ... ...

Abstract	The treatment and evacuation of people with lower limb fractures in austere environments presents unique challenges that assistive exoskeletal devices could address. In these dangerous situations, independent mobility for the injured can preserve their vital capabilities so that they can safely evacuate and minimize the need for additional personnel to help. This expert view article discusses how different exoskeleton archetypes could provide independent mobility while satisfying the requisite needs for portability, maintainability, durability, and adaptability to be available and useful within austere environments. The authors also discuss areas of development that would enable exoskeletons to operate more effectively in these scenarios as well as preserve the health of the injured limb so that definitive treatment after evacuation will produce better outcomes.
Language	English
Publishing date	2023-02-28
Publishing country	England
Document type	Journal Article ; Review
ISSN	2631-7176
ISSN (online)	2631-7176
DOI	10.1017/wtc.2022.26
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Article ; Online: Accelerated Hypofractionated Chemoradiation Followed by Stereotactic Ablative Radiotherapy Boost for Locally Advanced, Unresectable Non-Small Cell Lung Cancer: A Nonrandomized Controlled Trial.

Wu, Trudy C / Luterstein, Elaine / Neilsen, Beth K / Goldman, Jonathan W / Garon, Edward B / Lee, Jay M / Felix, Carol / Cao, Minsong / Tenn, Stephen E / Low, Daniel A / Kupelian, Patrick A / Steinberg, Michael L / Lee, Percy

JAMA oncology

2024 Volume 10, Issue 3, Page(s) 352–359

Abstract: Importance: Intrathoracic progression remains the predominant pattern of failure in patients treated with concurrent chemoradiation followed by a consolidation immune checkpoint inhibitor for locally advanced, unresectable non-small cell lung cancer ( ... ...

Abstract	Importance: Intrathoracic progression remains the predominant pattern of failure in patients treated with concurrent chemoradiation followed by a consolidation immune checkpoint inhibitor for locally advanced, unresectable non-small cell lung cancer (NSCLC). Objective: To determine the maximum tolerated dose (MTD) and use of hypofractionated concurrent chemoradiation with an adaptive stereotactic ablative radiotherapy (SABR) boost. Design, setting, and participants: This was an early-phase, single-institution, radiation dose-escalation nonrandomized controlled trial with concurrent chemotherapy among patients with clinical stage II (inoperable/patient refusal of surgery) or III NSCLC (American Joint Committee on Cancer Staging Manual, seventh edition). Patients were enrolled and treated from May 2011 to May 2018, with a median patient follow-up of 18.2 months. Patients advanced to a higher SABR boost dose if dose-limiting toxic effects (any grade 3 or higher pulmonary, gastrointestinal, or cardiac toxic effects, or any nonhematologic grade 4 or higher toxic effects) occurred in fewer than 33% of the boost cohort within 90 days of follow-up. The current analyses were conducted from January to September 2023. Intervention: All patients first received 4 Gy × 10 fractions followed by an adaptive SABR boost to residual metabolically active disease, consisting of an additional 25 Gy (low, 5 Gy × 5 fractions), 30 Gy (intermediate, 6 Gy × 5 fractions), or 35 Gy (high, 7 Gy × 5 fractions) with concurrent weekly carboplatin/paclitaxel. Main outcome and measure: The primary outcome was to determine the MTD. Results: Data from 28 patients (median [range] age, 70 [51-88] years; 16 [57%] male; 24 [86%] with stage III disease) enrolled across the low- (n = 10), intermediate- (n = 9), and high- (n = 9) dose cohorts were evaluated. The protocol-specified MTD was not exceeded. The incidences of nonhematologic acute and late (>90 days) grade 3 or higher toxic effects were 11% and 7%, respectively. No grade 3 toxic effects were observed in the intermediate-dose boost cohort. Two deaths occurred in the high-dose cohort. Two-year local control was 74.1%, 85.7%, and 100.0% for the low-, intermediate-, and high-dose cohorts, respectively. Two-year overall survival was 30.0%, 76.2%, and 55.6% for the low-, intermediate-, and high-dose cohorts, respectively. Conclusions and relevance: This early-phase, dose-escalation nonrandomized controlled trial showed that concurrent chemoradiation with an adaptive SABR boost to 70 Gy in 15 fractions with concurrent chemotherapy is a safe and effective regimen for patients with locally advanced, unresectable NSCLC. Trial registration: ClinicalTrials.gov Identifier: NCT01345851.
MeSH term(s)	Humans ; Male ; Aged ; Female ; Carcinoma, Non-Small-Cell Lung/radiotherapy ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Lung Neoplasms/drug therapy ; Radiosurgery/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Dose Fractionation, Radiation
Language	English
Publishing date	2024-02-02
Publishing country	United States
Document type	Journal Article ; Comment
ISSN	2374-2445
ISSN (online)	2374-2445
DOI	10.1001/jamaoncol.2023.6033
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Article ; Online: Prolonged field care for traumatic extremity injuries: defining a role for biologically focused technologies.

Dolan, Connor P / Valerio, Michael S / Lee Childers, W / Goldman, Stephen M / Dearth, Christopher L

NPJ Regenerative medicine

2021 Volume 6, Issue 1, Page(s) 6

Language	English
Publishing date	2021-02-04
Publishing country	United States
Document type	Journal Article
ISSN	2057-3995
ISSN (online)	2057-3995
DOI	10.1038/s41536-020-00117-9
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Article ; Online: Severe cutaneous adverse reactions: comparing outcomes in children with and without complex chronic conditions.

Antoon, James W / Goldman, Jennifer L / Lee, Brian R

The journal of allergy and clinical immunology. In practice

2019 Volume 8, Issue 2, Page(s) 790–792.e3

MeSH term(s)	Administration, Cutaneous ; Child ; Drug Eruptions ; Humans ; Skin
Language	English
Publishing date	2019-08-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2019.07.043
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Article ; Online: Health Consequences of Family Member Incarceration for Adults in the Household.

Wildeman, Christopher / Goldman, Alyssa W / Lee, Hedwig

Public health reports (Washington, D.C. : 1974)

2019 Volume 134, Issue 1_suppl, Page(s) 15S–21S

MeSH term(s)	Adult ; Aged ; Aged, 80 and over ; Family ; Family Characteristics ; Female ; Health Status Disparities ; Humans ; Male ; Middle Aged ; Prisoners/statistics & numerical data ; United States
Language	English
Publishing date	2019-05-06
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Review
ZDB-ID	120953-x
ISSN	1468-2877 ; 0033-3549
ISSN (online)	1468-2877
ISSN	0033-3549
DOI	10.1177/0033354918807974
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Article ; Online: Lysosomal lipid peroxidation regulates tumor immunity.

Bhardwaj, Monika / Lee, Jennifer J / Versace, Amanda M / Harper, Sandra L / Goldman, Aaron R / Crissey, Mary Ann S / Jain, Vaibhav / Singh, Mahendra Pal / Vernon, Megane / Aplin, Andrew E / Lee, Seokwoo / Morita, Masao / Winkler, Jeffrey D / Liu, Qin / Speicher, David W / Amaravadi, Ravi K

The Journal of clinical investigation

2023 Volume 133, Issue 8

Abstract: Lysosomal inhibition elicited by palmitoyl-protein thioesterase 1 (PPT1) inhibitors such as DC661 can produce cell death, but the mechanism for this is not completely understood. Programmed cell death pathways (autophagy, apoptosis, necroptosis, ... ...

Abstract	Lysosomal inhibition elicited by palmitoyl-protein thioesterase 1 (PPT1) inhibitors such as DC661 can produce cell death, but the mechanism for this is not completely understood. Programmed cell death pathways (autophagy, apoptosis, necroptosis, ferroptosis, and pyroptosis) were not required to achieve the cytotoxic effect of DC661. Inhibition of cathepsins, or iron or calcium chelation, did not rescue DC661-induced cytotoxicity. PPT1 inhibition induced lysosomal lipid peroxidation (LLP), which led to lysosomal membrane permeabilization and cell death that could be reversed by the antioxidant N-acetylcysteine (NAC) but not by other lipid peroxidation antioxidants. The lysosomal cysteine transporter MFSD12 was required for intralysosomal transport of NAC and rescue of LLP. PPT1 inhibition produced cell-intrinsic immunogenicity with surface expression of calreticulin that could only be reversed with NAC. DC661-treated cells primed naive T cells and enhanced T cell-mediated toxicity. Mice vaccinated with DC661-treated cells engendered adaptive immunity and tumor rejection in "immune hot" tumors but not in "immune cold" tumors. These findings demonstrate that LLP drives lysosomal cell death, a unique immunogenic form of cell death, pointing the way to rational combinations of immunotherapy and lysosomal inhibition that can be tested in clinical trials.
MeSH term(s)	Mice ; Animals ; Lipid Peroxidation ; Apoptosis ; Cell Death ; Neoplasms/pathology ; Antioxidants/pharmacology ; Lysosomes/metabolism
Chemical Substances	Antioxidants
Language	English
Publishing date	2023-04-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	3067-3
ISSN	1558-8238 ; 0021-9738
ISSN (online)	1558-8238
ISSN	0021-9738
DOI	10.1172/JCI164596
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Article ; Online: Brief Report: Severe Pneumonitis After Combined Thoracic Radiotherapy and Osimertinib.

Smith, Clayton P / Xiang, Michael / Yoon, Stephanie M / Lee, Alan / Ruan, Dan / Goldman, Jonathan W / Cummings, Amy L / Lisberg, Aaron / Garon, Edward B / Moghanaki, Drew

JTO clinical and research reports

2023 Volume 4, Issue 3, Page(s) 100468

Abstract: Introduction: Osimertinib is an effective treatment for metastatic NSCLC. Occasionally, thoracic radiation therapy (TRT) is delivered to patients receiving osimertinib to treat residual or progressing pulmonary tumors. Anecdotal reports suggest that the ...

Abstract	Introduction: Osimertinib is an effective treatment for metastatic NSCLC. Occasionally, thoracic radiation therapy (TRT) is delivered to patients receiving osimertinib to treat residual or progressing pulmonary tumors. Anecdotal reports suggest that the delivery of TRT in combination with osimertinib may be associated with a high risk of severe pneumonitis. Methods: A retrospective study was performed at a single academic medical center in the United States to investigate the incidence of severe pneumonitis among patients treated with combined TRT and osimertinib between June 2016 and December 2021. Baseline patient characteristics, tumor size and location, and dosimetric parameters were evaluated. The highest grade of radiation pneumonitis that developed within 6 months of treatment was scored in accordance with the Common Terminology Criteria for Adverse Events version 5.0. Results: A total of 16 patients were identified who were treated with combined TRT and osimertinib. All had a diagnosis of metastatic NSCLC. Treatment-related grade greater than or equal to 2 pneumonitis developed in 56%, grade greater than or equal to 3 in 37.5%, and grade 4 in 6.3%; no patient developed grade 5 pneumonitis. Median time to any-grade pneumonitis was 29 days (1-84 d); all patients had symptom resolution with expectant management or oral steroid therapies. All patients discovered to have grade greater than or equal to 3 pneumonitis (n = 6) received TRT to tumors located within 2 cm of the proximal bronchial tree, including tumors abutting the proximal bronchial tree (n = 2) and within the mediastinum (n = 1). Conclusions: The combination of TRT with osimertinib was associated with a high rate of severe pneumonitis that required oral steroid medications. Larger studies are needed to validate these findings and to understand the clinical and treatment factors that influence this risk and how they can be mitigated.
Language	English
Publishing date	2023-02-02
Publishing country	United States
Document type	Journal Article
ISSN	2666-3643
ISSN (online)	2666-3643
DOI	10.1016/j.jtocrr.2023.100468
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Article ; Online: Summary of Research: Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC.

Targeted oncology

2024 Volume 19, Issue 2, Page(s) 131–134

Abstract: This is a summary of the original article ‟Overall survival with osimertinib in resected EGFR-mutated NSCLC.ˮ Osimertinib blocks the activity of the epidermal growth factor receptor (EGFR) on cancer cells, causing cancer cell death and tumor shrinkage, ... ...

Abstract	This is a summary of the original article ‟Overall survival with osimertinib in resected EGFR-mutated NSCLC.ˮ Osimertinib blocks the activity of the epidermal growth factor receptor (EGFR) on cancer cells, causing cancer cell death and tumor shrinkage, and is an effective treatment for EGFR-mutated non-small cell lung cancer (NSCLC). The ADAURA study assessed the effects of osimertinib versus placebo in patients with EGFR-mutated (exon 19 deletion or L858R) early stage (IB-IIIA) NSCLC removed by surgery (resected). Previous results from ADAURA demonstrated that patients treated with osimertinib stayed alive and cancer-free (disease-free survival) significantly longer than patients who received placebo. Recent data showed the overall length of time patients were alive after starting treatment (overall survival). In both the primary stage II-IIIA and overall stage IB-IIIA populations, patients in the osimertinib group had a significant 51% reduction in the risk of death compared with the placebo group. The data demonstrated that osimertinib after surgery significantly improved overall survival in patients with resected, EGFR-mutated, stage IB-IIIA NSCLC.
MeSH term(s)	Humans ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/genetics ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Protein Kinase Inhibitors/pharmacology ; Protein Kinase Inhibitors/therapeutic use ; Mutation ; Aniline Compounds/pharmacology ; Aniline Compounds/therapeutic use ; ErbB Receptors/genetics ; ErbB Receptors/therapeutic use ; Acrylamides ; Indoles ; Pyrimidines
Chemical Substances	osimertinib (3C06JJ0Z2O) ; Protein Kinase Inhibitors ; Aniline Compounds ; ErbB Receptors (EC 2.7.10.1) ; EGFR protein, human (EC 2.7.10.1) ; Acrylamides ; Indoles ; Pyrimidines
Language	English
Publishing date	2024-03-11
Publishing country	France
Document type	Letter
ZDB-ID	2222136-0
ISSN	1776-260X ; 1776-2596
ISSN (online)	1776-260X
ISSN	1776-2596
DOI	10.1007/s11523-024-01034-3
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Article ; Online: A Retrospective Cohort Study of the Management and Outcomes of Children Hospitalized with Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis.

Antoon, James W / Goldman, Jennifer L / Shah, Samir S / Lee, Brian

The journal of allergy and clinical immunology. In practice

2018 Volume 7, Issue 1, Page(s) 244–250.e1

Abstract: Background: Severe cutaneous adverse reactions are rare yet life-threatening conditions. The current management and outcomes of these conditions in US children are unclear.: Objective: To characterize the current management and outcomes of Stevens- ... ...

Abstract	Background: Severe cutaneous adverse reactions are rare yet life-threatening conditions. The current management and outcomes of these conditions in US children are unclear. Objective: To characterize the current management and outcomes of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) across US children's hospitals. Methods: We performed a retrospective cohort study of children younger than 18 years hospitalized with a primary diagnosis of SJS or TEN at 47 US freestanding children's hospitals. We compared treatment (intravenous immunoglobulin [IVIG], steroids, antibiotics, and others) and outcomes (length of stay [LOS], hospital mortality, readmission, recurrence, related complications, and adjusted hospital costs) across hospitals and by SJS versus TEN diagnoses. Results: We identified 898 pediatric patients hospitalized with a primary diagnosis of SJS or TEN. Of these patients, 167 (18.6%) were prescribed steroids only, 229 (25.5%) IVIG only, and 153 (17.04%) both IVIG and steroids. Median LOS was 8 days (interquartile range, 5-13) with median hospital-adjusted costs of $16,265. Readmissions were common, with 88 (9.9%) patients readmitted within 30 days of discharge and a recurrence rate of 2.7%. Overall hospital mortality in children was low at 0.56%. TEN was associated with higher mortality (3.23%) compared with SJS (0.13%). There was no association between the use of IVIG, systemic steroids, or IVIG and steroids during the first 2 days of hospitalization and decreased LOS or mechanical ventilation. Complex chronic conditions and TEN diagnoses were associated with increased LOS and increased odds of mechanical ventilation. Conclusion: Survival in children with SJS and TEN is significantly better than that observed in adults. However, there is variability in the management and outcomes in children diagnosed with these severe cutaneous reactions. Further studies are needed to determine the most effective treatment strategies given the extent of health care utilization and high rate of readmissions observed in this population.
MeSH term(s)	Adolescent ; Anti-Bacterial Agents/therapeutic use ; Child ; Child, Preschool ; Cohort Studies ; Female ; Humans ; Immunoglobulins, Intravenous/therapeutic use ; Male ; Retrospective Studies ; Steroids/therapeutic use ; Stevens-Johnson Syndrome/epidemiology ; Stevens-Johnson Syndrome/mortality ; Stevens-Johnson Syndrome/therapy ; Survival Analysis ; Treatment Outcome ; United States/epidemiology
Chemical Substances	Anti-Bacterial Agents ; Immunoglobulins, Intravenous ; Steroids
Language	English
Publishing date	2018-05-30
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2843237-X
ISSN	2213-2201 ; 2213-2198
ISSN (online)	2213-2201
ISSN	2213-2198
DOI	10.1016/j.jaip.2018.05.024
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Article ; Online: Incidence, outcomes, and resource use in children with Stevens-Johnson syndrome and toxic epidermal necrolysis.

Antoon, James W / Goldman, Jennifer L / Lee, Brian / Schwartz, Alan

Pediatric dermatology

2018 Volume 35, Issue 2, Page(s) 182–187

Abstract: Background/objectives: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening cutaneous reactions, typically to drugs or infection. The incidence and outcomes of these conditions in children are unknown. The objective ... ...

Abstract	Background/objectives: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are life-threatening cutaneous reactions, typically to drugs or infection. The incidence and outcomes of these conditions in children are unknown. The objective of this study was to report the overall burden of Stevens-Johnson syndrome and toxic epidermal necrolysis in children in the United States. Methods: We performed a retrospective cohort analysis of children and adolescents younger than 18 years of age using the 2009 and 2012 Kids' Inpatient Database. Results: We identified 1486 children and adolescents hospitalized with a diagnosis of Stevens-Johnson syndrome or toxic epidermal necrolysis. The national incidence per 100 000 was 6.3 for Stevens-Johnson syndrome, 0.7 for Stevens-Johnson syndrome/toxic epidermal necrolysis overlap syndrome, and 0.5 for toxic epidermal necrolysis. The highest incidence in children was in those aged 11-15 years (38.4 per 100 000). Toxic epidermal necrolysis and Stevens-Johnson syndrome/toxic epidermal necrolysis overlap syndrome were associated with longer stay, greater mortality, and higher hospital charges than those with Stevens-Johnson syndrome. Hospital mortality was highest in children with toxic epidermal necrolysis and in children aged 0-5 years. Conclusions: The incidence of Stevens-Johnson syndrome and toxic epidermal necrolysis in children is higher than reported in adults, and there are significant age-based variations in incidence and outcomes across the pediatric population. Further study is needed to determine the most effective treatment strategies to reduce costs and improve outcomes in children hospitalized with severe cutaneous reactions.
MeSH term(s)	Adolescent ; Child ; Child, Preschool ; Cohort Studies ; Cost of Illness ; Databases, Factual ; Female ; Health Resources/statistics & numerical data ; Hospital Charges/statistics & numerical data ; Hospital Mortality ; Humans ; Incidence ; Length of Stay/statistics & numerical data ; Male ; Retrospective Studies ; Stevens-Johnson Syndrome/economics ; Stevens-Johnson Syndrome/epidemiology ; Stevens-Johnson Syndrome/mortality ; United States/epidemiology
Language	English
Publishing date	2018-01-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	605539-4
ISSN	1525-1470 ; 0736-8046
ISSN (online)	1525-1470
ISSN	0736-8046
DOI	10.1111/pde.13383
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