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Article ; Online: HIV, Social Networks, and Loneliness among Older Adults in Uganda.

Quach, Lien T / Ritchie, Christine S / Reynolds, Zahra / Paul, Robert / Seeley, Janet / Tong, Yao / Hoeppner, Susanne / Okello, Samson / Nakasujja, Noeline / Olivieri-Mui, Brianne / Saylor, Deanna / Greene, Meredith / Asiimwe, Stephen / Tindimwebwa, Edna / Atwiine, Flavia / Sentongo, Ruth / Siedner, Mark J / Tsai, Alexander C

AIDS and behavior

2024 Volume 28, Issue 2, Page(s) 695–704

Abstract: Loneliness among older adults has been identified as a major public health problem. Yet little is known about loneliness, or the potential role of social networks in explaining loneliness, among older people with HIV (PWH) in sub-Saharan Africa, where 70% ...

Abstract	Loneliness among older adults has been identified as a major public health problem. Yet little is known about loneliness, or the potential role of social networks in explaining loneliness, among older people with HIV (PWH) in sub-Saharan Africa, where 70% of PWH reside. To explore this issue, we analyzed data from 599 participants enrolled in the Quality of Life and Ageing with HIV in Rural Uganda study, including older adults with HIV in ambulatory care and a comparator group of people without HIV of similar age and gender. The 3-item UCLA Loneliness Scale was used to measure loneliness, and HIV status was the primary explanatory variable. The study found no statistically significant correlation between loneliness and HIV status. However, individuals with HIV had smaller households, less physical and financial support, and were less socially integrated compared to those without HIV. In multivariable logistic regressions, loneliness was more likely among individuals who lived alone (aOR:3.38, 95% CI:1.47-7.76) and less likely among those who were married (aOR:0.34, 95% CI:0.22-0.53) and had a higher level of social integration (aOR:0.86, 95% CI: 0.79-0.92). Despite having smaller social networks and less support, older adults with HIV had similar levels of loneliness as those without HIV, which may be attributed to resiliency and access to HIV-related health services among individuals with HIV. Nonetheless, further research is necessary to better understand the mechanisms involved.
MeSH term(s)	Humans ; Aged ; Loneliness ; Quality of Life ; Uganda/epidemiology ; HIV Infections/epidemiology ; Social Networking
Language	English
Publishing date	2024-01-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	1339885-4
ISSN	1573-3254 ; 1090-7165
ISSN (online)	1573-3254
ISSN	1090-7165
DOI	10.1007/s10461-023-04258-y
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Article ; Online: Performance of Febrile Infant Decision Tools on Hypothermic Infants Evaluated for Infection.

Westphal, Kathryn / Adib, Hania / Doraiswamy, Vignesh / Basiago, Kevin / Lee, Jennifer / Banker, Sumeet L / Morrison, John / McCartor, Saylor / Berger, Stephanie / Schmit, Erinn O / Van Meurs, Annalise / Mitchell, Meredith / Lee, Clifton / Wood, Julie K / Tapp, Lauren G / Kunkel, Deborah / Halvorson, Elizabeth E / Potisek, Nicholas M

Hospital pediatrics

2024 Volume 14, Issue 3, Page(s) 163–171

Abstract: Background: Given the lack of evidence-based guidelines for hypothermic infants, providers may be inclined to use febrile infant decision-making tools to guide management decisions. Our objective was to assess the diagnostic performance of febrile ... ...

Abstract	Background: Given the lack of evidence-based guidelines for hypothermic infants, providers may be inclined to use febrile infant decision-making tools to guide management decisions. Our objective was to assess the diagnostic performance of febrile infant decision tools for identifying hypothermic infants at low risk of bacterial infection. Methods: We conducted a secondary analysis of a retrospective cohort study of hypothermic (≤36.0 C) infants ≤90 days of age presenting to the emergency department or inpatient unit among 9 participating sites between September 1, 2016 and May 5, 2021. Well-appearing infants evaluated for bacterial infections via laboratory testing were included. Infants with complex chronic conditions or premature birth were excluded. Performance characteristics for detecting serious bacterial infection (SBI; urinary tract infection, bacteremia, bacterial meningitis) and invasive bacterial infection (IBI; bacteremia, bacterial meningitis) were calculated for each tool. Results: Overall, 314 infants met the general inclusion criteria, including 14 cases of SBI (4.5%) and 7 cases of IBI (2.2%). The median age was 5 days, and 68.1% of the infants (214/314) underwent a full sepsis evaluation. The Philadelphia, Boston, IBI Score, and American Academy of Pediatrics Clinical Practice Guideline did not misclassify any SBI or IBI as low risk; however, they had low specificity and positive predictive value. Rochester and Pediatric Emergency Care Applied Research Network tools misclassified infants with bacterial infections. Conclusions: Several febrile infant decision tools were highly sensitive, minimizing missed SBIs and IBIs in hypothermic infants. However, the low specificity of these decision tools may lead to unnecessary testing, antimicrobial exposure, and hospitalization.
MeSH term(s)	Infant ; Female ; Pregnancy ; Humans ; Child ; Child, Preschool ; Retrospective Studies ; Bacteremia/diagnosis ; Sepsis ; Boston ; Fever/diagnosis ; Fever/therapy ; Meningitis, Bacterial/diagnosis ; Meningitis, Bacterial/therapy
Language	English
Publishing date	2024-02-01
Publishing country	United States
Document type	Journal Article
ISSN	2154-1671
ISSN (online)	2154-1671
DOI	10.1542/hpeds.2023-007525
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Article ; Online: Priorities for health and wellbeing for older people with and without HIV in Uganda: a qualitative methods study.

Reynolds, Zahra / Gilbert, Rebecca / Sentongo, Ruth / Meyer, Ana-Claire / Saylor, Deanna / Okello, Samson / Nakasujja, Noeline / Greene, Meredith / Seeley, Janet / Tsai, Alexander C / Asiimwe, Stephen / Quach, Lien / Olivieri-Mui, Brianne / Siedner, Mark J

Journal of the International AIDS Society

2022 Volume 25 Suppl 4, Page(s) e26000

Abstract: Introduction: With improved HIV treatment availability in sub-Saharan Africa, the population of older people with HIV (PWH) is growing. In this qualitative study, we intended to understand (1) the lived experiences of ageing people in rural Uganda, with ...

Abstract	Introduction: With improved HIV treatment availability in sub-Saharan Africa, the population of older people with HIV (PWH) is growing. In this qualitative study, we intended to understand (1) the lived experiences of ageing people in rural Uganda, with and without HIV, (2) their fears and health priorities as they grow older. Methods: We conducted 36 semi-structured interviews with individuals with and without HIV in Mbarara, Uganda from October 2019 to February 2020. Interview guide topics included priorities in older age, physical functioning in daily activities, social functioning, HIV-related stigma and the impact of multimorbidity on health and independence. Interviews were conducted in Runyankole, transcribed, translated and inductively coded thematically by two researchers with tests for inter-coder reliability. Results: The respondents were purposively sampled to be evenly divided by sex and HIV serostatus. The median age of respondents was 57 (49-73). Two-thirds were married or cohabitating, 94% had biological children and 75% cited farming as their primary livelihood. Overall, PWH considered themselves as healthy or healthier than people without HIV (PWOH). PWH rarely considered their HIV status a barrier to a healthy life, but some reported a constant sense of anxiety as it relates to their long-term health. Irrespective of HIV status, nearly all respondents noted concerns about memory loss, physical pain, reductions in energy and the effect of these changes on their ability to complete physical tasks like small-scale farming, and activities of daily living important to the quality of life, such as participating in community groups. Increasing reliance on others for social, physical and financial support was also a common theme. The most prevalent health concern among participants involved the threat of non-communicable diseases and perceptions that physical functioning may diminish. Conclusions: In rural Uganda, we found that PWH consider themselves to be healthy and do not anticipate a different ageing experience from PWOH. Common priorities shared by both groups included the desire for physical and financial independence, health maintenance and social support for daily functioning and social needs. Entities supporting geriatric care in Uganda would benefit from attention to concerns about functional limitations and reported needs as people age with and without HIV.
MeSH term(s)	Activities of Daily Living ; Aged ; Child ; HIV Infections/epidemiology ; Humans ; Qualitative Research ; Quality of Life ; Reproducibility of Results ; Uganda/epidemiology
Language	English
Publishing date	2022-09-29
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2467110-1
ISSN	1758-2652 ; 1758-2652
ISSN (online)	1758-2652
ISSN	1758-2652
DOI	10.1002/jia2.26000
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Article ; Online: The benefits of care: treated HIV infection and health-related quality of life among older-aged people in Uganda.

Quach, Lien T / Ritchie, Christine S / Tsai, Alexander C / Reynolds, Zahra / Paul, Robert / Seeley, Janet / Tong, Yao / Hoeppner, Susanne / Okello, Samson / Nakasujja, Noeline / Olivieri-Mui, Brianne / Saylor, Deanna / Greene, Meredith / Asiimwe, Stephen / Siedner, Mark J

Aging & mental health

2022 Volume 27, Issue 9, Page(s) 1853–1859

Abstract: Objectives: The objective of this study is to explore how HIV care affects health-related quality of life (HRQoL) among older people in Uganda.: Methods: We enrolled older-aged (≥49 years) people with HIV receiving HIV care and treatment, along with ... ...

Abstract	Objectives: The objective of this study is to explore how HIV care affects health-related quality of life (HRQoL) among older people in Uganda. Methods: We enrolled older-aged (≥49 years) people with HIV receiving HIV care and treatment, along with age- and sex-similar people without HIV. We measured health-related quality of life using the EQ-5D-3L scale. Results: People with HIV ( Conclusions: Older people with HIV receiving care and treatment reported higher health-related quality of life than people without HIV in Uganda. Access to primary care through HIV programs and/or social network mobilization may explain this difference, but further research is needed to elucidate the mechanisms.
Language	English
Publishing date	2022-12-12
Publishing country	England
Document type	Journal Article
ZDB-ID	1474804-6
ISSN	1364-6915 ; 1360-7863
ISSN (online)	1364-6915
ISSN	1360-7863
DOI	10.1080/13607863.2022.2150143
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Article ; Online: Associations of the COVID-19 pandemic with quality of life: A cross-sectional study of older-age people with and without HIV in rural Uganda.

Journal of global health

2023 Volume 13, Page(s) 6003

Abstract: Background: COVID-19-related lockdowns and other public health measures may have differentially affected the quality of life (QOL) of older people with and without human immunodeficiency virus (HIV) in rural Uganda.: Methods: The Quality of Life and ... ...

Abstract	Background: COVID-19-related lockdowns and other public health measures may have differentially affected the quality of life (QOL) of older people with and without human immunodeficiency virus (HIV) in rural Uganda. Methods: The Quality of Life and Aging with HIV in Rural Uganda study enrolled people with and without HIV aged over 49 from October 2020 to October 2021. We collected data on COVID-19-related stressors (behavior changes, concerns, interruptions in health care, income, and food) and the participants' QOL. We used linear regression to estimate the associations between COVID-19-related stressors and QOL, adjusting for demographic characteristics, mental and physical health, and time before vs after the lockdown during the second COVID-19 wave in Uganda. Interaction between HIV and COVID-19-related stressors evaluated effect modification. Results: We analyzed complete data from 562 participants. Mean age was 58 (standard deviation (SD) = 7); 265 (47%) participants were female, 386 (69%) were married, 279 (50%) had HIV, and 400 (71%) were farmers. Those making ≥5 COVID-19-related behavior changes compared to those making ≤2 had worse general QOL (estimated linear regression coefficient (b) = - 4.77; 95% confidence interval (CI) = -6.61, -2.94) and health-related QOL (b = -4.60; 95% CI = -8.69, -0.51). Having access to sufficient food after the start of the COVID-19 pandemic (b = 3.10, 95% CI = 1.54, 4.66) and being interviewed after the start of the second lockdown (b = 2.79, 95% CI = 1.30, 4.28) were associated with better general QOL. Having HIV was associated with better health-related QOL (b = 5.67, 95% CI = 2.91,8.42). HIV was not associated with, nor did it modify the association of COVID-19-related stressors with general QOL. Conclusions: In the context of the COVID-19 pandemic in an HIV-endemic, low-resource setting, there was reduced QOL among older Ugandans making multiple COVID-19 related behavioral changes. Nonetheless, good QOL during the second COVID-19 wave may suggest resilience among older Ugandans.
MeSH term(s)	Humans ; Female ; Aged ; Middle Aged ; Male ; Quality of Life ; HIV ; Cross-Sectional Studies ; Uganda/epidemiology ; Pandemics ; HIV Infections/epidemiology ; COVID-19/complications ; Communicable Disease Control
Language	English
Publishing date	2023-01-20
Publishing country	Scotland
Document type	Journal Article
ZDB-ID	2741629-X
ISSN	2047-2986 ; 2047-2986
ISSN (online)	2047-2986
ISSN	2047-2986
DOI	10.7189/jogh.13.06003
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Article ; Online: Declining bone marrow harvest quality over 24 years: a single institution experience.

Spitzer, Thomas R / Kim, Se Eun / Cohen, Rachel / Mathews, Richard / Li, Shuli / McAfee, Steven L / Dey, Bimalangshu R / El-Jawahri, Areej / DeFilipp, Zachariah / Frigault, Matthew / O'Donnell, Paul / Hunnewell, Chrisa / Saylor, Meredith / Vanderklish, Julie / Danielson, Colleen / Poliquin, Cathleen / Chen, Yi-Bin

Bone marrow transplantation

2020 Volume 56, Issue 4, Page(s) 983–985

MeSH term(s)	Bone Marrow ; Bone Marrow Transplantation ; Humans ; Tissue and Organ Harvesting
Language	English
Publishing date	2020-11-21
Publishing country	England
Document type	Letter
ZDB-ID	632854-4
ISSN	1476-5365 ; 0268-3369 ; 0951-3078
ISSN (online)	1476-5365
ISSN	0268-3369 ; 0951-3078
DOI	10.1038/s41409-020-01143-3
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Zs.A 2168: Show issues

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Article ; Online: The current state of ptosis repair: a comparison of internal and external approaches.

Allen, Richard C / Saylor, Meredith A / Nerad, Jeffrey A

Current opinion in ophthalmology

2011 Volume 22, Issue 5, Page(s) 394–399

Abstract: Purpose of review: Posterior approach ptosis repair has made a resurgence over the last decade. The purpose of this review is to examine the history of posterior approach ptosis repair and the events that have led to its current favorable status.: ... ...

Abstract	Purpose of review: Posterior approach ptosis repair has made a resurgence over the last decade. The purpose of this review is to examine the history of posterior approach ptosis repair and the events that have led to its current favorable status. Recent findings: The evolution of the posterior and anterior approach ptosis surgeries has resulted in two favored techniques for involutional ptosis repair: the Müller muscle-conjunctiva resection (MMCR) and the external levator advancement. Each procedure has strong and prominent proponents in the oculoplastic surgery community. Recently, the MMCR has converted surgeons who have previously favored the external levator advancement. A number of factors have influenced this recent elevation of the MMCR including differing opinions on the cause of involutional ptosis, the mechanism by which the MMCR works, the predictability and speed of the MMCR, and the current reimbursements for ptosis repair by insurance companies. Summary: The recent preference for posterior approach ptosis surgery, in particular the MMCR, is multifactorial. In order to understand the evolution of opinions about the procedure, a historical knowledge of involutional ptosis and ptosis repair is necessary.
MeSH term(s)	Blepharoplasty/methods ; Blepharoplasty/trends ; Blepharoptosis/surgery ; Conjunctiva/surgery ; Esthetics ; Eyelids/surgery ; Female ; Humans ; Male ; Oculomotor Muscles/surgery ; Treatment Outcome
Language	English
Publishing date	2011-09
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1049383-9
ISSN	1531-7021 ; 1040-8738
ISSN (online)	1531-7021
ISSN	1040-8738
DOI	10.1097/ICU.0b013e32834994a0
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Article ; Online: Safety and efficacy of tisagenlecleucel in primary CNS lymphoma: a phase 1/2 clinical trial.

Frigault, Matthew J / Dietrich, Jorg / Gallagher, Kathleen / Roschewski, Mark / Jordan, Justin T / Forst, Deborah / Plotkin, Scott R / Cook, Daniella / Casey, Keagan S / Lindell, Kevin A / Depinho, Gabriel D / Katsis, Katelin / Elder, Eva Lynn / Leick, Mark B / Choi, Bryan / Horick, Nora / Preffer, Frederic / Saylor, Meredith / McAfee, Steven /

O'Donnell, Paul V / Spitzer, Thomas R / Dey, Bimalangshu / DeFilipp, Zachariah / El-Jawahri, Areej / Batchelor, Tracy T / Maus, Marcela V / Chen, Yi-Bin

Blood

2022 Volume 139, Issue 15, Page(s) 2306–2315

Abstract: CD19-directed chimerical antigen receptor T-cell (CAR-T) products have gained US Food and Drug Administration approval for systemic large B-cell lymphoma. Because of concerns about potential immune cell-associated neurotoxicity syndrome (ICANS), patients ...

Abstract	CD19-directed chimerical antigen receptor T-cell (CAR-T) products have gained US Food and Drug Administration approval for systemic large B-cell lymphoma. Because of concerns about potential immune cell-associated neurotoxicity syndrome (ICANS), patients with primary central nervous system (CNS) lymphoma (PCNSL) were excluded from all pivotal CAR-T studies. We conducted a phase 1/2 clinical trial of tisagenlecleucel in a highly refractory patients with PCNSL and significant unmet medical need. Here, we present results of 12 relapsed patients with PCNSL who were treated with tisagenlecleucel and followed for a median time of 12.2 months (range, 3.64-23.5). Grade 1 cytokine release syndrome was observed in 7/12 patients (58.3%), low-grade ICANS in 5/12 (41.6%) patients, and only 1 patient experienced grade 3 ICANS. Seven of 12 patients (58.3%) demonstrated response, including a complete response in 6/12 patients (50%). There were no treatment-related deaths. Three patients had ongoing complete remission at data cutoff. Tisagenlecleucel expanded in the peripheral blood and trafficked to the CNS. Exploratory analysis identified T-cell, CAR T, and macrophage gene signatures in cerebrospinal fluid following infusion when compared with baseline. Overall, tisagenlecleucel was well tolerated and resulted in a sustained remission in 3/7 (42.9%) of initial responders. These data suggest that tisagenlecleucel is safe and effective in this highly refractory patient population. This trial was registered at www.clinicaltrials.gov as #NCT02445248.
MeSH term(s)	Antigens, CD19/therapeutic use ; Central Nervous System Neoplasms/therapy ; Humans ; Immunotherapy, Adoptive/adverse effects ; Lymphoma/therapy ; Receptors, Antigen, T-Cell/therapeutic use ; Receptors, Chimeric Antigen/therapeutic use
Chemical Substances	Antigens, CD19 ; Receptors, Antigen, T-Cell ; Receptors, Chimeric Antigen ; tisagenlecleucel (Q6C9WHR03O)
Language	English
Publishing date	2022-01-31
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood.2021014738
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Article ; Online: Coping and Modifiable Psychosocial Factors are Associated with Mood and Quality of Life in Patients with Chronic Graft-versus-Host Disease.

Jacobs, Jamie M / Fishman, Sarah / Sommer, Robert / Sereno, Isabella / Fenech, Alyssa / Jankowski, Amanda L / Traeger, Lara / Greer, Joseph A / Vanderklish, Julie / Hunnewell, Chrisa / Saylor, Meredith / Chen, Yi-Bin / Spitzer, Thomas / DeFilipp, Zachariah / Temel, Jennifer S / El-Jawahri, Areej

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2019 Volume 25, Issue 11, Page(s) 2234–2242

Abstract: Chronic graft-versus-host disease (GVHD) is one of most common complications following allogeneic hematopoietic cell transplantation (HCT) and the most significant contributor to morbidity and nonrelapse mortality. The physical burdens and psychosocial ... ...

Abstract	Chronic graft-versus-host disease (GVHD) is one of most common complications following allogeneic hematopoietic cell transplantation (HCT) and the most significant contributor to morbidity and nonrelapse mortality. The physical burdens and psychosocial difficulties of these patients have not been described systematically. An exploration into the rates and correlates of mood and quality of life (QOL) in patients with chronic GVHD is necessary to develop a clinically relevant, evidence-based intervention to promote well-being. From July 2015 to July 2017, adult allogeneic HCT survivors with established moderate to severe chronic GVHD (N = 52) enrolled in a prospective, longitudinal study at a tertiary academic center. We examined the rates and correlates of depression and anxiety symptoms (Hospital Anxiety and Depression Scale) and explored whether constructs including coping strategies (Coping Inventory for Stressful Situations), symptom burden (Lee Symptom Assessment Scale), physical functioning (Human Activity Profile), and perceived social support (Medical Outcomes Study Social Support Survey) predicted QOL trajectory over time (Functional Assessment of Cancer Therapy-Bone Marrow Transplant) at the baseline, 3-month, and 6-month follow-up. Analyses adjusted for age, sex, chronic GVHD severity, and time since chronic GVHD diagnosis. At the baseline, 3-month, and 6-month follow-up, 32.7%, 31.1%, and 37.8% of patients reported clinically significant depression symptoms, and 30.8%, 20.0%, and 36.4% reported clinically elevated anxiety symptoms, respectively. Adjusting for covariates, greater use of negative emotion-oriented coping (β = 0.20, P = .002), less use of task-oriented coping (β = -0.10, P = .021), worse physical functioning (β = -0.07, P = .004), and higher symptom burden (β = 0.07, P = .002) were independently associated with depression symptoms at baseline. Greater use of negative emotion-oriented coping (β = 0.28, P < .001) and worse physical functioning (β = -0.05, P = .034) were independently associated with anxiety at baseline. Patients who used more negative emotion-oriented coping (β = -0.58, P = .035), had less task-oriented (β = 0.40, P = .028) and social diversion-oriented coping (β = 0.35, P = .039), and had higher symptom burden (β = -0.30, P = .001), worse physical functioning (β = 0.32, P < .001), and lower perceived social support (β = 6.47, P = .003) at baseline reported poorer QOL over time. The unmet physical and psychosocial needs of patients with chronic GVHD are substantial and warrant investigation into evidence-based interventions that may improve QOL and mood by targeting modifiable psychosocial constructs identified in this study.
MeSH term(s)	Adult ; Affect ; Aged ; Anxiety/psychology ; Anxiety/therapy ; Depression/psychology ; Depression/therapy ; Female ; Follow-Up Studies ; Graft vs Host Disease/psychology ; Hematopoietic Stem Cell Transplantation/psychology ; Humans ; Male ; Middle Aged ; Quality of Life ; Retrospective Studies ; Risk Factors ; Stress, Psychological/psychology ; Stress, Psychological/therapy
Language	English
Publishing date	2019-06-28
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2019.06.024
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Article ; Online: Phase I Trial of Brentuximab Vedotin for Steroid-Refractory Chronic Graft-versus-Host Disease after Allogeneic Hematopoietic Cell Transplantation.

DeFilipp, Zachariah / Li, Shuli / Kempner, Maria E / Brown, Jami / Del Rio, Candice / Valles, Betsy / Hunnewell, Chrisa / Saylor, Meredith / Vanderklish, Julie / Dey, Bimalangshu R / El-Jawahri, Areej / McAfee, Steven L / Spitzer, Thomas R / Chen, Yi-Bin

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2018 Volume 24, Issue 9, Page(s) 1836–1840

Abstract: We conducted a phase I study of brentuximab vedotin (BV), an antibody-drug conjugate targeting CD30, for the treatment of steroid-refractory chronic graft-versus-host disease (cGVHD). A modified 3 + 3 study design was used with the primary endpoint to ... ...

Abstract	We conducted a phase I study of brentuximab vedotin (BV), an antibody-drug conjugate targeting CD30, for the treatment of steroid-refractory chronic graft-versus-host disease (cGVHD). A modified 3 + 3 study design was used with the primary endpoint to determine the maximum tolerated dose of BV in this population. Escalating doses of BV were planned, starting with .6 mg/kg every 3 weeks (dose level 0) and increasing by .3 mg/kg per dose level. BV was administered in 21-day cycles for up to 16 cycles of therapy. Nineteen patients were enrolled on the study, with 2 withdrawing consent before dosing. The median number of cycles of therapy was 4 (range, 1 to 16). Reasons for stopping therapy prematurely included toxicities (n = 9), patient decision (n = 3), lack of response (n = 2), and death (n = 1). There were 2 dose-limiting toxicities observed: posterior reversible encephalopathy syndrome (cohort 4, grade 3) and sepsis (cohort 4, grade 4). The maximum tolerated dose was not reached because the trial was prematurely closed due to toxicity. Seven patients (41%) developed grade 3 or 4 adverse events that were attributed to therapy, including 4 patients who developed moderate or severe peripheral neuropathy that led to cessation of treatment in each case. According to National Institutes of Health cGVHD response criteria, 8 patients (47%) experienced a partial response, whereas 9 patients (53%) had a lack of response. There were no complete responses observed. Eleven patients (65%) were able to decrease their systemic corticosteroid dose by ≥50% by 6 months after initiation of BV, including 3 patients who were able to stop corticosteroids completely. The median soluble CD30 level before therapy was 61.5 ng/mL (range, 7.8 to 474.9); however, we did not observe any association between soluble CD30 level and cGVHD severity at enrollment or clinical responses to BV. In conclusion, BV may have activity in treatment of steroid-refractory cGVHD, yet its use is limited by treatment-emergent toxicities, including peripheral neuropathy. Continued efforts to investigate targeted approaches to cGVHD that do not cause broad immunosuppression are needed.
MeSH term(s)	Adult ; Aged ; Female ; Graft vs Host Disease/drug therapy ; Graft vs Host Disease/pathology ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Immunoconjugates/pharmacology ; Immunoconjugates/therapeutic use ; Male ; Middle Aged ; Transplantation Conditioning/methods ; Transplantation, Homologous/methods ; Young Adult
Chemical Substances	Immunoconjugates ; brentuximab vedotin (7XL5ISS668)
Language	English
Publishing date	2018-05-24
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2018.05.012
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Zs.A 5082: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 462: Show issues

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