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1.
Blood ; 129(16): 2224-2232, 2017 04 20.
Article in English | MEDLINE | ID: mdl-28167659

ABSTRACT

Marginal zone lymphoma (MZL) is a heterogeneous B-cell malignancy for which no standard treatment exists. MZL is frequently linked to chronic infection, which may induce B-cell receptor (BCR) signaling, resulting in aberrant B-cell survival and proliferation. We conducted a multicenter, open-label, phase 2 study to evaluate the efficacy and safety of ibrutinib in previously treated MZL. Patients with histologically confirmed MZL of all subtypes who received ≥1 prior therapy with an anti-CD20 antibody-containing regimen were treated with 560 mg ibrutinib orally once daily until progression or unacceptable toxicity. The primary end point was independent review committee-assessed overall response rate (ORR) by 2007 International Working Group criteria. Among 63 enrolled patients, median age was 66 years (range, 30-92). Median number of prior systemic therapies was 2 (range, 1-9), and 63% received ≥1 prior chemoimmunotherapy. In 60 evaluable patients, ORR was 48% (95% confidence interval [CI], 35-62). With median follow-up of 19.4 months, median duration of response was not reached (95% CI, 16.7 to not estimable), and median progression-free survival was 14.2 months (95% CI, 8.3 to not estimable). Grade ≥3 adverse events (AEs; >5%) included anemia, pneumonia, and fatigue. Serious AEs of any grade occurred in 44%, with grade 3-4 pneumonia being the most common (8%). Rates of discontinuation and dose reductions due to AEs were 17% and 10%, respectively. Single-agent ibrutinib induced durable responses with a favorable benefit-risk profile in patients with previously treated MZL, confirming the role of BCR signaling in this malignancy. As the only approved therapy, ibrutinib provides a treatment option without chemotherapy for MZL. This study is registered at www.clinicaltrials.gov as #NCT01980628.


Subject(s)
Antineoplastic Agents/administration & dosage , B-Lymphocytes/drug effects , Lymphoma, B-Cell, Marginal Zone/therapy , Protein Kinase Inhibitors/administration & dosage , Protein-Tyrosine Kinases/antagonists & inhibitors , Pyrazoles/administration & dosage , Pyrimidines/administration & dosage , Adenine/analogs & derivatives , Adult , Agammaglobulinaemia Tyrosine Kinase , Aged , Aged, 80 and over , Anemia/chemically induced , Anemia/pathology , Antineoplastic Agents/adverse effects , B-Lymphocytes/enzymology , B-Lymphocytes/immunology , B-Lymphocytes/pathology , Disease-Free Survival , Drug Administration Schedule , Fatigue/chemically induced , Fatigue/pathology , Female , Humans , Immunotherapy/methods , Lymphoma, B-Cell, Marginal Zone/immunology , Lymphoma, B-Cell, Marginal Zone/mortality , Lymphoma, B-Cell, Marginal Zone/pathology , Male , Middle Aged , Piperidines , Pneumonia/chemically induced , Pneumonia/pathology , Protein Kinase Inhibitors/adverse effects , Protein-Tyrosine Kinases/metabolism , Pyrazoles/adverse effects , Pyrimidines/adverse effects , Recurrence
2.
World Neurosurg ; 2024 Aug 17.
Article in English | MEDLINE | ID: mdl-39159672

ABSTRACT

BACKGROUND: Spinal cord injury (SCI) affects around 18,000 individuals annually, representing nearly one-third of all paralysis cases. Stem cell therapy, a focal point in contemporary neuroregeneration research for SCI treatment, holds potential in leveraging undifferentiated stem cells to regenerate damaged tissues. This study seeks to comprehensively analyze current clinical trials exploring the potential use of stem cells in treating spinal cord injuries. METHODS: A data retrieval approach examined the ClinicalTrials.gov database using the terms "spinal cord injury" and "stem cells." Exclusion criteria eliminated studies not recruiting, terminated prematurely, suspended, withdrawn, or of unknown status. Data for each trial, including ClinicalTrial.gov NCT identifier, title, intervention details, initiation/completion dates, and sample size, were systematically collected. Literature searches on PubMed.gov were conducted for completed trials with results. RESULTS: Thirty clinical trials were analyzed, with 20 completed and six with published results on PubMed.gov. Interventions included 20 biological (66.7%), 6 procedural (20%), and 4 drug interventions (13.3%). Stem cell sources varied, including bone marrow (46.7%), umbilical cells (20%), adipose tissue (20%), embryonic cells (6.7%), and neural cells (6.7%). Trials spanned 2005 to 2022, with 11 (36.7%) commencing in or after 2017. Among six trials with results, 50% used bone marrow-derived stem cells. CONCLUSIONS: The promising potential of stem cells in neuroregenerative SCI treatment necessitates further exploration through large-scale, multicenter clinical trials to enhance understanding and guide wider adoption of this emerging treatment paradigm.

3.
J Clin Neurosci ; 129: 110841, 2024 Sep 13.
Article in English | MEDLINE | ID: mdl-39276495

ABSTRACT

INTRODUCTION: Professional society awards can substantially impact career trajectory of awardees in neurosurgery. Past studies have discussed the demographics of neurosurgery conference awardees in terms of gender and professional experience; however, a full assessment of awardee qualities and characteristics has yet to be studied. OBJECTIVE: The goal of this study is to provide a comprehensive evaluation of neurosurgical society winners that focuses on gender, race, academic degrees, and institutional/geographic affiliation. METHODS: Data of awardees across 14 neurosurgical societies from 2019 to 2022 was recorded. Variables recorded include professional society, award classification, year won, age, gender, race and ethnicity, board certification status, MD graduation year, degrees obtained, awardee home institution location, h-index, and NIH-funding. Statistical analysis was performed using IBM SPSS. RESULTS: A total of 102 unique awards from 14 different societies between 2019 and 2022 were identified. Significantly more men (83 %) as compared to women (17 %) were awardees (p < 0.001). Awardees were significantly more likely to be Caucasian as compared to any other race (p < 0.001), and Caucasian awardees were more likely to be board certified and receive NIH funding. A higher proportion of male awardees had a PhD; however, the majority of all awardees were significantly more likely to not have a PhD or be board certified (p < 0.001). The majority of awardees were based in the Northeastern United States. CONCLUSIONS: Among winners of neurosurgical society awards, significant differences exist with respect to gender, race, ethnicity, degree type, and geographic location. Future research endeavors are needed to explore the reason for why these differences exist to ultimately develop strategies that promote equal opportunities for all neurosurgeons.

4.
Suicide Life Threat Behav ; 32(2): 139-45, 2002.
Article in English | MEDLINE | ID: mdl-12079030

ABSTRACT

The role of neighborhood factors in predicting hopelessness among adolescent suicide attempters was examined in this study. Forty-eight adolescents who attempted suicide were administered measures of hopelessness and depression. Family socioeconomic status (SES) was calculated based on family demographics and characteristics of neighborhood context were examined using a geocoding software package. Adolescents who lived in neighborhoods with weak social networks reported higher levels of hopelessness, even after controlling for SES and depression. These preliminary findings suggest that environmental context may play a role in the emotional status of adolescents who attempt suicide.


Subject(s)
Depression/psychology , Motivation , Residence Characteristics , Social Environment , Suicide, Attempted/psychology , Adolescent , Female , Humans , Male , Personality Assessment , Risk Factors , Social Support , Socioeconomic Factors
5.
Behav Modif ; 28(4): 548-64, 2004 Jul.
Article in English | MEDLINE | ID: mdl-15186515

ABSTRACT

This article assesses the relation between health risk behaviors and varying levels of exposure to violence in an effort to inform assessment and intervention efforts of a school-based mental health program serving inner-city youth. Health risk behaviors such as involvement in violence, risky sexual behavior, and substance use are clearly associated, both with each other and with violence exposure. However, differential relationships were observed depending on the nature of violence exposure. Knowledge of violence was associated with substance use and sexual behavior variables. Witnessing violence was associated with violence involvement, substance use, and exercise variables. Finally, violent victimization was associated with violence involvement and sexual behavior variables. A more complete understanding of the associations among health risk factors and violence exposure variables has the potential to improve implementation of school mental health services for urban youth.


Subject(s)
Adolescent Behavior/psychology , Mental Health Services/organization & administration , Risk-Taking , School Health Services/organization & administration , Violence/psychology , Adolescent , Adult , Age Factors , Female , Health Knowledge, Attitudes, Practice , Humans , Male , Maryland/epidemiology , Regression Analysis , Sex Factors , Substance-Related Disorders , Surveys and Questionnaires , Urban Population , Violence/statistics & numerical data
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