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2.
Nicotine Tob Res ; 26(Supplement_2): S112-S120, 2024 May 31.
Article En | MEDLINE | ID: mdl-38817030

INTRODUCTION: The purpose of this research was to identify how young adult sexual gender minority (SGM) women who use cigarillos may respond to cigar flavor restrictions. AIMS AND METHODS: Young adults aged 21-28 years in the United States who currently use cigarillos were recruited between October 2020 and April 2021 to participate in an online survey. Due to high prevalence of cigarillo use among individuals who identify as sexual and/or gender minority (SGM) women, their (n = 192) flavored tobacco-use behaviors and anticipated responses to cigarillo flavor restrictions were compared to cisgender heterosexual (CisHet) women (n = 110). Logistic regression was used to model cigarillo cessation and product-switching behaviors (flavored and unflavored). RESULTS: SGM women were significantly less likely to report the use of flavor at the initiation of cigarillo use (61.7% vs. 86.1%) but were no different in current flavor use compared to CisHet women, with more than 80% of all women using any flavor. SGM women were 2.36 times as likely to say they would discontinue using cigarillos if flavors were unavailable. Among those who would continue using cigarillos, SGM women were 4.53 times as likely to endorse switching to an unflavored tobacco product but had the same likelihood of saying they would switch to flavored product compared to CisHet women. CONCLUSIONS: Flavor restriction policies may not reduce the initiation of cigarillos among SGM women and may elicit differential cigarillo use and tobacco product substitution by SGM identity. Flavor restriction policies should be coupled with targeted cessation resources to address potential remaining disparities. IMPLICATIONS: SGM US women have a unique cigarillo-use trajectory. These women are more likely to initiate cigarillos without flavor and then later integrate it into their behavior. National cigar flavor restrictions are expected to have a greater impact decreasing cigarillo initiation among CisHet women and decreasing current cigarillo use among SGM women. However, for those who would continue using unflavored cigarillos, SGM women may remain at risk for nicotine dependence due to increased product substitution. SGM women should be prioritized for cessation resources to reduce tobacco-use disparities leading up to and following the implementation of cigar flavor restrictions.


Flavoring Agents , Sexual and Gender Minorities , Tobacco Products , Humans , Female , Adult , Young Adult , Sexual and Gender Minorities/statistics & numerical data , Sexual and Gender Minorities/psychology , Tobacco Products/statistics & numerical data , United States/epidemiology , Cigar Smoking/epidemiology , Surveys and Questionnaires
3.
J Appl Stat ; 51(6): 1191-1209, 2024.
Article En | MEDLINE | ID: mdl-38628449

Health warning labels have been found to increase awareness of the harmful effects of tobacco products. An eye tracking study was conducted to determine the optimal placement and type of a health warning label on tobacco waterpipes. Participants viewed images that contained one of (1) four waterpipes, (2) three different types of warning labels, (3) placed in three locations. Typically, statistical analysis of eye tracking data is conducted based on summary statistics such as total dwell time, duration score, and number of visits to an area of interest. However, these summary statistics fail to capture the complete variability in a participant's eye movement. Instead, we propose to estimate heat maps defined on the entire image domain using the raw two-dimensional coordinates of eye movement via kernel density estimation. For statistical analysis of heat maps, we adopt the Fisher-Rao Riemannian geometric framework, which enables computationally efficient comparisons of heat maps, statistical summarization and exploration of variability in a sample of heat maps, and metric-based hierarchical clustering. We apply this framework to eye tracking data from the tobacco waterpipe study and comment on the results in the context of the optimal placement and type of health warning labels on tobacco waterpipes.

4.
Transplant Cell Ther ; 2024 Apr 20.
Article En | MEDLINE | ID: mdl-38643958

The clinical value of serial routine bone marrow aspirates (rBMAs) in the first year after allogeneic hematopoietic cell transplantation (alloHCT) to detect or predict relapse of acute leukemia (AL) and myelodysplastic syndrome (MDS) in pediatric and young adult patients is unclear. The purpose of this analysis was to determine if assessment of minimal residual disease (MRD) by multiparameter flow cytometry (MFC, MFC-MRD) or donor chimerism (DC) in rBMAs or serial complete blood counts (CBCs) done in the year after alloHCT predicted relapse of AL or MDS in pediatric and young adult patients. We completed a retrospective analysis of patients with AL or MDS who had rBMAs performed after alloHCT between January 2012 and June 2018. Bone marrow (BM) was evaluated at approximately 3, 6, and 12 months for disease recurrence by morphology, MFC-MRD, and percent DC by short tandem repeat molecular testing. CBCs were performed at every clinic visit. The main outcome of interest was an assessment of whether MFC-MRD or DC in rBMAs or serial CBCs done in the year after alloHCT predicted relapse in AL or MDS pediatric and young adult patients. A total of 121 recipients with a median age of 13 years (range 1 to 32) were included: 108 with AL and, 13 with MDS. A total of 423 rBMAs (median 3; 0 to 13) were performed. Relapse at 2 years was 23% (95% CI: 16% to 31%) and at 5 years 25% (95% CI: 18% to 33%). One hundred fifty-four of 157 (98%) rBMAs evaluated for MRD by MFC were negative and did not preclude subsequent relapse. Additionally, low DC (<95%) did not predict relapse and high DC (≥95%) did not preclude relapse. For patients alive without relapse at 1 year, BM DC (P = .74) and peripheral T-cell DC (P = .93) did not predict relapse. Six patients with low-level T-cell and/or BM DC had a total of 8 to 20 BM evaluations, none of these patients relapsed. However, CBC results were informative for relapse; 28 of 31 (90%) relapse patients presented with an abnormal CBC with peripheral blood (PB) blasts (16 patients), cytopenias (9 patients), or extramedullary disease (EMD, 3 patients). Two patients with BM blasts >5% on rBMA had circulating blasts within 5 weeks of rBMA. Neutropenia (ANC <1.5 K/mcl) at 1 year was predictive of relapse (P = .01). Neutropenia and thrombocytopenia (<160 K/mcl) were predictive of disease-free survival (DFS) with inferior DFS for ANC <1.5 K/mcl, P = .001, or platelet count <160 K/mcl (P = .04). These results demonstrate rBMAs after alloHCT assessed for MRD by MFC and/or for level of DC are poor predictors for relapse in pediatric and young adult patients with AL or MDS. Relapse in these patients presents with PB blasts, cytopenias, or EMD. ANC and platelet count at 1-year were highly predictive for DFS.

6.
Article En | MEDLINE | ID: mdl-38666216

INTRODUCTION: E-cigarette use is most prevalent among adolescents and young adults - and there are often misperceptions about product risk. The purpose of this study was to determine what nicotine information is provided on e-cigarette brand websites. METHODS: Based on national and local surveys, we identified 44 e-cigarette brands commonly used in the US by adolescents and young adults. For each of these brands, their associated websites were analyzed for disclosed nicotine information. Specifically, for each brand's website, we coded whether there was information on nicotine concentration (recorded if a numerical value was provided such as '5% nicotine'), nicotine form (free-base, nicotine salts, or not stated), and nicotine type (tobacco-derived, synthetically derived, or not stated). Coding allowed for both lay (e.g. 'nic salts') as well as scientific (e.g. 'isomers') terms. RESULTS: Of the 44 brands examined, all provided basic information on nicotine concentration (e.g. '5% nicotine'). However, 23% of brands did not disclose information on nicotine form (i.e. nicotine salt vs free-base), and 66% of brands did not disclose information on nicotine type (i.e. synthetic vs tobacco-derived). CONCLUSIONS: Overall, these results suggest that the e-cigarette industry is not fully informing its consumers about the nicotine in their products. Given that nicotine form and type have implications for e-cigarette addiction potential, these findings highlight a public health concern. There is a need for more comprehensive national regulations for mandating product constituents and emissions disclosures.

7.
Cytotherapy ; 26(4): 351-359, 2024 04.
Article En | MEDLINE | ID: mdl-38349310

BACKGROUND AIMS: Traditional weight-based dosing of rabbit anti-thymocyte globulin (rATG) used in allogeneic hematopoietic cell transplantation (HCT) to prevent graft-versus-host disease (GVHD) and graft rejection leads to variable exposures. High exposures induce delayed CD4+immune reconstitution (CD4+IR) and greater mortality. We sought to determine the impact of rATG exposure in children and young adults receiving various types of EX-VIVO T-cell-depleted (EX-VIVO-TCD) HCT. METHODS: Patients receiving their first EX-VIVO-TCD HCT (CliniMACS CD34+, Isolex or soybean lectin agglutination), with removal of residual T cells by E-rosette depletion (E-) between 2008 and 2018 at Memorial Sloan Kettering Cancer Center were retrospectively analyzed. rATG exposure post-HCT was estimated (AU*d/L) using a validated population pharmacokinetic model. Previously defined rATG-exposures, <30, 30-55, ≥55 AU*d/L, were related with outcomes of interest. Cox proportional hazard and cause-specific models were used for analyses. RESULTS: In total, 180 patients (median age 11 years; range 0.1-44 years) were included, malignant 124 (69%) and nonmalignant 56 (31%). Median post-HCT rATG exposure was 32 (0-104) AU*d/L. Exposure <30 AU*d/L was associated with a 3-fold greater probability of CD4+IR (P < 0.001); 2- to 4-fold lower risk of death (P = 0.002); and 3- to 4-fold lower risk of non-relapse mortality (NRM) (P = 0.02). Cumulative incidence of NRM was 8-fold lower in patients who attained CD4+IR compared with those who did not (P < 0.0001). There was no relation between rATG exposure and aGVHD (P = 0.33) or relapse (P = 0.23). Effect of rATG exposure on outcomes was similar in three EX-VIVO-TCD methods. CONCLUSIONS: Individualizing rATG dosing to target a low rATG exposure post-HCT while maintaining total cumulative exposure may better predict CD4+IR, reduce NRM and increase overall survival, independent of the EX-VIVO-TCD method.


Graft vs Host Disease , Hematopoietic Stem Cell Transplantation , Humans , Child , Young Adult , Antilymphocyte Serum , Retrospective Studies , T-Lymphocytes , Hematopoietic Stem Cell Transplantation/adverse effects , Transplantation Conditioning
8.
Subst Use Addctn J ; 45(2): 232-239, 2024 Apr.
Article En | MEDLINE | ID: mdl-38258811

BACKGROUND: Among adolescents and young adults (AYAs), "current use" of electronic cigarettes (e-cigarettes) is commonly defined as any use in the past 30 days. However, few studies have examined differences among those within this broad category. This study examined characteristics of AYAs who used e-cigarettes at a low frequency (within the last 3 months but <6 days out of the past 30 days) and those who used e-cigarettes at a high frequency (6+ days out of the past 30 days). METHODS: We conducted cross-sectional analyses among 551 Ohio AYAs (15- to 24-year-olds) who reported using an e-cigarette to vape nicotine in the past 3 months. We used descriptive statistics and logistic regression to characterize those using e-cigarettes at a low frequency and a high frequency. RESULTS: Among our sample of AYAs who reported past 3-month e-cigarette use, about half (50.8%) reported using an e-cigarette 6 or more days out of the past 30 days (ie, high frequency). In the multivariable analysis, reported nicotine dependence (Odds Ratio [OR]: 7.0, 95% CI: 4.8, 10.3) and current other tobacco product use (OR: 1.8, 95% CI: 1.1, 2.9) were associated with high-frequency e-cigarette use. CONCLUSION: Our results suggest that frequency of use is an important characteristic in understanding AYA e-cigarette use. Any use in the past 30 days may not be sensitive enough to understand dependence and tobacco-use behaviors. Further characterizing "current" e-cigarette use by frequency of use may provide meaningful information for public health professionals to better target intervention and cessation efforts to AYAs.


Electronic Nicotine Delivery Systems , Tobacco Use Disorder , Vaping , Humans , Adolescent , Young Adult , Cross-Sectional Studies , Demography
9.
J Community Health ; 49(1): 108-116, 2024 Feb.
Article En | MEDLINE | ID: mdl-37531047

The 2014-2016 West Africa Ebola outbreak was the largest in history, resulting in approximately 11,000 deaths. Despite the outbreak's eventual end, national and international health sensitization and containment efforts were subject to criticism. This study investigates disease-related knowledge and beliefs, as well as trusted sources of health information among EVD-survivors and their family members, highlighting the importance of community-informed public health responses. Participants (n = 134) were adults who were either EVD-infected, affected families/caregivers, or community leaders. In-depth interviews and focus groups explored EVD-related experiences, including health effects, stigma, and community relationships. Using a grounded theory and thematic content analysis approach, transcripts were coded for evidence of health sensitization, as well as compliance with mitigation measures and trusted sources of information. Participants displayed a high level of knowledge around EVD and reported compliance with mandated and personal prevention measures. Levels of health sensitization and subsequent reintegration of survivors were reported to be largely the products of community-based efforts, rather than the top-down, national public health response. Primary sources of trusted information included EVD survivors acting as peer educators; local leaders; and EVD sensitization by community health workers. This study highlights the importance of a community-based response for increasing the effectiveness of public health campaigns. Participants expressed that relying on the experiences of trusted cultural insiders led to a deeper understanding of Ebola compared to top-down public health campaigns, and helped infected and affected community members reintegrate. Future public health efforts should incorporate community-based participatory approaches to address infectious disease outbreaks.


Hemorrhagic Fever, Ebola , Adult , Humans , Hemorrhagic Fever, Ebola/epidemiology , Sierra Leone/epidemiology , Disease Outbreaks/prevention & control , Family , Health Promotion
11.
Bone Marrow Transplant ; 59(1): 34-40, 2024 01.
Article En | MEDLINE | ID: mdl-37848556

Allogeneic hematopoietic cell transplantation (HCT) remains the only cure for the hematologic manifestations of Fanconi anemia (FA). We performed retrospective predictor analyses for HCT outcomes in FA for pediatric and young adult patients transplanted between 2007 and 2020 across three large referral institutions. Eighty-nine patients, 70 with bone marrow failure +/- cytogenetic abnormalities, 19 with MDS/AML, were included. Five-year overall survival (OS) was 83.2% and event-free survival (EFS) was 74%. Age ≥19, HLA mismatch and year of HCT were multivariable predictors (MVPs) for OS, EFS and treatment-related mortality (TRM). In the pediatric group, TCD was a borderline MVP (P = 0.059) with 5-year OS of 73.0% in TCD vs. 100% for T-replete HCT. The cumulative incidence of day 100 grade II-IV aGvHD and 5-year cGvHD were 5.6% and 4.6%, respectively. Relapse in the MDS/AML subgroup occurred in 4 patients (16%). Graft failure was seen in 9 patients (TCD 6/37 [16%]; T-replete 3/52 [5.7%]). Six patients developed malignancy after HCT. Survival chances after HCT for FA are excellent and associated with high engrafted survival and low toxicity. Age ≥19, HLA mismatch, year of transplant and 'TCD in the <19 years group' (although borderline) were found to be negative predictors for survival.


Fanconi Anemia , Graft vs Host Disease , Hematopoietic Stem Cell Transplantation , Child , Humans , Young Adult , Fanconi Anemia/therapy , Graft vs Host Disease/etiology , Hematopoietic Stem Cell Transplantation/adverse effects , Leukemia, Myeloid, Acute , Retrospective Studies
12.
Bone Marrow Transplant ; 59(1): 23-33, 2024 01.
Article En | MEDLINE | ID: mdl-37773270

The only curative approach for myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) arising in patients with Fanconi anemia (FA) is allogeneic hematopoietic stem cell transplantation (HCT); however, HCT approaches are inconsistent and limited data on outcomes exist. We retrospectively evaluated outcomes of thirty patients with FA and MDS/AML who underwent first allogeneic HCT with a T-cell depleted (TCD) graft at our institution. Patients were transplanted on successive protocols with stepwise changes in cytoreduction and GVHD prophylaxis. All but two patients (93%) experienced durable hematopoietic engraftment. With median follow-up of 8.7 years, 5-year OS was 66.8% and DFS 53.8%. No significant differences in survival were found in patients with high-risk prognostic features (age ≥20 years, AML diagnosis, alternative donor graft) or when stratified by conditioning regimen. The 5-year cumulative incidences of relapse and NRM were 24.3% and 21.9%, respectively. NRM was higher in patients ≥20 years at HCT but did not otherwise differ. We herein demonstrate promising outcomes following allogeneic HCT for patients with FA and MDS/AML using TCD grafts, particularly in a cohort of high-risk patients with 50% ≥20 years and a majority receiving mismatched grafts. Future prospective studies are needed to compare this approach with other HCT platforms.


Fanconi Anemia , Graft vs Host Disease , Hematopoietic Stem Cell Transplantation , Leukemia, Myeloid, Acute , Humans , Young Adult , Adult , Fanconi Anemia/therapy , Fanconi Anemia/complications , Retrospective Studies , Transplantation, Homologous/adverse effects , Transplantation Conditioning/methods , T-Lymphocytes , Hematopoietic Stem Cell Transplantation/methods , Graft vs Host Disease/etiology
14.
J Drugs Dermatol ; 22(12): 1235-1236, 2023 12 01.
Article En | MEDLINE | ID: mdl-38051833

Since the initial coverage of the monkeypox virus, there has been debate among physicians over how to responsibly communicate public health information without harming historically marginalized communities. On November 28, 2022, the World Health Organization (WHO) announced its plan to rename monkeypox "mpox" following growing concern regarding the stigmatizing nature of the disease's original name. We believe providers, and especially dermatologists, have an opportunity to further shape conversations about the virus to mitigate the same stigmas that were perpetuated by media coverage surrounding the HIV epidemic and contributed to the rise of anti-LGBTQ and HIV+ violence. Specifically, dermatologists have an opportunity to engage in conversations about the psychosocial impact of visible skin disease, advocating for healthcare equity by using both inclusive imagery and non-discriminatory language.J Drugs Dermatol. 2023;22(12):1235-1236. doi:10.36849/JDD.7482.


HIV Infections , Mpox (monkeypox) , Humans , Monkeypox virus , Communication , Language , HIV Infections/prevention & control
15.
Article En | MEDLINE | ID: mdl-38107407

The concept of "fatherhood" in many African countries has traditionally been understood in terms of instrumental support to one's family, most notably, financial provision. However, in Sierra Leone and elsewhere, this narrow understanding of fatherhood is changing as a result of shifting demographic trends and responses to recent crises such as the Ebola pandemic and the aftermath of a civil war. Very little is understood about how male former children associated with armed forces and armed groups (CAAFAG) are navigating fatherhood and understanding their roles as fathers, particularly as many have grown up without fathers or parents themselves and experienced violence. Our study builds upon previous ethnographic research in Sierra Leone, and uses a phenomenological approach to understand 1) the meaning and importance of fatherhood to former child soldiers in Sierra Leone, 2) what fatherhood looks like normatively and ideally, with attention to norms about nurturing care as well as violence, and 3) how ideals of fatherhood may or may not be in tension with socioeconomic circumstances. We find that CAAFAG fathers in Sierra Leone are committed to providing emotional support, encouragement, and a loving upbringing in addition to striving to provide financially. CAAFAG fathers experienced the greatest tension between their ideals of fatherhood and their socio-economic circumstances in terms of financial support, such as paying school fees. In other words, fathers felt inhibited in becoming the types of fathers they hoped to be due to their experiences in a post-conflict, resource-constrained environment.

16.
Diagnostics (Basel) ; 13(22)2023 Nov 19.
Article En | MEDLINE | ID: mdl-37998614

Genital mycoplasmas are sexually transmitted Mollicutes with a high prevalence of urogenital tract colonization among females of reproductive age. Current guidelines recommend against routine screening for these organisms, since their role in the pathogenesis of pelvic inflammatory disease and tubo-ovarian abscesses (TOAs) remains unclear. However, genital mycoplasmas harbor pathogenic potential in immunocompromised hosts, especially patients with hypogammaglobulinemia. It is important to identify such infections early, given their potential for invasive spread and the availability of easily accessible treatments. We present a young adult female with multiple sclerosis and iatrogenic hypogammaglobulinemia, with refractory, bilateral pelvic inflammatory disease and TOAs due to Ureaplasma urealyticum, identified as a single pathogen via three distinct molecular tests. To our knowledge, this is the second case of TOAs caused by U. urealyticum in the literature, and the first diagnosed by pathogen cell-free DNA metagenomic next-generation sequencing in plasma.

17.
Tob Control ; 2023 Nov 16.
Article En | MEDLINE | ID: mdl-37973361

INTRODUCTION: In recent years, the nicotine in e-cigarettes has been available in either a 'free-base' (unprotonated) or 'nicotine salt' (protonated) form. Additionally, e-cigarette nicotine can be either 'synthetic' or 'tobacco-derived'. These dimensions of nicotine have implications for nicotine absorption, bioavailability and sensory experiences. However, it is unclear if the young people using e-cigarettes are aware of these nicotine dimensions. METHODS: Data came from a cohort of Ohio youth (aged 15-24) who reported using an e-cigarette in the past 4 months (N=271). Participants were enrolled and provided background information in 2021; their 12-month follow-up survey asked about the presence, form and type of nicotine in their usual e-cigarette. Individuals who reported that they could distinguish between tobacco-derived and synthetic nicotine were additionally asked to describe the difference. RESULTS: Of the 247 youth who reported that there was nicotine in their usual e-cigarette, 71.7% did not know whether it was free-base or nicotine salt and 75.7% did not know whether it was synthetic or tobacco-derived. Awareness was higher among youth who were using e-cigarettes at a greater frequency and quantity. The majority reported that they could not detect a difference between the experience of using synthetic vs tobacco-derived nicotine. CONCLUSIONS: These findings indicate the generally limited awareness about nicotine among youth who used e-cigarettes. Improvements in health communications and requirements for e-cigarette industry disclosures are necessary to ensure that consumers are better informed about the dimensions-and the risks-of the nicotine they are consuming.

18.
Elife ; 122023 10 17.
Article En | MEDLINE | ID: mdl-37846664

Background: Limited information is available for patients with breast cancer (BC) and coronavirus disease 2019 (COVID-19), especially among underrepresented racial/ethnic populations. Methods: This is a COVID-19 and Cancer Consortium (CCC19) registry-based retrospective cohort study of females with active or history of BC and laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection diagnosed between March 2020 and June 2021 in the US. Primary outcome was COVID-19 severity measured on a five-level ordinal scale, including none of the following complications, hospitalization, intensive care unit admission, mechanical ventilation, and all-cause mortality. Multivariable ordinal logistic regression model identified characteristics associated with COVID-19 severity. Results: 1383 female patient records with BC and COVID-19 were included in the analysis, the median age was 61 years, and median follow-up was 90 days. Multivariable analysis revealed higher odds of COVID-19 severity for older age (aOR per decade, 1.48 [95% CI, 1.32-1.67]); Black patients (aOR 1.74; 95 CI 1.24-2.45), Asian Americans and Pacific Islander patients (aOR 3.40; 95 CI 1.70-6.79) and Other (aOR 2.97; 95 CI 1.71-5.17) racial/ethnic groups; worse ECOG performance status (ECOG PS ≥2: aOR, 7.78 [95% CI, 4.83-12.5]); pre-existing cardiovascular (aOR, 2.26 [95% CI, 1.63-3.15])/pulmonary comorbidities (aOR, 1.65 [95% CI, 1.20-2.29]); diabetes mellitus (aOR, 2.25 [95% CI, 1.66-3.04]); and active and progressing cancer (aOR, 12.5 [95% CI, 6.89-22.6]). Hispanic ethnicity, timing, and type of anti-cancer therapy modalities were not significantly associated with worse COVID-19 outcomes. The total all-cause mortality and hospitalization rate for the entire cohort was 9% and 37%, respectively however, it varied according to the BC disease status. Conclusions: Using one of the largest registries on cancer and COVID-19, we identified patient and BC-related factors associated with worse COVID-19 outcomes. After adjusting for baseline characteristics, underrepresented racial/ethnic patients experienced worse outcomes compared to non-Hispanic White patients. Funding: This study was partly supported by National Cancer Institute grant number P30 CA068485 to Tianyi Sun, Sanjay Mishra, Benjamin French, Jeremy L Warner; P30-CA046592 to Christopher R Friese; P30 CA023100 for Rana R McKay; P30-CA054174 for Pankil K Shah and Dimpy P Shah; KL2 TR002646 for Pankil Shah and the American Cancer Society and Hope Foundation for Cancer Research (MRSG-16-152-01-CCE) and P30-CA054174 for Dimpy P Shah. REDCap is developed and supported by Vanderbilt Institute for Clinical and Translational Research grant support (UL1 TR000445 from NCATS/NIH). The funding sources had no role in the writing of the manuscript or the decision to submit it for publication. Clinical trial number: CCC19 registry is registered on ClinicalTrials.gov, NCT04354701.


Breast Neoplasms , COVID-19 , United States/epidemiology , Humans , Female , Middle Aged , SARS-CoV-2 , Cohort Studies , Breast Neoplasms/epidemiology , Retrospective Studies
19.
Front Oncol ; 13: 1221782, 2023.
Article En | MEDLINE | ID: mdl-37649924

Background: Patients with leukemia relapse after allogeneic hematopoietic cell transplant (HCT) have poor survival due to toxicity and disease progression. A second HCT often offers the only curative treatment. Methods: We retrospectively reviewed our bi-institutional experience (MSKCC-USA; Utrecht-NL) with unrelated cord blood transplantation (CBT) for treatment of post-transplant relapse. Overall survival (OS) and event-free survival (EFS) were evaluated using the Kaplan-Meier method, treatment-related mortality (TRM) and relapse were evaluated using the competing risk method by Fine-Gray. Results: Twenty-six patients age < 21 years received a second (n=24) or third (n=2) HCT with CB grafts during the period 2009-2021. Median age at first HCT (HCT1) was 11.5 (range: 0.9-17.7) years and all patients received myeloablative cytoreduction. Median time from HCT1 to relapse was 12.8 (range 5.5-189) months. At CBT, median patient age was 13.5 (range 1.4-19.1) years. Diagnoses were AML: 13; ALL: 4, MDS: 5, JMML: 2; CML: 1; mixed phenotype acute leukemia: 1. Sixteen patients (62%) were in advanced stage, either CR>2 or with active disease. Median time from HCT1 to CBT was 22.2 (range 7-63.2) months. All patients engrafted after CBT. Thirteen patients developed acute GvHD; 7 had grade III or IV. With a median survivor follow-up of 46.6 (range 17.4-155) months, 3-year OS was 69.2% (95% CI 53.6-89.5%) and 3-year EFS was 64.9% (95% CI 48.8-86.4%). Eight patients died, 3 of AML relapse and 5 due to toxicity (respiratory failure [n=4], GvHD [n=1]) at a median time of 7.7 (range 5.9-14.4) months after CBT. Cumulative incidence of TRM at 3 years was 19.2% (95% CI 4.1-34.4%). Notably, all TRM events occurred in patients transplanted up to 2015; no toxicity-related deaths were seen in the 16 patients who received CBT after 2015. Cumulative incidence of relapse was 15.9% (95% CI 1.6-30.2%) at 3 years, remarkably low for these very high-risk patients. Conclusions: Survival was very encouraging following CB transplants in pediatric patients with recurrent leukemia after first HCT, and TRM has been low over the last decade. CBT needs to be strongly considered as a relatively safe salvage therapy option for post-transplant relapse.

20.
JAMA Oncol ; 9(10): 1390-1400, 2023 Oct 01.
Article En | MEDLINE | ID: mdl-37589970

Importance: Systematic data on the association between anticancer therapies and thromboembolic events (TEEs) in patients with COVID-19 are lacking. Objective: To assess the association between anticancer therapy exposure within 3 months prior to COVID-19 and TEEs following COVID-19 diagnosis in patients with cancer. Design, Setting, and Participants: This registry-based retrospective cohort study included patients who were hospitalized and had active cancer and laboratory-confirmed SARS-CoV-2 infection. Data were accrued from March 2020 to December 2021 and analyzed from December 2021 to October 2022. Exposure: Treatments of interest (TOIs) (endocrine therapy, vascular endothelial growth factor inhibitors/tyrosine kinase inhibitors [VEGFis/TKIs], immunomodulators [IMiDs], immune checkpoint inhibitors [ICIs], chemotherapy) vs reference (no systemic therapy) in 3 months prior to COVID-19. Main Outcomes and Measures: Main outcomes were (1) venous thromboembolism (VTE) and (2) arterial thromboembolism (ATE). Secondary outcome was severity of COVID-19 (rates of intensive care unit admission, mechanical ventilation, 30-day all-cause mortality following TEEs in TOI vs reference group) at 30-day follow-up. Results: Of 4988 hospitalized patients with cancer (median [IQR] age, 69 [59-78] years; 2608 [52%] male), 1869 had received 1 or more TOIs. Incidence of VTE was higher in all TOI groups: endocrine therapy, 7%; VEGFis/TKIs, 10%; IMiDs, 8%; ICIs, 12%; and chemotherapy, 10%, compared with patients not receiving systemic therapies (6%). In multivariable log-binomial regression analyses, relative risk of VTE (adjusted risk ratio [aRR], 1.33; 95% CI, 1.04-1.69) but not ATE (aRR, 0.81; 95% CI, 0.56-1.16) was significantly higher in those exposed to all TOIs pooled together vs those with no exposure. Among individual drugs, ICIs were significantly associated with VTE (aRR, 1.45; 95% CI, 1.01-2.07). Also noted were significant associations between VTE and active and progressing cancer (aRR, 1.43; 95% CI, 1.01-2.03), history of VTE (aRR, 3.10; 95% CI, 2.38-4.04), and high-risk site of cancer (aRR, 1.42; 95% CI, 1.14-1.75). Black patients had a higher risk of TEEs (aRR, 1.24; 95% CI, 1.03-1.50) than White patients. Patients with TEEs had high intensive care unit admission (46%) and mechanical ventilation (31%) rates. Relative risk of death in patients with TEEs was higher in those exposed to TOIs vs not (aRR, 1.12; 95% CI, 0.91-1.38) and was significantly associated with poor performance status (aRR, 1.77; 95% CI, 1.30-2.40) and active/progressing cancer (aRR, 1.55; 95% CI, 1.13-2.13). Conclusions and Relevance: In this cohort study, relative risk of developing VTE was high among patients receiving TOIs and varied by the type of therapy, underlying risk factors, and demographics, such as race and ethnicity. These findings highlight the need for close monitoring and perhaps personalized thromboprophylaxis to prevent morbidity and mortality associated with COVID-19-related thromboembolism in patients with cancer.


COVID-19 , Neoplasms , Venous Thromboembolism , Humans , Male , Aged , Female , Venous Thromboembolism/chemically induced , Venous Thromboembolism/epidemiology , Anticoagulants/therapeutic use , Cohort Studies , Retrospective Studies , COVID-19 Testing , Vascular Endothelial Growth Factor A , SARS-CoV-2 , Neoplasms/complications , Neoplasms/drug therapy , Neoplasms/epidemiology , Immunomodulating Agents
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