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  • 1
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    Presentation of BK polyomavirus–associated hemorrhagic cystitis after allogeneic hematopoietic cell transplantation
    American Society of Hematology ; 2020
    In:  Blood Advances Vol. 4, No. 4 ( 2020-02-25), p. 617-628
    Details
    In: Blood Advances, American Society of Hematology, Vol. 4, No. 4 ( 2020-02-25), p. 617-628
    Abstract: BK polyomavirus (BKPyV) has been associated with hemorrhagic cystitis (HC) after allogeneic hematopoietic cell transplantation (HCT), but the natural history of HC and factors associated with the clinical course are incompletely understood. We retrospectively analyzed allogeneic HCT patients transplanted from 2007-2017 who presented after platelet engraftment or after day 28 post-HCT with BKPyV-associated HC (BKPyV-HC), which was defined as a positive urine BKPyV PCR, ≥1 plasma BKPyV viral load result, and macroscopic hematuria (Bedi grade ≥2). Factors associated with resolution of macroscopic hematuria and resolution of all cystitis symptoms within 90 days after HC diagnosis were investigated in multivariable models. In 128 patients with BKPyV-HC, the median times from diagnosis to resolution of all symptoms, macroscopic hematuria, and urinary clots (present in 55% [71/128]) were 24 days (15-44), 17 days (10-30), and 14 days (5-26), respectively. Ninety percent of patients had BKPyV viremia at the onset of HC with a median viral load of 1850 copies/mL (interquartile range, 240-8550). In multivariable models, high plasma viral load (≥10 000 copies/mL) and cytopenias at the beginning of BKPyV-HC were significantly associated with longer macroscopic hematuria and cystitis symptoms. Use of cidofovir was not associated with shorter duration of illness. In conclusion, BKPyV-HC after allogeneic HCT is characterized by prolonged and severe symptoms and requires improved management strategies. High-grade viremia and cytopenias were associated with a longer duration of BKPyV-associated HC. Accurate descriptions of disease and factors associated with prolonged recovery will inform end points of future clinical trials.
    Type of Medium: Online Resource
    ISSN: 2473-9529 , 2473-9537
    URL: Article
    DOI: 10.1182/bloodadvances.2019000802
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2020
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  • 2
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    A Patient-Reported Outcome Measure for Symptoms and Symptom Burden of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 2094-2094
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 2094-2094
    Abstract: Background: Patient report of disease- and treatment-related symptom burden in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) is scarce. Symptom burden is the combined impact of disease and treatment symptoms on daily functioning. Lack of recognition and monitoring of symptoms and symptom burden can lead to inadequate management and possible treatment non-adherence. Aims: Our aim is to develop a short, valid, reliable patient-reported outcome measure of symptoms and symptom burden experienced by AML and MDS patients and to determine the validity of a single measure for research and practice. Methods: After obtaining IRB approval, patients with AML (N=152) and MDS (N=97) were recruited to this cross-sectional study. Patients rated the 13 core symptom items (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, trouble remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness and tingling), 6 proposed AML/MDS symptom items (muscle weakness, malaise, fever, headache, diarrhea, skin problems), and 6 interference items (general activities, mood, work, relations with others, walking, and enjoyment of life) of the MD Anderson Symptom Inventory (MDASI) on 0-to-10 scales (0 = not present or no interference; 10 = as bad as can be imagined or complete interference) twice 1-2 days apart. Clinical and demographic information was collected from medical records and analyzed using descriptive statistics. Means of the symptom and interference ratings for the AML and MDS patients were compared using T-tests. Standard psychometric techniques were used to determine the reliability, stability, and validity of the instrument in patients with AML and MDS. Results: All MDS patients were outpatients while 75 of the AML patients were inpatients and 77 were outpatients. The AML and MDS patients had been diagnosed a mean of 13.8 months (standard deviation [SD]=23.9) and 30.5 months (SD=32.4) respectively. The mean (Mn) symptom and interference ratings respectively for the AML inpatients (Mn=2.8, SD=1.6; Mn=4.0, SD=2.4) were significantly higher than for the AML outpatients (Mn=1.8, SD=1.4, p 〈 0.01; Mn=2.7, SD=2.3, p 〈 0.01) or MDS patients (Mn=1.9, SD=1.5, p 〈 0.01; Mn=2.7, SD=2.5, p 〈 0.01). The mean ratings for the 5 most severe symptom means for AML and MDS patients respectively were: fatigue (Mn=4.0, SD=2.8; Mn=4.0, SD=2.5; p =0.97), disturbed sleep (Mn=3.3, SD=3.2; Mn=2.7, SD=3.3; p=0.19), drowsiness (Mn=3.0, SD=2.8; Mn=2.8, SD=3.1; p=0.70), muscle weakness (Mn=2.9, SD=2.8; Mn=2.9, SD=3.0; p=0.91), dry mouth for AML patients (Mn=3.4, SD=3.2; Mn=2.2,SD=2.8; p 〈 0.01), and shortness of breath for MDS patients (Mn=2.7, SD=2.8; 1.9, SD=2.3; p=0.02). Two of the 6 AML/MDS symptom items (fever and headache) were dropped because so few patients said they experienced the symptoms at more than a mild (0-4 rating) level (12% and 11% respectively). Both groups of patients endorsed similar symptoms, and none of the means of the 4 final AML/MDS symptoms were significantly different between the groups. Cronbach's reliability for all symptom items for AML and MDS respectively were 0.88 and 0.91 and for all interference items were 0.86 and 0.92. The test-retest reliability intra-class correlations were 0.85 for the core symptoms, 0.77 for AML/MDS symptoms, and 0.84 for the interference items. The MDASI-AML/MDS can be completed by patients in less than 5 minutes. Conclusion/Summary: Lack of recognition of symptoms experienced by patients with AML and MDS can lead to inadequate management of symptoms, interfere with the ability of patients to function and enjoy life, and impact the tolerability of and adherence to treatment regimens. While the symptoms experienced by the two groups had some variation in severity, a similar group of symptoms were the most common and relevant for both groups of patients, and the same measure was appropriate for both groups. The MDASI-AML/MDS is a brief, easily-completed, and validated measure of symptom burden for patients with AML and MDS that can be used for accurate and consistent monitoring of symptoms by clinicians and researchers. Disclosures Williams: Amgen: Consultancy; Novartis: Research Funding. Cortes:Pfizer: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; BerGenBio AS: Research Funding; Teva: Research Funding; Ariad: Consultancy, Research Funding; Astellas: Consultancy, Research Funding; Ambit: Consultancy, Research Funding; Arog: Research Funding; Celator: Research Funding; Jenssen: Consultancy. Mendoza:Amgen Inc.: Consultancy. Shi:Amgen Inc.: Consultancy. Cleeland:Amgen Inc.: Consultancy.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.2094.2094
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 3
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    Functional Comparison and Longitudinal Assessment of Tri-Functional T-Cells Recognizing CMV pp65 and IE-1 Polypeptides in Hematopoietic Stem Cell and Solid Organ Transplant Recipients.
    American Society of Hematology ; 2006
    In:  Blood Vol. 108, No. 11 ( 2006-11-16), p. 2936-2936
    Details
    In: Blood, American Society of Hematology, Vol. 108, No. 11 ( 2006-11-16), p. 2936-2936
    Abstract: Reconstitution of adaptive T-cell responses to human cytomegalovirus (CMV) is critical to protection from CMV disease following hematopoietic stem cell (HSCT) or solid organ transplantation (SOT). However, there is an incomplete understanding of which CMV antigens and epitopes are most crucial to providing protective responses. The functional status of cytotoxic T-lymphocyte (CTL) populations recognizing cytomegalovirus IE-1 and pp65 polypeptides was investigated in PBMC from either HSCT or SOT recipients. Our previous finding of differing levels of degranulation between CMV IE1 and pp65/pp50 specific T-cells was complicated by the possibility that differences were epitope and/or HLA-specific. We generalized the approach using a combined flow-based CD107a/b degranulation/mobilization and intracellular cytokine (ICC) assays using peptide libraries as antigens. These assays indicated that a significantly higher proportion of pp65-specific CTLs were in a more mature functional state compared to IE-1-specific CTLs. Degranulation/multicytokine ICC assays also indicated that a significantly higher proportion of the pp65-specific versus IE-1-specific CTLs secreted both IFN-γ and TNF-α, in addition to possessing greater cytotoxic potential. These results support our earlier findings of functional differences between CTLs recognizing individual epitopes within the IE-1 and pp65 antigens in HSCT recipients, and extend them to a broader array of HLA-restricted responses to those antigens. A report that a subset of HIV-1 specific CTLs capable of producing both IFN-γ and TNF-α was associated with improved cytotoxic activity prompted us to investigate whether degranulation, a functional correlate of cytotoxicity, was positively associated with dual cytokine production and predicted differences between IE1 and pp65-specific CD8+ T-cells. A higher proportion of pp65-specific compared to IE1-specific T-cells were present in the trifunctional IFN-γ+,TNF-α+, CD107+ population (p=0.008) in HSCT recipients. We have extended these findings to investigate the role of donor CMV status in terms of functional maturity of CMV-specific T cell response in transplant recipients. T cell maturation/function may act as a mechanistic correlate to the survival advantage of recipients receiving a stem-cell graft from CMV sero-positive donors. These principles have also been applied to investigations of a high risk population of sero-negative recipients of a sero-positive liver allograft. Data from this study will also be reviewed in the context of the model of trifunctional T cells being indicative of enhanced protective capacity against CMV disease and associated with survival.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V108.11.2936.2936
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2006
    detail.hit.zdb_id: 1468538-3
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  • 4
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    Sphingosine kinase-1 enhances endothelial cell survival through a PECAM-1–dependent activation of PI-3K/Akt and regulation of Bcl-2 family members
    American Society of Hematology ; 2005
    In:  Blood Vol. 105, No. 8 ( 2005-04-15), p. 3169-3177
    Details
    In: Blood, American Society of Hematology, Vol. 105, No. 8 ( 2005-04-15), p. 3169-3177
    Abstract: Sphingosine-1-phosphate (S1P), the bioactive product of sphingosine kinase (SK) activation, is a survival factor for endothelial cells. The mechanism of SK-mediated survival was investigated in endothelial cells with moderately raised intracellular SK activity. Overexpression of SK mediated survival primarily through the activation of the phosphatidyl inositol 3-kinase (PI-3K)/protein kinase B (Akt/PKB) pathway and an associated up-regulation of the antiapoptotic protein B cell lymphoma gene 2 (Bcl-2) and down-regulation of the proapoptotic protein bisindolylmaleimide (Bcl-2 interacting mediator of cell death; Bim). In addition there was an up-regulation and dephosphorylation of the junctional molecule platelet endothelial cell adhesion molecule-1 (PECAM-1), which was obligatory for activation of the PI-3K/Akt pathway, for SK-induced cell survival, and for the changes in the apoptosis-related proteins. Thus, raised intracellular SK activity induced a molecule involved in cell–cell interactions to augment cell survival through a PI-3K/Akt–dependent pathway. This is distinct from the activation of both PI-3K/Akt and mitogen-activated protein kinase (MAPK) pathways seen with exogenously added S1P. Cells overexpressing SK showed enhanced survival under conditions of serum deprivation and absence of attachment to extracellular matrix, suggesting a role for SK in the regulation of vascular phenomena that occur under conditions of stress, such as angiogenesis and survival in unattached states, as would be required for a circulating endothelial cell.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood-2004-02-0452
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2005
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  • 5
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    Comparison of Symptom Burden in Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)
    American Society of Hematology ; 2014
    In:  Blood Vol. 124, No. 21 ( 2014-12-06), p. 2652-2652
    Details
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 2652-2652
    Abstract: Objective: Patient report of symptom burden from acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) is scarce. Symptom burden is the combined impact of symptoms from disease and treatment on daily functioning. We are developing a measure of symptom burden in AML and MDS. The purpose of this interim analysis is to compare the symptom burden of patients with AML and MDS. Methods: Patients with AML or MDS rated the 13 core symptom items, 6 proposed AML/MDS-specific symptom items, and 6 interference items of the MD Anderson Symptom Inventory on a 0-10 scale (0 = not present or no interference; 10 = as bad as can be imagined or complete interference). Patient clinical and demographic information was collected from medical records. The symptom burden of AML/MDS was determined and compared using descriptive statistics and t-tests. Results: Mean ages of the 45 AML patients and 48 MDS patients were 62.4 (standard deviation [SD] = 11.3) and 68.5 years (SD = 9.2; p = 0.005), respectively; 61% and 60% (p = not significant), respectively, were male; 76% and 92% (p = 0.043), respectively, were white. The composite mean severity score of the core symptom items was 2.75 (SD = 1.58) and 1.84 (SD = 1.52; p = 0.006), the composite mean of the AML/MDS specific items was 2.51 (SD = 1.87) and 1.49 (1.60; p = 0.005), and the composite mean score of the interference items was 3.96 (SD = 2.72) and 2.81 (SD = 2.69; p = 0.042) for the AML and MDS patients, respectively. The means, ranks, significance of difference in ratings, and prevalence of the individual symptom and interference items for the AML and MDS patients are in Table 1. Cronbach α for all symptom items was 0.94 and for all interference items was 0.92. Conclusions: Patients with AML and MDS experience similar symptoms. However, patients with AML report significantly more severe pain, fatigue, nausea, lack of appetite, dry mouth, vomiting, fever, and headache than patients with MDS. Only prevalence of shortness of breath and diarrhea was higher in MDS patients, but there was no difference in reported mean severity of these symptoms. Except for general activity, rating of symptom interference with daily activities is similar for the two groups. Lack of recognition of symptoms experienced by patients with AML and MDS can lead to inadequate management of symptoms, interfere with patients' ability to function and enjoy life, and impact the tolerability of and adherence to treatment regimens. Validation of this measure of symptom burden for patients with AML and MDS to allow more accurate and consistent monitoring of symptoms by clinicians and in clinical research is ongoing. Table 1. Individual MDASI Item Means and Significance for AML and MDS Patients Core Symptom Items N Mean SD p-value Rank Prevalence (%) Pain MDS 48 2.00 2.760 0.009* 9 58 AML 45 3.69 3.309 3 69 Fatigue MDS 47 3.45 2.947 0.037* 1 79 AML 45 4.69 2.653 1 91 Nausea MDS 48 .50 1.368 〈 0.001* 17 23 AML 45 2.67 3.233 9 58 Disturbed Sleep MDS 48 2.38 3.050 0.124 4 56 AML 45 3.38 3.172 7 71 Distress MDS 48 2.19 2.498 0.476 7 63 AML 45 2.56 2.455 10 71 Shortness of Breath MDS 48 2.15 2.518 0.543 8 65 AML 45 1.84 2.215 17 53 Problems Remembering MDS 48 1.94 2.025 0.663 10 71 AML 45 2.13 2.292 14 71 Lack of Appetite MDS 48 1.33 2.035 〈 0.001* 13 48 AML 45 3.73 3.460 2 76 Drowsiness MDS 48 2.85 3.032 0.187 2 71 AML 45 3.69 3.021 3 78 Dry Mouth MDS 48 2.31 2.746 0.045* 6 69 AML 44 3.59 3.223 5 73 Sadness MDS 48 1.83 2.127 0.394 11 60 AML 45 2.22 2.255 11 73 Vomiting MDS 48 0.00 0.000 0.009* 19 0 AML 45 .73 1.912 19 22 Numbness or Tingling MDS 48 1.08 2.071 .712 15 33 AML 45 .93 1.814 18 33 AML/MDS-Specific Symptom Items Malaise MDS 48 2.46 2.843 0.133 3 65 AML 46 3.35 2.838 8 78 Fever MDS 48 .50 1.544 0.006* 18 19 AML 46 1.91 3.002 16 41 Headache MDS 48 .81 1.483 0.011* 16 35 AML 46 2.22 3.339 11 44 Diarrhea MDS 48 1.56 2.567 0.512 12 48 AML 46 1.96 3.211 15 41 Muscle Weakness MDS 48 2.35 2.899 0.063 5 60 AML 46 3.43 2.664 6 83 Rash or Skin Problems MDS 48 1.23 2.469 0.065 14 38 AML 46 2.22 2.666 11 59 Interference Items General Activity MDS 46 3.20 3.449 0.031* 3 65 AML 46 4.83 3.696 2 80 Mood MDS 48 2.38 2.687 0.066 5 65 AML 44 3.48 2.984 5 80 Work MDS 48 3.54 3.638 0.086 1 67 AML 46 4.87 3.781 1 78 Relations with Others MDS 48 1.69 2.683 0.154 6 48 AML 46 2.54 3.082 6 52 Walking MDS 48 2.88 3.112 0.275 4 71 AML 46 3.57 2.971 4 78 Enjoyment of Life MDS 48 3.21 3.261 0.055 2 73 AML 46 4.54 3.397 3 80 * Significant at p 〈 0.05. Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V124.21.2652.2652
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
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  • 6
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    Symptom Burden of Busulfan + Melphalan Versus Melphalan Alone for Multiple Myeloma
    American Society of Hematology ; 2014
    In:  Blood Vol. 124, No. 21 ( 2014-12-06), p. 1277-1277
    Details
    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 1277-1277
    Abstract: Background: High-dose melphalan at 200 mg/m2 (Mel) is the standard for autologous hematopoietic stem cell transplantation (autoHSCT) for multiple myeloma. Two recent retrospective analyses suggested that a combination of busulfan and melphalan (Bu-Mel) may be associated with a longer progression-free survival (PFS). A secondary aim of a randomized phase III trial that compared the safety and efficacy of Bu-Mel vs Mel was to compare the symptom severity and symptom burden of the two regimens. Symptom burden is defined as the combined impact of disease- and therapy-related symptoms on patient functional ability. Methods: Patients were randomized to Bu-Mel or Mel. In the Bu-Mel arm, Bu 130 mg/m2 was infused daily for 4 days, either as a fixed dose or to target an average daily area under the curve (AUC) of 5000 μmol-min, followed by 2 daily doses of Mel at 70 mg/m2. A subset of patients completed the 20 symptom severity and 6 interference items of MD Anderson Symptom Inventory for Multiple Myeloma (MDASI-MM) prior to the start of the treatment regimen and weekly for 5 weeks post autoHSCT. Symptoms and interference are rated on 0-10 scales (0 = none or no interference, 10 = worst imaginable or complete interference). Differences in individual symptom severity and interference and symptom burden (the composite mean scores of the 5 most severe symptoms and the 6 interference items) between the two arms were assessed by t-tests and mixed modeling at each time point. Results: As previously reported, 92 patients (Bu-Mel: 49, Mel: 43) were enrolled between October 2011 and August 2013. Grade 3-4 non-hematologic toxicity was seen in 41 (84%) and 20 (47%) patients in Bu-Mel and Mel, respectively (p=0.0003). At day 90, 8 (18%) and 15 (35%) patients had achieved a CR (p=0.05), and 13 (27%) and 20 (47%) patients had achieved a CR + nCR (p=0.05) in Bu-Mel and Mel, respectively. One-year PFS was 93% and 82% (p=0.26), and 1-year OS was 100% and 100% in Bu-Mel and Mel arms, respectively. Fifty-six of the patients (Bu-Mel: 29, Mel: 27) completed at least one MDASI-MM assessment between October 2011 and July 2013. Median ages at autoHSCT were 55.5 and 55.1 years in Bu-Mel and Mel groups, respectively (p=0.862). At baseline, t-tests showed significantly higher mean severity for bone aches (3.00, standard deviation [SD] = 2.85 vs 1.40, SD = 1.94; p=0.022), drowsiness (2.96, SD = 3.12 vs 1.44, SD = 1.87; p=0.034), muscle weakness (2.98, SD = 2.68 vs 0.79, SD = 1.14; p=0.001, appetite (1.93, SD = 2.60 vs 0.44, SD = 1.19; p=0.009), and overall interference (3.46, SD = 2.89 vs 1.03, SD = 1.04; p 〈 0.001) in the Bu-Mel arm than the Mel arm. Longitudinal analysis using mixed modeling showed a significant difference in the combined mean of the 5 most severe symptoms (fatigue, pain, drowsiness, disturbed sleep, and lack of appetite) at baseline (estimated difference [ED] = 1.16, p=0.016) between the arms and a significant increase in the top 5 symptoms for both arms between baseline and Weeks 1 (ED = 3.30, p 〈 0.0001), 2 (ED = 2.06, p=0.002), and 3 (ED = 2.28, p=0.003). The Bu-Mel arm had a significantly lower mean severity of disturbed sleep at Week 4 (ED = -3.69, p=0.022) and significantly lower mean severity of lack of appetite at Week 2 (ED = -3.08, p=0.016) and 3 (ED = –3.15, p=0.033) than the Mel arm, but a significantly higher mean severity of sore mouth at Week 1 (ED = 2.35, p=0.018) and 2 (ED = 2.51, p=0.009). Conclusions: Patients with MM undergoing autoHSCT report a significant increase in symptom severity and interference during Weeks 1 to 3 post autoHSCT, with the greatest increase occurring during the first week. In addition, patients receiving Bu-Mel vs Mel report differences in individual symptom severity, with Mel patients having significantly more problems with disturbed sleep and lack of appetite and Bu-Mel patients reporting significantly more severe sore mouth and throat. The effect of the significant differences prior to the start of autoHSCT between these two groups, despite randomization, in the severity of the top 5 symptoms and interference on symptom report during autoHSCT is unclear and will be further explored. Additional differences in symptom severity may have gone undetected in this study because of initial differences. Systematic measurement of symptom burden during clinical trials can provide useful information for clinicians and patients in evaluating the full impact of different treatment regimens. Disclosures Off Label Use: Busulfan and melphalan for conditioning regimen prior to autologous hematopoietic stem cell transplantation for multiple myeloma. Qazilbash:Otsuka Pharmaceutical Company: Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V124.21.1277.1277
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2014
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