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Pulmonary symptoms measured by the national institutes of health lung score predict overall survival, nonrelapse mortality, and patient-reported outcomes in chronic graft-versus-host disease.
Palmer J, Williams K, Inamoto Y, Chai X, Martin PJ, Tomas LS, Cutler C, Weisdorf D, Kurland BF, Carpenter PA, Pidala J, Pavletic SZ, Wood W, Jacobsohn D, Arai S, Arora M, Jagasia M, Vogelsang GB, Lee SJ
(2014) Biol Blood Marrow Transplant 20: 337-44
MeSH Terms: Adolescent, Adult, Child, Child, Preschool, Chronic Disease, Female, Graft vs Host Disease, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Humans, Lung, Male, National Institutes of Health (U.S.), Patient Outcome Assessment, Proportional Hazards Models, Prospective Studies, Research Design, Respiratory Function Tests, Severity of Illness Index, Survival Analysis, Transplantation, Homologous, United States
Show Abstract · Added March 20, 2014
The 2005 National Institutes of Health (NIH) Consensus Conference recommended assessment of lung function in patients with chronic graft-versus-host disease (GVHD) by both pulmonary function tests (PFTs) and assessment of pulmonary symptoms. We tested whether pulmonary measures were associated with nonrelapse mortality (NRM), overall survival (OS), and patient-reported outcomes (PRO). Clinician and patient-reported data were collected serially in a prospective, multicenter, observational study. Available PFT data were abstracted. Cox regression models were fit for outcomes using a time-varying covariate model for lung function measures and adjusting for patient and transplantation characteristics and nonlung chronic GVHD severity. A total of 1591 visits (496 patients) were used in this analysis. The NIH symptom-based lung score was associated with NRM (P = .02), OS (P = .02), patient-reported symptoms (P < .001) and functional status (P < .001). Worsening of NIH symptom-based lung score over time was associated with higher NRM and lower survival. All other measures were not associated with OS or NRM; although, some were associated with patient-reported lung symptoms. In conclusion, the NIH symptom-based lung symptom score of 0 to 3 is associated with NRM, OS, and PRO measures in patients with chronic GVHD. Worsening of the NIH symptom-based lung score was associated with increased mortality.
Copyright © 2014 American Society for Blood and Marrow Transplantation. All rights reserved.
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22 MeSH Terms
Geographic distance is not associated with inferior outcome when using long-term transplant clinic strategy.
Ragon BK, Clifton C, Chen H, Savani BN, Engelhardt BG, Kassim AA, Vaughan LA, Lucid C, Jagasia M
(2014) Biol Blood Marrow Transplant 20: 53-7
MeSH Terms: Adult, Aged, Female, Graft vs Host Disease, Health Services Accessibility, Hematologic Neoplasms, Hematopoietic Stem Cell Transplantation, Humans, Long-Term Care, Male, Middle Aged, Proportional Hazards Models, Survival Analysis, Transplantation, Homologous, Treatment Outcome
Show Abstract · Added March 20, 2014
The optimal healthcare model for follow-up of allogeneic hematopoietic stem cell transplantation (HSCT) recipients after day 100 is not clear. We previously demonstrated that longitudinal follow-up at the transplant center using a multidisciplinary approach is associated with superior survival. Recent data suggest that increased distance from the transplant center is associated with inferior survival. A dedicated long-term transplant clinic (LTTC) was established in 2006 at our center. We hypothesized that geographic distance would not be associated with inferior outcome if patients are followed in the LTTC. We studied 299 consecutive patients who underwent HSCT and established care in an LTTC. The median distance from the transplant center was 118 miles (range, 1 to 1591). The 75th percentile (170 miles) was used as the cut-off to analyze the impact of distance from the center on outcome (219 patients ≤ 75th percentile; 80 patients >75th percentile). The 2 groups were balanced for pretransplant characteristics. In multivariate analyses adjusted for donor type, Center for International Blood and Marrow Transplant Research risk, and transplant regimen intensity, distance from transplant center did not impact outcome. Our study suggests that geographic distance from the transplant center is not associated with inferior outcome when follow-up care is delivered via a dedicated LTTC incorporating well-coordinated multidisciplinary care.
Published by Elsevier Inc.
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15 MeSH Terms
Allogeneic hematopoietic stem cell transplantation for infants with idiopathic myelofibrosis.
Hussein AA, Hamadah T, Domm J, Al-Zaben A, Frangoul H
(2013) Pediatr Transplant 17: 815-9
MeSH Terms: Blood Platelets, Busulfan, Child, Preschool, Cohort Studies, Cyclophosphamide, Female, Follow-Up Studies, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Immunosuppressive Agents, Infant, Male, Neutrophils, Primary Myelofibrosis, Stem Cells, Transplantation Conditioning, Treatment Outcome
Show Abstract · Added March 7, 2014
IMF is a rare disease in children that can present during infancy and has a protracted course. The only known curative approach for this disease in adult patients is allogeneic HSCT. There are very few reports describing the long-term outcome of young children following stem cell transplantation for IMF. We report on eight patients less than two yr of age with IMF that did not resolve with supportive care measures. All patients underwent myeloablative conditioning regimen with busulfan and cyclophosphamide ± ATG followed by HSCT from matched related (n = 6) or unrelated donor (n = 2). All patients achieved neutrophil and platelet engraftment. Four patients had grade II-III acute GVHD, and chronic GVHD developed in five patients (three mild and two severe). At a median follow-up of eight and a half yr (0.7-9), all patients are alive with complete resolution of their hematologic manifestations. At the last follow-up, all patients had normal endocrine function except for one patient who developed hypothyroidism. To date, this is the largest cohort of young children with IMF treated successfully with HSCT, with the longest duration of follow-up. In conclusion, our study showed that HSCT is a curative option for infants with IMF.
© 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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18 MeSH Terms
Six-month freedom from treatment failure is an important end point for acute GVHD clinical trials.
Sengsayadeth S, Savani BN, Jagasia M, Goodman S, Greer JP, Chen H, Chinratanalab W, Kassim AA, Engelhardt BG
(2014) Bone Marrow Transplant 49: 236-40
MeSH Terms: Acute Disease, Adult, Aged, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Survival Analysis, Transplantation Conditioning, Transplantation, Homologous, Treatment Failure, Treatment Outcome
Show Abstract · Added March 20, 2014
We studied the American Society for Blood and Marrow Transplantation (ASBMT) 6-month (m) freedom from treatment failure (FFTF) as a predictor of survival for patients with acute GVHD (aGVHD) requiring treatment. Adult patients undergoing allogeneic hematopoietic cell transplant (HCT) from February 2007 to March 2009 who were enrolled in a prospective biomarker clinical trial and developed aGVHD requiring systemic corticosteroids by day +100 were included (N=44). Six-month FFTF was defined as per the ASBMT guidelines (absence of death, malignancy relapse/progression or systemic immunosuppression change within 6 months of starting steroids and before chronic GVHD development). aGVHD was treated with systemic corticosteroids in 44 patients. Day 28 response after steroid initiation (complete response+very good partial response+partial response) occurred in 38 (87%) patients, but only 28 (64%) HCT recipients met the 6-m FFTF end point. Day 28 response predicted 6-m FFTF. Achieving 6-m FFTF was associated with improved 2-year (y) OS (81% vs 48%; P=0.03) and decreased 2-y non-relapse mortality (8% vs 49%; P=0.01). In multivariate analysis, 6-m FFTF continued to predict improved OS (hazard ratio, 0.27; P=0.03). The 6-m FFTF end point measures fixed outcomes, predicts long-term therapeutic success and could be less prone to measurement error than aGVHD clinical response at day 28.
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14 MeSH Terms
Comorbidity burden in patients with chronic GVHD.
Wood WA, Chai X, Weisdorf D, Martin PJ, Cutler C, Inamoto Y, Wolff D, Pavletic SZ, Pidala J, Palmer JM, Arora M, Arai S, Jagasia M, Storer B, Lee SJ, Mitchell S
(2013) Bone Marrow Transplant 48: 1429-36
MeSH Terms: Adolescent, Adult, Aged, Child, Child, Preschool, Chronic Disease, Comorbidity, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Prospective Studies, Transplantation Conditioning, Treatment Outcome, Young Adult
Show Abstract · Added March 20, 2014
Chronic GVHD (cGVHD) is associated with mortality, disability and impaired quality of life. Understanding the role of comorbidity in patients with cGVHD is important both for prognostication and potentially for tailoring treatments based on mortality risks. In a prospective cohort study of patients with cGVHD (n=239), we examined the performance of two comorbidity scales, the Functional Comorbidity Index (FCI) and the Hematopoietic Cell Transplantation-specific Comorbidity Index (HCT-CI). Both scales detected a higher number of comorbidities at cGVHD cohort enrollment than pre-hematopoietic cell transplant (HCT) (P<0.001). Higher HCT-CI scores at the time of cGVHD cohort enrollment were associated with higher non-relapse mortality (HR: 1.21:1.04-1.42, P=0.01). For overall mortality, we detected an interaction with platelet count. Higher HCT-CI scores at enrollment were associated with an increased risk of overall mortality when the platelet count was ≤ 100,000/μL (HR: 2.01:1.20-3.35, P=0.01), but not when it was >100,000/μL (HR: 1.05:0.90-1.22, P=0.53). Comorbidity scoring may help better to predict survival outcomes in patients with cGVHD. Further studies to understand vulnerability unrelated to cGVHD activity in this patient population are needed.
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17 MeSH Terms
T cell-specific notch inhibition blocks graft-versus-host disease by inducing a hyporesponsive program in alloreactive CD4+ and CD8+ T cells.
Sandy AR, Chung J, Toubai T, Shan GT, Tran IT, Friedman A, Blackwell TS, Reddy P, King PD, Maillard I
(2013) J Immunol 190: 5818-28
MeSH Terms: Animals, CD4-Positive T-Lymphocytes, CD8-Positive T-Lymphocytes, Cytotoxicity, Immunologic, Enzyme Activation, Gene Expression Regulation, Graft vs Host Disease, Interferon-gamma, Lymphocyte Activation, Mice, Mitogen-Activated Protein Kinases, NF-kappa B, Proto-Oncogene Proteins p21(ras), Receptors, Notch, T-Box Domain Proteins, T-Lymphocytes, Regulatory
Show Abstract · Added March 7, 2014
Graft-versus-host disease (GVHD) induced by donor-derived T cells remains the major limitation of allogeneic bone marrow transplantation (allo-BMT). We previously reported that the pan-Notch inhibitor dominant-negative form of Mastermind-like 1 (DNMAML) markedly decreased the severity and mortality of acute GVHD mediated by CD4(+) T cells in mice. To elucidate the mechanisms of Notch action in GVHD and its role in CD8(+) T cells, we studied the effects of Notch inhibition in alloreactive CD4(+) and CD8(+) T cells using mouse models of allo-BMT. DNMAML blocked GVHD induced by either CD4(+) or CD8(+) T cells. Both CD4(+) and CD8(+) Notch-deprived T cells had preserved expansion in lymphoid organs of recipients, but profoundly decreased IFN-γ production despite normal T-bet and enhanced Eomesodermin expression. Alloreactive DNMAML T cells exhibited decreased Ras/MAPK and NF-κB activity upon ex vivo restimulation through the TCR. In addition, alloreactive T cells primed in the absence of Notch signaling had increased expression of several negative regulators of T cell activation, including Dgka, Cblb, and Pdcd1. DNMAML expression had modest effects on in vivo proliferation but preserved overall alloreactive T cell expansion while enhancing accumulation of pre-existing natural regulatory T cells. Overall, DNMAML T cells acquired a hyporesponsive phenotype that blocked cytokine production but maintained their expansion in irradiated allo-BMT recipients, as well as their in vivo and ex vivo cytotoxic potential. Our results reveal parallel roles for Notch signaling in alloreactive CD4(+) and CD8(+) T cells that differ from past reports of Notch action and highlight the therapeutic potential of Notch inhibition in GVHD.
1 Communities
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16 MeSH Terms
Extracorporeal photopheresis versus anticytokine therapy as a second-line treatment for steroid-refractory acute GVHD: a multicenter comparative analysis.
Jagasia M, Greinix H, Robin M, Das-Gupta E, Jacobs R, Savani BN, Engelhardt BG, Kassim A, Worel N, Knobler R, Russell N, Socie G
(2013) Biol Blood Marrow Transplant 19: 1129-33
MeSH Terms: Acute Disease, Adolescent, Adrenal Cortex Hormones, Adult, Aged, Antineoplastic Agents, Child, Child, Preschool, Cytokines, Drug Administration Schedule, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Photopheresis, Prognosis, Retrospective Studies, Survival Analysis, Transplantation Conditioning, Transplantation, Homologous, Treatment Outcome
Show Abstract · Added March 5, 2014
The optimal therapy for steroid-refractory (SR) acute graft-versus-host disease (aGVHD) is undefined. We studied patients with SR aGVHD, comparing extracorporeal photopheresis (ECP; n = 57) and anticytokine therapy (n = 41). In multivariate analyses, ECP, adjusted for steroid dose (odds ratio, 3.42; P = .007), and grade >II aGVHD (odds ratio, 68; P < .001) were independent predictors of response. ECP therapy, adjusted for conditioning regimen intensity and steroid dose, was associated with superior survival (hazard ratio [HR], 4.6; P = .016) in patients with SR grade II aGVHD. Grade >II aGVHD at onset of salvage therapy (HR, 9.4; P < .001) and lack of response to therapy (HR, 3.09; P = .011) were associated with inferior survival. These findings require validation in a prospective randomized study.
Copyright © 2013 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
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23 MeSH Terms
Hand grip strength and 2-minute walk test in chronic graft-versus-host disease assessment: analysis from the Chronic GVHD Consortium.
Pidala J, Chai X, Martin P, Inamoto Y, Cutler C, Palmer J, Weisdorf D, Pavletic S, Arora M, Jagasia M, Jacobsohn D, Lee SJ
(2013) Biol Blood Marrow Transplant 19: 967-72
MeSH Terms: Adolescent, Adult, Aged, Biomarkers, Child, Child, Preschool, Chronic Disease, Female, Graft vs Host Disease, Hand Strength, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Multivariate Analysis, Prospective Studies, Quality of Life, Recurrence, Severity of Illness Index, Survival Analysis, Transplantation, Homologous, Treatment Outcome, Walking
Show Abstract · Added March 20, 2014
Hand grip strength (HGS) and the 2-minute walk test (2MWT) have been proposed as elements of chronic graft-versus-host disease (GVHD) assessment in clinical trials. Using all available data (n = 584 enrollment visits, 1689 follow-up visits, total of 2273 visits) from a prospective observational cohort study, we explored the relationship between HGS and 2MWT and patient-reported measures (Lee symptom scale, MOS 36-Item Short-Form Health Survey [SF-36], and Functional Assessment of Cancer Therapy [FACT]-Bone Marrow Transplantation quality of life instruments and Human Activity Profile [HAP]), chronic GVHD global severity (National Institutes of Health global score, clinician global score, and patient-reported global score), calculated and clinician-reported chronic GVHD response, and mortality (overall survival, nonrelapse mortality, and failure-free survival) in multivariable analyses adjusted for significant covariates. 2MWT was significantly associated with intuitive domains of the Lee Symptom Scale (overall, skin, lung, energy), SF-36 domain and summary scores, FACT summary and domain scores, and HAP scores (all P < .001). Fewer associations were detected with the HGS. The 2MWT and HGS both had significant association with global chronic GVHD severity. In multivariable analysis, 2MWT was significantly associated with overall survival, nonrelapse mortality, and failure-free survival, whereas no association was found for HGS. 2MWT and HGS were not sensitive to National Institutes of Health or clinician-reported response. Based on independent association with mortality, these data support the importance of the 2MWT for identification of high-risk chronic GVHD patients. However, change in 2MWT is not sensitive to chronic GVHD response, limiting its usefulness in clinical trials.
Copyright © 2013 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
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23 MeSH Terms
Analysis of gastrointestinal and hepatic chronic graft-versus-host [corrected] disease manifestations on major outcomes: a chronic graft-versus-host [corrected] disease consortium study.
Pidala J, Chai X, Kurland BF, Inamoto Y, Flowers ME, Palmer J, Khera N, Jagasia M, Cutler C, Arora M, Vogelsang G, Lee SJ
(2013) Biol Blood Marrow Transplant 19: 784-91
MeSH Terms: Adolescent, Adult, Aged, Child, Child, Preschool, Chronic Disease, Cohort Studies, Female, Gastrointestinal Tract, Graft vs Host Disease, Humans, Liver Diseases, Male, Middle Aged, Prognosis, Young Adult
Show Abstract · Added March 20, 2014
Although data support adverse prognosis of overlap subtype of chronic grant-versus-host disease (GVHD), the importance of site of gastrointestinal (GI) and type of hepatic involvement is not known. Using data from the Chronic GVHD Consortium observational cohort study (N = 567, total of 2115 visits), we examined whether the site of GI (esophageal, upper GI, or lower GI) and type of hepatic (bilirubin, alkaline phosphatase, alanine aminotransferase) involvement are associated with overall survival (OS) and nonrelapse mortality (NRM), symptoms, quality of life (QOL) and functional status measures. In multivariate analysis utilizing data from enrollment visits only, lower GI involvement (HR, 1.67; P = .05) and elevated bilirubin (HR, 2.46; P = .001) were associated with OS; both were also associated with NRM. In multivariable analysis using all visits (time-dependent covariates), GI score greater than zero (HR, 1.69; P = .02) and elevated bilirubin (HR, 3.73; P < .001) were associated with OS; results were similar for NRM. Any esophageal involvement and GI score greater than zero were associated with both symptoms and QOL, whereas elevated bilirubin was associated with QOL. We found no consistent evidence that upper GI involvement, alkaline phosphatase, alanine aminotransferase, or NIH liver score add prognostic value for survival, overall symptom burden, or QOL. These data support important differences in patient-reported outcomes according to GI and hepatic involvement among chronic GVHD-affected patients and identify those with elevated bilirubin or higher GI score at any time, or lower GI involvement at cohort enrollment, as patients at greater risk for mortality under current treatment approaches.
Copyright © 2013 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
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16 MeSH Terms
Measurement of oral chronic GVHD: results from the Chronic GVHD Consortium.
Treister N, Chai X, Kurland B, Pavletic S, Weisdorf D, Pidala J, Palmer J, Martin P, Inamoto Y, Arora M, Flowers M, Jacobsohn D, Jagasia M, Arai S, Lee SJ, Cutler C
(2013) Bone Marrow Transplant 48: 1123-8
MeSH Terms: Adolescent, Adult, Aged, Child, Child, Preschool, Chronic Disease, Cohort Studies, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Mouth Diseases, National Institutes of Health (U.S.), Prospective Studies, Quality of Life, United States, Young Adult
Show Abstract · Added March 20, 2014
Oral chronic GVHD (cGVHD) is a serious complication of alloSCT. Scales and instruments to measure oral cGVHD activity and severity have not been prospectively validated. The objective of this study was to describe the characteristics of oral cGVHD and determine the measures most sensitive to change. Patients enrolled in the cGVHD Consortium with oral involvement were included. Clinicians scored oral changes according to the National Institutes of Health (NIH) criteria, and patients completed symptom and quality-of-life measures at each visit. Both rated change on an eight-point scale. Of the 458 participants, 72% (n=331) had objective oral involvement at enrollment. Lichenoid change was the most common feature (n=293; 89%). At visits where oral change could be assessed, 50% of clinicians and 56% of patients reported improvement, with worsening reported in 4-5% for both the groups (weighted kappa=0.41). Multivariable regression modeling suggested that the measurement changes most predictive of perceived change by clinicians and patients were erythema and lichenoid, NIH severity and symptom scores. Oral cGVHD is common and associated with a range of signs and symptoms. Measurement of erythema and lichenoid changes and symptoms may adequately capture the activity of oral cGVHD in clinical trials but require prospective validation.
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19 MeSH Terms