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Yahng, Seung-Ah,Jang, Eun-Jung,Choi, Soo-Young,Lee, Sung-Eun,Kim, Soo-Hyun,Kim, Dong-Wook Elsevier Science Publishers 2014 INTERNATIONAL JOURNAL OF HEMATOLOGY Vol.100 No.2
<P>Beyond the conventional Sokal and Euro scores, a new prognostic risk classification, based on the European Treatment Outcome Study (EUTOS), has been developed to predict the outcome of treatment with tyrosine kinase inhibitors (TKI) in chronic myeloid leukemia (CML). In the present study, each risk score was validated by various endpoints in 206 Korean patients with early chronic-phase CML treated with up-front standard dose imatinib. In our analysis, all three scores were found to be valid. The 5-year event-free survival (EFS) was significantly discriminated using Sokal (P = 0.002), Euro (P = 0.003), and EUTOS (P = 0.029), with the worst probability by Euro high-risk (62 vs. 49 vs. 67 %) and better EFS in Sokal low-risk (89 vs. 86 vs. 82 %). Combining all scores identified 6 % of all patients having homogeneous high-risk with distinctively worse outcomes (5-year EFS of 41 %, cumulative complete cytogenetic response rate of 56 %, and cumulative major molecular response rate of 27 %), whereas the group of discordance in risk scores (60 %) had similar results to those of intermediate-risk groups of Sokal and Euro scores. Combining all risk scores for baseline risk assessment may be useful in clinical practice for identifying groups of patients who may benefit from treatment initiation with a more potent TKI among the currently available first-line TKIs.</P>
Yi, Hyeon Gyu,Yahng, Seung-Ah,Kim, Inho,Lee, Je-Hwan,Min, Chang-Ki,Kim, Jun Hyung,Kim, Chul Soo,Song, Sun U. The Korean Society of Pharmacology 2016 The Korean Journal of Physiology & Pharmacology Vol.20 No.1
Severe graft-versus-host disease (GVHD) is an often lethal complication of allogeneic hematopoietic stem cell transplantation (HSCT). The safety of clinical-grade mesenchymal stem cells (MSCs) has been validated, but mixed results have been obtained due to heterogeneity of the MSCs. In this phase I study, the safety of bone marrow-derived homogeneous clonal MSCs (cMSCs) isolated by a new subfractionation culturing method was evaluated. cMSCs were produced in a GMP facility and intravenously administered to patients who had refractory GVHD to standard treatment resulting after allogeneic HSCT for hematologic malignancies. After administration of a single dose ($1{\times}10^6cells/kg$), 11 patients were evaluated for cMSC treatment safety and efficacy. During the trial, nine patients had 85 total adverse events and the rate of serious adverse events was 27.3% (3/11 patients). The only one adverse drug reaction related to cMSC administration was grade 2 myalgia in one patient. Treatment response was observed in four patients: one with acute GVHD (partial response) and three with chronic GVHD. The other chronic patients maintained stable disease during the observation period. This study demonstrates single cMSC infusion to have an acceptable safety profile and promising efficacy, suggesting that we can proceed with the next stage of the clinical trial.
Hyeon Gyu Yi,Seung-Ah Yahng,Inho Kim,Je-Hwan Lee,Chang-Ki Min,Jun Hyung Kim,Chul Soo Kim,Sun U. Song 대한생리학회-대한약리학회 2016 The Korean Journal of Physiology & Pharmacology Vol.20 No.1
Severe graft-versus-host disease (GVHD) is an often lethal complication of allogeneic hematopoietic stem cell transplantation (HSCT). The safety of clinicalgrade mesenchymal stem cells (MSCs) has been validated, but mixed results have been obtained due to heterogeneity of the MSCs. In this phase I study, the safety of bone marrow-derived homogeneous clonal MSCs (cMSCs) isolated by a new subfractionation culturing method was evaluated. cMSCs were produced in a GMP facility and intravenously administered to patients who had refractory GVHD to standard treatment resulting after allogeneic HSCT for hematologic malignancies. After administration of a single dose (1×10<sup>6</sup> cells/kg), 11 patients were evaluated for cMSC treatment safety and efficacy. During the trial, nine patients had 85 total adverse events and the rate of serious adverse events was 27.3% (3/11 patients). The only one adverse drug reaction related to cMSC administration was grade 2 myalgia in one patient. Treatment response was observed in four patients: one with acute GVHD (partial response) and three with chronic GVHD. The other chronic patients maintained stable disease during the observation period. This study demonstrates single cMSC infusion to have an acceptable safety profile and promising efficacy, suggesting that we can proceed with the next stage of the clinical trial.
Cho, Byung-Sik,Yahng, Seung-Ah,Lee, Sung-Eun,Eom, Ki-Seong,Kim, Yoo-Jin,Kim, Hee-Je,Lee, Seok,Min, Chang-Ki,Cho, Seok-Goo,Kim, Dong-Wook,Lee, Jong-Wook,Min, Woo-Sung,Park, Chong-Won Lippincott Williams Wilkins, Inc. 2010 Transplantation Vol.90 No.8
BACKGROUND.: The lack of an accepted definition of transplantation-associated thrombotic microangiopathy (TMA) has led the Blood and Marrow Transplants Clinical Trials Network (CTN) and International Working Group (IWG) to propose a definition for TMA with some differences. However, there have been few studies validating and comparing both newly proposed criteria for TMA. METHODS.: To validate recently proposed criteria for TMA by CTN and IWG, we analyzed 672 patients who underwent allogeneic stem-cell transplantation between January 2002 and December 2006. RESULTS.: The cumulative incidences of TMA by CTN and IWG were 6.1% and 2.5%, respectively. The cumulative incidence of overall TMA (O-TMA) including probable-TMA defined as meeting CTN criteria without renal or neurologic dysfunction, as well as TMA by CTN (definite-TMA), was 12.7%. Sixty-six percent of TMA by CTN did not have any degree of schistocytosis by IWG criteria (≥4%), and 18% of TMA by IWG criteria did not have renal or neurologic dysfunction. On multivariate analyses, probable-TMA as well as definite-TMA adversely affected the survival of a cohort including all patients. In patients with O-TMA, the degree of schistocytosis (≥4% or not) failed to show prognostic significance, whereas renal involvement was a significant prognostic factor associated with poor survival. CONCLUSIONS.: Both proposed consensus criteria have major pitfalls in their use as uniformly accepted diagnostic criteria for TMA. The use of O-TMA as a broad definition for TMA and the grading system by the presence of renal involvement may be a counterproposal for future trials.
Lee, Sung-Eun,Lim, Jihyang,Yahng, Seung-Ah,Cho, Byung-Sik,Eom, Ki-Seong,Kim, Myungshin,Kim, Yoo-Jin,Kim, Hee-Je,Min, Chang-Ki,Lee, Seok,Kim, Dong-Wook,Lee, Jong-Wook,Min, Woo-Sung,Park, Chong-Won,Cho, S. Karger AG 2011 Acta haematologica Vol.126 No.1
<P>Abstract</P><P>Although reduced-intensity conditioning (RIC) has been increasingly used in patients with myelodysplastic syndrome (MDS) to reduce transplant-related mortality, a high relapse rate in RIC remains an unresolved problem. Considering the additive antileukemic effect of low-dose total body irradiation (TBI), we evaluated the feasibility of combining RIC regimens with low-dose TBI in de novo MDS. The RIC regimen combined with low-dose TBI in this study consisted of fludarabine (150 mg/m<SUP>2</SUP>), intravenous busulfan (6.4 mg/kg), and TBI (400 cGy). Antithymocyte globulin was used to overcome HLA mismatching. A total of 31 subjects were recruited with a median age of 39 years (range 19–63). The patients received transplants from siblings (n = 20) or unrelated donors (n = 11). All patients rapidly achieved full-donor chimerism. At a median follow-up for survivors of 35 months (range 6.0–54.9), the 3-year overall survival, event-free survival, transplantation-related mortality, and relapse rates were 67.6, 63.2, 20.5 and 11.4%, respectively. The 3-year cumulative incidence of acute (grades II–IV) and chronic extensive graft-versus-host disease in patients who survived at least 100 days was 39.2 and 44.6%, respectively. These results suggest that an RIC combined with low-dose TBI may be a feasible therapeutic approach for treating de novo MDS.</P><P>Copyright © 2011 S. Karger AG, Basel</P>
Cho, Byung-Sik,Min, Gi-June,Park, Sung-Su,Shin, Seung-Hwan,Yahng, Seung-Ah,Jeon, Young-Woo,Yoon, Jae-Ho,Lee, Sung-Eun,Eom, Ki-Seong,Kim, Yoo-Jin,Lee, Seok,Min, Chang-Ki,Cho, Seok-Goo,Kim, Dong-Wook,Le Elsevier 2019 BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION Vol.25 No.10
<P><B>ABSTRACT</B></P> <P>The absence of relevant guidelines for <I>Wilms tumor 1</I> (<I>WT1</I>) gene quantification as a measurable residual disease (MRD) assessment for patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) has limited the widespread use in practice. We investigated optimal time points, thresholds, and candidates for the bone marrow <I>WT1</I> MRD assay in 425 consecutive patients with AML who underwent allo-HSCT. <I>WT1</I> expression kinetics before allo-HSCT and at 1 or 3 months after allo-HSCT were determined by real-time PCR using the European LeukemiaNet (ELN) normalized method. Relapsed patients had significantly higher <I>WT1</I> levels before allo-HSCT and at 3 months after allo-HSCT. The best time point for the <I>WT1</I> MRD assay was before allo-HSCT by the receiver operating characteristic curve. Among various thresholds, 250 copies recommended from ELN researchers were mostly predictive of post-transplant relapse. In multivariate analysis, <I>WT1</I> MRD positivity independently predicted relapse, resulting in inferior survival. In subgroup analyses, pretransplant <I>WT1</I> MRD positivity was predictive of post-transplant relapse in the intermediate group, whereas <I>WT1</I> MRD positivity occurred at 3 months after allo-HSCT in favorable and adverse risk groups. Among MRD-positive patients before allo-HSCT, all patients who were MRD positive at 3 months relapsed within 6 months. The <I>WT1</I> MRD assay before allo-HSCT or 3 months after allo-HSCT is useful for predicting post-transplant relapse with a different significance in each risk group by time points, showing the benefit of multiple tests over time. Such monitoring is particularly available in patients with AML without specific molecular targets.</P> <P><B>Highlights</B></P> <P> <UL> <LI> <I>WT1</I> assay is useful for predicting post-transplant relapse in acute myeloid leukemia (AML). </LI> <LI> Optimal threshold for the <I>WT1</I> assay would be 250 copies/10<SUP>4</SUP> copies of <I>ABL1</I>. </LI> <LI> <I>WT1</I> assay is particularly available in AML without specific molecular targets. </LI> <LI> <I>WT1</I> assay in each risk group by time points have different significance. </LI> </UL> </P>
Lee, Sung‐,Eun,Min, Chang‐,Ki,Yahng, Seung‐,Ah,Cho, Byung‐,Sik,Eom, Ki‐,Seong,Kim, Yoo‐,Jin,Kim, Hee‐,Je,Lee, Seok,Cho, Seok‐,Goo,Kim, Dong‐,Wook Blackwell Publishing Ltd 2011 European journal of haematology Vol.86 No.1
<P><B>Abstract</B></P><P>Osteolytic lesions with activated osteoclast (OC) and suppressed osteoblast (OB) activity are characteristics of myeloma bone lesion. Recently, it has been shown that bortezomib treatment enhances OB function. To evaluate the effect of bortezomib on myeloma bone lesions, we performed bone scans, where increased uptake of the radiopharmaceutical by OBs is associated with re‐building activity. Bortezomib treatment markedly enhanced bone metabolic activity and increased alkaline phosphatase levels, and decreased monoclonal protein levels. These findings suggest that bortezomib has potent anti‐myeloma activity and bone‐protecting effects, with enhanced OB function.</P>