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  • 1
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    Prognostic Value Of Five-Group Cytogenetic Risk Classification In Patients With MDS After Allogeneic Hematopoietic Stem Cell Transplantation: A Retrospective Multicenter Study Of The Chronic Malignancies Working Party Of The EBMT
    American Society of Hematology ; 2013
    In:  Blood Vol. 122, No. 21 ( 2013-11-15), p. 2092-2092
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    In: Blood, American Society of Hematology, Vol. 122, No. 21 ( 2013-11-15), p. 2092-2092
    Abstract: The only curative treatment approach for patients with myelodysplastic syndromes (MDS) is allogeneic hematopoietic stem cell transplantation (HSCT), but disease relapse after transplantation is a major concern. Predictors for disease outcome after HSCT are limited. However, unfavorable cytogenetic abnormalities have been shown to serve as predictors for MDS-relapse after transplantation. Similar to the data available in MDS-patients not undergoing HSCT (Schanz et al. J Clin Oncol 2012), there is evidence that the novel 5-group cytogenetic classification has a better predictive value for outcome after HSCT than standard IPSS cytogenetics (Deeg et al. Blood 2012). The aim of this large multicentric, international study was to retrospectively determine the impact of the new 5-group cytogenetic MDS classification on outcome after HSCT. Patients and Methods Patients were selected from the EBMT database who had received HSCT for the treatment of MDS between 1982 and 2010 and for whom sufficient cytogenetic information was available. In total, 903 patients were included into the study. At time of HSCT, 97 (10.7%) patients had untreated MDS, 218 (24.1%) patients had advanced MDS or AML evolving from MDS in complete remission, and 227 (25.1%) patients were not in remission after treatment (in 12.3% information on stage of the disease was not available). Median time between diagnosis and transplant was 6.6 months (range 0.2-359.3). Matched related donor HSCT was performed in 574 patients (63.6%), and matched unrelated donor HSCT in 329 patients (36.4%). Bone marrow (35.4%) or peripheral blood (64.6%) served as stem cell graft. Myeloablative preparative regimens were used in 582 patients (64.5%), and a non-myeloablative regimen was given to 320 patients (35.4%). Impact of cytogenetic classification was analyzed in uni- and multivariate models regarding overall survival (OS) and relapse free survival (RFS) after HSCT. Predictive performance of the 2 classifications was compared by means of the cross-validated log partial likelihood. Results Estimated 5-year RFS and OS were 32% and 36% respectively. According to the 5-group cytogenetic classification 19 (2.1%) patients had very good risk cytogenetics, 204 (22.6%) normal risk cytogenetics, 438 (48.5%) intermediate risk cytogenetics, 178 (19.7%) poor risk cytogenetics, and 64 (7.1%) very poor risk cytogenetics. Good, intermediate, and poor risk cytogenetics according to IPSS were found in 192 (38.0%), 500 (40.2%), and 211 (23.7%) patients, respectively. In univariate analysis 5-group cytogenetic information was found to be strongly associated with OS and RFS (OS: log-rank test P 〈 .01, RFS: P 〈 .01) (Figure 1). Further clinicopathologic factors showed a significant impact on impaired OS and RFS: Disease status at HSCT (RA/RARS no pretreatment; RAEB(t)/sAML in CR; RAEB(t)/sAML not in CR, RAEB(t)/sAML untreated) (OS: P 〈 .01, RFS: P 〈 .01) and IPSS cytogenetics (good; intermediate; poor) (OS: P 〈 .01, RFS: P 〈 .01). Patient age showed an impact for RFS (P=.05), but not for OS (P=.09). In multivariate analysis, statistically significant predictors for RFS and OS at HSCT were 5-group cytogenetics, IPSS-cytogenetics, disease status and patient's age. Using 5-group cytogenetics classification, patients with poor risk [(RFS: P=.001, HR=1.40 (95% CI: 1.15-1.71); OS: P=.003, HR=1.38 (95% CI: 1.12-1.70)] or very poor risk cytogenetics [(RFS: P 〈 .001, HR=2.14 (95% CI: 1.6-2.9); OS: P 〈 .001, HR=2.14 (95% CI: 1.59-2.87)] had worse RFS and OS than patients in the other 3 risk groups. Patients with very poor risk cytogenetics had worse RFS and OS compared to patients with poor risk cytogenetics [(RFS: P 〈 .01, HR=1.53 (95-% CI: 1.11-2.11), OS: P 〈 .01, HR=1.55 (95-% CI: 1.11-2.15)]. When comparing the predictive performance of a series of 3 models both for OS and for RFS – (1) with only classical risk factors, (2) these extended with IPSS cytogenetics, (3) extended with 5-group classification instead-, the model with 5-group cytogenetics performed best. Conclusion In this international, multicentric analysis we confirm that MDS patients with poor and very poor risk cytogenetics had significantly worse RFS and OS after HSCT than patients in the other risk groups of the 5-group cytogenetic classifier. New therapeutic strategies to prevent relapse after HSCT in patients with poor or very poor cytogenetics are urgently needed. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V122.21.2092.2092
    RVK:
    XA 33000
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2013
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  • 2
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    Allogeneic Stem Cell Transplantation for MDS Patients More Than 70 Years of Age: a Retrospective Study of the MDS Subcommittee of the Chronic Malignancies Working Party (CMWP) of the EBMT
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 4390-4390
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    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 4390-4390
    Abstract: Introduction Myelodysplastic syndromes (MDS) are diagnosed at median age of 70 years. Allogeneic stem cell transplantation (HSCT) is the only curative treatment option, but with an increasing age, morbidity escalates. Treatment guidelines suggest HSCT for intermediate-II and high risk constellations up to the age of 65, and reduced intensity conditioning (RIC) regimens are commonly used up to 70 years of age. However, increasing life expectancy, availability of RIC regimens and good Karnofsky performance status (KPS) of MDS patients more than 70 years of age, has led to an increased use of HSCT. We performed a retrospective analysis to investigate results after HSCT for those patients and influence of KPS on outcome. Patients and methods We analyzed data of 345 patients in the EMBT database older than 70 years with MDS/sAML. The disease status at transplantation was available in 233 patients and most of the them were in more advanced stage of the disease: RA/RARS,RCMD (n=25) , RAEB (n=68) and RAEB-T/secondary acute leukemia (sAL, n=140). Donor were: related (n=88) and unrelated (n=257). Cytogenetic data were available only in 73 patients and classified as good (58), intermediate (6), poor (5) and very poor (4). Median follow up was 29.7 months. Median age at transplantation was 72 years (70-79 years) with 249 male and 96 female patients. KPS was defined in 300 cases, being 90-100% in 61% and 80% or less in 39%. Stem cell source was peripheral blood (94%) or bone marrow (6%). The intensity of the conditioning regimen was mainly reduced intensity (78%) rather than myeloablative (22%). Negative or positive CMV sero-status of the patient were seen in 35% and 65%, respectively. Results The number of HSCT for MDS patients of 70 years or more has increased over time. While 2000-2004 only 19 patients received transplantation, the following 3-year periods included 28 (2005-2007), 97 (2008-2010) and 200 (2011-2013) patients, respectively. The estimated 3-year OS was 33% (27-39%). A significant better 3 year OS in the univariate analysis was seen for Karnofsky (90-100%) vs 80% or less (41 vs 23%, p=0.008) and for CMV negative sero-status (46% vs 27%, p 〉 〈 0.001) while disease status, remission status, intensity of the conditioning regimen, and donor source did not influence OS significantly. The cumulative incidence of relapse at 3 years was 40% (95% CI: 32-48) and significantly lower with unrelated than related donors (24% vs 43%, p =0.004). There was only a trend for a lower incidence of relapse after myeloablative conditioning in comparison to RIC (22% vs 31%, p=0.09), while remission status, T-cell depletion or disease stage did not influence the risk of relapse. The cumulative incidence of non-relapse mortality at 1 year was 36% (95% CI: 30-42) and significantly influenced by CMV sero-negativity of the recipient (22% vs 38%, p=0.02) and by Karnofsky index 90-100% (29% vs 34% and at 2 years: 32% vs 46%, p=0.01). A trend for lower NRM was seen for related donors (24% vs 35%, p=0.07) and after reduced intensity conditioning (29% vs 41%, p=0.09). No impact on NRM was seen for disease and remission status. In a multivariate analysis (MVA) significant factor for improved OS was Karnofsky index of 90-100% (HR 0.65: 95% CI: 0.48-0.88, p=0.001) and for worse survival CMV sero-positivity (HR 1.61; 95% CI: 1.15-2.21, p 〈 0.001). For relapse the only significant factor was the use of unrelated donors (HR 0.50; 95% CI: 0.32-0.80, p=0.004). Significant factors for NRM in the MVA were Karnofsky index 90-100% (HR 0.63; 95% CI: 0.42-0.96, p=0.03), CMV sero-positivity of the recipient (HR 1.76; 95% CI: 1.12-2.76, p=0.001) and unrelated donors (HR 1.67; 95% CI: 0.16-2.76, p=0.04). Conclusion HSCT from related or unrelated donor after myeloablative or dose reduced intensity conditioning for advanced MDS patients 70-years and more is a curative treatment option with a 3-year OS of 33%. Good performance, determined by KPS, and sero-negativity for CMV in the patient increase the 3 year estimated overall survival to 41 and 46%, respectively. Disclosures Platzbecker: Boehringer: Research Funding; Novartis: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Niederwieser:Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Einsele:Novartis: Consultancy, Honoraria, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Amgen/Onyx: Consultancy, Honoraria, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau. Tischer:Sanofi-Aventis: Other: advisory board. Nagler:Novaratis Pharmaceuticals Corporation: Consultancy, Honoraria, Research Funding. Glass:Roche, MSD, Takeda, Riemser, Ctilifesciences: Honoraria, Research Funding. Sill:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. de Witte:Novartis: Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.4390.4390
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    XA 33000
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    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 3
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    The EBMT Score Predicts Transplant Related Mortality and Overall Survival after Allogeneic Stem Cell Transplantation for Myelodysplastic Syndromes
    American Society of Hematology ; 2015
    In:  Blood Vol. 126, No. 23 ( 2015-12-03), p. 3223-3223
    Details
    In: Blood, American Society of Hematology, Vol. 126, No. 23 ( 2015-12-03), p. 3223-3223
    Abstract: Introduction: Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) is still the only curative treatment for myelodysplastic syndromes (MDS). However, the so far perceived high transplant related mortality (TRM) limits the number of patients referred for alloSCT. Materials (or patients) and methods: We retrospectively analyzed 9741 consecutive patients diagnosed with primary or secondary MDS aged 18 or older undergoing allogeneic transplantation at EBMT centers between 1997 and 2013. Cord blood and haploidentical donors and second or further transplants were excluded. Results: Patients´ characteristics: Median age at time of transplant was 54.9 years (18-79) with 5804 patients (60%) being male. WHO classification at transplant (available from 2009) in 4033 patients showed: 634 (16%) patients with RA/RARS/del5q, 406 (10%) with RCMD (+/-RS), 964 (24%) with RAEB-1, 1707 (42%) with RAEB-2 and 322 (8%) with secondary AML. A total of 1437 (19%) patients had secondary MDS. Transplant characteristics: Peripheral blood was the preferred source of stem cells (82.5%).The conditioning was reduced intensity in 4987 (53%) and myeloablative in 4492 (47%). The reasons for RIC included institutional protocol (44%), patient age (38%) and co-morbidities (14%).Donor was unrelated in 5475 (56%) patients and an HLA-identical sibling in 4266 (44%). GvHD prophylaxis consisted of cyclosporine and short-course MTX with (1585 patients - 16%) or without (1906- 20%) in vivo T-cell depletion with alemtuzumab or ATG. In addition, MMF was used instead of MTX in 1320 (14%) and 751 (8%) patients respectively. The EBMT risk score reported by Gratwohl et al. was calculated in our cohort (Table 1). The EBMT score separated patients into 3 groups: low risk (0-2 points, n=1949, 22%), intermediate risk (3-4 points, n=4795, 53%) and poor risk (5-7 points, n=2229, 25%). Primary and secondary graft failure was reported in 419 (4%) and 71 (0.7%) patients respectively. Grade 0-I GvHD developed in 6314 (69%) and grade II-IV in 2789 (31%). 2270 (23%) patients relapsed during follow-up. At time of analysis, 4390 (45%) patients were alive without relapse and 4902 (50%) of patients had died, of whom 3081 (32%) never relapsed. We analyzed the cause of death of this latter population: 1004 (33%) died of GvHD, 996 (32%) due to infections, 86 (3%) of haemorrhages, 130 (4%), due to multi-organ failure, 69 (2%) of secondary malignancies and 796 (26%) from other causes. The overall survival was 60% at 12 months and 41% at 5 years. The EBMT score strongly separated patients with good (50%), intermediate (41%) and poor (31%) survival at 5 years (p 〈 0.001). TRM was 27% at 12 months and 37% at 5 years. TRM for patients with a low EBMT score was 20% at 12 months compared with 26% and 35% for intermediate and poor-risk EBMT scores respectively (p 〈 0.001). No differences in the cumulative incidence of relapse among the three EBMT score risk groups (CI at 3 years for low was 27%, intermediate 25% and poor risk 26%). For patients with RA/RARS/del5q and low-risk EBMT score, the TRM was 23% at 5 years. We found small but statistically significance differences in TRM in favor of patients who received reduced intensity vs myeloablative conditionings (p=0). In addition, the overall TRM at 12 months has slightly improved (p=0.008): 1997-2001 (32%), 2002-2006 (27%) and 2007-2013 (26%). Conclusion: The EBMT Score accurately predicts OS and TRM but does not correlate with the relapse risk. The TRM for MDS patients after alloHSCT is lower than previously described and this should no longer be an obstacle for referring patients for transplantation. Patients with low risk MDS (RA/RARS/del5q) who are otherwise candidates for alloHSCT, should expect a low TRM of 23% at 5 years from transplant if their EBMT score is low. Table 1. EBMT Risk Score RISK FACTOR POINTS PATIENTS (%) AGE OF PATIENT (years) 〈 20 0 129 (1%) 20-40 1 1542 (16%) 〉 40 2 8070 (83%) DISEASE STATUS Early (first CR, untreated) 0 5575 (62%) Intermediate (second CR, PR) 1 1163 (13%) Late (other) 2 2283 (25%) TIME INTERVAL DIAGNOSIS-TRANSPLANT (months)* Does not apply if CR 〈 12 0 6154 (63%) 〉 12 1 3587 (37%) DONOR TYPE HLA-identical sibling 0 4266 (44%) Unrelated, other 1 5475 (56%) DONOR RECIPIENT SEX COMBINATION All other 0 7679 (81%) Female donor, male recipient 1 1847 (19%) Figure 1. OS by EBMT Score Figure 1. OS by EBMT Score Figure 2. NRM by EBMT Score Figure 2. NRM by EBMT Score Disclosures Niederwieser: Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Schönland:Janssen, Prothena: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V126.23.3223.3223
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2015
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  • 4
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    Comparison of Allogeneic Stem Cell Transplantation for Transformed Acute Myeloid Leukemia Derived from MDS, CMML or MPN. a Report of the Chronic Malignancies Working Party of EBMT
    American Society of Hematology ; 2016
    In:  Blood Vol. 128, No. 22 ( 2016-12-02), p. 3499-3499
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    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 3499-3499
    Abstract: Introduction Myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN) and chronic myelomonocytic leukemia (CMML) can progress to acute myeloid leukemia (transformed AML). The aim of this EBMT registry study was to compare 3 year outcome in patients with transformed AMLwho received allogeneic stem cell transplantation according to the primary disease. Patients and Methods Within the European Society of Blood and Marrow Transplantation (EBMT) registry, we found 4214 patients (female: 39%, male: 61%) with transformed acute myeloid leukemia, who received allogeneic stem cell transplantation between 2000 and 2014. The primary disease was MDS (n=3541), CMML (n=251) or MPN (n=422). The median age at transplantation was 58 years (range, 18-79) and 59% received a reduced intensity (RIC) conditioning regimen. The majority of the patients received stem cells from an unrelated donor (62%) and 50% were in complete remission at time of transplantation. Within the different groups of primary diseases, MDS patients were more often in CR (53%) than patients with CMML (47%) or MPN (43%). RIC was also more frequently used in MDS patients (65%), than in CMML (64%) and MPN patients (58%). Results After a median follow up of 46.5 months , the estimated 3 year relapse-free (RFS) and overall survival (OS) for the entire group was 36% (95%CI: 34-38%) and 40% (95% CI: 33-42%), respectively.The cumulative incidence of relapse and non-relapse mortality (NRM) was 37% (95% CI: 35-39%) and 27% (95% CI: 26-29%), respectively. In a univariate analysis, patients with primary disease MDS had a significant better 3 year OS and RFS (41% and 37%) than patients with CMML (36% and 30) and MPN (32% and 25%) (p 〈 0.001), due to a significant lower incidence of relapse at 3 years (35% vs 43% vs 50%, p 〈 0.001). Other risk factors for worse OS were higher patient's age ( 〉 60 years), unrelated donor, not being in complete remission and low Karnofsky index ( 〈 80%), while T-cell depletion, intensity of the conditioning regimen and TBI as conditioning regimen did not influence survival significantly. In a multivariate analysis for OS beside age 〉 60 years (HR 1.31; 95% CI: 1.13-1.52, p 〈 0.001), unrelated donor (HR 1.12; 95% CI: 1.04-1.23, p=0.005), CMV +/- constellation (HR 1.13; 95%CI: 0.99-1.28, p=0.05), Karnofsky index 〉 80 (HR 0.66; 95% CI: 0.58-0.74, p 〈 0.001), non CR (HR 1.50; 95% CI: 1.38-1.63, p 〈 0.001) PBSC as stem cell source (HR 0.86; 95% CI:0.75-0.97, p=0.02) and transformed AML from MPN (HR 1.24; 95% CI: 1.085-1.41, p=0.002) remained a significant factor in comparison to transformed AML from MDS, while outcome of transformed AML from CMML did not reach statistical significance in comparison to MDS (HR 1.10; 95% CI: 0.933-1.30, p=0.25) Conclusion This large EBMT registry study demonstrates that the primary underlying disease influence outcome of transformed acute myeloid leukemia in addition to other risk factors. Disclosures Kröger: Novartis: Honoraria, Research Funding. Maertens:Merck Sharp & Dohme: Consultancy, Honoraria, Research Funding, Speakers Bureau; Gilead: Consultancy, Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria, Research Funding, Speakers Bureau; Astellas: Consultancy, Speakers Bureau; Amgen: Consultancy. Kobbe:Jansen: Honoraria, Other: travel support; Celgene: Honoraria, Other: travel support, Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V128.22.3499.3499
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
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  • 5
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    Allogeneic Hematopoietic Stem Cell Transplantation in Myelodysplastic Syndrome (MDS) Patients at Lower Risk According to International Prognostic Scoring System (IPSS) : A Retrospective Study on Behalf of the Cmwp of the EBMT
    American Society of Hematology ; 2014
    In:  Blood Vol. 124, No. 21 ( 2014-12-06), p. 2530-2530
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    In: Blood, American Society of Hematology, Vol. 124, No. 21 ( 2014-12-06), p. 2530-2530
    Abstract: The allogeneic hematopoietic stem cell transplantation (HSCT) is the only curative treatment in patients with MDS. Indeed, many retrospective studies have shown that the higher risk patients according to IPSS (intermediate-2 and high) have a better overall survival with HSCT if performed at time of diagnosis while HSCT in lower risk patients (low and intermediate-1) should be postponed. Actually, some lower risk patients have poor prognostic features leading to propose the transplantation before they evolve to a higher risk. In this registry study from the CMWP, we analyzed outcome of patients who were diagnosed low risk MDS and who finally were transplanted without evolving to a higher risk. As more and more of these patients are proposed to the transplantation, their survey may give information about their prognostic risks. All adult patients transplanted between 2000 and 2011 and registered in the EBMT registry could be included if they have a low risk MDS at time of diagnosis and at time of transplantation. Overall and progression-free survival (OS and PFS) were estimated using Kaplan-Meier product limit estimator. For competing risk, cumulative incidence functions were estimated using usual methodology. Cox proportional hazard model were used to test the potential risk factors (age, gender, CMV recipient/donor, disease, IPSS, transfusion, donor type, conditioning). Missing data were handled through multiple imputations by chained equations methods. 291 patients met the inclusion criteria: 126 women and 165 men. Median age at diagnosis was 53 years and inter-quartile range (IQR) from 44 to 59. The majority of patients have refractory anemia or refractory cytopenia with multilineage dysplasia (66%), while one third of patients have refractory anemia with excess blasts. Most patients were intermediate-1 (80%) and required transfusions before the transplantation (84%). Median age at time of transplantation was 55 years (IQR: 46-60). Median time from diagnosis to transplantation was 11 months (IQR: 7-22). Donor was an HLA matched sibling in 122 (42%) patients and an unrelated donor in the remaining patients. The preferred source of stem cells was peripheral blood stem cells (PB) (78%) followed by bone marrow (19%) and cord blood (3%). Conditioning regimen consisted in a reduced intensity conditioning regimen in the majority of patients (59%) and 58% received an in vivo T depletion. PFS and OS of the whole patients are shown in Figure 1 A and 1 B. Cumulative incidence of grade II-IV acute GVHD, chronic GVHD, non-relapse mortality and relapse are shown in Figure 2 A-D. Multivariate analysis with original data set (excluding missing data) found the following factors as poor prognostic for PFS: age 〈 35 years (Hazard ratio (HR): 4.22, p=0.009) or 〉 45 years (p 〈 0.05), blast count in bone marrow 〉 5% (HR: 1.67, p=0.05), bone marrow (HR: 2.18, p=0.003) or cord blood (HR: 5.28, p=0.014) as sources of stem cells rather than PB and CMV serostatus positive for the recipient and negative for the donor (HR: 2.50, p=0.002) while transfusion before the transplantation (HR): 0.51, p=0.013) and T-depletion (HR: 0.60, p=0.43) were protective. The second multivariate analysis included all patients with imputed datasets showing similar results. To conclude, outcome after HSCT in patients with lower risk IPSS are better than those observed in higher risk. In favorable transplant condition (PB, T-depletion), expected OS reaches 70% with a low mortality rate after the second year which could be a valid option in some lower risk patients presenting some high risk factors as poor molecular biology or resistance to agents stimulating erythropoiesis. Figure 1 Figure 1. Figure 2 Figure 2. Disclosures Blaise: Sanofi: Honoraria, Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V124.21.2530.2530
    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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    Relapse Risk Score after Allogeneic Stem Cell Transplantation for MDS Patients. an EBMT Study from the MDS Subcommittee of Chronic Malignancies Working Party (CMWP)
    American Society of Hematology ; 2016
    In:  Blood Vol. 128, No. 22 ( 2016-12-02), p. 4701-4701
    Details
    In: Blood, American Society of Hematology, Vol. 128, No. 22 ( 2016-12-02), p. 4701-4701
    Abstract: Introduction The number of MDS patients who receive allogeneic stem cell transplantation is steadily increasing. However, the main cause for treatment failure is relapse which exceeds 50%. Post transplant strategies such as novel agents (5-azacytidine, HDAC inhibitor etc.) as well as adoptive immunotherapy (e.g. DLI) are currently under investigation to reduce the risk of relapse. Patients and methods In order to have a valid tool for stratification in phase III studies, the CMWP of EBMT is developing a simplified "Relapse-risk score" for MDS patients. For this purpose 1638 patients with MDS who received an allogeneic stem cell transplantation from HLA-identical sibling or a matched unrelated donor between 1995 and 2012 and reported to EBMT registry were included. The median age of the patients was 54 years (range 18-76) and diagnosis were: RAR/RARS/RCDM-(RS) and RAEB. Variables which were taken into the analysis were: age, classification of MDS, donor source (HLA-identical sibling vs matched unrelated donors), acute and chronic GvHD,stem cell source (PBSC vs bone marrow), T-cell depletion , intensity of the conditioning regimen (reduced intensity vs standard myeloablative), blasts in bone marrow at time of transplant, and cytogenetic: very poor (very poor according to IPSS revised or monosomal karyotype), poor (according to IPSS-revised), and good (according to IPSS-revised) and unclassifiable. To take the different risks of relapse depending on time from transplant into account we developed 4 different prognostic models: 1) relapse between SCT and 6 months after SCT, 2) relapse between 6 and 12 months post-SCT, 3) relapse between 12 and 24 months post-SCT and 4) relapse after 24 months post-SCT. Results Multivariate Fine and Gray regression models were used to assess the impact of risk factors on the cumulative incidence of relapse. Disease status RAEB remains significant in all 4 models (1: HR 1.62 (95% CI 1.14-2.86), 2: HR 2.51 (95% CI 1.49-4.20), 3: HR 2.10 (95% CI 1.19-3.73), and 4: HR 2.97 (95% 1.56-5.60), whereas very poor cytogenetic was significant in model 1: HR 4.33 (95% CI 2.85-6.60), and model 3: HR 3.51 (95% CI 1.69-7.29)), poor cytogenetic only for early relapse: model 1: HR 2.19 (95% CI 1.39-3.27). RIC was significant for model 1: HR 2.04 (95% CI 1.51-2.75 and 2: HR 1.72 (95% CI 1.06-2.77), T-cell depletion for model 2: HR 1.61 (95% CI 1.02-2.56), and 3: HR 2.01 (95% CI 1.19-3.39). The prognostic risk scores are directly obtained by adding up the relevant log-hazard ratios, which allows dividing patients into three risk groups, low, medium, high, defined by tertiles in the study population. Cumulative incidence plots of relapse for each of the three groups are shown. Conclusion Relapse as most common treatment failure of allogeneic SCT in MDS can occur even after 24 months. Several risk factors influence the incidence of relapse, however while RAEB disease status influence early, intermediate and late relapse, other risk factors such as cGvHD influence only late ( 〉 24 months relapse. Therefore, these risk scores may help to stratify patients according to their risk of relapse after stem cell transplantation which can be used for stratification in further prospective trials using post transplant therapies at different time points after stem cell transplantation to reduce the risk of relapse. Figure Figure. Disclosures Kröger: Sanofi: Honoraria, Research Funding. Maertens:Amgen: Consultancy; Merck Sharp & Dohme: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pfizer: Consultancy, Honoraria, Research Funding, Speakers Bureau; Astellas: Consultancy, Speakers Bureau; Gilead: Consultancy, Honoraria, Speakers Bureau. Schetelig:Sanofi: Honoraria.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V128.22.4701.4701
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2016
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 7
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    Monosomal Karyotype Predicts Poor Outcome for MDS/sAML Patients with Chromosome 7 Abnormalities After Allogeneic Stem Cell Transplantation for MDS/sAML. A Study of the MDS Subcommittee of the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT).
    American Society of Hematology ; 2009
    In:  Blood Vol. 114, No. 22 ( 2009-11-20), p. 293-293
    Details
    In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 293-293
    Abstract: Abstract 293 Background. High-risk MDS/sAML patients have a poor prognosis with conventional therapies. One constant factor predisposing for high risk is the presence of a chromosome 7 abnormality. It is common practice that patients with a chromosome 7 abnormality and other factors that classify them as high-risk are offered allogeneic SCT (alloSCT) as it is believed that this treatment has curative potential. Data on the effect of this approach in these patients are scarce. Methods. The EBMT database was searched for MDS/sAML patients having any chromosome 7 abnormalities and were treated with alloSCT. 278 patients who underwent alloSCT between 1981 and November 2006 were included. Stem cells from related donors were transplanted in 192 patients (177 HLA-identical) while 85 received unrelated grafts. Bone marrow was used as stem cell source in 148 patients while 126 received blood stem cells. Standard conditioning was applied in 222 patients. Sixty-three patients fulfilled the criterion for having complex cytogenetic abnormalities. A monosomal karyotype (MK), defined as at least one monosomy and at least one other chromosomal abnormality (Breems DA et al., JCO 2008;26:4791–7), was present in 63 patients, of whom 23 did not have complex cytogenetic abnormalities. Results. Median follow-up (FU) of patients alive at last FU was 5 years (range, 0–18 years). Estimate 5–year overall (OS), and relapse-free (RFS) survival was 28±5.5% (see figure) and 26±5.5% respectively. The relapse rate at 3, 12 and 60 months was 9±3%, 29±5% and 39±6% respectively. Non-relapse mortality (NRM) at 3, 12 and 60 months was 21±5%, 36±6% and 40±6% respectively. In multivariate models including age, MK, complex karyotype, blasts at alloSCT, donor type, sex match, conditioning regimen, T-cell depletion and year of alloSCT, a MK highly significantly predicted for extremely poor outcome: the adjusted hazard ratios of MK were for OS 2.4 (95% CI, 1.6 to 3.6), for RFS 2.4 (95% CI, 1.7 to 3.9) and for relapse 3.2 (95% CI, 1.8 to 5.7) (p 〈 0.001 for each endpoint). Five-year OS and RFS for patients with a MK were 0% and 0% compared to 37±7% and 34±7% for patients without MK (p 〈 0.001 for both log rank tests) respectively (see figure). Five-year incidences of relapse and NRM of patients with MK were 52±13% and 48±13% compared to 33±7% and 37±7% for patients without MK (gray tests, p=0.002 and p=0.1). Conclusion. This large study of alloSCT for patients with MDS/sAML and any chromosome 7 abnormality shows that long-term survival can be achieved in about 37% of patients without a MK. In contrast, patients with a MK do extremely poor (5-year OS 0%) with standard alloSCT approaches; for these patients new approaches must be explored. Disclosures: Schetelig: Bayer Schering: Research Funding.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
    URL: Article
    DOI: 10.1182/blood.V114.22.293.293
    RVK:
    XA 33000
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2009
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  • 8
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    Allogeneic Stem Cell Transplantation for Patients Age ≥ 70 Years with Myelodysplastic Syndrome: A Retrospective Study of the MDS Subcommittee of the Chronic Malignancies Working Party of the EBMT
    Elsevier BV ; 2017
    In:  Biology of Blood and Marrow Transplantation Vol. 23, No. 1 ( 2017-01), p. 44-52
    Details
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 23, No. 1 ( 2017-01), p. 44-52
    Type of Medium: Online Resource
    ISSN: 1083-8791
    URL: Article
    DOI: 10.1016/j.bbmt.2016.09.027
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2017
    detail.hit.zdb_id: 3056525-X
    detail.hit.zdb_id: 2057605-5
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  • 9
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    Allogeneic Stem Cell Transplantation for Myelodysplastic Syndrome Patients with a 5q Deletion
    Elsevier BV ; 2018
    In:  Biology of Blood and Marrow Transplantation Vol. 24, No. 3 ( 2018-03), p. 507-513
    Details
    In: Biology of Blood and Marrow Transplantation, Elsevier BV, Vol. 24, No. 3 ( 2018-03), p. 507-513
    Type of Medium: Online Resource
    ISSN: 1083-8791
    URL: Article
    DOI: 10.1016/j.bbmt.2017.11.017
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2018
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  • 10
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    Conditioning‐based outcomes after allogeneic transplantation for myeloma following a prior autologous transplant (1991‐2012) on behalf of EBMT CMWP
    Wiley ; 2020
    In:  European Journal of Haematology Vol. 104, No. 3 ( 2020-03), p. 181-189
    Details
    In: European Journal of Haematology, Wiley, Vol. 104, No. 3 ( 2020-03), p. 181-189
    Abstract: The aim of this study was to compare the effect of the intensity of conditioning approaches used in allogeneic transplantation in myeloma—reduced intensity conditioning (RIC), non‐myeloablative (NMA), myeloablative conditioning (MAC) or Auto‐AlloHCT—on outcomes in patients who had had a prior autologous transplant. Methods A retrospective analysis of the EBMT database (1991‐2012) was performed. Results A total of 344 patients aged between 40 and 60 years at the time of alloHCT were identified: 169 RIC, 69 NMA, 65 MAC and 41 Auto‐Allo transplants. At a median follow‐up of 54 months, the probabilities of overall survival (OS) at 5 years were 39% (95% CI 31%‐47%), 45% (95% CI 32%‐57%), 19% (95% CI 6%‐32%) and 34% (95% CI 17%‐51%), respectively. Status at allogeneic HCT other than CR or PR conferred a 70% higher risk of death and a 40% higher risk of relapse. OS was markedly lower in the MAC group ( P  = .004). MAC alloHCT was associated with a higher risk of death than RIC alloHCT until 2002 (HR = 4.1, P   〈  .001) but not after 2002 (HR = 1.2, P  = .276). Conclusion From 1991 to 2002, MAC was associated with poorer OS. Between 2003 and 2012, there were no significant differences in outcomes based on these different approaches.
    Type of Medium: Online Resource
    ISSN: 0902-4441 , 1600-0609
    URL: Issue
    URL: Article
    DOI: 10.1111/ejh.v104.3
    DOI: 10.1111/ejh.13352
    Language: English
    Publisher: Wiley
    Publication Date: 2020
    detail.hit.zdb_id: 2027114-1
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