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  • 1
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 28 ( 2023-10-01), p. 4486-4496
    Abstract: Long-term eltrombopag was safe and effective for the treatment of thrombocytopenia in low-risk MDS
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
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    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
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  • 2
    In: International Journal of Laboratory Hematology, Wiley, Vol. 45, No. 6 ( 2023-12), p. 881-889
    Abstract: Implementing artificial intelligence‐based instruments in hematology laboratories requires evidence of efficiency in classifying pathological cells. In two‐Universities, we assessed the performance of the Mindray® MC‐80 for hematology patients with frequent leukemic and dysplastic cells. Methods The Mindray MC‐80® locates and pre‐classifies cells in blood films. In a two‐university study, four films were prepared from 591 samples, two each for the analyser MC‐80 and the microscope reference method, using reagents from two different manufacturers. We used Microsoft Excel® statistics for imprecision and distributional inaccuracy and a matrix table model (H20‐A2 CLSI standard) for sensitivity, specificity and predictive value for atypical cells. Results The results indicate minimal within‐run imprecision (ICSH method) and good intra‐method consistency even on duplicate analysis of 413 samples with a high incidence of hematological abnormalities ( r = 0.942 or more, except for basophils, r = 0.841, and reactive lymphocytes, r = 0.847). Distributional inaccuracy was also very low compared to the microscope reference, with a pass rate higher than 80% for pathological cells (except 75.1% for reactive lymphocytes). The primary causes of discrepancy were bizarre shapes of dysplastic neutrophils and inconsistent nomenclature for lymphoma cells. Sensitivity for critical samples containing cells typically absent in circulating blood (immature or malignant) was 98.8% for immature granulocytes, 83.8% for all types of neoplastic cells, 93.6% for reactive lymphocytes and 97.5% for nucleated red blood cells. The negative predictive values of MC‐80 were 98.8% for immature granulocytes, 88.4% for the different types of neoplastic cells, 97.8% for reactive lymphocytes, and 96.9% for nucleated red blood cells. Conclusion Our study highlights the outstanding diagnostic performance of this artificial intelligence–based blood film analyzer for hematology patients with circulating abnormal cells. We appreciated the morphological harmonization of cells observed on the screen and those seen in the microscope.
    Type of Medium: Online Resource
    ISSN: 1751-5521 , 1751-553X
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2023
    detail.hit.zdb_id: 2268600-9
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  • 3
    In: Transfusion Medicine Reviews, Elsevier BV, Vol. 37, No. 2 ( 2023-04), p. 150725-
    Type of Medium: Online Resource
    ISSN: 0887-7963
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
    detail.hit.zdb_id: 2121215-6
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  • 4
    In: European Journal of Haematology, Wiley, Vol. 96, No. 4 ( 2016-04), p. 344-351
    Abstract: Azacitidine is the standard of care for higher‐risk myelodysplastic syndromes ( MDS ). We evaluated factors affecting the outcome of azacitidine treatment in 196 ‘real‐world’ patients, retrospectively collected by two Italian cooperative groups. Methods The study included 184 MDS and 12 low blast count acute myeloid leukemia ( AML ). Azacitidine was administered at the standard dose of 75 mg/m 2 /d for 7 d (SD) in 163 patients and 100 mg/d for 5–7 d in 33 patients. Results After a median of 4.5 azacitidine cycles (range 7–15 cycles), 182 patients were evaluable for response. Nineteen percent achieved complete remission ( CR ), 17% partial remission ( PR ), and 21% hematological improvement ( HI ). The disease was stable or progressive in 29% and 14% of patients, respectively. The probability of response was significantly higher in patients who received the 75 mg/m 2 /7 d compared with 100 mg through 5–7 d dose ( CR / PR / HI : 63 vs. 29%, P  = 0.0005). Median overall survival was 17.1 months. Low MDS ‐ CI and achievement of CR / PR / HI were significant predictors of survival in the multivariable analysis. Conclusions Our data show that maximal azacitidine efficacy is associated with the standard dose and with prolonged treatment, beyond 4–6 cycles, with the goal of also improving the ‘quality’ of response. Lower MDS ‐ CI and IPSS ‐R scores, hematologic response and disease stability, are associated with longer survival. The risk of febrile events is highest during the first treatment cycles and is associated with active disease.
    Type of Medium: Online Resource
    ISSN: 0902-4441 , 1600-0609
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2016
    detail.hit.zdb_id: 2027114-1
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  • 5
    Online Resource
    Online Resource
    Elsevier BV ; 2000
    In:  Fertility and Sterility Vol. 74, No. 3 ( 2000-09), p. 461-464
    In: Fertility and Sterility, Elsevier BV, Vol. 74, No. 3 ( 2000-09), p. 461-464
    Type of Medium: Online Resource
    ISSN: 0015-0282
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2000
    detail.hit.zdb_id: 1500469-7
    SSG: 12
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  • 6
    In: Blood, American Society of Hematology, Vol. 104, No. 11 ( 2004-11-16), p. 4823-4823
    Abstract: Alemtuzumab is effective for CLL patients previously treated with purine analogues and/or alkylating agents. Currently, pretreated or refractory CLL receive iv alemtuzumab 30 mg 3 times/week for 12 wk. During alemtuzumab an increase of infections (particularly CMV) and a long term reduction of lymphoid subset were described. Some authors have used alemtuzumab 10 mg (4–8 weeks) for minimal residual disease or in combination with fludarabine. Primary endpoint was to assess the efficacy of alemtuzumab, iv at the targeted dose of 10 mg. Secondary endpoints were duration of remission, infectious complications and immune recovery. Twelve CLL patients either in relapse or refractory were treated with alemtuzumab 10 mg for 10 wks (total dose 300 mg). All patients were previously treated with at least two lines of chemotherapy. Median age of the patients was 61.5 years. At the time of treatment 5 patients were in stage B/II, 6 in stage C/IV and 1 in stage A/progressive, the median of lymphocytes in peripheral blood (PB) was 45,030/ μl and 80 % in bone marrow (BM). Six patients showed unmutated VH status, 3 patients had mutated VH status and 3 patients were not evaluable. FISH analysis was evaluable in 11 patients and detected in 1 patient 17p- and 13q-, in 1 patient 11q-, in 1 patient 17 p-, in1 patient 13q-. Trisomy 12 was not detected in any samples. Patients were weekly monitored for CMVAg and CMV PCR and monthly physical examination and BM until the end of the study. Immunological subset (CD3, CD4, CD8, CD16/56, IgG, IgM, IgA) were studied on day 60, 120, 180 and 240 after the end of treatment. Two months after the end of treatment 2 patients obtained CR, and 3 patients PR (OR 41%). At this time 2 patients are in continuous CR at 10 and 15 months. One patient died in continuous PR at 11 months from pneumonia with persistent lymphopenia (200/mmc). One patient in PR showed progression at 5 months and is alive at 21 months, the other is in continuos PR at 11 months. Among 7 patients not responsive to alemtuzumab 2 patients died for progression at 4 and 15 months, while 5 patients are alive at a median of 9 months. Eight patients (66%) showed CMV reactivation by antigenemia and/or CMV DNA. No patient showed CMV disease. Patients were immediately treated, after discontinuation of alemtuzumab, with oral ganciclovir 1000 mg tid. After a median of 14 days all patients achieved negativization of CMV PCR and/or antigenemia. Until the end of the study no patients showed further CMV reactivation. Before treatment all lymphoid subsets, except for total lymphocytes and NK cells, showed median values into the normal range. Total T lymphocytes and CD4 subset rapidly decreased achieving minimum level on day +60; thereafter a mild recovery was noticed but until day +240 median values were constantly below the normal range. CD8 subset showed a trend to normalization even if at the end of the study the median values were below the normal range. NK cells (CD16/56) showed median values above the normal range during the study period, IgA, IgG, IgM showed normal values before and after treatment. Low-dose alemtuzumab in this heavily pre-treated group of patients, was well tolerated and induced good response rate (OR 41%) similarly to standard dose but high incidence of CMV reactivation and the delay of immune reconstitution, still remain a maior issue.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2004
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 7
    Online Resource
    Online Resource
    American Society of Hematology ; 2008
    In:  Blood Vol. 112, No. 11 ( 2008-11-16), p. 4710-4710
    In: Blood, American Society of Hematology, Vol. 112, No. 11 ( 2008-11-16), p. 4710-4710
    Abstract: Tutorials are yearly diagnostic courses on Hematological Malignancies organized by the European School of Hematology (ESH) and the European Hematology Association (EHA), in close collaboration with the Catholic University of Rome and “La Sapienza” University of Rome, carried out from 2004 and accredited by the European Council for Accreditation in Hematology (ECAH). For the first 4 years, Tutorials were also supported by a grant from the Marie Curie EC action. The main innovative aspect is the use of technological support for interactive self-evaluation sessions, prepared by the speakers, with real-time performance assessment. For technical reasons, the number of participant in each Tutorial is limited to 100. Tutorial sessions are organized around three different didactical tools: nine sessions of formal lectures during which the speakers move from principles of blood cytomorphology in the different categories of hematology malignancies according to the WHO classification to the analysis of the usability of gene profiling in class discovery and class prediction, nine sessions of tutored clinical case presentations: the same speakers present two to three interactive clinical cases, each going through the diagnostic pathway with special attention to differential diagnosis, different treatment opportunities and patient follow-up. A detailed final case-comment is also provided for all cases together with an updated and specific list of references, five sessions of self-evaluation tests: for each session, four clinical cases are presented in a standard format of six multiple choice questions with a list of five possible answers for each question. Each trainee has a personal ID number to enable participation in the interactive tests by selecting one response to each question. At the end of the tests, results are anonymously and actively discussed with the authors. Speakers are leading European hematologists selected according to their specific competence in a specific field. The user appreciation and the validity of the didactic model is attested to by the worldwide participation: during these years, participants have come from 40 different countries from all five continents. EHA and ESH have been requested to duplicate these courses: the scientific material is organized on medial support and can be represented in other venues. From the year 2006, three Tutorials were successfully repeated in Brazil in association with the Escola Brasileira de Hematologia (the fourth is planned for October 2008). The organization of the repeated Tutorials (so called Type II Tutorials) is simpler than for the original ones: the local chair involves mainly local speakers for the lectures, while the didactic material (clinical cases and test cases) is the same as was used in the original Tutorial (Type I), with the support of just one or two faculty members from the original type I tutorial who have had experience in managing the didactic material. The organization of the courses is expensive and technically complex: the didactic material of each course is uploaded on an intranet platform connected with 25 PC stations (one for every four participants). For this reason, the Tutorial held in Paris in February 2008 was technically organized with a specially developed software connected to a Voting Boxes System (VBS), which is portable and allows the same course interactivity; this system will be used in forthcoming years. In addition, the VBS will easily permit the organization of Type II Tutorials for training programs in hematology in developing countries. This will represent one of the forthcoming didactic programs of EHA and ESH.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2008
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 8
    In: Blood, American Society of Hematology, Vol. 134, No. Supplement_1 ( 2019-11-13), p. 3332-3332
    Abstract: Background .There has been a decrease in the use of unrelated cord blood transplants (UCBT) in the past years: this is probably due to slow hematologic and immune recovery, resulting in a relatively high non relapse mortality (NRM). The addition of anti-thymocyte globulin (ATG) in the conditioning prevents graft versus host disease (GvHD) but makes immune recovery very slow. In addition there is a growing competition of unmanipulated haploidentical transplants. Aim of the study. We have opened a pilot study to test whether high dose post-transplant cyclophosphamide (PT-CY) would prevent GvHD but still allow for robust immune and hematologic recovery . Methods. We have grafted 10 patients with an unrelated CB unit and PT-CY. The conditioning regimen was thiotepa (10 mg/kg), busulfan 9.6 mg/kg and fludarabine 150 mg/m^2 (TBF). GvHD prophylaxis was cyclosporin (CSA) starting day 0 (3 mg/kg/day(i.v.), mycophenolate (MMF) 30 mg/kg starting day +1 (p.o) , and PT-CY 30 mg/kg days +3 and +5. The median patients' age was 58 (43-66), and the median weight was 75 kg (54-85) the diagnosis was AML in 8 patients, Ph'+ALL in one and RAEB in one patient; 6 patients were in remission and 4 had active disease. CB units. The HLA matching of the CB unit was 5/8 antigens/alleles (A,B,C,DRB1) in six patients, 4/8 in two and 2/8 in one. The median nucleated cell dose was 3.1x10^7/kg (range 1.8- 4.5). The ABO was mismatched in all 10 patients. Hematologic recovery: median time to neutrophils 0.5x10^9/l was day 23 days (range 17-27) and the median time to a platelet count of 20x10^9/L was 38 days (range 34-40). The median counts on day +50 were as follows: Hb 9,1 gr/dL (range 8.7-11.1), Neutrophils 2,3 x10e9/L (range 1-5), PLTs 56 x10e9/L (10-90). One patient failed to engraft and received a second transplant from an unrelated donor, which was successful. No patient developed pure red cell aplasia despite 9/10 being ABO major mismatched. CD4 recovery : the median CD4 count on day +50 was 74 /cmm (range 67-116) and on day +100 it was 111/cmm(range 100-136). CMV pre-emptive therapy occurred in 3/6 evaluable patients Outcome: two patients with advanced disease, died early of infections, within day +20. GvHD was seen in 1 patient as a transient rash. No patient was treated for GvHD. No patient developed chronic GvHD. No patient relapsed. Eight patients survive in remission, with a median follow up of 6 months, and a projected one year actuarial survival of 80%. Readmissions were extremely rare. Conclusions. These first 10 patients suggest that UCBT followed by PT-CY, CSA, MMF, as GvHD prophylaxis is feasible and leads to encouraging hematologic and immunologic recovery. We were particularly impressed with the lack of GvHD, the absence of relapses and the good quality of life. Figure Disclosures No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2019
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 9
    In: Blood, American Society of Hematology, Vol. 122, No. 21 ( 2013-11-15), p. 1159-1159
    Abstract: Hemovigilance studies report that from 6.7% to 15% of overall transfusion-related acute lung injury (TRALI) events occur among obstetrics-gynecological patients (Chapman et al, 2009, Transfusion, 49:440; Ozier et al, 2011, Transfusion, 51: 2102). Severe postpartum hemorrhage (sPPH, i.e. the blood loss in excess of 1000 ml), complicates from 1 to 5% of all deliveries and requires massive transfusion, which is a well acknowledged TRALI risk factor. In this retrospective study we evaluate the incidence and risk factors for TRALI among patients with sPPH. We identified in the blood bank database EmoNet those patients admitted to the delivery room of our hospital from January 2005 to December 2011, necessitating the urgent transfusion of a minimum of 3 red blood cell (RBC) units, with or without fresh frozen plasma (FFP) and platelet (PLT) concentrates. Clinical records of identified patients were then retrieved and demographics, clinical and obstetric data and laboratory and radiological findings were collected. Two anesthesiologists blinded to all information of transfused units independently examined clinical records. Suspected or possible TRALI were diagnosed according to the 2004 consensus criteria; (Kleinman et al. 2004; Transfusion 44: 1774; Toy et al. 2005; Crit Care Med 33:721). In total 71 patients received at least 3 RBC units for sPPH; suspected or possible TRALI was identified in 14 cases (overall incidence 21,6%). The 2 patients with possible TRALI had pneumonia and pulmonary embolism, respectively. On the whole, patients with TRALI were more frequently admitted to the intensive care unit and had a longer hospitalization (p=0.021 and p=0.001, respectively). At univariate analysis, patients with TRALI received a higher number of RBC (p=0,008), PLT (p =0,008,) and FFP units (p =0,034). No difference were found between TRALI and no TRALI groups according to the number of PLT and FFP units from female donors, the storage time of RBC and PLT units or the number of transfused RBC units with a storage time longer than 14 days. Relatively to patient-related factors, TRALI was not associated with age or smoke habit, or with the presence of co-morbidities pre-existing to pregnancy. In contrast, the presence of pregnancy-related hypertensive disorders (PR-HD, including gestational hypertension and preeclampsia /eclampsia) (8 patients, p=0.006) was an important risk factor for TRALI. The poor adverse role was confirmed also in gestational hypertension (6 patients, p=0.012 ) or preeclampsia/eclampsia (4 patients, p=0.022) separately evaluated. In a multivariate model combining both transfusion- and patient-related factors with significance level equal or inferior to 10% at univariate analysis, only PR-HD, gestational hypertension and preeclampsia/eclampsia maintained their significance. In particular, we found that the odds ratio for TRALI was 15.98 (95% IC 2.5-103.5, p=0.004) in PR-HD in total, 24.8 (95% IC 2.5 - 248.4, p=0.006) in gestational hypertension and 33.8 (95% IC 2.2-484.1, p=0.011) in preeclampsia/eclampsia. The strong association between PR-HD and TRALI has never been reported before and it is probably due to the widespread endothelial cell activation occurring in PR-HD. These results impose a careful observation when PR-HD patients receive transfusions. The study was supported by the “Gruppo Donatori Sangue, Francesco Olgiati” Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2013
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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  • 10
    In: Blood, American Society of Hematology, Vol. 120, No. 21 ( 2012-11-16), p. 275-275
    Abstract: Abstract 275 Newborns are currently transfused with RBCs from adults, which mainly contain adult hemoglobin (HbA). HbA has a lower affinity for oxygen than fetal hemoglobin: therefore adult red cell transfusion could be responsible for increased oxygen increasing the risk of the “oxygen radicals disease of the newborn”. Autologous umbilical cord blood has been suggested as the only alternative source of blood for newborn transfusions. Previous studies, however, demonstrated that autologous cord blood transfusions in newborns are not sufficient to entirely cover the early neonatal blood requests. We reported the preliminary results of our study carried out to assess the feasibility of an allogeneic cord blood (ACB) transfusion program for prematures in terms of preparation and yield of valid ACB red blood cell (RBC) units. ACB units collected at the Cord Blood Bank but not suitable for processing and storage for allogeneic transplant cord blood were evaluated. Eligible criteria for cord blood collection were: more than 37 weeks of gestation, absence of mother's infection or fever 24 hours before the delivery, no stain of the amniotic fluid. ACB units eligible for our study contained more than 60 mL of cord blood, with no clots or hemolysis. We prepared buffy coat–depleted ACB RC units by automated separation (Compomat G4®, Fresenius HemoCare, Germany) in a processing set (Compoflex®). Suspension in SAG-mannitol and post-storage filtration was performed to obtain a leukocyte-depleted red cell unit. Resuspended units were stored for fourteen days after manipulation (2–6°C). Cultures for bacterial contamination were performed immediately after manipulation and after 14 days; biochemical determination (LDH, glucose, lactate, potassium, chloride, sodium, pH and pO2) were performed the day of fractionation (=0) and after 7 and 14 days of storage. Biochemical data were also compared to the same parameters obtained from adult red blood cell concentrates. We collected 76 ACB units. Thirty-three were discharged for insufficient volume or clots. The median collection volume of the 43 remaining units was 92.3 (± 18.3) ml. After fractionation, 43 ACB RC units were obtained with a median volume of 31.2 (± 8.2) ml and a median hematocrit of 59 ± 2%. Microbial contamination was absent in all units after manipulation and after 14 days; viral tests carried out on mother's blood at the time of cord blood collection were negative. Biochemical parameters maintained rather well up to 14 days of storage, but less resistant than adult red cells. Our data highlight that ACB is a promising source of RBC for transfusion in preterm infants. Besides the reduction of waste of not validated ACB units collected in the Cord Blood Bank, transfusional utilization of ACB RBC can overcome several problems of autologous cord blood transfusion: insufficient volumes is less frequent in ACB from term newborns and the incidence of clots, which is one of the more frequent cause of ineligibility of cord blood units, is substantially reduced when collection is performed by trained staff, in term neonates and using adequate blood shakers. Microbial contamination is prevented by adopting the strict eligibility criteria and the adequate aseptic collection technique adopted in the Cord Blood Bank. In conclusion, the preparation of transfusionally valid RCs from ACB is possible and convenient. Clinical studies are needed to evaluate the efficacy and safety of this new transfusion practice. Disclosures: No relevant conflicts of interest to declare.
    Type of Medium: Online Resource
    ISSN: 0006-4971 , 1528-0020
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    Language: English
    Publisher: American Society of Hematology
    Publication Date: 2012
    detail.hit.zdb_id: 1468538-3
    detail.hit.zdb_id: 80069-7
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