Publications by authors named "Barbara Loteta"

9 Publications

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Granisetron transdermal system and dexamethasone for the prevention of nausea and vomiting in multiple myeloma patients receiving chemo-mobilization: An observational real-world study of effectiveness and safety.

Transfus Apher Sci 2020 Dec 24;59(6):102911. Epub 2020 Aug 24.

CNR-IFC, Research Unit of Reggio Calabria, Reggio Calabria, Italy.

Purpose: Cyclophosphamide (CY) in a dose of 2-4 g/m is widely used for hemopoietic progenitor stem cells mobilization. CY administration is associated with several adverse effects, including chemotherapy-induced nausea and vomiting (CINV). This study aimed to evaluate the efficacy and tolerability of granisetron transdermal system (GTDS) plus dexamethasone in the management of CINV in MM patients undergoing chemo-mobilization with CY.

Methods: In this single-center, prospective, observational, real world study, GTDS plus dexamethasone was administered to MM patients receiving chemo-mobilization based on CY 2 g/m2 plus G-CSF in an outpatient setting. The rate of complete response was evaluated as the main outcome. Other outcomes were rate of complete control of CINV, incidence of nausea/vomiting of any grade and safety.

Results: A total of 88 patients were enrolled. A complete response was achieved in 45.5 % of patients; among them, 39.77 % attained complete control of CINV. Nausea and vomiting never occurred in 34.1 % and 45.5 % of patients, respectively. No episodes of grade 3-4 nausea and/or vomiting were documented. GTDS was safe and well tolerated.

Conclusion: In real world, GTDS provided an innovative, effective, and well-tolerated control of CINV in MM patients after chemo-mobilization with CY. The study found out effectiveness of a non-invasive delivery system of antiemetic.
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http://dx.doi.org/10.1016/j.transci.2020.102911DOI Listing
December 2020

Impact of donor age and kinship on clinical outcomes after T-cell-replete haploidentical transplantation with PT-Cy.

Blood Adv 2020 08;4(16):3900-3912

Department of Oncology/Hematology, Azienda Ospedaliera Universitaria (AOU) Città della Salute e della Scienza di Torino, Presidio Molinette, Turin, Italy.

Donor selection contributes to improve clinical outcomes of T-cell-replete haploidentical stem cell transplantation (haplo-SCT) with posttransplant cyclophosphamide (PT-Cy). The impact of donor age and other non-HLA donor characteristics remains a matter of debate. We performed a multicenter retrospective analysis on 990 haplo-SCTs with PT-Cy. By multivariable analysis, after adjusting for donor/recipient kinship, increasing donor age and peripheral blood stem cell graft were associated with a higher risk of grade 2 to 4 acute graft-versus-host-disease (aGVHD), whereas 2-year cumulative incidence of moderate-to-severe chronic GVHD was higher for transplants from female donors into male recipients and after myeloablative conditioning. Increasing donor age was associated with a trend for higher nonrelapse mortality (NRM) (hazard ratio [HR], 1.05; P = .057) but with a significant reduced risk of disease relapse (HR, 0.92; P = .001) and improved progression-free survival (PFS) (HR, 0.97; P = .036). Increasing recipient age was a predictor of worse overall survival (OS). Risk of relapse was higher (HR, 1.39; P < .001) in patients aged ≤40 years receiving a transplant from a parent as compared with a sibling. Moreover, OS and PFS were lower when the donor was the mother rather than the father. Pretransplant active disease status was an invariably independent predictor of worse clinical outcomes, while recipient positive cytomegalovirus serostatus and hematopoietic cell transplant comorbidity index >3 were associated with worse OS and PFS. Our results suggest that younger donors may reduce the incidence of aGVHD and NRM, though at higher risk of relapse. A parent donor, particularly the mother, is not recommended in recipients ≤40 years.
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http://dx.doi.org/10.1182/bloodadvances.2020001620DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448598PMC
August 2020

A comparative effectiveness study of lipegfilgrastim in multiple myeloma patients after high dose melphalan and autologous stem cell transplant.

Ann Hematol 2020 Feb 18;99(2):331-341. Epub 2019 Dec 18.

CNR-IFC, Rome, Italy.

G-CSF administration after high-dose chemotherapy and autologous stem cell transplantation (ASCT) has been shown to expedite neutrophil recovery. Several studies comparing filgrastim and pegfilgrastim in the post-ASCT setting concluded that the two are at least equally effective. Lipegfilgrastim (LIP) is a new long-acting, once-per-cycle G-CSF. This multicentric, prospective study aimed to describe the use of LIP in multiple myeloma patients receiving high-dose melphalan and autologous stem cell transplantation (ASCT) and compare LIP with historic controls of patients who received short-acting agent (filgrastim [FIL]). Overall, 125 patients with a median age of 60 years received G-CSF after ASCT (80 patients LIP on day 1 post-ASCT and 45 patients FIL on day 5 post-ASCT). The median duration of grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10 [9]/L) was 5 days in both LIP and FIL groups, whereas the median number of days to reach ANC ≥ 0.5 × 10 [9]/L was 10% lower in the LIP than in the FIL group (10 vs 11 days), respectively. Male sex was significantly associated with a faster ANC ≥ 0.5 × 10 [9] L response (p = 0.015). The incidence of FN was significantly lower in the LIP than in the FIL group (29% vs 49%, respectively, p = 0.024). The days to discharge after ASCT infusion were greater in patients with FN (p < 0.001). The study indicates that LIP had a shorter time to ANC recovery and is more effective than FIL for the prevention of FN in the ASCT setting.
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http://dx.doi.org/10.1007/s00277-019-03901-wDOI Listing
February 2020

Quality of life outcomes in multiple myeloma patients: a summary of recent clinical trials.

Expert Rev Hematol 2019 08 3;12(8):665-684. Epub 2019 Jul 3.

f Hematology Unit, Department of Hemato-Oncology, Ospedale Annunziata , Cosenza , Italy.

: Management of multiple myeloma (MM) has improved over recent years. Health-related quality of life (HRQoL) data is becoming increasingly important, owing to improved survival outcomes. : The authors performed an expert review of the literature to identify evidence-based data available on HRQoL in frontline and relapsed/refractory MM (RRMM) patients. : De-novo patients should be informed that the HRQoL is expected to improve during first-line treatment with different degrees of possible deterioration during the first cycles. Achievement of a maximal response should be strongly considered, particularly in the frontline setting, but must also be balanced with tolerability, HRQoL, and patient preferences. The same degree of improvement in HRQoL cannot be expected during conventional relapse treatments, where patients should be prepared only for stabilization of HRQoL. However, focusing attention only on measures such as toxicity may provide just a partial view of overall treatment effectiveness. Nonetheless, the authors believe the added value of taking into consideration the patient's perspectives and the importance of patient-reported outcomes in the evaluation of treatment effects should be considered mandatory. The incorporation of quality of life assessment into clinical and research practice has the potential of improving treatment outcomes.
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http://dx.doi.org/10.1080/17474086.2019.1634541DOI Listing
August 2019

Challenge to Predict Mobilized Peripheral Blood Stem Cells on the Fourth Day of Granulocyte Colony-Stimulating Factor Treatment in Healthy Donors: Predictive Value of Basal CD34 Cell and Platelet Counts.

Biol Blood Marrow Transplant 2019 08 17;25(8):1586-1591. Epub 2019 Apr 17.

Institute of Clinical Physiology (IFC-CNR), Rome, Italy.

A longitudinal, prospective, observational, single-center cohort study on healthy donors was designed to identify predictors of CD34 cell mobilization on day 4 after granulocyte colony-stimulating factor (G-CSF) administration. As potential predictors of mobilization, age, sex, body weight, height, blood volume, WBC count, peripheral blood (PB) mononuclear cell count, platelet (Plt) count, and hematocrit and hemoglobin levels were considered. Two different evaluations of CD34 cell counts were determined for each donor: baseline (before G-CSF administration) and in PB on day 4 after G-CSF administration. One hundred twenty-two consecutive healthy donors with a median age of 47.5 years were enrolled. The median value of CD34 on day 4 was 43 cells/µL (interquartile range, 23 to 68), and 81.1% of donors had ≥20 cells/µL. Basal WBC count, Plt count, and CD34 were significantly higher for the subjects with CD34 levels over median values on day 4. A multivariate quartile regression analysis, adjusted by sex, age, basal CD34, and basal Plt count, showed a progressively stronger relationship between baseline CD34 and Plt levels and the CD34 levels on day 4. The basal CD34 cut-off level to predict the levels of CD34 on day 4 was either ≤2 cells/μL or ≥3 cells/μL and that of basal Plt count was ≤229 × 10/L or ≥230 × 10/L, respectively, to determine whether mobilization therapy should or should not be attempted. PB stem cell mobilization with G-CSF was highly effective on day 4, and herein we describe a model for predicting the probability of performing PB stem cell collection after a short course of G-CSF.
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http://dx.doi.org/10.1016/j.bbmt.2019.04.011DOI Listing
August 2019

Ibrutinib Treatment of Mantle Cell Lymphoma Relapsing at Central Nervous System: A Case Report and Literature Review.

Case Rep Hematol 2017 16;2017:9583257. Epub 2017 Jul 16.

Hematology Unit, Papardo Hospital, c/da Papardo, 98158 Messina, Italy.

Mantle cell lymphoma (MCL) accounts for about 5% of all lymphomas. Its clinical and histological features are heterogeneous. After a frequently good initial response, the disease generally and repeatedly relapses and finally the outcome is poor. Particularly severe is the prognosis of the rare occurrence of CNSi (Central Nervous System involvement). Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has shown strong activity in relapsing patients with Chronic Lymphocytic Leukemia (CLL) and MCL. Few reports are available about treatment with ibrutinib of patients presenting CNSi by lymphoproliferative diseases (LPD). In all of them, ibrutinib, at the dosage between 420 and 560 mg/day, showed an impressive effectiveness. Here we describe a case of MCL with CNS relapse showing an excellent response to ibrutinib administered at the unusual dose of 280 mg/day because of concomitant treatment of cardiological disease.
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http://dx.doi.org/10.1155/2017/9583257DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5534293PMC
July 2017

B-cell chronic lymphocytic leukemia: clinical impact of biological prognostic factors and updated treatment strategies.

Lijec Vjesn 2007 May;129 Suppl 3:26-8

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May 2007

Levels of soluble angiogenin in chronic myeloid malignancies: clinical implications.

Eur J Haematol 2004 Jun;72(6):416-9

Division of Hematology, University of Messina, Messina, Italy.

Angiogenesis is critical for the clinical progression of haematopoietic malignancies and depends on angiogenic factors. Angiogenin is a powerful factor produced by neoplastic cells and host microenvironment. High levels of soluble angiogenin (sAng) correlate with a poor prognosis in patients affected by acute myeloid leukaemia and myelodysplastic syndromes, but no data are available on sAng in chronic myeloproliferative disorders (CMD). Therefore, in this study we investigated the clinical significance of the angiogenin in sera of patients with chronic myeloid leukaemia (CML) (n = 14) or essential thrombocythaemia (ET) (n = 20), and correlated them with those of soluble transforming growth factor-beta(1) (sTGF beta(1)). Enzyme-linked immunosorbent assay detected (P < 0.05) higher levels of sAng in CMD compared with healthy subjects (1026.74 +/- 464.60 pg/mL and 196.00 +/- 39.90 pg/mL, respectively). The highest levels of sAng were detected in CML patients (1349.23 +/- 549.55 pg/mL). Interestingly, CML patients who achieved haematological remission after interferon therapy showed circulating levels of angiogenin significantly (P < 0.05) decreased when compared with those at diagnosis. In ET patients, levels of angiogenin (889.34 +/- 267.66 pg/mL) and sTGF beta(1) (76.69 +/-6.08 pg/mL) were higher (P < 0.05) compared with healthy controls (57.93 +/- 19.39 pg/mL). No correlation was found between levels of sAng and levels of sTGF beta(1) or platelet count among ET patients. Our results show for the first time that elevated blood levels of angiogenin feature chronic myeloid malignancies, suggesting a role of angiogenin in the pathogenesis of these diseases.
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http://dx.doi.org/10.1111/j.1600-0609.2004.00253.xDOI Listing
June 2004

[Lipid profile in hematologic neoplasms].

Recenti Prog Med 2002 May;93(5):298-301

Divisione di Ematologia, Dipartimento di Medicina Interna, Università, Messina.

Background And Objective: Abnormal blood lipid profiles have been reported in human malignancies. So, it is likely an overall involvement of tumoral cell metabolism. The aim of this study was to evaluate clinico-biological implications of altered lipid profiles in oncohaematologic patients.

Design And Methods: The plasma lipids, lipoproteins and apolipoproteins were determined at the time of diagnosis in 48 previously untreated patients (35M, 13F, median age 60 years), 11 with multiple myeloma (MM), 11 with non-Hodgkin's lymphoma (NHL), 11 with acute leukemia (AL), 10 with chronic myeloproliferative disorders (CMD) and 5 with B-chronic lymphocytic leukemia (B-CLL). The results were correlated with known prognostic serum markers, such as lactate dehydrogenase (LDH), beta-2-microglobulin (beta 2m), and soluble molecule ICAM1 (sICAM1).

Results: Altered blood lipid profiles were observed in all concohaematologic patients. Statistically significant values included reduced cholesterol (155 +/- 47.36 vs 205 +/- 35 mg/dl; p < 0.001), HDL-C (30.47 +/- 13.36 vs 45 +/- 10 mg/dl; p < 0.003) and apo A (118.86 +/- 49.98 vs 182.69 mg/dl; p < 0.0001) levels. No correlations were found between cholesterol levels and clinico-biological features representative of tumor mass (LDH, beta 2m, sICAM-1). A significant increase of cholesterol levels was observed in all patients responding to therapy.

Interpretation And Conclusion: These results support the idea that the cholesterol, its fractions and the apolipoproteins determinations might be considered as useful biochemical and prognostic markers in hematologic neoplasms.
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May 2002