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Article ; Online: Predictors of unsustained measurable residual disease negativity in patients with multiple myeloma.

D'Agostino, Mattia / Bertuglia, Giuseppe / Rota-Scalabrini, Delia / Belotti, Angelo / Morè, Sonia / Corradini, Paolo / Oliva, Stefania / Ledda, Antonio / Grasso, Mariella / Pavone, Vincenzo / Ronconi, Sonia / Vincelli, Iolanda Donatella / Ballanti, Stelvio / Velluti, Cristina / Cellini, Claudia / Gozzetti, Alessandro / Palmas, Angelo D / Gamberi, Barbara / Mancuso, Katia /

Paris, Laura / Zambello, Renato / Petrucci, Maria Teresa / Bruno, Benedetto / Musto, Pellegrino / Gay, Francesca

Blood

2023 Volume 143, Issue 7, Page(s) 592–596

Abstract: Abstract: The prognostic impact of achieving and in particular maintaining measurable residual disease (MRD) negativity in multiple myeloma is now established; therefore, identifying among MRD-negative patients the ones at higher risk of losing MRD ... ...

Abstract	Abstract: The prognostic impact of achieving and in particular maintaining measurable residual disease (MRD) negativity in multiple myeloma is now established; therefore, identifying among MRD-negative patients the ones at higher risk of losing MRD negativity is of importance. We analyzed predictors of unsustained MRD negativity in patients enrolled in the FORTE trial (NCT02203643). MRD was performed by multiparameter flow cytometry (sensitivity of 10-5) at premaintenance and every 6 months thereafter. The cumulative incidence (CI) of MRD resurgence and/or progression was analyzed in MRD-negative patients. A total of 306 of 474 (65%) MRD-negative patients were analyzed. After a median follow-up of 50.4 months from MRD negativity, 185 of 306 (60%) patients were still MRD negative and progression free, 118 (39%) lost their MRD-negative status, and 3 patients (1%) died without progression. Amp1q vs normal (4-year CI, 63% vs 34), ≥2 concomitant high-risk cytogenetic abnormalities vs 0 (4-year CI, 59% vs 33%), circulating tumor cells at baseline (high vs low at 4-year CI, 62% vs 32%), and time-to-reach MRD negativity postconsolidation vs preconsolidation (4-year CI, 46% vs 35%) were associated with a higher risk of unsustained MRD negativity in a multivariate Fine-Gray model. During the first 2 years of maintenance, patients receiving carfilzomib-lenalidomide vs lenalidomide alone had a lower risk of unsustained MRD negativity (4-year CI, 20% vs 33%).
MeSH term(s)	Humans ; Multiple Myeloma/drug therapy ; Lenalidomide/therapeutic use ; Treatment Outcome ; Neoplasm, Residual ; Prognosis
Chemical Substances	Lenalidomide (F0P408N6V4)
Language	English
Publishing date	2023-12-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood.2023022080
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Article: Molecular Characterization of Severe Acute Respiratory Syndrome Coronavirus 2 Isolates From Central Inner Sardinia.

Malune, Paolo / Piras, Giovanna / Monne, Maria / Fiamma, Maura / Asproni, Rosanna / Fancello, Tatiana / Manai, Antonio / Carta, Franco / Pira, Giovanna / Fancello, Patrizia / Rosu, Valentina / Uras, Antonella / Mereu, Caterina / Mameli, Giuseppe / Lo Maglio, Iana / Garau, Maria Cristina / Palmas, Angelo Domenico

Frontiers in microbiology

2022 Volume 12, Page(s) 827799

Abstract: Background: The SARS-CoV-2 pandemic stimulated an outstanding global sequencing effort, which allowed to monitor viral circulation and evolution. Nuoro province (Sardinia, Italy), characterized by a relatively isolated geographical location and a low ... ...

Abstract	Background: The SARS-CoV-2 pandemic stimulated an outstanding global sequencing effort, which allowed to monitor viral circulation and evolution. Nuoro province (Sardinia, Italy), characterized by a relatively isolated geographical location and a low population density, was severely hit and displayed a high incidence of infection. Methods: Amplicon approach Next Generation Sequencing and subsequent variant calling in 92 respiratory samples from SARS-CoV-2 infected patients involved in infection clusters from March 2020 to May 2021. Results: Phylogenetic analysis displayed a coherent distribution of sequences in terms of lineage and temporal evolution of pandemic. Circulating lineage/clade characterization highlighted a growing diversity over time, with an increasingly growing number of mutations and variability of spike and nucleocapsid proteins, while viral RdRp appeared to be more conserved. A total of 384 different mutations were detected, of which 196 were missense and 147 synonymous ones. Mapping mutations along the viral genome showed an irregular distribution in key genes. Conclusion: The analysis of the 92 viral genome highlighted evolution over time and identified which mutations are more widespread than others. The high number of sequences also permits the identification of subclusters that are characterized by subtle differences, not only in terms of lineage, which may be used to reconstruct transmission clusters. The disclosure of viral genetic diversity and timely identification of new variants is a useful tool to guide public health intervention measures.
Language	English
Publishing date	2022-01-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587354-4
ISSN	1664-302X
ISSN	1664-302X
DOI	10.3389/fmicb.2021.827799
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Article: Early Diffusion of SARS-CoV-2 Infection in the Inner Area of the Italian Sardinia Island.

Piras, Giovanna / Grandi, Nicole / Monne, Maria / Asproni, Rosanna / Fancello, Tatiana / Fiamma, Maura / Mameli, Giuseppe / Casu, Gavino / Lo Maglio, Iana / Palmas, Angelo D / Tramontano, Enzo

Frontiers in microbiology

2021 Volume 11, Page(s) 628194

Abstract: Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been responsible for the coronavirus disease 2019 (COVID-19) pandemic, which started as a severe pneumonia outbreak in Wuhan, China, in December 2019. Italy has been the first ... ...

Abstract	Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been responsible for the coronavirus disease 2019 (COVID-19) pandemic, which started as a severe pneumonia outbreak in Wuhan, China, in December 2019. Italy has been the first European country affected by the pandemic, registering a total of 300,363 cases and 35,741 deaths until September 24, 2020. The geographical distribution of SARS-CoV-2 in Italy during early 2020 has not been homogeneous, including regions severely affected as well as administrative areas being only slightly interested by the infection. Among the latter, Sardinia represents one of the lowest incidence areas likely due to its insular nature. Methods: Next-generation sequencing of a small number of complete viral genomes from clinical samples and their virologic and phylogenetic characterization was performed. Results: We provide a first overview of the SARS-CoV-2 genomic diversity in Sardinia in the early phase of the March-May 2020 pandemic based on viral genomes isolated in the most inner regional hospital of the island. Our analysis revealed a remarkable genetic diversity in local SARS-CoV-2 viral genomes, showing the presence of at least four different clusters that can be distinguished by specific amino acid substitutions. Based on epidemiological information, these sequences can be linked to at least eight different clusters of infection, four of which likely originates from imported cases. In addition, the presence of amino acid substitutions that were not previously reported in Italian patients has been observed, asking for further investigations in a wider population to assess their prevalence and dynamics of emergence during the pandemic. Conclusion: The present study provides a snapshot of the initial phases of the SARS-CoV-2 infection in inner area of the Sardinia Island, showing an unexpected genomic diversity.
Language	English
Publishing date	2021-02-12
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2587354-4
ISSN	1664-302X
ISSN	1664-302X
DOI	10.3389/fmicb.2020.628194
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Article ; Online: Systemic mastocytosis with associated BCRABL1-negative atypical chronic myeloid leukemia.

Caocci, Giovanni / Greco, Marianna / Frau, Veronica / Asproni, Rosanna / Piras, Giovanna / Palmas, Angelo / Casula, Paolo / La Nasa, Giorgio

Annals of hematology

2019 Volume 99, Issue 2, Page(s) 363–365

MeSH term(s)	Aged, 80 and over ; Bone Marrow/pathology ; Granulocytes/pathology ; Humans ; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative/blood ; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative/diagnosis ; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative/genetics ; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative/pathology ; Male ; Mast Cells/pathology ; Mastocytosis, Systemic/blood ; Mastocytosis, Systemic/diagnosis ; Mastocytosis, Systemic/genetics ; Mastocytosis, Systemic/pathology ; Mutation, Missense ; Neoplasm Proteins/genetics ; Neoplasms, Multiple Primary/pathology ; Neutrophils/pathology ; Point Mutation ; Proto-Oncogene Proteins c-kit/genetics ; Splicing Factor U2AF/genetics
Chemical Substances	Neoplasm Proteins ; Splicing Factor U2AF ; U2AF1 protein, human ; KIT protein, human (EC 2.7.10.1) ; Proto-Oncogene Proteins c-kit (EC 2.7.10.1)
Language	English
Publishing date	2019-12-06
Publishing country	Germany
Document type	Case Reports ; Letter
ZDB-ID	1064950-5
ISSN	1432-0584 ; 0939-5555 ; 0945-8077
ISSN (online)	1432-0584
ISSN	0939-5555 ; 0945-8077
DOI	10.1007/s00277-019-03875-9
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Article ; Online: Pomalidomide in heavily pretreated refractory multiple myeloma: a case report.

Palmas, Angelo / Piras, Giovanna / Uras, Antonella / Asproni, Rosanna / Murineddu, Marco / Monne, Maria / Stradoni, Roberta / Latte, Giancarlo

Future oncology (London, England)

2017 Volume 13, Issue 5s, Page(s) 7–9

Abstract: We present the case of a 70-year-old man diagnosed with multiple myeloma in 2008, who after four therapy lines initiated a fifth-line treatment with pomalidomide (4 mg orally, days 1-21 of a 28-day cycle) and low-dose dexamethasone (40 mg weekly orally). ...

Abstract	We present the case of a 70-year-old man diagnosed with multiple myeloma in 2008, who after four therapy lines initiated a fifth-line treatment with pomalidomide (4 mg orally, days 1-21 of a 28-day cycle) and low-dose dexamethasone (40 mg weekly orally). The patient was treated with pomalidomide for almost 2 years achieving a complete remission after 12 cycles. Complete remission was maintained for 9 months. This case illustrates the potential of pomalidomide plus low-dose dexamethasone to overcome multiple myeloma refractoriness inducing a quick and very prolonged remission.
MeSH term(s)	Aged ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Drug Resistance, Neoplasm ; Humans ; Immunologic Factors/administration & dosage ; Immunologic Factors/adverse effects ; Immunologic Factors/therapeutic use ; Male ; Multiple Myeloma/diagnosis ; Multiple Myeloma/drug therapy ; Multiple Myeloma/genetics ; Retreatment ; Thalidomide/administration & dosage ; Thalidomide/adverse effects ; Thalidomide/analogs & derivatives ; Thalidomide/therapeutic use ; Treatment Outcome
Chemical Substances	Antineoplastic Agents ; Immunologic Factors ; Thalidomide (4Z8R6ORS6L) ; pomalidomide (D2UX06XLB5)
Language	English
Publishing date	2017-02
Publishing country	England
Document type	Case Reports ; Journal Article
ZDB-ID	2184533-5
ISSN	1744-8301 ; 1479-6694
ISSN (online)	1744-8301
ISSN	1479-6694
DOI	10.2217/fon-2016-0460
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Article ; Online: Acute basophilic leukemia with U2AF1 mutation.

Carruale, Antonio / Muntone, Giuseppina / Rojas, Rodrigo / Bonfigli, Silvana / Virdis, Patrizia / Longu, Francesco / Valdes, Giovanni / Piras, Giovanna / Uras, Antonella / Palmas, Angelo / Caocci, Giovanni / La Nasa, Giorgio / Fozza, Claudio

Blood cells, molecules & diseases

2019 Volume 76, Page(s) 63–65

MeSH term(s)	Humans ; Leukemia, Basophilic, Acute/genetics ; Male ; Middle Aged ; Mutation ; Splicing Factor U2AF/genetics
Chemical Substances	Splicing Factor U2AF ; U2AF1 protein, human
Language	English
Publishing date	2019-02-22
Publishing country	United States
Document type	Case Reports ; Letter
ZDB-ID	1237083-6
ISSN	1096-0961 ; 1079-9796
ISSN (online)	1096-0961
ISSN	1079-9796
DOI	10.1016/j.bcmd.2019.02.002
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Article ; Online: Treosulfan-fludarabine-thiotepa conditioning before allogeneic haemopoietic stem cell transplantation for patients with advanced lympho-proliferative disease. A single centre study.

Baronciani, Donatella / Depau, Cristina / Targhetta, Clara / Derudas, Daniele / Culurgioni, Fabio / Tandurella, Igor / Latte, Giancarlo / Palmas, Angelo / Angelucci, Emanuele

Hematological oncology

2016 Volume 34, Issue 1, Page(s) 17–21

Abstract: In recent years, with the aim of reducing transplant-related mortality, new conditioning regimens have been explored in patients not eligible for conventional haemopoietic stem cell transplantation. In this setting, we investigated safety and feasibility ...

Abstract	In recent years, with the aim of reducing transplant-related mortality, new conditioning regimens have been explored in patients not eligible for conventional haemopoietic stem cell transplantation. In this setting, we investigated safety and feasibility of the treosulfan-fludarabine-thiotepa combination prior to allogeneic haemopoietic stem cell transplantation in patients with advanced lympho-proliferative diseases and at high transplant risk. Twenty-seven consecutive patients, median age 43 years (range 19-60), entered this study. All of them were affected by lympho-proliferative disease in advanced phase and have been heavily pre-treated. The median haemopoietic stem cell transplant co-morbidity index was 1 (range 0-3). Twenty-five patients had regular engraftment, while the remaining two patients were not evaluable for early deaths. Non-haematological toxicity was limited. No patient developed veno-occlusive disease. The estimated probability of overall survival and progression-free survival with a median follow-up of 40 months was 52% (95% confidence interval 33-73) and 50% (95% confidence interval 30-70) respectively. Six patients have relapsed; all of them were not in remission before transplantation. The treosulfan-fludarabine-thiotepa combination is a reduced toxicity but myeloablative regimen that can be proposed to patients not fitting criteria for conventional myeloablative transplant regimens. Longer follow-up and prospective randomized studies are necessary to evaluate this regimen.
MeSH term(s)	Adult ; Bone Marrow Transplantation ; Busulfan/adverse effects ; Busulfan/analogs & derivatives ; Busulfan/therapeutic use ; Combined Modality Therapy ; Disease-Free Survival ; Female ; Graft Survival ; Graft vs Host Disease ; Hematologic Neoplasms/drug therapy ; Hematologic Neoplasms/therapy ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Peripheral Blood Stem Cell Transplantation/mortality ; Recurrence ; Remission Induction ; Salvage Therapy ; Thiotepa/adverse effects ; Thiotepa/therapeutic use ; Transplantation Conditioning/adverse effects ; Transplantation Conditioning/methods ; Transplantation, Autologous ; Transplantation, Homologous/mortality ; Treatment Outcome ; Vidarabine/adverse effects ; Vidarabine/analogs & derivatives ; Vidarabine/therapeutic use ; Young Adult
Chemical Substances	Thiotepa (905Z5W3GKH) ; treosulfan (CO61ER3EPI) ; Vidarabine (FA2DM6879K) ; Busulfan (G1LN9045DK) ; fludarabine (P2K93U8740)
Language	English
Publishing date	2016-03
Publishing country	England
Document type	Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	604884-5
ISSN	1099-1069 ; 0278-0232
ISSN (online)	1099-1069
ISSN	0278-0232
DOI	10.1002/hon.2187
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Article ; Online: Carfilzomib with cyclophosphamide and dexamethasone or lenalidomide and dexamethasone plus autologous transplantation or carfilzomib plus lenalidomide and dexamethasone, followed by maintenance with carfilzomib plus lenalidomide or lenalidomide alone for patients with newly diagnosed multiple myeloma (FORTE): a randomised, open-label, phase 2 trial.

Gay, Francesca / Musto, Pellegrino / Rota-Scalabrini, Delia / Bertamini, Luca / Belotti, Angelo / Galli, Monica / Offidani, Massimo / Zamagni, Elena / Ledda, Antonio / Grasso, Mariella / Ballanti, Stelvio / Spadano, Antonio / Cea, Michele / Patriarca, Francesca / D'Agostino, Mattia / Capra, Andrea / Giuliani, Nicola / de Fabritiis, Paolo / Aquino, Sara /

Palmas, Angelo / Gamberi, Barbara / Zambello, Renato / Petrucci, Maria Teresa / Corradini, Paolo / Cavo, Michele / Boccadoro, Mario

The Lancet. Oncology

2021 Volume 22, Issue 12, Page(s) 1705–1720

Abstract: Background: Bortezomib-based induction followed by high-dose melphalan (200 mg/m: Methods: UNITO-MM-01/FORTE was a randomised, open-label, phase 2 trial done in 42 Italian academic and community practice centres. We enrolled transplant-eligible ... ...

Abstract	Background: Bortezomib-based induction followed by high-dose melphalan (200 mg/m Methods: UNITO-MM-01/FORTE was a randomised, open-label, phase 2 trial done in 42 Italian academic and community practice centres. We enrolled transplant-eligible patients with newly diagnosed multiple myeloma aged 65 years or younger with a Karnofsky Performance Status of 60% or higher. Patients were stratified according to International Staging System stage (I vs II/III) and age (<60 years vs 60-65 years) and randomly assigned (1:1:1) to KRd plus ASCT (four 28-day induction cycles with carfilzomib plus lenalidomide plus dexamethasone [KRd], melphalan at 200 mg/m Findings: Between Feb 23, 2015, and April 5, 2017, 474 patients were randomly assigned to one of the induction-intensification-consolidation groups (158 to KRd plus ASCT, 157 to KRd12, and 159 to KCd plus ASCT). The median duration of follow-up was 50·9 months (IQR 45·7-55·3) from the first randomisation. 222 (70%) of 315 patients in the KRd group and 84 (53%) of 159 patients in the KCd group had at least a very good partial response after induction (OR 2·14, 95% CI 1·44-3·19, p=0·0002). 356 patients were randomly assigned to maintenance treatment with carfilzomib plus lenalidomide (n=178) or lenalidomide alone (n=178). The median duration of follow-up was 37·3 months (IQR 32·9-41·9) from the second randomisation. 3-year progression-free survival was 75% (95% CI 68-82) with carfilzomib plus lenalidomide versus 65% (58-72) with lenalidomide alone (hazard ratio [HR] 0·64 [95% CI 0·44-0·94], p=0·023). During induction and consolidation, the most common grade 3-4 adverse events were neutropenia (21 [13%] of 158 patients in the KRd plus ASCT group vs 15 [10%] of 156 in the KRd12 group vs 18 [11%] of 159 in the KCd plus ASCT group); dermatological toxicity (nine [6%] vs 12 [8%] vs one [1%]); and hepatic toxicity (13 [8%] vs 12 [8%] vs none). Treatment-related serious adverse events were reported in 18 (11%) of 158 patients in the KRd-ASCT group, 29 (19%) of 156 in the KRd12 group, and 17 (11%) of 159 in the KCd plus ASCT group; the most common serious adverse event was pneumonia, in seven (4%) of 158, four (3%) of 156, and five (3%) of 159 patients. Treatment-emergent deaths were reported in two (1%) of 158 patients in the KRd plus ASCT group, two (1%) of 156 in the KRd12 group, and three (2%) of 159 in the KCd plus ASCT group. During maintenance, the most common grade 3-4 adverse events were neutropenia (35 [20%] of 173 patients on carfilzomib plus lenalidomide vs 41 [23%] of 177 patients on lenalidomide alone); infections (eight [5%] vs 13 [7%]); and vascular events (12 [7%] vs one [1%]). Treatment-related serious adverse events were reported in 24 (14%) of 173 patients on carfilzomib plus lenalidomide versus 15 (8%) of 177 on lenalidomide alone; the most common serious adverse event was pneumonia, in six (3%) of 173 versus five (3%) of 177 patients. One patient died of a treatment-emergent adverse event in the carfilzomib plus lenalidomide group. Interpretation: Our data show that KRd plus ASCT showed superiority in terms of improved responses compared with the other two treatment approaches and support the prospective randomised evaluation of KRd plus ASCT versus standards of care (eg, daratumumab plus bortezomib plus thalidomide plus dexamethasone plus ASCT) in transplant-eligible patients with multiple myeloma. Carfilzomib plus lenalidomide as maintenance therapy also improved progression-free survival compared with the standard-of-care lenalidomide alone. Funding: Amgen, Celgene/Bristol Myers Squibb. Translation: For the Italian translation of the abstract see Supplementary Materials section.
MeSH term(s)	Antibodies, Monoclonal/administration & dosage ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Bortezomib/administration & dosage ; Combined Modality Therapy ; Cyclophosphamide/administration & dosage ; Dexamethasone/administration & dosage ; Female ; Follow-Up Studies ; Hematopoietic Stem Cell Transplantation/mortality ; Humans ; Lenalidomide/administration & dosage ; Male ; Melphalan/administration & dosage ; Middle Aged ; Multiple Myeloma/pathology ; Multiple Myeloma/therapy ; Oligopeptides/administration & dosage ; Prognosis ; Survival Rate ; Thalidomide/administration & dosage ; Transplantation, Autologous
Chemical Substances	Antibodies, Monoclonal ; Oligopeptides ; daratumumab (4Z63YK6E0E) ; Thalidomide (4Z8R6ORS6L) ; Bortezomib (69G8BD63PP) ; carfilzomib (72X6E3J5AR) ; Dexamethasone (7S5I7G3JQL) ; Cyclophosphamide (8N3DW7272P) ; Lenalidomide (F0P408N6V4) ; Melphalan (Q41OR9510P)
Language	English
Publishing date	2021-11-11
Publishing country	England
Document type	Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(21)00535-0
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Article ; Online: Carfilzomib induction, consolidation, and maintenance with or without autologous stem-cell transplantation in patients with newly diagnosed multiple myeloma: pre-planned cytogenetic subgroup analysis of the randomised, phase 2 FORTE trial.

Mina, Roberto / Musto, Pellegrino / Rota-Scalabrini, Delia / Paris, Laura / Gamberi, Barbara / Palmas, Angelo / Aquino, Sara / de Fabritiis, Paolo / Giuliani, Nicola / De Rosa, Luca / Gozzetti, Alessandro / Cellini, Claudia / Bertamini, Luca / Capra, Andrea / Oddolo, Daniela / Vincelli, Iolanda Donatella / Ronconi, Sonia / Pavone, Vincenzo / Pescosta, Norbert /

Cea, Michele / Fioritoni, Francesca / Ballanti, Stelvio / Grasso, Mariella / Zamagni, Elena / Belotti, Angelo / Boccadoro, Mario / Gay, Francesca

The Lancet. Oncology

2022 Volume 24, Issue 1, Page(s) 64–76

Abstract: Background: Patients with newly diagnosed multiple myeloma and high-risk cytogenetic abnormalities (HRCA) represent an unmet medical need. In the FORTE trial, lenalidomide and dexamethasone plus carfilzomib (KRd) induction resulted in a higher ... ...

Abstract	Background: Patients with newly diagnosed multiple myeloma and high-risk cytogenetic abnormalities (HRCA) represent an unmet medical need. In the FORTE trial, lenalidomide and dexamethasone plus carfilzomib (KRd) induction resulted in a higher proportion of patients with at least a very good partial response as compared with carfilzomib, cyclophosphamide, and dexamethasone (KCd), and carfilzomib plus lenalidomide maintenance prolonged progression-free survival compared with lenalidomide maintenance. In this prespecified analysis of the FORTE trial, we described the outcomes of enrolled patients according to their cytogenetic risk. Methods: The UNITO-MM-01/FORTE was a randomised, open-label, phase 2 trial done at 42 Italian academic and community practice centres, which enrolled transplant-eligible patients with newly diagnosed multiple myeloma aged 18-65 years. Eligible patients had newly diagnosed multiple myeloma based on standard International Myeloma Working Group criteria, a Karnofsky performance status of at least 60%, and had not received any previous treatment with anti-myeloma therapy. At enrolment, patients were stratified according to International Staging System stage (I vs II/III) and age (<60 years vs 60-65 years) and randomly assigned (1:1:1) to KRd plus autologous stem-cell transplantation (ASCT; four 28-day induction cycles with KRd, melphalan at 200 mg/m Findings: Between Feb 23, 2015, and April 5, 2017, 477 patients were enrolled, of whom 396 (83%) had complete cytogenetic data and were analysed (176 [44%] of whom were women and 220 [56%] were men). The median follow-up from first randomisation was 51 months (IQR 46-56). 4-year progression-free survival was 71% (95% CI 64-78) in patients with zero HRCA, 60% (95% CI 52-69) in patients with one HRCA, and 39% (95% CI 30-50) in patients with two or more HRCA. Compared with patients with zero HRCA, the risk of progression or death was similar in patients with one HRCA (hazard ratio [HR] 1·33 [95% CI 0·90-1·97]; p=0·15) and higher in patients with two or more HRCA (HR 2·56 [95% CI 1·74-3·75]); p<0·0001) across the induction-intensification-consolidation groups. Moreover, the risk of progression or death was also higher in patients with two or more HRCA versus those with one HRCA (HR 1·92 [95% CI 1·34-2·76]; p=0·0004). 4-year overall survival from the first randomisation was 94% (95% CI 91-98) in patients with zero HRCA, 83% (95% CI 76-90) in patients with one HRCA, and 63% (95% CI 54-74) in patients with two or more HRCA. Compared with patients with zero HRCA, the risk of death was significantly higher in patients with one HRCA (HR 2·55 [95% CI 1·22-5·36]; p=0·013) and two or more HRCA (HR 6·53 [95% CI 3·24-13·18]; p<0·0001). Patients with two or more HRCA also had a significantly higher risk of death than those with one HRCA (HR 2·56 [95% CI 1·53-4·28]; p=0·0004). The rates of 1-year sustained minimal residual disease negativity were similar in patients with zero HRCA (53 [35%] of 153] and with one HRCA (57 [41%] of 138) and were lower in patients with two or more HRCA (25 [24%] of 105). The median duration of follow-up from second randomisation was 37 months (IQR 33-42). 3-year progression-free survival from the second randomisation was 80% (95% CI 74-88) in patients with zero HRCA, 68% (95% CI 59-78) in patients with one HRCA, and 53% (95% CI 42-67) in patients with two or more HRCA. The risk of progression or death was higher in patients with one HRCA (HR 1·68 [95% CI 1·01-2·80]; p=0·048) and two or more HRCA (2·74 [95% CI 1·60-4·69], p=0·0003) than in patients with zero HRCA. Interpretation: This preplanned analysis of the FORTE trial showed that carfilzomib-based induction-intensification-consolidation regimens are effective strategies in patients with standard risk (zero HRCA) and high-risk (one HRCA) myeloma, resulting in similar rates of progression-free survival and 1-year sustained minimal residual disease negativity. Despite promising progression-free survival, patients with ultra-high-risk disease (those with 2 or more HRCA) still have an increased risk of progression and death and therefore represent an unmet medical need. Funding: Amgen and Celgene/Bristol Myers Squibb.
MeSH term(s)	Male ; Humans ; Female ; Multiple Myeloma/drug therapy ; Multiple Myeloma/genetics ; Lenalidomide ; Neoplasm, Residual ; Dexamethasone ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Hematopoietic Stem Cell Transplantation/adverse effects ; Cyclophosphamide/therapeutic use ; Cytogenetic Analysis ; Transplantation, Autologous/methods
Chemical Substances	Lenalidomide (F0P408N6V4) ; carfilzomib (72X6E3J5AR) ; Dexamethasone (7S5I7G3JQL) ; Cyclophosphamide (8N3DW7272P)
Language	English
Publishing date	2022-12-14
Publishing country	England
Document type	Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2049730-1
ISSN	1474-5488 ; 1470-2045
ISSN (online)	1474-5488
ISSN	1470-2045
DOI	10.1016/S1470-2045(22)00693-3
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Article: Methylation analysis of the phosphates and tensin homologue on chromosome 10 gene (PTEN) in multiple myeloma.

Piras, Giovanna / Monne, Maria / Palmas, Angelo D / Calvisi, Anna / Asproni, Rosanna / Vacca, Francesco / Pilo, Laura / Gabbas, Attilio / Latte, Giancarlo

Clinical epigenetics

2014 Volume 6, Issue 1, Page(s) 16

Abstract: Background: Aberrant DNA methylation of promoter region CpG islands is an alternative mechanism that leads to genetic defects in the inactivation of tumor suppressor genes during myelomagenesis. The aim of this study was to examine the promoter ... ...

Abstract	Background: Aberrant DNA methylation of promoter region CpG islands is an alternative mechanism that leads to genetic defects in the inactivation of tumor suppressor genes during myelomagenesis. The aim of this study was to examine the promoter methylation status of the phosphates and tensin homologue on chromosome 10 (PTEN) gene in a cohort of multiple myeloma patients. Findings: The PTEN gene was hypermethylated in 7 out of 58 (12%) primary myeloma samples. The correlation between functional inactivation and PTEN mRNA levels was not statistically significant. The multiple myeloma subgroup with an aberrant PTEN status had a prevalence of the component IgG, Salmon Durie stage I, lower lactate dehydrogenase levels, intermediate-standard cytogenetic risk and longer overall survival with the respect to the unmethylated subgroup. Conclusions: This is the first report demonstrating the presence of PTEN promoter hypermethylation in multiple myeloma.
Language	English
Publishing date	2014-08-20
Publishing country	Germany
Document type	Journal Article
ZDB-ID	2553921-8
ISSN	1868-7083 ; 1868-7075
ISSN (online)	1868-7083
ISSN	1868-7075
DOI	10.1186/1868-7083-6-16
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