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  • 1
    Language: English
    In: The lancet oncology, 2015, Vol.16 (16), p.1617-1629
    Description: Summary Background High-dose melphalan plus autologous stem-cell transplantation (ASCT) is the standard approach in transplant-eligible patients with newly diagnosed myeloma. Our aims were to compare consolidation with high-dose melphalan plus ASCT versus chemotherapy (cyclophosphamide and dexamethasone) plus lenalidomide, and maintenance with lenalidomide plus prednisone versus lenalidomide alone. Methods We did an open-label, randomised, multicentre, phase 3 study at 59 centres in Australia, Czech Republic, and Italy. We enrolled transplant-eligible patients with newly diagnosed myeloma aged 65 years or younger. Patients received a common induction with four 28-day cycles of lenalidomide (25 mg, days 1–21) and dexamethasone (40 mg, days 1, 8, 15, and 22) and subsequent chemotherapy with cyclophosphamide (3 g/m2 ) followed by granulocyte colony-stimulating factor for stem-cell mobilisation and collection. Using a 2 × 2 partial factorial design, we randomised patients to consolidation with either chemotherapy plus lenalidomide (six cycles of cyclophosphamide [300 mg/m2 , days 1, 8, and 15], dexamethasone [40 mg, days 1, 8, 15, and 22], and lenalidomide [25 mg, days 1–21]) or two courses of high-dose melphalan (200 mg/m2 ) and ASCT. We also randomised patients to maintenance with lenalidomide (10 mg, days 1–21) plus prednisone (50 mg, every other day) or lenalidomide alone. A simple randomisation sequence was used to assign patients at enrolment into one of the four groups (1:1:1:1 ratio), but the treatment allocation was disclosed only when the patient reached the end of the induction and confirmed their eligibility for consolidation. Both the patient and the treating clinician did not know the consolidation and maintenance arm until that time. The primary endpoint was progression-free survival assessed by intention-to-treat. The trial is ongoing and some patients are still receiving maintenance. This study is registered at ClinicalTrials.gov , number NCT01091831. Findings 389 patients were enrolled between July 6, 2009, and May 6, 2011, with 256 eligible for consolidation (127 high-dose melphalan and ASCT and 129 chemotherapy plus lenalidomide) and 223 eligible for maintenance (117 lenalidomide plus prednisone and 106 lenalidomide alone). Median follow-up was 52·0 months (IQR 30·4–57·6). Progression-free survival during consolidation was significantly shorter with chemotherapy plus lenalidomide compared with high-dose melphalan and ASCT (median 28·6 months [95% CI 20·6–36·7] vs 43·3 months [33·2–52·2]; hazard ratio [HR] for the first 24 months 2·51, 95% CI 1·60–3·94; p〈0·0001). Progression-free survival did not differ between maintenance treatments (median 37·5 months [95% CI 27·8–not evaluable] with lenalidomide plus prednisone vs 28·5 months [22·5–46·5] with lenalidomide alone; HR 0·84, 95% CI 0·59–1·20; p=0·34). Fewer grade 3 or 4 adverse events were recorded with chemotherapy plus lenalidomide than with high-dose melphalan and ASCT; the most frequent were haematological (34 [26%] of 129 patients vs 107 [84%] of 127 patients), gastrointestinal (six [5%] vs 25 [20%]), and infection (seven [5%] vs 24 [19%]). Haematological serious adverse events were reported in two (2%) patients assigned chemotherapy plus lenalidomide and no patients allocated high-dose melphalan and ASCT. Non-haematological serious adverse events were reported in 13 (10%) patients assigned chemotherapy plus lenalidomide and nine (7%) allocated high-dose melphalan and ASCT. During maintenance, adverse events did not differ between groups. The most frequent grade 3 or 4 adverse events were neutropenia (nine [8%] of 117 patients assigned lenalidomide plus prednisone vs 14 [13%] of 106 allocated lenalidomide alone), infection (eight [8%] vs five [5%]), and systemic toxicities (seven [6%] vs two [2%]). Non-haematological serious adverse events were reported in 13 (11%) patients assigned lenalidomide plus prednisone versus ten (9%) allocated lenalidomide alone. Four patients died because of adverse events, three from infections (two during induction and one during consolidation) and one because of cardiac toxic effects. Interpretation Consolidation with high-dose melphalan and ASCT remains the preferred option in transplant-eligible patients with multiple myeloma, despite a better toxicity profile with chemotherapy plus lenalidomide. Funding Celgene.
    Subject(s): Hematology, Oncology and Palliative Medicine ; Multiple Myeloma - mortality ; Humans ; Middle Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Male ; Transplantation, Autologous ; Melphalan - therapeutic use ; Hematopoietic Stem Cell Transplantation - mortality ; Cyclophosphamide - therapeutic use ; Thalidomide - analogs & derivatives ; Multiple Myeloma - therapy ; Time Factors ; Hematopoietic Stem Cell Transplantation - adverse effects ; Female ; Maintenance Chemotherapy ; Chemotherapy, Adjuvant ; Thalidomide - adverse effects ; Prednisone - adverse effects ; Multiple Myeloma - diagnosis ; Risk Factors ; Kaplan-Meier Estimate ; Proportional Hazards Models ; Treatment Outcome ; Disease Progression ; Disease-Free Survival ; Czech Republic ; Dexamethasone - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Italy ; Aged ; Thalidomide - therapeutic use ; Australia ; Prednisone - therapeutic use ; Medical colleges ; Cyclophosphamide ; Care and treatment ; Chemotherapy ; Dexamethasone ; Multiple myeloma ; Stem cells ; Product development ; Prednisone ; Transplantation ; Cancer ; Index Medicus
    ISSN: 1470-2045
    E-ISSN: 1474-5488
    Source: Alma/SFX Local Collection
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  • 2
    Language: English
    In: The Lancet (British edition), 2010, Vol.376 (9758), p.2075-2085
    Description: Summary Background Thalidomide plus dexamethasone (TD) is a standard induction therapy for myeloma. We aimed to assess the efficacy and safety of addition of bortezomib to TD (VTD) versus TD alone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma. Methods Patients (aged 18–65 years) with previously untreated symptomatic myeloma were enrolled from 73 sites in Italy between May, 2006, and April, 2008, and data collection continued until June 30, 2010. Patients were randomly allocated (1:1 ratio) by a web-based system to receive three 21-day cycles of thalidomide (100 mg daily for the first 14 days and 200 mg daily thereafter) plus dexamethasone (40 mg daily on 8 of the first 12 days, but not consecutively; total of 320 mg per cycle), either alone or with bortezomib (1·3 mg/m2 on days 1, 4, 8, and 11). The randomisation sequence was computer generated by the study coordinating team and was stratified by disease stage. After double autologous stem-cell transplantation, patients received two 35-day cycles of their assigned drug regimen, VTD or TD, as consolidation therapy. The primary endpoint was the rate of complete or near complete response to induction therapy. Analysis was by intention to treat. Patients and treating physicians were not masked to treatment allocation. This study is still underway but is not recruiting participants, and is registered with ClinicalTrials.gov , number NCT01134484 , and with EudraCT , number 2005-003723-39. Findings 480 patients were enrolled and randomly assigned to receive VTD (n=241 patients) or TD (n=239). Six patients withdrew consent before start of treatment, and 236 on VTD and 238 on TD were included in the intention-to-treat analysis. After induction therapy, complete or near complete response was achieved in 73 patients (31%, 95% CI 25·0–36·8) receiving VTD, and 27 (11%, 7·3–15·4) on TD (p〈0·0001). Grade 3 or 4 adverse events were recorded in a significantly higher number of patients on VTD (n=132, 56%) than in those on TD (n=79, 33%; p〈0·0001), with a higher occurrence of peripheral neuropathy in patients on VTD (n=23, 10%) than in those on TD (n=5, 2%; p=0·0004). Resolution or improvement of severe peripheral neuropathy was recorded in 18 of 23 patients on VTD, and in three of five patients on TD. Interpretation VTD induction therapy before double autologous stem-cell transplantation significantly improves rate of complete or near complete response, and represents a new standard of care for patients with multiple myeloma who are eligible for transplant. Funding Seràgnoli Institute of Haematology at the University of Bologna, Bologna, Italy.
    Subject(s): Internal Medicine ; Immunopathology ; General aspects ; Pharmacology. Drug treatments ; Biological and medical sciences ; Immunoglobulinopathies ; Medical sciences ; Immunodeficiencies. Immunoglobulinopathies ; Antibacterial agents ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Humans ; Middle Aged ; Pyrazines - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Boronic Acids - adverse effects ; Dexamethasone - adverse effects ; Male ; Transplantation, Autologous ; Multiple Myeloma - drug therapy ; Adult ; Female ; Boronic Acids - administration & dosage ; Chemotherapy, Adjuvant ; Multiple Myeloma - surgery ; Thalidomide - adverse effects ; Reoperation ; Bortezomib ; Dexamethasone - administration & dosage ; Drug Administration Schedule ; Multiple Myeloma - diagnosis ; Kaplan-Meier Estimate ; Hematopoietic Stem Cell Transplantation ; Treatment Outcome ; Thalidomide - administration & dosage ; Remission Induction ; Disease-Free Survival ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Neoadjuvant Therapy - methods ; Pyrazines - adverse effects ; Italy ; Aged ; Complications and side effects ; Dexamethasone ; Multiple myeloma ; Dosage and administration ; Drug therapy ; Thalidomide ; Index Medicus ; Abridged Index Medicus
    ISSN: 0140-6736
    E-ISSN: 1474-547X
    Source: Backfile Package - All of Back Files EBS [ALLOFBCKF]
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  • 3
    Language: English
    In: The New England journal of medicine, 2014-09-04, Vol.371 (10), p.895-905
    Description: In patients 65 or younger with multiple myeloma, high-dose consolidation therapy was associated with longer survival and more myelotoxicity than conventional-dose therapy. Lenalidomide maintenance improved progression-free survival but not overall survival. High-dose chemotherapy plus autologous stem-cell transplantation, as compared with conventional chemotherapy, prolongs progression-free survival and overall survival among patients with newly diagnosed multiple myeloma. 1 – 4 and it is currently the standard of care for patients who are younger than 65 years of age. However, since autologous stem-cell transplantation has substantial toxic effects and requires prolonged hospitalization, the comparison with less toxic, orally administered treatments is important. Immunomodulatory drugs and proteasome inhibitors have significantly improved outcomes in patients, regardless of whether they are eligible for transplantation. 5 – 18 These improvements have raised questions about the role of transplantation in comparison with conventional . . .
    Subject(s): Hematologic and hematopoietic diseases ; Immunopathology ; General aspects ; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis ; Biological and medical sciences ; Immunoglobulinopathies ; Medical sciences ; Immunodeficiencies. Immunoglobulinopathies ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Multiple Myeloma - mortality ; Humans ; Middle Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Transplantation, Autologous ; Consolidation Chemotherapy ; Antineoplastic Agents, Alkylating - administration & dosage ; Thalidomide - analogs & derivatives ; Multiple Myeloma - drug therapy ; Multiple Myeloma - therapy ; Melphalan - adverse effects ; Adult ; Maintenance Chemotherapy ; Neutropenia - chemically induced ; Thalidomide - adverse effects ; Prednisone - administration & dosage ; Prednisone - adverse effects ; Kaplan-Meier Estimate ; Combined Modality Therapy ; Thalidomide - administration & dosage ; Disease-Free Survival ; Melphalan - administration & dosage ; Aged ; Antineoplastic Agents, Alkylating - adverse effects ; Stem Cell Transplantation - adverse effects ; Complications and side effects ; Care and treatment ; Patient outcomes ; Multiple myeloma ; Stem cells ; Transplantation ; Research ; Health aspects ; Autografts ; Chemotherapy ; Cell survival ; Transplants & implants ; Melphalan ; Stem cell transplantation ; Death ; Prednisone ; Drug dosages ; Neutropenia
    ISSN: 0028-4793
    E-ISSN: 1533-4406
    Source: Single Journals
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 4
    Language: English
    In: The New England journal of medicine, 2016-01-07, Vol.374 (1), p.43-53
    Description: Antilymphocyte globulin (ATG) added to the conditioning regimen before allogeneic hematopoietic stem-cell transplantation resulted in a lower rate of chronic graft-versus-host disease at 2 years than the rate without ATG (32% vs. 68%), with no apparent increased risk of relapse. Chronic graft-versus-host disease (GVHD) is a major complication of allogeneic stem-cell transplantation that results in later illness and death and a reduction in quality of life. 1 , 2 Risk factors for chronic GVHD are the use of peripheral blood as a source of stem cells, a history of acute GVHD, and the use of donated stem cells with high numbers of T cells. 3 – 7 In a meta-analysis, the Stem Cell Trialists’ Collaborative Group reported an incidence of extensive chronic GVHD of 47% after peripheral-blood stem-cell transplantation from an HLA-identical sibling. 4 In 2012, more than 70% of the stem-cell transplantations performed in . . .
    Subject(s): Graft vs Host Disease - epidemiology ; Prospective Studies ; Humans ; Immunosuppressive Agents - therapeutic use ; Middle Aged ; Proportional Hazards Models ; Child, Preschool ; Male ; Survival Rate ; Transplantation, Homologous ; Incidence ; Young Adult ; Disease-Free Survival ; Graft vs Host Disease - mortality ; Adolescent ; Antilymphocyte Serum - therapeutic use ; Adult ; Female ; Graft vs Host Disease - prevention & control ; T-Lymphocytes - immunology ; Child ; Chronic Disease ; Prevention ; Treatment outcome ; Graft versus host reaction ; Immunoglobulins ; Dosage and administration ; Analysis ; Graft-versus-host reaction ; Transplants & implants ; Leukemia ; Stem cell transplantation ; Lymphocytes T ; Preventive medicine ; Hemopoiesis ; Globulins ; Risk assessment ; Peripheral blood ; Stem cells ; Bone marrow ; Histocompatibility antigen HLA ; Index Medicus ; Abridged Index Medicus
    ISSN: 0028-4793
    E-ISSN: 1533-4406
    Source: Single Journals
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  • 5
    Language: English
    In: Journal of clinical oncology, 2011-03-10, Vol.29 (8), p.986-993
    Description: In patients with myeloma, thalidomide significantly improves outcomes but increases the risk of thromboembolic events. In this randomized, open-label, multicenter trial, we compared aspirin (ASA) or fixed low-dose warfarin (WAR) versus low molecular weight heparin (LMWH) for preventing thromboembolism in patients with myeloma treated with thalidomide-based regimens. A total of 667 patients with previously untreated myeloma who received thalidomide-containing regimens and had no clinical indication or contraindication for a specific antiplatelet or anticoagulant therapy were randomly assigned to receive ASA (100 mg/d), WAR (1.25 mg/d), or LMWH (enoxaparin 40 mg/d). A composite primary end point included serious thromboembolic events, acute cardiovascular events, or sudden deaths during the first 6 months of treatment. Of 659 analyzed patients, 43 (6.5%) had serious thromboembolic events, acute cardiovascular events, or sudden death during the first 6 months (6.4% in the ASA group, 8.2% in the WAR group, and 5.0% in the LMWH group). Compared with LMWH, the absolute differences were +1.3% (95% CI, -3.0% to 5.7%; P = .544) in the ASA group and +3.2% (95% CI, -1.5% to 7.8%; P = .183) in the WAR group. The risk of thromboembolism was 1.38 times higher in patients treated with thalidomide without bortezomib. Three major (0.5%) and 10 minor (1.5%) bleeding episodes were recorded. In patients with myeloma treated with thalidomide-based regimens, ASA and WAR showed similar efficacy in reducing serious thromboembolic events, acute cardiovascular events, and sudden deaths compared with LMWH, except in elderly patients where WAR showed less efficacy than LMWH.
    Subject(s): Immunopathology ; Biological and medical sciences ; Immunoglobulinopathies ; Medical sciences ; Immunodeficiencies. Immunoglobulinopathies ; Tumors ; Multiple Myeloma - mortality ; Cardiovascular Diseases - prevention & control ; Humans ; Middle Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Warfarin - adverse effects ; Male ; Antineoplastic Agents - administration & dosage ; Enoxaparin - therapeutic use ; Enoxaparin - adverse effects ; Warfarin - therapeutic use ; Fibrinolytic Agents - adverse effects ; Multiple Myeloma - drug therapy ; Thromboembolism - prevention & control ; Time Factors ; Aspirin - adverse effects ; Fibrinolytic Agents - therapeutic use ; Cardiovascular Diseases - mortality ; Female ; Aspirin - therapeutic use ; Platelet Aggregation Inhibitors - therapeutic use ; Platelet Aggregation Inhibitors - adverse effects ; Cardiovascular Diseases - etiology ; Risk Assessment ; Multiple Myeloma - complications ; Risk Factors ; Anticoagulants - therapeutic use ; Treatment Outcome ; Thromboembolism - etiology ; Thromboembolism - mortality ; Thalidomide - administration & dosage ; Anticoagulants - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Italy ; Aged ; Hemorrhage - chemically induced ; Index Medicus
    ISSN: 0732-183X
    E-ISSN: 1527-7755
    Source: Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
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  • 6
    Language: English
    In: Journal of clinical oncology, 2010-12-01, Vol.28 (34), p.5101-5109
    Description: The combination of bortezomib-melphalan-prednisone (VMP) is a new standard of care for newly diagnosed multiple myeloma. This phase III study examined the efficacy of the four-drug combination of bortezomib-melphalan-prednisone-thalidomide (VMPT) followed by maintenance with bortezomib-thalidomide (VMPT-VT) compared with VMP treatment alone in untreated multiple myeloma patients who are ineligible for autologous stem-cell transplantation. A total of 511 patients were randomly assigned to receive nine cycles of VMPT followed by continuous VT as maintenance, or nine cycles of VMP at the same doses with no additional therapy. The primary end point was progression-free survival. The 3-year estimates of progression-free survival were 56% in patients receiving VMPT-VT and 41% in those receiving VMP (hazard ratio [HR], 0.67; 95% CI, 0.50 to 0.90; P = .008). At 3 years, the cumulative proportions of patients who did not go on to the next therapy were 72% with VMPT-VT and 60% with VMP (HR, 0.58; 95% CI, 0.50 to 0.90; P = .007). Complete response rates were 38% in the VMPT-VT group and 24% in the VMP group (P 〈 .001). The 3-year overall survival was 89% with VMPT-VT and 87% with VMP (HR, 0.92; 95% CI, 0.53 to 1.60; P = .77). Grade 3 to 4 neutropenia (38% v 28%; P = .02), cardiologic events (10% v 5%; P = .04), and thromboembolic events (5% v 2%; P = .08) were more frequent among patients assigned to the VMPT-VT group than among those assigned to the VMP group; treatment-related deaths were 4% with VMPT-VT and 3% with VMP. VMPT followed by VT as maintenance was superior to VMP alone in patients with multiple myeloma who are ineligible for autologous stem-cell transplantation.
    Subject(s): Immunopathology ; Biological and medical sciences ; Immunoglobulinopathies ; Medical sciences ; Immunodeficiencies. Immunoglobulinopathies ; Tumors ; Thalidomide - adverse effects ; Prednisone - administration & dosage ; Bortezomib ; Prednisone - adverse effects ; Multiple Myeloma - mortality ; Humans ; Pyrazines - administration & dosage ; Kaplan-Meier Estimate ; Proportional Hazards Models ; Boronic Acids - adverse effects ; Treatment Outcome ; Thalidomide - administration & dosage ; Disease-Free Survival ; Melphalan - administration & dosage ; Multiple Myeloma - drug therapy ; Melphalan - adverse effects ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Pyrazines - adverse effects ; Boronic Acids - administration & dosage ; Index Medicus
    ISSN: 0732-183X
    E-ISSN: 1527-7755
    Source: Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
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  • 7
    Language: English
    In: Journal of medical virology, 2021-03, Vol.93 (3), p.1244-1246
    Subject(s): COVID-19 - immunology ; Triage - methods ; Follow-Up Studies ; Humans ; Middle Aged ; Male ; Serologic Tests - methods ; COVID-19 - diagnosis ; Young Adult ; Outpatients ; Diagnostic Tests, Routine - methods ; Nasopharynx - virology ; SARS-CoV-2 - drug effects ; Adult ; Female ; SARS-CoV-2 - immunology ; Aged ; Hematopoietic Stem Cell Transplantation - methods ; Index Medicus
    ISSN: 0146-6615
    E-ISSN: 1096-9071
    Source: Alma/SFX Local Collection
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  • 8
    Language: English
    In: European journal of nuclear medicine and molecular imaging, 2018-05, Vol.45 (5), p.712-719
    Description: FDG PET/CT (18F-fluoro-deoxy-glucose positron emission tomography/computed tomography) is a useful tool to image multiple myeloma (MM). However, simple and reproducible reporting criteria are still lacking and there is the need for harmonization. Recently, a group of Italian nuclear medicine experts defined new visual descriptive criteria (Italian Myeloma criteria for Pet Use: IMPeTUs) to standardize FDG PET/CT evaluation in MM patients. The aim of this study was to assess IMPeTUs reproducibility on a large prospective cohort of MM patients.Patients affected by symptomatic MM who had performed an FDG PET/CT at baseline (PET0), after induction (PET-AI), and the end of treatment (PET-EoT) were prospectively enrolled in a multicenter trial (EMN02)(NCT01910987; MMY3033). After anonymization, PET images were uploaded in the web platform WIDEN® and hence distributed to five expert nuclear medicine reviewers for a blinded independent central review according to the IMPeTUs criteria. Consensus among reviewers was measured by the percentage of agreement and the Krippendorff’s alpha. Furthermore, on a patient-based analysis, the concordance among all the reviewers in terms of positivity or negativity of the FDG PET/CT scan was tested for different thresholds of positivity (Deauville score (DS 2, 3, 4, 5) for the main parameters (bone marrow, focal score, extra-medullary disease).Eighty-six patients (211 FDG PET/CT scans) were included in this analysis. Median patient age was 58 years (range, 35–66 years), 45% were male, 15% of them were in stage ISS (International Staging System) III, and 42% had high-risk cytogenetics. The percentage agreement was superior to 75% for all the time points, reaching 100% of agreement in assessing the presence skull lesions after therapy. Comparable results were obtained when the agreement analysis was performed using the Krippendorff’s alpha coefficient, either in every single time point of scanning (PET0, PET-AI or PET-EoT) or overall for all the scans together. DS proved highly reproducible with the highest reproducibility for score 4.IMPeTUs criteria proved highly reproducible and could therefore be considered as a base for harmonizing PET interpretation in multiple myeloma. A prospective clinical validation of IMPeTUs criteria is underway.
    Subject(s): Medicine & Public Health ; Orthopedics ; Multiple myeloma ; Standardization ; Oncology ; Nuclear Medicine ; IMPeTUs ; Imaging / Radiology ; Cardiology ; FDG PET/CT ; Interpretation criteria ; Multiple Myeloma - diagnostic imaging ; Reproducibility of Results ; Prospective Studies ; Humans ; Middle Aged ; Male ; Tomography, X-Ray Computed ; Positron-Emission Tomography ; Positron Emission Tomography Computed Tomography ; Adult ; Female ; Fluorodeoxyglucose F18 ; Italy ; Aged ; Radiopharmaceuticals ; Analysis ; Index Medicus
    ISSN: 1619-7070
    E-ISSN: 1619-7089
    Source: Academic Search Ultimate
    Source: Alma/SFX Local Collection
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  • 9
    Language: English
    In: Journal of clinical oncology, 2014-03-01, Vol.32 (7), p.634-640
    Description: Bortezomib-melphalan-prednisone (VMP) has improved overall survival in multiple myeloma. This randomized trial compared VMP plus thalidomide (VMPT) induction followed by bortezomib-thalidomide maintenance (VMPT-VT) with VMP in patients with newly diagnosed multiple myeloma. We randomly assigned 511 patients who were not eligible for transplantation to receive VMPT-VT (nine 5-week cycles of VMPT followed by 2 years of VT maintenance) or VMP (nine 5-week cycles without maintenance). In the initial analysis with a median follow-up of 23 months, VMPT-VT improved complete response rate from 24% to 38% and 3-year progression-free-survival (PFS) from 41% to 56% compared with VMP. In this analysis, median follow-up was 54 months. The median PFS was significantly longer with VMPT-VT (35.3 months) than with VMP (24.8 months; hazard ratio [HR], 0.58; P 〈 .001). The time to next therapy was 46.6 months in the VMPT-VT group and 27.8 months in the VMP group (HR, 0.52; P 〈 .001). The 5-year overall survival (OS) was greater with VMPT-VT (61%) than with VMP (51%; HR, 0.70; P = .01). Survival from relapse was identical in both groups (HR, 0.92; P = .63). In the VMPT-VT group, the most frequent grade 3 to 4 adverse events included neutropenia (38%), thrombocytopenia (22%), peripheral neuropathy (11%), and cardiologic events (11%). All of these, except for thrombocytopenia, were significantly more frequent in the VMPT-VT patients. Bortezomib and thalidomide significantly improved OS in multiple myeloma patients not eligible for transplantation.
    Subject(s): Immunopathology ; Biological and medical sciences ; Immunoglobulinopathies ; Medical sciences ; Immunodeficiencies. Immunoglobulinopathies ; Tumors ; Peripheral Nervous System Diseases - chemically induced ; Follow-Up Studies ; Multiple Myeloma - mortality ; Humans ; Middle Aged ; Pyrazines - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Boronic Acids - adverse effects ; Induction Chemotherapy ; Male ; Multiple Myeloma - drug therapy ; Melphalan - adverse effects ; Adult ; Female ; Maintenance Chemotherapy ; Boronic Acids - administration & dosage ; Neutropenia - chemically induced ; Thalidomide - adverse effects ; Prednisone - administration & dosage ; Bortezomib ; Prednisone - adverse effects ; Kaplan-Meier Estimate ; Treatment Outcome ; Thrombocytopenia - chemically induced ; Thalidomide - administration & dosage ; Disease-Free Survival ; Melphalan - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Pyrazines - adverse effects ; Aged ; Index Medicus
    ISSN: 0732-183X
    E-ISSN: 1527-7755
    Source: Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
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  • 10
    Language: English
    In: European journal of nuclear medicine and molecular imaging, 2016-03, Vol.43 (3), p.414-421
    Description: FDG PET/CT is able to detect active disease in patients with multiple myeloma (MM) and can be helpful for staging and assessing therapy response, but no standard interpretation criteria have been proposed for the evaluation of FDG PET/CT in MM.A group of Italian nuclear medicine physicians and haematologists met to propose new visual interpretation criteria to standardize FDG PET/CT evaluation in MM patients (Italian Myeloma criteria for PET USe; IMPeTUs) and the reproducibility of these criteria was tested. This Italian multicentre protocol was set up as a subprotocol of EMN02, an international prospective multicentre trial of the European Myeloma Network. The criteria were agreed at multidisciplinary consensus meetings. They include a description of the metabolic state of the bone marrow (BM), number and site of focal PET-positive lesions, the number of osteolytic lesions, and the presence and site of extramedullary disease, paramedullary disease and fractures. A visual degree of uptake was defined for the target lesion and extramedullary lesions according to modified Deauville criteria. MM patients who had undergone FDG PET/CT at baseline (PET-0), after induction (PET-AI) and at the end of treatment (PET-EoT) were enrolled. The patients had been prospectively enrolled in EMN02 and their PET scans were a posteriori reinterpreted in a blinded independent central review process managed by WIDEN®. Five expert nuclear medicine physicians scored the scans according to the new criteria. A case was considered read when four out of the five reviewers completed the report. Concordance among reviewers on different metrics was calculated using Krippendorff’s alpha coefficient.A total of 17 consecutive patients were enrolled. On PET-0, the alpha coefficients for the BM score, the score for the hottest focal lesion, the number of focal lesions and the number of lytic lesions were 0.33 and 0.47, 0.40 and 0.32, respectively. On PET-AI, the alpha coefficients were 0.09 and 0.43, 0.22 and 0.21, respectively, and on PET-EoT, the alpha coefficients were 0.07, 0.28, 0.25 and 0.21, respectively. BM was generally difficult to score since grades 2 and 3 are difficult to discriminate. However, since neither of the two grades is related to BM myelomatous involvement, the difference was not clinically relevant. Agreement on focal lesion scores and on the number of focal lesions was good.The new visual criteria for interpreting FDG PET/CT imaging in MM patients, IMPeTUs, were found to be feasible in clinical practice.
    Subject(s): Medicine & Public Health ; Orthopedics ; Multiple myeloma ; Standardization ; Oncology ; Nuclear Medicine ; IMPeTUs ; Imaging / Radiology ; Cardiology ; FDG PET/CT ; Interpretation criteria ; Multiple Myeloma - diagnostic imaging ; Reproducibility of Results ; Prospective Studies ; Humans ; Image Interpretation, Computer-Assisted - methods ; Middle Aged ; Fluorodeoxyglucose F18 - chemistry ; Tomography, X-Ray Computed ; Positron-Emission Tomography ; Neoplasm Staging - methods ; Multimodal Imaging ; Image Processing, Computer-Assisted ; Fractures, Bone - complications ; Adult ; Italy ; Aged ; Nuclear Medicine - standards ; Observer Variation ; PET imaging ; Pets ; Index Medicus
    ISSN: 1619-7070
    E-ISSN: 1619-7089
    Source: Academic Search Ultimate
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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