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1.
Leuk Res ; 81: 88-94, 2019 06.
Article in English | MEDLINE | ID: mdl-31055248

ABSTRACT

The introduction of new therapeutic agents in chronic lymphocytic leukemia (CLL), including the new kinase inhibitors (KIs) ibrutinib and idelalisib, has changed the therapeutic landscape of the disease. The new KIs have also changed frequency and epidemiology of infections, that represent a major cause of morbidity and mortality of the disease. Hence, the great strides in the indications and use of new KIs need parallel amelioration of prophylaxis and supportive treatment for infections. Moving from the recognition that infection control represents an unmet need, the Italian Society of Hematology (SIE) convened a panel of experts who had published and/or expressed an interest in infection complications in CLL. The goal of the project was to provide practice recommendations for the management of the infectious complications of CLL during ibrutinib or idelalisib therapy. The present publication represents the results of a series of email correspondences and meetings held during 2017 and 2018. Three domains of infectious complications during KIs therapy for CLL were explored: risk assessment, risk management and risk monitoring. We hope these recommendations will help to minimize infectious adverse events, and we believe that an optimal management of them will be rewarded by better outcomes, and better quality of life.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Infection Control/standards , Infections/therapy , Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy , Practice Guidelines as Topic/standards , Quality of Life , Adenine/analogs & derivatives , Hematology , Humans , Infections/chemically induced , Infections/pathology , Italy , Piperidines , Purines/administration & dosage , Pyrazoles/administration & dosage , Pyrimidines/administration & dosage , Quinazolinones/administration & dosage
4.
Eur J Haematol ; 101(1): 78-85, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29569278

ABSTRACT

OBJECTIVE: The most typical cytogenetic aberration in myelodysplastic syndromes is del(5q), which, when isolated, is associated with refractory anaemia and good prognosis. Based on high rates of erythroid response and transfusion independence, Lenalidomide (LEN) became the standard treatment. This multi-centre study was designed to supplement Italian Registry data on LEN by addressing prescription, administration appropriateness, haematological and cytogenetic responses and disease evolution. METHODS: MORE study was an observational, non-interventional, multi-centre, retrospective and prospective study. Cases were recruited from 45 Haematological Centres throughout Italy. Data were collected from the Italian National Registry for Lenalidomide administration and supplemented by a MORE data form. RESULTS: Data from 190/213 patients were analysed. In all, 149 had been diagnosed by conventional cytogenetics (GROUP A) and 41 only by FISH (GROUP B). Overall erythroid response was obtained in 92.8% of cases. Overall cytogenetic remission was achieved in 22.6% of cases. Disease progression occurred in 15.6% of cases. Clonal cytogenetic evolution characterised progression to AML but not to higher risk MDS. CONCLUSIONS: Erythroid response to Lenalidomide was similar in MDS with isolated del(5q) and with del(5q) plus one anomaly. Progression to AML or higher risk MDS showed different cytogenetic features.


Subject(s)
Chromosome Deletion , Chromosomes, Human, Pair 5/chemistry , Immunologic Factors/therapeutic use , Leukemia, Myeloid, Acute/drug therapy , Myelodysplastic Syndromes/drug therapy , Registries , Thalidomide/analogs & derivatives , Aged , Disease Progression , Female , Humans , Italy , Karyotyping , Lenalidomide , Leukemia, Myeloid, Acute/etiology , Leukemia, Myeloid, Acute/genetics , Leukemia, Myeloid, Acute/immunology , Male , Middle Aged , Myelodysplastic Syndromes/complications , Myelodysplastic Syndromes/genetics , Myelodysplastic Syndromes/immunology , Prospective Studies , Remission Induction , Retrospective Studies , Thalidomide/therapeutic use
5.
Leuk Res ; 62: 108-115, 2017 11.
Article in English | MEDLINE | ID: mdl-29054020

ABSTRACT

Myelodysplastic syndromes (MDS) are a group of clonally-acquired blood disorders characterized by ineffective hematopoiesis leading to cytopenias. Red blood cell transfusions are an important component of supportive care in patients with MDS. Prolonged exposure to transfusions can lead to iron overload, which results in iron-induced toxicity caused by the production of reactive oxygen species (ROS). ROS accumulation has detrimental effects also on hematopoietic stem cells and may contribute to MDS progression. The observation that iron chelation improves hematologic parameters and reduces transfusion dependence further indicates that iron overload impairs hematopoiesis. Over the past decade, the mechanisms regulating iron homeostasis and the complex interplay between iron overload and toxicity, ineffective hematopoiesis, and transformation to leukemia have become clearer. In this narrative review, we provide an overview of recent findings pertaining to iron overload in patients with MDS and its effects on hematopoiesis. We also briefly discuss the position of chelation therapy in the context of the new developments.


Subject(s)
Hematopoiesis/physiology , Iron Overload/etiology , Myelodysplastic Syndromes/complications , Animals , Erythrocyte Transfusion/adverse effects , Humans , Iron Overload/prevention & control , Myelodysplastic Syndromes/therapy
6.
Leuk Res ; 58: 63-72, 2017 07.
Article in English | MEDLINE | ID: mdl-28460339

ABSTRACT

The discovery that Philadelphia-negative classical myeloproliferative neoplasms (MPNs) present with several molecular abnormalities, including the mostly represented JAK2V617F mutation, opened new horizons in the diagnosis, prognosis, and monitoring of these disorders. However, the great strides in the knowledge on molecular genetics need parallel progresses on the best approach to methods for detecting and reporting disease-associated mutations, and to shape the most effective and rationale testing pathway in the diagnosis, prognosis and monitoring of MPNs. The MPN taskforce of the Italian Society of Hematology (SIE) assessed the scientific literature and composed a framework of the best, possibly evidence-based, recommendations for optimal molecular methods as well as insights about the applicability and interpretation of those tests in the clinical practice, and clinical decision for testing MPNs patients. The issues dealt with: source of samples and nucleic acid template, the most appropriate molecular abnormalities and related detection methods required for diagnosis, prognosis, and monitoring of MPNs, how to report a diagnostic molecular test, calibration and quality control. For each of these issues, practice recommendations were provided.


Subject(s)
Molecular Diagnostic Techniques , Myeloproliferative Disorders/diagnosis , Myeloproliferative Disorders/genetics , Humans , Italy
7.
Eur J Haematol ; 97(6): 554-561, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27124765

ABSTRACT

OBJECTIVES: In this paper, we present a review of critical concepts and research perspectives and produce recommendations on the optimal use of pixantrone in non-Hodgkin lymphoma (NHL) by group discussion from an expert panel appointed by the Italian Society of Hematology and the affiliate societies, Società Italiana di Ematologia Sperimentale and Gruppo Italiano Trapianto di Midollo Osseo. METHODS: Recommendations were produced using the Delphi process. Scientific evidence on pixantrone efficacy was analyzed using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology in the areas where at least one randomized trial was published. The following key issues were addressed for practical recommendations: pixantrone monotherapy in aggressive relapsed or refractory non-Hodgkin B-cell lymphomas and toxicity risk management in patients candidates to pixantrone. RESULTS AND CONCLUSIONS: After a balanced and value-oriented discussion, the panel agreed that the benefit/risk profile was in favor of pixantrone in the treatment of adult patients with multiply relapsed or refractory aggressive NHL B-cell lymphomas. Pixantrone was deemed to be contraindicated in patients with uncontrolled cardiovascular disease. Despite a low rate of cardiotoxicity of pixantrone reported in clinical trials, the panel recommended that all patients receiving pixantrone should undergo periodical cardiac monitoring.


Subject(s)
Antineoplastic Agents/therapeutic use , Isoquinolines/therapeutic use , Lymphoma, Non-Hodgkin/drug therapy , Topoisomerase II Inhibitors/therapeutic use , Antineoplastic Agents/pharmacology , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Combined Modality Therapy , Disease Management , Drug Evaluation, Preclinical , Drug Resistance, Neoplasm , Humans , Isoquinolines/pharmacology , Lymphoma, Non-Hodgkin/pathology , Practice Guidelines as Topic , Recurrence , Topoisomerase II Inhibitors/pharmacology
8.
Clin Lymphoma Myeloma Leuk ; 15(9): 507-13, 2015 Sep.
Article in English | MEDLINE | ID: mdl-26195435

ABSTRACT

Brentuximab vedotin (BV) is approved for the treatment of patients with relapsed or refractory CD30-positive Hodgkin lymphoma, and relapsed or refractory systemic anaplastic large-cell lymphoma. Several uncertainties remain regarding the optimal use of the drug in its approved indications as well as outside them. This article reports recommendations on the use of BV issued during a consensus project, sponsored by the Italian Society of Hematology (SIE) and its affiliate societies, Società Italiana di Ematologia Sperimentale (SIES) and Gruppo Italiano Trapianto di Midollo Osseo (GITMO). Scientific evidence on BV was evaluated by a panel of experts, and consensus was developed by group discussion for key questions selected according to the clinical relevance. The following key issues were addressed: testing CD30 positivity to assess eligibility to BV; assessing practice indications of BV in Hodgkin lymphoma and systemic anaplastic large-cell lymphoma; providing pretreatment evaluation of patients candidates to BV; monitoring the response to BV; managing patients treated with BV; and assessing the role of BV in other CD30-positive lymphomas.


Subject(s)
Hodgkin Disease/drug therapy , Immunoconjugates/therapeutic use , Ki-1 Antigen/metabolism , Lymphoma, Large-Cell, Anaplastic/drug therapy , Brentuximab Vedotin , Hodgkin Disease/metabolism , Humans , Italy , Lymphoma, Large-Cell, Anaplastic/metabolism
9.
Clin Lymphoma Myeloma Leuk ; 15(2): 75-85, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25108679

ABSTRACT

Indolent nonfollicular B-cell lymphoma (INFBCL) has been classified in the World Health Organization 2008 system among the mature B-cell neoplasms and includes nodal and extranodal marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), and small lymphocytic lymphoma (SLL). Recently, the array and sequencing technologies have provided new insights into their molecular pathogenesis; the molecular discoveries, however, have not yet translated into consistent changes in their management. Thus, the therapy for INFBCL remains challenging. To promote widespread adoption of appropriate clinical practice, the Italian Society of Hematology and affiliate societies (Italian Society of Experimental Hematology and Italian Group for Bone Marrow Transplantation) reviewed the evidence regarding the management of these lymphomas to produce evidence-based recommendations aimed at contributing to therapy optimization and standardization. We used the Grades of Recommendation, Assessment, Development, and Evaluation system, which is based on a sequential assessment of the quality of evidence, followed by an analysis of the benefit/risk balance and subsequent judgment about the strength of recommendations. For issues without consistent evidence, we used the consensus technique. We have provided separate recommendations for diagnostic and staging requirements, first-line therapy, and postinduction therapy for the most frequent INFBCLs (ie, LPL, SLL, and nodal, splenic, and gastric MZL).


Subject(s)
Bone Marrow Transplantation/methods , Bone Marrow Transplantation/standards , Lymphoma, B-Cell/therapy , Hematology/methods , Hematology/standards , Humans , Italy , Practice Guidelines as Topic
10.
Leuk Lymphoma ; 56(6): 1671-6, 2015 Jun.
Article in English | MEDLINE | ID: mdl-25241999

ABSTRACT

Clinical trial results indicate that lenalidomide, an immunomodulatory drug, is a promising treatment in relapsed/refractory non-Hodgkin lymphoma (NHL). This retrospective multicenter study was conducted in patients with relapsed/refractory NHL treated with lenalidomide monotherapy through a Named Patient Program in Italy. Principal endpoints were overall response rate (ORR), safety and overall survival (OS). The ORR in 64 evaluable patients was 42.2% and was similar among patients receiving 10, 15 or 25 mg/day lenalidomide. Response rates in patients with mantle cell, diffuse large B-cell and follicular lymphoma were 45.5%, 42.1% and 20%, respectively. Among patients who responded to most recent prior therapy, ORR was 50.0% versus 36.8% in patients with refractory NHL. Mean duration of response in patients receiving any lenalidomide dose was 10.5 months; 1-year progression-free survival and OS were 50.3% and 82.6%, respectively. These findings suggest that lenalidomide is effective and safe for heavily pretreated patients with NHL in the clinical setting.


Subject(s)
Immunologic Factors/therapeutic use , Lymphoma, Non-Hodgkin/drug therapy , Thalidomide/analogs & derivatives , Adult , Aged , Aged, 80 and over , Disease-Free Survival , Female , Humans , Italy , Lenalidomide , Lymphoma, Non-Hodgkin/mortality , Male , Middle Aged , Neoplasm Recurrence, Local , Off-Label Use , Retrospective Studies , Survival Rate , Thalidomide/therapeutic use
11.
Leuk Res ; 38(11): 1269-77, 2014 Nov.
Article in English | MEDLINE | ID: mdl-25063524

ABSTRACT

By using the GRADE system we produced the following recommendations for the use of bendamustine in the first-line treatment of CLL: (1) bendamustine with rituximab is recommended in elderly fit patients potentially eligible to FCR; (2) Bendamustine alone is recommended in patients who are candidate to chlorambucil alone; (3) Rituximab-bendamustine is recommended in patients not eligible to FCR, but suitable to receive rituximab. Consensus-based recommendations addressed evidence-orphan issues concerning the use of bendamustine in genetically-defined high-risk patients and the appropriate dose of bendamustine as single agent or in association with rituximab.


Subject(s)
Antineoplastic Agents, Alkylating/therapeutic use , Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy , Nitrogen Mustard Compounds/therapeutic use , Bendamustine Hydrochloride , Humans
12.
Eur J Haematol ; 92(6): 527-36, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24580147

ABSTRACT

BACKGROUND: In the absence of randomized, controlled trial data to support iron chelation therapy in transfusion-dependent patients with myelodysplastic syndromes (MDS), continued evidence from large prospective clinical trials evaluating the efficacy and safety of iron chelation therapy in this patient population is warranted. METHODS: The safety and efficacy of deferasirox was examined in a prospective, open-label, single-arm, multicenter trial of transfusion-dependent patients with International Prognostic Scoring System low- or intermediate-1-risk MDS and evidence of transfusion-related iron overload. The effects of deferasirox therapy on hematological response and disease progression were also examined. RESULTS: Of 159 participants enrolled from 37 Italian centers, 152 received ≥1 dose of deferasirox (initiated at 10-20 mg/kg/day and titrated as appropriate), and 68 completed the study. Of 84 patients who discontinued deferasirox therapy, 22 died during the trial, and 28 withdrew due to an adverse event (AE). Fourteen treatment-related grade 3 AEs occurred in 11 patients, whereas no grade 4 or 5 drug-related AEs were reported. Significant risks for dropout were a higher serum ferritin level at baseline, a higher MDS-Specific Comorbidity Index, and a shorter diagnosis-enrollment interval. Median serum ferritin level fell from 1966 ng/mL to 1475 ng/mL (P < 0.0001). The cumulative incidence of transfusion independence, adjusted for death and disease progression, was 2.6%, 12.3%, and 15.5% after 6, 9, and 12 months, respectively. CONCLUSIONS: Deferasirox therapy in transfusion-dependent patients with MDS was moderately well tolerated and effectively lowered serum ferritin levels. Positive hematological responses were observed, and a subset of patients achieved transfusion independence.


Subject(s)
Benzoates/therapeutic use , Blood Transfusion , Iron Chelating Agents/therapeutic use , Iron Overload/drug therapy , Iron Overload/etiology , Myelodysplastic Syndromes/complications , Myelodysplastic Syndromes/therapy , Triazoles/therapeutic use , Adult , Aged , Aged, 80 and over , Benzoates/adverse effects , Deferasirox , Female , Ferritins/blood , Humans , Iron Chelating Agents/adverse effects , Male , Middle Aged , Risk Factors , Transfusion Reaction , Treatment Outcome , Triazoles/adverse effects , Young Adult
13.
Leuk Res ; 38(2): 155-60, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24378116

ABSTRACT

This article presents the results of group discussion among experts from SIE, SIES and GITMO societies aimed at highlighting unmet challenges in the management of Ph-neg myeloproliferative neoplasms (MPNs). The issues analyzed were: diagnosis of prefibrotic myelofibrosis; diagnosis of Ph-neg MPNs in the setting of splanchnic vein thrombosis (SVT); management of low-risk PV and low-risk ET patients with JAK2V617F mutation; molecular biomarkers in the prognostic evaluation of myelofibrosis (MF); ruxolitinib therapy in low-risk MF; therapy in patients with SVT-associated Ph-neg MPN; indications of splenectomy in MF. For each of these issues, proposals for advancement in clinical research were addressed.


Subject(s)
Health Services Needs and Demand , Myeloproliferative Disorders/diagnosis , Myeloproliferative Disorders/therapy , Aged , Aged, 80 and over , Amino Acid Substitution , Consensus , Expert Testimony , Female , Health Services Accessibility , Humans , Janus Kinase 2/genetics , Male , Middle Aged , Myeloproliferative Disorders/classification , Myeloproliferative Disorders/genetics , Philadelphia Chromosome , Societies, Medical , Uncertainty , World Health Organization
14.
Haematologica ; 98(9): 1344-52, 2013 Sep.
Article in English | MEDLINE | ID: mdl-24006407

ABSTRACT

With the aim of reviewing critical concepts and producing recommendations for the management of chronic myelomonocytic leukemia, key questions were selected according to the criterion of clinical relevance. Recommendations were produced using a Delphi process and four consensus conferences involving a panel of experts appointed by the Italian Society of Hematology and affiliated societies. This report presents the final statements and recommendations, covering patient evaluation at diagnosis, diagnostic criteria, risk classification, first-line therapy, monitoring, second-line therapy and allogeneic stem cell transplantation. For the first-line therapy, the panel recommended that patients with myelodysplastic-type chronic myelomonocytic leukemia and less than 10% blasts in bone marrow should be managed with supportive therapy aimed at correcting cytopenias. In patients with myelodysplastic-type chronic myelomonocytic leukemia with a high number of blasts in bone marrow (≥ 10%), supportive therapy should be integrated with the use of 5-azacytidine. Patients with myeloproliferative-type chronic myelomonocytic leukemia with a low number of blasts (<10%) should be treated with cytoreductive therapy. Hydroxyurea is the drug of choice to control cell proliferation and to reduce organomegaly. Patients with myeloproliferative-type chronic myelomonocytic leukemia, and a high number of blasts should receive polychemotherapy. Both in myelodysplastic-type and myeloproliferative-type chronic myelomonocytic leukemia, allogeneic stem cell transplantation should be offered within clinical trials in selected patients.


Subject(s)
Consensus , Leukemia, Myelomonocytic, Chronic/therapy , Practice Guidelines as Topic/standards , Societies, Medical/standards , World Health Organization , Disease Management , Humans , Leukemia, Myelomonocytic, Chronic/diagnosis
15.
Am J Hematol ; 88(3): 185-92, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23339086

ABSTRACT

By using the GRADE system, we updated the guidelines for management of follicular cell lymphoma issued in 2006 from SIE, SIES, and GITMO group. We confirmed our recommendation to frontline chemoimmunotherapy in patients with Stage III-IV disease and/or high tumor burden. Maintenance rituximab was also recommended in responding patients. In patients relapsing after an interval longer than 12 months from frontline therapy, we recommended chemoimmunotherapy with non cross-resistant regimens followed by rituximab maintenance. High dose chemotherapy followed by hematopoietic stem cell transplant was recommended for young fit patients who achieve a response after salvage chemoimmunotherapy.


Subject(s)
Antibodies, Monoclonal, Murine-Derived/therapeutic use , Antineoplastic Agents/therapeutic use , Hematopoietic Stem Cell Transplantation , Immunotherapy , Lymphoma, Follicular/therapy , Adult , Antibodies, Monoclonal, Murine-Derived/pharmacology , Antineoplastic Agents/pharmacology , Disease Management , Drug Administration Schedule , Female , Humans , Lymphoma, Follicular/pathology , Male , Middle Aged , Neoplasm Staging , Rituximab , Secondary Prevention , Time Factors
16.
Ann Hematol ; 91(6): 875-88, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22476884

ABSTRACT

In this project, we produced drug-specific recommendations targeting the use of new agents for multiple myeloma (MM). We used the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system which separates the judgments on quality of evidence from the judgment about strength of recommendations. We recommended thalidomide and bortezomib in MM patients candidates to autologous stem cell transplantation (ASCT) (weak positive). We did not recommend novel agents as maintenance therapy after ASCT (weak negative). In patients not candidate to ASCT, thalidomide or bortezomib (strong positive) associated with melphalan and prednisone were recommended. In these patients, no specific course of action could be recommended as for maintenance therapy. In patients who are refractory or relapsing after first-line therapy, we recommended bortezomib and pegylated liposomal doxorubicin, or lenalidomide and dexamethasone combinations (weak positive).


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Evidence-Based Practice , Hematology/methods , Multiple Myeloma/drug therapy , Practice Guidelines as Topic , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Boronic Acids/administration & dosage , Bortezomib , Hematology/legislation & jurisprudence , Hematology/organization & administration , Humans , Lenalidomide , Multiple Myeloma/pathology , Neoplasm Grading/methods , Pyrazines/administration & dosage , Societies, Medical/legislation & jurisprudence , Societies, Medical/organization & administration , Thalidomide/administration & dosage , Thalidomide/analogs & derivatives
17.
Ann Hematol ; 91(4): 527-32, 2012 Apr.
Article in English | MEDLINE | ID: mdl-21964878

ABSTRACT

Essential thrombocythaemia (ET) is a myeloproliferative neoplasm characterized by elevated platelet counts and increased incidence of thrombosis and haemorrhage. Median age at diagnosis is 65-70 years. Life expectancy is similar to that of the healthy population. Symptoms and complications may affect quality of life (QoL); in particular, in elderly patients ET may represent an additional burden. We performed a survey in 494 elderly ET patients to evaluate patient-reported outcomes (PROs). Comorbidities were present in 305 (62%) patients. Factorial analysis based on survey items representing psychological aspects of daily life identified an "attitude domain" with four clusters of patients: (A) very pessimistic (n = 99), (B) pessimistic (n = 101), (C) optimistic (n = 90), and (D) very optimistic (n = 107). Patients in cluster A had more comorbidities (p = 0.003) while patients in cluster D required fewer medical visits and were less disturbed by medications (p < 0.0001). Independent factors predicting Short-Form Health Survey, version 2 physical QoL were grade of optimism (p < 0.0001), gender (p = 0.007), and Charlson comorbidity index (p < 0.0001)). Grade of optimism and disturbances related to medication predicted mental QOL (p < 0.0001). In conclusion, physicians should take into consideration PROs, as "attitude" is associated with physical and mental QoL. Treatment should be tailored to patients' needs according to comorbidities, lifestyle, and psychological conditions.


Subject(s)
Quality of Life , Thrombocythemia, Essential/physiopathology , Aged , Cross-Sectional Studies , Female , Humans , Italy , Male , Middle Aged , Surveys and Questionnaires , Thrombocythemia, Essential/pathology
18.
Leuk Res ; 36(4): 459-66, 2012 Apr.
Article in English | MEDLINE | ID: mdl-21885123

ABSTRACT

By using GRADE system we updated the guidelines for management of CLL issued in 2006 from SIE, SIES and GITMO group. We recommended fludarabine, cyclophosphamide, rituximab (FCR) in younger and selected older patients with a good fitness status, no unfavourable genetics (deletion 17p and/or p53 mutations), and a less toxic treatment in nonfit and elderly patients. In patients without unfavourable genetics, relapsed after 24 months the same initial treatment including rituximab can be considered. In patients with unfavourable genetics, refractory or relapsed within 24 months from a prior fludarabine-based treatment, allogeneic SCT or experimental treatments should be given.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Leukemia, Lymphocytic, Chronic, B-Cell/drug therapy , Humans
19.
Ann. hematol ; 91(6): 875-888, 2012.
Article in English | BIGG - GRADE guidelines | ID: biblio-1015316

ABSTRACT

In this project, we produced drug-specific recommendations targeting the use of new agents for multiple myeloma (MM). We used the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) system which separates the judgments on quality of evidence from the judgment about strength of recommendations. We recommended thalidomide and bortezomib in MM patients candidates to autologous stem cell transplantation (ASCT) (weak positive). We did not recommend novel agents as maintenance therapy after ASCT (weak negative). In patients not candidate to ASCT, thalidomide or bortezomib (strong positive) associated with melphalan and prednisone were recommended. In these patients, no specific course of action could be recommended as for maintenance therapy. In patients who are refractory or relapsing after first-line therapy, we recommended bortezomib and pegylated liposomal doxorubicin, or lenalidomide and dexamethasone combinations (weak positive).


Subject(s)
Humans , Antineoplastic Combined Chemotherapy Protocols , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Neoplasm Grading , Multiple Myeloma/pathology , Pyrazines/administration & dosage , Societies, Medical/legislation & jurisprudence , Thalidomide/therapeutic use , Boronic Acids/therapeutic use , Bortezomib/therapeutic use , Lenalidomide/therapeutic use , Hematology/legislation & jurisprudence , Hematology/methods
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