Randomized trial of two schedules of low-dose gemtuzumab ozogamicin as induction monotherapy for newly diagnosed acute myeloid leukaemia in older patients not considered candidates for intensive chemotherapy. A phase II study of the EORTC and GIMEMA leukaemia groups (AML-19).

PubWeight™: 0.89‹?›

🔗 View Article (PMC 2864316)

Published in Br J Haematol on March 08, 2010

Authors

Sergio Amadori1, Stefan Suciu, Dominik Selleslag, Roberto Stasi, Giuliana Alimena, Liliana Baila, Vittorio Rizzoli, Erika Borlenghi, Gianluca Gaidano, Domenico Magro, Giuseppe Torelli, Petra Muus, Adriano Venditti, Emma Cacciola, Francesco Lauria, Marco Vignetti, Theo de Witte

Author Affiliations

1: Tor Vergata University Hospital, Rome, Italy.

Associated clinical trials:

Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (AML-19) | NCT00091234

Articles cited by this

The World Health Organization (WHO) classification of the myeloid neoplasms. Blood (2002) 10.87

Age and acute myeloid leukemia. Blood (2006) 6.46

Composite outcomes in randomized trials: greater precision but with greater uncertainty? JAMA (2003) 5.67

A comparison of low-dose cytarabine and hydroxyurea with or without all-trans retinoic acid for acute myeloid leukemia and high-risk myelodysplastic syndrome in patients not considered fit for intensive treatment. Cancer (2007) 4.60

Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol (2001) 2.71

Final report of the efficacy and safety of gemtuzumab ozogamicin (Mylotarg) in patients with CD33-positive acute myeloid leukemia in first recurrence. Cancer (2005) 2.08

The outcomes and costs of acute myeloid leukemia among the elderly. Arch Intern Med (2002) 1.90

Selective ablation of acute myeloid leukemia using antibody-targeted chemotherapy: a phase I study of an anti-CD33 calicheamicin immunoconjugate. Blood (1999) 1.90

Targeting of the CD33-calicheamicin immunoconjugate Mylotarg (CMA-676) in acute myeloid leukemia: in vivo and in vitro saturation and internalization by leukemic and normal myeloid cells. Blood (2001) 1.59

A phase I trial of monoclonal antibody M195 in acute myelogenous leukemia: specific bone marrow targeting and internalization of radionuclide. J Clin Oncol (1991) 1.42

High efficacy and safety profile of fractionated doses of Mylotarg as induction therapy in patients with relapsed acute myeloblastic leukemia: a prospective study of the alfa group. Leukemia (2006) 1.06

Composite and surrogate outcomes in randomised controlled trials. BMJ (2007) 0.97

Gemtuzumab ozogamicin (Mylotarg) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups. Leukemia (2005) 0.95

Treatment of acute myeloid leukemia. Haematologica (2009) 0.94

Gemtuzumab ozogamicin in the treatment of acute myeloid leukemia. Cancer Treat Rev (2007) 0.93

Acute myelogenous leukemia in elderly patients not eligible for intensive chemotherapy: the dark side of the moon. Ann Oncol (2005) 0.81

Advances in the management of AML in the elderly. Clin Adv Hematol Oncol (2007) 0.80

Articles by these authors

Gene expression profile of adult T-cell acute lymphocytic leukemia identifies distinct subsets of patients with different response to therapy and survival. Blood (2003) 20.10

Cytoplasmic nucleophosmin in acute myelogenous leukemia with a normal karyotype. N Engl J Med (2005) 12.18

Acquired mutations in TET2 are common in myelodysplastic syndromes. Nat Genet (2009) 8.03

International consensus report on the investigation and management of primary immune thrombocytopenia. Blood (2009) 7.72

Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood (2008) 7.06

The complement inhibitor eculizumab in paroxysmal nocturnal hemoglobinuria. N Engl J Med (2006) 6.90

Analysis of the coding genome of diffuse large B-cell lymphoma. Nat Genet (2011) 6.06

Retinoic acid and arsenic trioxide for acute promyelocytic leukemia. N Engl J Med (2013) 5.72

Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia. N Engl J Med (2015) 5.69

Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood (2007) 5.54

Inactivating mutations of acetyltransferase genes in B-cell lymphoma. Nature (2011) 5.20

Levofloxacin to prevent bacterial infection in patients with cancer and neutropenia. N Engl J Med (2005) 4.96

Somatic mutations of the histone methyltransferase gene EZH2 in myelodysplastic syndromes. Nat Genet (2010) 4.90

Analysis of the chronic lymphocytic leukemia coding genome: role of NOTCH1 mutational activation. J Exp Med (2011) 4.37

Competing risks in epidemiology: possibilities and pitfalls. Int J Epidemiol (2012) 3.81

Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial. Lancet (2008) 3.62

R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage follicular lymphoma: results of the FOLL05 trial conducted by the Fondazione Italiana Linfomi. J Clin Oncol (2013) 3.58

A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood (2011) 3.28

Somatically acquired JAK1 mutations in adult acute lymphoblastic leukemia. J Exp Med (2008) 3.24

Romiplostim or standard of care in patients with immune thrombocytopenia. N Engl J Med (2010) 3.20

Diagnosis and treatment of primary myelodysplastic syndromes in adults: recommendations from the European LeukemiaNet. Blood (2013) 2.97

Efficacy and safety of caspofungin for treatment of invasive aspergillosis in patients refractory to or intolerant of conventional antifungal therapy. Clin Infect Dis (2004) 2.89

Efficacy and safety of once-weekly bortezomib in multiple myeloma patients. Blood (2010) 2.84

Prognostic impact of monocyte count at presentation in mantle cell lymphoma. Br J Haematol (2013) 2.66

Post-transplant Kaposi sarcoma originates from the seeding of donor-derived progenitors. Nat Med (2003) 2.61

Integrated mutational and cytogenetic analysis identifies new prognostic subgroups in chronic lymphocytic leukemia. Blood (2012) 2.58

Improved risk classification for risk-specific therapy based on the molecular study of minimal residual disease (MRD) in adult acute lymphoblastic leukemia (ALL). Blood (2009) 2.54

Clinical impact of small TP53 mutated subclones in chronic lymphocytic leukemia. Blood (2014) 2.53

Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol (2009) 2.50

Low-dose decitabine versus best supportive care in elderly patients with intermediate- or high-risk myelodysplastic syndrome (MDS) ineligible for intensive chemotherapy: final results of the randomized phase III study of the European Organisation for Research and Treatment of Cancer Leukemia Group and the German MDS Study Group. J Clin Oncol (2011) 2.48

Retrospective comparison of reduced-intensity conditioning and conventional high-dose conditioning for allogeneic hematopoietic stem cell transplantation using HLA-identical sibling donors in myelodysplastic syndromes. Blood (2006) 2.46

Mutations of the SF3B1 splicing factor in chronic lymphocytic leukemia: association with progression and fludarabine-refractoriness. Blood (2011) 2.44

Long-term results of the randomized phase III trial EORTC 18991 of adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma. J Clin Oncol (2012) 2.42

AML with mutated NPM1 carrying a normal or aberrant karyotype show overlapping biologic, pathologic, immunophenotypic, and prognostic features. Blood (2009) 2.41

Hypermethylation of the DNA repair gene O(6)-methylguanine DNA methyltransferase and survival of patients with diffuse large B-cell lymphoma. J Natl Cancer Inst (2002) 2.38

The NF-{kappa}B negative regulator TNFAIP3 (A20) is inactivated by somatic mutations and genomic deletions in marginal zone lymphomas. Blood (2009) 2.36

Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria. Blood (2007) 2.36

Induction chemotherapy strategies for primary mediastinal large B-cell lymphoma with sclerosis: a retrospective multinational study on 426 previously untreated patients. Haematologica (2002) 2.34

Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group. Blood (2010) 2.20

Combination antifungal therapy for invasive aspergillosis: a randomized trial. Ann Intern Med (2015) 2.18

Relative response of patients with myelodysplastic syndromes and other transfusion-dependent anaemias to deferasirox (ICL670): a 1-yr prospective study. Eur J Haematol (2007) 2.14

Prognostic and therapeutic implications of minimal residual disease detection in acute myeloid leukemia. Blood (2011) 2.13

Chronic myeloid leukemia in blast crisis treated with imatinib 600 mg: outcome of the patients alive after a 6-year follow-up. Haematologica (2008) 2.12

Risk score for outcome after allogeneic hematopoietic stem cell transplantation: a retrospective analysis. Cancer (2009) 2.12

Long-term follow-up of 233 patients with hairy cell leukaemia, treated initially with pentostatin or cladribine, at a median of 16 years from diagnosis. Br J Haematol (2009) 2.10

Genomic and expression profiling identifies the B-cell associated tyrosine kinase Syk as a possible therapeutic target in mantle cell lymphoma. Br J Haematol (2006) 2.09

The prognostic significance of CDKN2A, CDKN2B and MTAP inactivation in B-lineage acute lymphoblastic leukemia of childhood. Results of the EORTC studies 58881 and 58951. Haematologica (2006) 2.09

Does adjuvant interferon-alpha for high-risk melanoma provide a worthwhile benefit? A meta-analysis of the randomised trials. Cancer Treat Rev (2003) 2.08

Predictive gene signature in MAGE-A3 antigen-specific cancer immunotherapy. J Clin Oncol (2013) 2.08

Comparison of Escherichia coli-asparaginase with Erwinia-asparaginase in the treatment of childhood lymphoid malignancies: results of a randomized European Organisation for Research and Treatment of Cancer-Children's Leukemia Group phase 3 trial. Blood (2002) 2.05

Mutations of NOTCH1 are an independent predictor of survival in chronic lymphocytic leukemia. Blood (2011) 2.04

Dasatinib as first-line treatment for adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Blood (2011) 2.02

Superiority of the triple combination of bortezomib-thalidomide-dexamethasone over the dual combination of thalidomide-dexamethasone in patients with multiple myeloma progressing or relapsing after autologous transplantation: the MMVAR/IFM 2005-04 Randomized Phase III Trial from the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation. J Clin Oncol (2012) 2.01

The prognostic value of TP53 mutations in chronic lymphocytic leukemia is independent of Del17p13: implications for overall survival and chemorefractoriness. Clin Cancer Res (2009) 2.01

Nilotinib for the frontline treatment of Ph(+) chronic myeloid leukemia. Blood (2009) 2.00

IKZF1 (Ikaros) deletions in BCR-ABL1-positive acute lymphoblastic leukemia are associated with short disease-free survival and high rate of cumulative incidence of relapse: a GIMEMA AL WP report. J Clin Oncol (2009) 2.00

Health-related quality of life in chronic myeloid leukemia patients receiving long-term therapy with imatinib compared with the general population. Blood (2011) 1.96

Gene expression profile analysis of AIDS-related primary effusion lymphoma (PEL) suggests a plasmablastic derivation and identifies PEL-specific transcripts. Blood (2003) 1.93

Superior outcome of women with stage I/II cutaneous melanoma: pooled analysis of four European Organisation for Research and Treatment of Cancer phase III trials. J Clin Oncol (2012) 1.93

CD49d is the strongest flow cytometry-based predictor of overall survival in chronic lymphocytic leukemia. J Clin Oncol (2014) 1.92

The coding genome of splenic marginal zone lymphoma: activation of NOTCH2 and other pathways regulating marginal zone development. J Exp Med (2012) 1.90

Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European LeukemiaNet Study. Blood (2009) 1.90

Disruption of BIRC3 associates with fludarabine chemorefractoriness in TP53 wild-type chronic lymphocytic leukemia. Blood (2012) 1.88

Delayed-onset peripheral blood cytopenia after rituximab: frequency and risk factor assessment in a consecutive series of 77 treatments. Leuk Lymphoma (2006) 1.88

The dynamic DNA methylomes of double-stranded DNA viruses associated with human cancer. Genome Res (2009) 1.87

Clinico-pathological characteristics of myeloid sarcoma at diagnosis and during follow-up: report of 12 cases from a single institution. Leuk Res (2004) 1.84

Allogeneic compared with autologous stem cell transplantation in the treatment of patients younger than 46 years with acute myeloid leukemia (AML) in first complete remission (CR1): an intention-to-treat analysis of the EORTC/GIMEMAAML-10 trial. Blood (2003) 1.84

Extended schedule, escalated dose temozolomide versus dacarbazine in stage IV melanoma: final results of a randomised phase III study (EORTC 18032). Eur J Cancer (2011) 1.78

Chemotherapy-phased imatinib pulses improve long-term outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia: Northern Italy Leukemia Group protocol 09/00. J Clin Oncol (2010) 1.77

Multiple myeloma bone disease: Pathophysiology of osteoblast inhibition. Blood (2006) 1.77

High rate of remissions in chronic myelomonocytic leukemia treated with 5-azacytidine: results of an Italian retrospective study. Leuk Lymphoma (2012) 1.77

Identification and molecular characterization of recurrent genomic deletions on 7p12 in the IKZF1 gene in a large cohort of BCR-ABL1-positive acute lymphoblastic leukemia patients: on behalf of Gruppo Italiano Malattie Ematologiche dell'Adulto Acute Leukemia Working Party (GIMEMA AL WP). Blood (2009) 1.76

Multilineage dysplasia has no impact on biologic, clinicopathologic, and prognostic features of AML with mutated nucleophosmin (NPM1). Blood (2010) 1.75

The proteasome inhibitor bortezomib affects osteoblast differentiation in vitro and in vivo in multiple myeloma patients. Blood (2007) 1.75

Diabetes impairs hematopoietic stem cell mobilization by altering niche function. Sci Transl Med (2011) 1.75

Chemokine induction by all-trans retinoic acid and arsenic trioxide in acute promyelocytic leukemia: triggering the differentiation syndrome. Blood (2009) 1.74

Long-term safety and efficacy of sustained eculizumab treatment in patients with paroxysmal nocturnal haemoglobinuria. Br J Haematol (2013) 1.68

Idiopathic thrombocytopenic purpura: current concepts in pathophysiology and management. Thromb Haemost (2008) 1.68

Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: results of a randomized phase II study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma. J Clin Oncol (2013) 1.67

Azacitidine for the treatment of patients with acute myeloid leukemia: report of 82 patients enrolled in an Italian Compassionate Program. Cancer (2011) 1.67

NOTCH1 mutations in +12 chronic lymphocytic leukemia (CLL) confer an unfavorable prognosis, induce a distinctive transcriptional profiling and refine the intermediate prognosis of +12 CLL. Haematologica (2011) 1.67

Improved outcome with pulses of vincristine and corticosteroids in continuation therapy of children with average risk acute lymphoblastic leukemia (ALL) and lymphoblastic non-Hodgkin lymphoma (NHL): report of the EORTC randomized phase 3 trial 58951. Blood (2010) 1.64

Higher incidence of relapse with peripheral blood rather than marrow as a source of stem cells in adults with acute myelocytic leukemia autografted during the first remission. J Clin Oncol (2009) 1.64

NF-κB as a potential therapeutic target in myelodysplastic syndromes and acute myeloid leukemia. Expert Opin Ther Targets (2010) 1.64

Amount of spontaneous apoptosis detected by Bax/Bcl-2 ratio predicts outcome in acute myeloid leukemia (AML). Blood (2002) 1.63

Simian virus 40 infection in lymphoproliferative disorders. Lancet (2003) 1.63

Activity and safety profile of low-dose rituximab for the treatment of autoimmune cytopenias in adults. Haematologica (2007) 1.62

Expression of mutated IGHV3-23 genes in chronic lymphocytic leukemia identifies a disease subset with peculiar clinical and biological features. Clin Cancer Res (2010) 1.62