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Berlin Brandenburg

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  • 1
    In: International Journal of Hematologic Oncology, April 2014, Vol.3(2), p.117-129
    Description: The ENESTnd trial is a Phase III, randomized, open-label, multicenter trial, in which 846 patients with newly diagnosed chromosome Philadelphia-positive chronic-phase chronic myeloid leukemia were randomly assigned in a 1:1:1 ratio between three arms of treatment: imatinib mesylate 400 mg once daily, nilotinib 300 mg twice daily (b.i.d.), nilotinib 400 mg b.i.d. Nilotinib appeared superior to imatinib in terms of complete cytogenetic response at 12 months (77 vs 87 vs 85%; p 〈 0.001); major molecular response at 12 months (primary end point ; BCR–ABL1 on an International Scale 〈 0.1%: 22 vs 44 vs 43%; p 〈 0.001); deep response at 4 years ( BCR–ABL1 IS 〈 0.0032%: 23 vs 40 vs 37%; p 〈 0.0001). Less progression to advanced phases at 4 years (0.7 vs 1.1 vs 4.2% on core treatment) converted into a slight advantage in terms of overall survival at 4 years for the nilotinib 400 mg b.i.d. arm in Sokal intermediate- and high-risk patients. Tolerance and quality of life were in favor of nilotinib, with the noteworthy exception of cardiovascular events (1.5 vs 6.4vs 8.7% at 4 years). This trial led to the approval of nilotinib 300 mg b.i.d. as front-line therapy of chronic-phase chronic myeloid leukemia in 2010.
    Keywords: chronic myeloid leukemia ; molecular response ; nilotinib ; Phase III trial
    ISSN: 2045-1393
    E-ISSN: 2045-1407
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  • 2
    Language: English
    In: Expert Opinion on Orphan Drugs, 02 November 2015, Vol.3(11), pp.1339-1356
    Description: Introduction: Despite considerable improvement in the prognosis of Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in the era of tyrosine-kinase inhibitors (TKI), less than half of the patients can be cured. Among several TKI now available, dasatinib (SPRYCEL...
    Keywords: Dasatinib ; Chronic Myeloid Leukemia in Lymphoid Blast Crisis ; Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia ; Tyrosine-Kinase Inhibitors ; Medicine
    E-ISSN: 2167-8707
    Source: Taylor & Francis (Taylor & Francis Group)
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  • 3
    In: Cancer, 15 December 2013, Vol.119(24), pp.4284-4289
    Description: The pegylated form of interferon‐α‐2a (PegIFNa2a) in combination with imatinib has demonstrated a molecular improvement in patients in chronic‐phase chronic myeloid leukemia. Reducing the dose of PegIFNa2a from 90 μg per week to 45 μg per week was found to improve the tolerability and preserve the molecular responses.
    Keywords: Imatinib ; Interferon ; Chronic Myeloid Leukemia ; Clinical Trial ; Molecular Response
    ISSN: 0008-543X
    E-ISSN: 1097-0142
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  • 4
    Language: French
    In: La Revue du praticien, May 2011, Vol.61(5), pp.603-9
    Description: The diagnosis of adult acute lymphoblastic leukemia (ALL) and the recognition of immuno-genetic entities according to the WHO classification require a comprehensive clinical and biological work-up. The diagnosis of Burkitt mature B-cell ALL is an emergency, since intensive chemotherapy and tumour lysis syndrome prevention lead to an 80% cure rate. Within one week, distinction must be established between B-cell Philadelphia chromosome-positive (Ph+) ALL on one side, Philadelphia-negative B-cell ALL and T cell ALL on the other. The once severe Ph+ ALL now displays a 70% long-term survival rate when treated by associations of chemotherapy and targeted therapy by tyrosine-kinase inhibitors. In Ph-negative ALL, identification of new relapse risk factors, mostly minimal residual disease, justifies to revisit the indications for allogeneic hematopoietic stem cell transplantation, in comparison to pediatric-inspired chemotherapy regimens, with the goal of curing 60% of the patients. However, the outcome of patients above the age of 60 remains dismal.
    Keywords: Precursor Cell Lymphoblastic Leukemia-Lymphoma
    ISSN: 0035-2640
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 5
    Language: English
    In: Blood, 30 August 2012, Vol.120(9), pp.1959-60
    Keywords: Leukemia, Myelogenous, Chronic, BCR-Abl Positive -- Drug Therapy ; Piperazines -- Therapeutic Use ; Pyrimidines -- Therapeutic Use
    ISSN: 00064971
    E-ISSN: 1528-0020
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  • 6
    Language: English
    In: Clinical Infectious Diseases, 01 June 2005, Vol.40(11), pp.1712-1712
    Description: Two black African immigrants, with no history of recent travel outside France, received a diagnosis of a malignant lymphoproliferative disorder and splenomegaly, and they subsequently underwent splenectomy. A few weeks after surgery, both patients experienced an acute episode of Plasmodium falciparum malaria, so the initial diagnosis was corrected retrospectively and changed to hyperreactive malarial splenomegaly. These cases illustrate the difficulty in distinguishing hyperreactive malarial splenomegaly from malignant lymphoproliferative disorders and therefore underline the role of the spleen in the immune system's defense against malaria.
    Keywords: Health sciences -- Medical conditions -- Diseases ; Health sciences -- Medical treatment -- Medical procedures ; Health sciences -- Medical conditions -- Symptoms
    ISSN: 10584838
    E-ISSN: 15376591
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  • 7
    Language: English
    In: Clinical Infectious Diseases, 01 June 2005, Vol.40(11), pp.1712-1712
    Description: Two black African immigrants, with no history of recent travel outside France, received a diagnosis of a malignant lymphoproliferative disorder and splenomegaly, and they subsequently underwent splenectomy. A few weeks after surgery, both patients experienced an acute episode of Plasmodium falciparum malaria, so the initial diagnosis was corrected retrospectively and changed to hyperreactive malarial splenomegaly. These cases illustrate the difficulty in distinguishing hyperreactive malarial splenomegaly from malignant lymphoproliferative disorders and therefore underline the role of the spleen in the immune system's defense against malaria.
    Keywords: Plasmodium Falciparum ; Splenomegaly ; Malaria ; Immunoproliferative Diseases ; Splenectomy ; Surgery ; Immune System ; Immigrants ; Travel ; Spleen ; Lymphoma ; Protozoa: Human;
    ISSN: 10584838
    Source: Archival Journals (JSTOR)
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  • 8
    Language: English
    In: Expert opinion on emerging drugs, March 2017, Vol.22(1), pp.107-121
    Description: Various settings of acute lymphoblastic leukemia (ALL) represent unmet medical needs: first remission at high risk of relapse, such as persistent minimal residual disease (MRD); relapse/refractoriness (R/R); elderly patients. Biological therapies targeting widely-shared antigens of blast cells have entered the clinic in B-cell precursor (BCP)-ALL. Area covered: Results of phase II/III trials of monoclonal antibodies (MoAbs) and phase I/II trials of adoptive cell therapy by chimeric antigen receptor-engineered T cells (CAR-T cells) are presented. Rituximab, a naked anti-CD20 MoAb, improves the results of chemotherapy in Philadelphia chromosome-negative BCP-ALL. Inotuzumab ozogamicin, an anti-CD22 immunotoxin, yields complete remission (CR) rates of 80% in R/R patients and in elderly newly diagnosed patients. Blinatumomab, a bispecific anti-CD19 and anti-CD3 agent redirects effector T cells towards B leukemic cells, is approved in R/R patients (40% CR, duration 6 months) and under investigation in MRD+ CR patients (80% negativation). Autologous anti-CD19 CAR-T cells undergo proliferation and persistence in the recipient. In limited series, they salvage more than 80% of advanced patients. Cytokine-release syndrome, encephalopathy and B-cell aplasia are shared, to varying extents, by blinatumomab and CAR-T cells. Expert opinion: Despite technological, ethical and clinical issues, biological therapies are currently changing the paradigm of treatment in BCP-ALL, and seem promised to dramatic developments.
    Keywords: Acute Lymphoblastic Leukemia ; Car-T Cells ; Adoptive Immunotherapy ; Biological Therapies ; Blinatumomab ; Inotuzumab Ozogamicin ; Monoclonal Antibodies ; Rituximab ; Antibodies, Monoclonal -- Therapeutic Use ; Antineoplastic Agents -- Therapeutic Use ; Precursor Cell Lymphoblastic Leukemia-Lymphoma -- Drug Therapy
    E-ISSN: 1744-7623
    Source: MEDLINE/PubMed (U.S. National Library of Medicine)
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  • 9
    In: The New England Journal of Medicine, 2010, Vol.363(26), pp.2511-2521
    Description: Background Imatinib (400 mg daily) is considered the best initial therapy for patients with newly diagnosed chronic myeloid leukemia (CML) in the chronic phase. However, only a minority of patients treated with imatinib have a complete molecular remission. Methods We randomly assigned 636 patients with untreated chronic-phase CML to receive imatinib alone at a dose of 400 mg daily, imatinib (400 mg daily) plus cytarabine (20 mg per square meter of body-surface area per day on days 15 through 28 of each 28-day cycle) or pegylated interferon (peginterferon) alfa-2a (90 μg weekly), or imatinib alone at a dose of 600 mg daily. Molecular and cytogenetic responses, time to treatment failure, overall and event-free survival, and adverse events were assessed. An analysis of molecular response at 12 months was planned. A superior molecular response was defined as a decrease in the ratio of transcripts of the tyrosine kinase gene BCR-ABL to transcripts of ABL of 0.01% or less, corresponding to a reduction of 4 log 10 units or more from the baseline level, as assessed by means of a real-time quantitative polymerase-chain-reaction assay. Results At 12 months, the rates of cytogenetic response were similar among the four groups. The rate of a superior molecular response was significantly higher among patients receiving imatinib and peginterferon alfa-2a (30%) than among patients receiving 400 mg of imatinib alone (14%) (P=0.001). The rate was significantly higher among patients treated for more than 12 months than among those treated for 12 months or less. Gastrointestinal events were more frequent among patients receiving cytarabine, whereas rash and depression were more frequent among patients receiving peginterferon alfa-2a. Conclusions As compared with other treatments, the addition of peginterferon alfa-2a to imatinib therapy resulted in significantly higher rates of molecular response in patients with chronic-phase CML. (Funded by the French Ministry of Health and others; ClinicalTrials.gov number, NCT00219739 .) In this study, adding pegylated interferon alfa-2a to imatinib therapy for chronic myeloid leukemia resulted in a greater reduction in the number of cells bearing BCR-ABL in a higher fraction of patients than did imatinib alone. However, pegylated interferon alfa-2a also has toxic effects. Chronic myeloid leukemia (CML) is characterized by translocation t(9;22)(q34;q11) — which causes the Philadelphia chromosome — on which a BCR-ABL fusion gene codes for a protein with constitutive tyrosine kinase activity.1–3 Imatinib, a rationally designed tyrosine kinase inhibitor, has shown activity against leukemic cells in vitro and in vivo.4,5 On the basis of the results of the large phase 3 International Randomized Study of Interferon and STI571 (IRIS; ClinicalTrials.gov number, NCT00006343), imatinib is recommended as first-line therapy.6,7 However, in some patients, the response to imatinib is not optimal and the risk of blast crisis is increased.8 The . . .
    Keywords: Adult–Chemically Induced ; Anemia–Adverse Effects ; Antineoplastic Combined Chemotherapy Protocols–Therapeutic Use ; Antineoplastic Combined Chemotherapy Protocols–Administration & Dosage ; Benzamides–Adverse Effects ; Cytarabine–Analysis ; Cytarabine–Genetics ; Female–Administration & Dosage ; Fusion Proteins, Bcr-Abl–Adverse Effects ; Fusion Proteins, Bcr-Abl–Drug Therapy ; Humans–Mortality ; Interferon-Alpha–Pathology ; Interferon-Alpha–Chemically Induced ; Leukemia, Myeloid, Chronic-Phase–Administration & Dosage ; Leukemia, Myeloid, Chronic-Phase–Adverse Effects ; Leukemia, Myeloid, Chronic-Phase–Administration & Dosage ; Male–Adverse Effects ; Middle Aged–Analysis ; Neutropenia–Genetics ; Piperazines–Administration & Dosage ; Piperazines–Adverse Effects ; Polyethylene Glycols–Analysis ; Polyethylene Glycols–Drug Effects ; Proto-Oncogene Proteins C-Abl–Chemically Induced ; Proto-Oncogene Proteins C-Abl–Chemically Induced ; Pyrimidines–Chemically Induced ; Pyrimidines–Chemically Induced ; RNA, Neoplasm–Chemically Induced ; Recombinant Proteins–Chemically Induced ; Remission Induction–Chemically Induced ; Stem Cells–Chemically Induced ; Survival Analysis–Chemically Induced ; Thrombocytopenia–Chemically Induced ; Transcription, Genetic–Chemically Induced ; Treatment Outcome–Chemically Induced ; Philadelphia Pennsylvania ; Leukemia ; Manuscripts ; Kinases ; Medical Research ; Benzamides ; Interferon-Alpha ; Piperazines ; Polyethylene Glycols ; Pyrimidines ; RNA, Neoplasm ; Recombinant Proteins ; Peginterferon Alfa-2a ; Cytarabine ; Interferon Alfa-2a ; Imatinib ; Fusion Proteins, Bcr-Abl ; Proto-Oncogene Proteins C-Abl;
    ISSN: 0028-4793
    E-ISSN: 1533-4406
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  • 10
    Language: English
    In: European Journal of Cancer, February 2012, Vol.48(3), pp.360-367
    Description: Granulocyte-colony stimulating factor (G-CSF) is used to prevent febrile neutropenia and support intense chemotherapy. However, its impact on long-term outcome in oncological patients including adults with acute lymphoblastic leukaemia (ALL) has not been determined so far. In the current study follow-up data from individual patients recruited in five multicentre, prospective, randomised trials were pooled to perform a joint analysis. Among 347 adults and adolescents with ALL, 185 were assigned to receive prophylactically G-CSF along with induction chemotherapy while 162 patients were treated without G-CSF support. With the median follow-up of 5.3 years, there was a tendency towards increased 5 year probability of the overall survival for the G-CSF arm compared to the controls (32% ± 4% versus 23% ± 4%, = .07), which reached statistical significance in a subgroup of T-ALL (51% ± 8% versus 29% ± 9%, = .01) and among patients aged 21–40 years (44% ± 6% versus 27% ± 6%, = .03). The probability of leukaemia-free survival was 38% ± 4% and 24% ± 4% ( = .01) while the median remission duration equalled 33 and 17 months ( = .007), respectively. In a multivariate analysis the prophylactic use of G-CSF was independently associated with reduced risk of relapse (hazard ratio (HR) = .64, = .007) and treatment failure (HR = .67, = .02). The prophylactic use of G-CSF during induction of ALL is associated with improved long-term outcome and should be recommended especially in a setting of T-ALL and in ‘young adults’. Our analysis provides the first direct evidence coming from prospective trials for the impact of primary G-CSF prophylaxis on disease-free survival of oncological patients.
    Keywords: Acute Lymphoblastic Leukaemia ; G-Csf ; Induction ; Survival ; Leukaemia-Free Survival ; Remission Duration ; Medicine
    ISSN: 0959-8049
    E-ISSN: 1879-0852
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