메뉴 건너뛰기




Volumn 16, Issue 16, 2015, Pages 1691-1699

Addition of sorafenib versus placebo to standard therapy in patients aged 60 years or younger with newly diagnosed acute myeloid leukaemia (SORAML): A multicentre, phase 2, randomised controlled trial

(44)  Röllig, Christoph a   Serve, Hubert b   Hüttmann, Andreas c   Noppeney, Richard c   Müller Tidow, Carsten d,e   Krug, Utz e,f   Baldus, Claudia D g   Brandts, Christian H b   Kunzmann, Volker h   Einsele, Hermann h   Krämer, Alwin i   Schäfer Eckart, Kerstin j   Neubauer, Andreas k   Burchert, Andreas k   Giagounidis, Aristoteles l   Krause, Stefan W m   Mackensen, Andreas m   Aulitzky, Walter n   Herbst, Regina o   Hänel, Mathias o   more..


Author keywords

[No Author keywords available]

Indexed keywords

AMYLASE; CYTARABINE; DAUNORUBICIN; PLACEBO; SORAFENIB; TRIACYLGLYCEROL LIPASE; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC ANTIBIOTIC; ANTINEOPLASTIC ANTIMETABOLITE; CARBANILAMIDE DERIVATIVE; NICOTINAMIDE; PROTEIN KINASE INHIBITOR;

EID: 84949484439     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(15)00362-9     Document Type: Article
Times cited : (348)

References (33)
  • 1
    • 33749238553 scopus 로고    scopus 로고
    • Discovery and development of sorafenib: a multikinase inhibitor for treating cancer
    • Wilhelm S, Carter C, Lynch M, et al. Discovery and development of sorafenib: a multikinase inhibitor for treating cancer. Nat Rev Drug Discov 2006, 5:835-844.
    • (2006) Nat Rev Drug Discov , vol.5 , pp. 835-844
    • Wilhelm, S.1    Carter, C.2    Lynch, M.3
  • 2
    • 57149145794 scopus 로고    scopus 로고
    • Combined tyrosine and serine/threonine kinase inhibition by sorafenib prevents progression of experimental pulmonary hypertension and myocardial remodeling
    • Klein M, Schermuly RT, Ellinghaus P, et al. Combined tyrosine and serine/threonine kinase inhibition by sorafenib prevents progression of experimental pulmonary hypertension and myocardial remodeling. Circulation 2008, 118:2081-2090.
    • (2008) Circulation , vol.118 , pp. 2081-2090
    • Klein, M.1    Schermuly, R.T.2    Ellinghaus, P.3
  • 3
    • 33644747449 scopus 로고    scopus 로고
    • BAY 43-9006 inhibition of oncogenic RET mutants
    • Carlomagno F, Anaganti S, Guida T, et al. BAY 43-9006 inhibition of oncogenic RET mutants. J Natl Cancer Inst 2006, 98:326-334.
    • (2006) J Natl Cancer Inst , vol.98 , pp. 326-334
    • Carlomagno, F.1    Anaganti, S.2    Guida, T.3
  • 4
    • 39149129114 scopus 로고    scopus 로고
    • Mutant FLT3: a direct target of sorafenib in acute myelogenous leukemia
    • Zhang W, Konopleva M, Shi YX, et al. Mutant FLT3: a direct target of sorafenib in acute myelogenous leukemia. J Natl Cancer Inst 2008, 100:184-198.
    • (2008) J Natl Cancer Inst , vol.100 , pp. 184-198
    • Zhang, W.1    Konopleva, M.2    Shi, Y.X.3
  • 5
    • 42349087045 scopus 로고    scopus 로고
    • Sorafenib induces apoptosis of AML cells via Bim-mediated activation of the intrinsic apoptotic pathway
    • Zhang W, Konopleva M, Ruvolo VR, et al. Sorafenib induces apoptosis of AML cells via Bim-mediated activation of the intrinsic apoptotic pathway. Leukemia 2008, 22:808-818.
    • (2008) Leukemia , vol.22 , pp. 808-818
    • Zhang, W.1    Konopleva, M.2    Ruvolo, V.R.3
  • 6
    • 84906854162 scopus 로고    scopus 로고
    • Sorafenib priming may augment salvage chemotherapy in relapsed and refractory FLT3-ITD-positive acute myeloid leukemia
    • Cummins KD, Jane SM, Ninkovic S, et al. Sorafenib priming may augment salvage chemotherapy in relapsed and refractory FLT3-ITD-positive acute myeloid leukemia. Blood Cancer J 2014, 4:e237.
    • (2014) Blood Cancer J , vol.4 , pp. e237
    • Cummins, K.D.1    Jane, S.M.2    Ninkovic, S.3
  • 7
    • 84869090342 scopus 로고    scopus 로고
    • High activity of sorafenib in FLT3-ITD-positive acute myeloid leukemia synergizes with allo-immune effects to induce sustained responses
    • Metzelder SK, Schroeder T, Finck A, et al. High activity of sorafenib in FLT3-ITD-positive acute myeloid leukemia synergizes with allo-immune effects to induce sustained responses. Leukemia 2012, 26:2353-2359.
    • (2012) Leukemia , vol.26 , pp. 2353-2359
    • Metzelder, S.K.1    Schroeder, T.2    Finck, A.3
  • 8
    • 84861384606 scopus 로고    scopus 로고
    • Survey and analysis of the efficacy and prescription pattern of sorafenib in patients with acute myeloid leukemia
    • Rollig C, Brandts C, Shaid S, et al. Survey and analysis of the efficacy and prescription pattern of sorafenib in patients with acute myeloid leukemia. Leuk Lymphoma 2012, 53:1062-1067.
    • (2012) Leuk Lymphoma , vol.53 , pp. 1062-1067
    • Rollig, C.1    Brandts, C.2    Shaid, S.3
  • 9
    • 77955983002 scopus 로고    scopus 로고
    • A case of blast clearance on sorafenib in relapsed FLT3-ITD acute myeloid leukemia: evidence of efficacy continues to mount
    • Fesler MJ, Richart JM, Petruska PJ A case of blast clearance on sorafenib in relapsed FLT3-ITD acute myeloid leukemia: evidence of efficacy continues to mount. Leuk Res 2010, 34:e268-e269.
    • (2010) Leuk Res , vol.34 , pp. e268-e269
    • Fesler, M.J.1    Richart, J.M.2    Petruska, P.J.3
  • 10
    • 80054771760 scopus 로고    scopus 로고
    • Treatment of FLT3-ITD-positive acute myeloid leukemia relapsing after allogeneic stem cell transplantation with sorafenib
    • Sharma M, Ravandi F, Bayraktar UD, et al. Treatment of FLT3-ITD-positive acute myeloid leukemia relapsing after allogeneic stem cell transplantation with sorafenib. Biol Blood Marrow Transplant 2011, 17:1874-1877.
    • (2011) Biol Blood Marrow Transplant , vol.17 , pp. 1874-1877
    • Sharma, M.1    Ravandi, F.2    Bayraktar, U.D.3
  • 11
    • 77955981259 scopus 로고    scopus 로고
    • Sorafenib induces sustained molecular remission in FLT3-ITD positive AML with relapse after second allogeneic stem cell transplantation without exacerbation of acute GVHD: a case report
    • Winkler J, Rech D, Kallert S, et al. Sorafenib induces sustained molecular remission in FLT3-ITD positive AML with relapse after second allogeneic stem cell transplantation without exacerbation of acute GVHD: a case report. Leuk Res 2010, 34:e270-e272.
    • (2010) Leuk Res , vol.34 , pp. e270-e272
    • Winkler, J.1    Rech, D.2    Kallert, S.3
  • 12
    • 69249221392 scopus 로고    scopus 로고
    • Compassionate use of sorafenib in FLT3-ITD-positive acute myeloid leukemia: sustained regression before and after allogeneic stem cell transplantation
    • Metzelder S, Wang Y, Wollmer E, et al. Compassionate use of sorafenib in FLT3-ITD-positive acute myeloid leukemia: sustained regression before and after allogeneic stem cell transplantation. Blood 2009, 113:6567-6571.
    • (2009) Blood , vol.113 , pp. 6567-6571
    • Metzelder, S.1    Wang, Y.2    Wollmer, E.3
  • 13
    • 84879150977 scopus 로고    scopus 로고
    • A phase I/II study of sorafenib in combination with low dose cytarabine in elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndrome from the National Cancer Institute of Canada Clinical Trials Group: trial IND.186
    • Macdonald DA, Assouline SE, Brandwein J, et al. A phase I/II study of sorafenib in combination with low dose cytarabine in elderly patients with acute myeloid leukemia or high-risk myelodysplastic syndrome from the National Cancer Institute of Canada Clinical Trials Group: trial IND.186. Leuk Lymphoma 2013, 54:760-766.
    • (2013) Leuk Lymphoma , vol.54 , pp. 760-766
    • Macdonald, D.A.1    Assouline, S.E.2    Brandwein, J.3
  • 14
    • 78650972911 scopus 로고    scopus 로고
    • Phase I study of sorafenib in patients with refractory or relapsed acute leukemias
    • Borthakur G, Kantarjian H, Ravandi F, et al. Phase I study of sorafenib in patients with refractory or relapsed acute leukemias. Haematologica 2011, 96:62-68.
    • (2011) Haematologica , vol.96 , pp. 62-68
    • Borthakur, G.1    Kantarjian, H.2    Ravandi, F.3
  • 15
    • 77951645227 scopus 로고    scopus 로고
    • Phase I/II study of combination therapy with sorafenib, idarubicin, and cytarabine in younger patients with acute myeloid leukemia
    • Ravandi F, Cortes JE, Jones D, et al. Phase I/II study of combination therapy with sorafenib, idarubicin, and cytarabine in younger patients with acute myeloid leukemia. J Clin Oncol 2010, 28:1856-1862.
    • (2010) J Clin Oncol , vol.28 , pp. 1856-1862
    • Ravandi, F.1    Cortes, J.E.2    Jones, D.3
  • 16
    • 84904043013 scopus 로고    scopus 로고
    • Final report of phase II study of sorafenib, cytarabine and idarubicin for initial therapy in younger patients with acute myeloid leukemia
    • Ravandi F, Arana YC, Cortes JE, et al. Final report of phase II study of sorafenib, cytarabine and idarubicin for initial therapy in younger patients with acute myeloid leukemia. Leukemia 2014, 28:1543-1545.
    • (2014) Leukemia , vol.28 , pp. 1543-1545
    • Ravandi, F.1    Arana, Y.C.2    Cortes, J.E.3
  • 17
    • 84886534519 scopus 로고    scopus 로고
    • Sorafenib in combination with intensive chemotherapy in elderly patients with acute myeloid leukemia: results from a randomized, placebo-controlled trial
    • Serve H, Krug U, Wagner R, et al. Sorafenib in combination with intensive chemotherapy in elderly patients with acute myeloid leukemia: results from a randomized, placebo-controlled trial. J Clin Oncol 2013, 31:3110-3118.
    • (2013) J Clin Oncol , vol.31 , pp. 3110-3118
    • Serve, H.1    Krug, U.2    Wagner, R.3
  • 18
    • 79960256952 scopus 로고    scopus 로고
    • Long-term prognosis of acute myeloid leukemia according to the new genetic risk classification of the European LeukemiaNet recommendations: evaluation of the proposed reporting system
    • Rollig C, Bornhauser M, Thiede C, et al. Long-term prognosis of acute myeloid leukemia according to the new genetic risk classification of the European LeukemiaNet recommendations: evaluation of the proposed reporting system. J Clin Oncol 2011, 29:2758-2765.
    • (2011) J Clin Oncol , vol.29 , pp. 2758-2765
    • Rollig, C.1    Bornhauser, M.2    Thiede, C.3
  • 19
    • 70349256226 scopus 로고    scopus 로고
    • The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes
    • Vardiman JW, Thiele J, Arber DA, et al. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia: rationale and important changes. Blood 2009, 114:937-951.
    • (2009) Blood , vol.114 , pp. 937-951
    • Vardiman, J.W.1    Thiele, J.2    Arber, D.A.3
  • 20
    • 0037097716 scopus 로고    scopus 로고
    • Analysis of FLT3-activating mutations in 979 patients with acute myelogenous leukemia: association with FAB subtypes and identification of subgroups with poor prognosis
    • Thiede C, Steudel C, Mohr B, et al. Analysis of FLT3-activating mutations in 979 patients with acute myelogenous leukemia: association with FAB subtypes and identification of subgroups with poor prognosis. Blood 2002, 99:4326-4335.
    • (2002) Blood , vol.99 , pp. 4326-4335
    • Thiede, C.1    Steudel, C.2    Mohr, B.3
  • 21
    • 0002429117 scopus 로고
    • A confidence interval for the median survival time
    • Brookmeyer R, Crowley J A confidence interval for the median survival time. Biometrics 1982, 38:29-41.
    • (1982) Biometrics , vol.38 , pp. 29-41
    • Brookmeyer, R.1    Crowley, J.2
  • 22
    • 84881035623 scopus 로고    scopus 로고
    • Phase 2 study of azacytidine plus sorafenib in patients with acute myeloid leukemia and FLT-3 internal tandem duplication mutation
    • Ravandi F, Alattar ML, Grunwald MR, et al. Phase 2 study of azacytidine plus sorafenib in patients with acute myeloid leukemia and FLT-3 internal tandem duplication mutation. Blood 2013, 121:4655-4662.
    • (2013) Blood , vol.121 , pp. 4655-4662
    • Ravandi, F.1    Alattar, M.L.2    Grunwald, M.R.3
  • 23
    • 42949142189 scopus 로고    scopus 로고
    • Mutations and treatment outcome in cytogenetically normal acute myeloid leukemia
    • Schlenk RF, Dohner K, Krauter J, et al. Mutations and treatment outcome in cytogenetically normal acute myeloid leukemia. N Engl J Med 2008, 358:1909-1918.
    • (2008) N Engl J Med , vol.358 , pp. 1909-1918
    • Schlenk, R.F.1    Dohner, K.2    Krauter, J.3
  • 24
    • 58149388069 scopus 로고    scopus 로고
    • Age-related risk profile and chemotherapy dose response in acute myeloid leukemia: a study by the German Acute Myeloid Leukemia Cooperative Group
    • Buchner T, Berdel WE, Haferlach C, et al. Age-related risk profile and chemotherapy dose response in acute myeloid leukemia: a study by the German Acute Myeloid Leukemia Cooperative Group. J Clin Oncol 2009, 27:61-69.
    • (2009) J Clin Oncol , vol.27 , pp. 61-69
    • Buchner, T.1    Berdel, W.E.2    Haferlach, C.3
  • 25
    • 36348930556 scopus 로고    scopus 로고
    • Establishment of baseline toxicity expectations with standard frontline chemotherapy in acute myelogenous leukemia
    • Atallah E, Cortes J, O'Brien S, et al. Establishment of baseline toxicity expectations with standard frontline chemotherapy in acute myelogenous leukemia. Blood 2007, 110:3547-3551.
    • (2007) Blood , vol.110 , pp. 3547-3551
    • Atallah, E.1    Cortes, J.2    O'Brien, S.3
  • 26
    • 41949087055 scopus 로고    scopus 로고
    • Prognostic relevance of FLT3-TKD mutations in AML: the combination matters-an analysis of 3082 patients
    • Bacher U, Haferlach C, Kern W, Haferlach T, Schnittger S Prognostic relevance of FLT3-TKD mutations in AML: the combination matters-an analysis of 3082 patients. Blood 2008, 111:2527-2537.
    • (2008) Blood , vol.111 , pp. 2527-2537
    • Bacher, U.1    Haferlach, C.2    Kern, W.3    Haferlach, T.4    Schnittger, S.5
  • 27
    • 77958178317 scopus 로고    scopus 로고
    • Platelet-derived growth factor (PDGF)-PDGF receptor interaction activates bone marrow-derived mesenchymal stromal cells derived from chronic lymphocytic leukemia: implications for an angiogenic switch
    • Ding W, Knox TR, Tschumper RC, et al. Platelet-derived growth factor (PDGF)-PDGF receptor interaction activates bone marrow-derived mesenchymal stromal cells derived from chronic lymphocytic leukemia: implications for an angiogenic switch. Blood 2010, 116:2984-2993.
    • (2010) Blood , vol.116 , pp. 2984-2993
    • Ding, W.1    Knox, T.R.2    Tschumper, R.C.3
  • 28
    • 0034655595 scopus 로고    scopus 로고
    • Increased angiogenesis in the bone marrow of patients with acute myeloid leukemia
    • Padro T, Ruiz S, Bieker R, et al. Increased angiogenesis in the bone marrow of patients with acute myeloid leukemia. Blood 2000, 95:2637-2644.
    • (2000) Blood , vol.95 , pp. 2637-2644
    • Padro, T.1    Ruiz, S.2    Bieker, R.3
  • 29
    • 77956553248 scopus 로고    scopus 로고
    • A novel prognostic model in elderly patients with acute myeloid leukemia: results of 909 patients entered into the prospective AML96 trial
    • Rollig C, Thiede C, Gramatzki M, et al. A novel prognostic model in elderly patients with acute myeloid leukemia: results of 909 patients entered into the prospective AML96 trial. Blood 2010, 116:971-978.
    • (2010) Blood , vol.116 , pp. 971-978
    • Rollig, C.1    Thiede, C.2    Gramatzki, M.3
  • 30
    • 0033179095 scopus 로고    scopus 로고
    • Frequency and clinical significance of the expression of the multidrug resistance proteins MDR1/P-glycoprotein, MRP1, and LRP in acute myeloid leukemia: a Southwest Oncology Group Study
    • Leith CP, Kopecky KJ, Chen IM, et al. Frequency and clinical significance of the expression of the multidrug resistance proteins MDR1/P-glycoprotein, MRP1, and LRP in acute myeloid leukemia: a Southwest Oncology Group Study. Blood 1999, 94:1086-1099.
    • (1999) Blood , vol.94 , pp. 1086-1099
    • Leith, C.P.1    Kopecky, K.J.2    Chen, I.M.3
  • 31
    • 79960735923 scopus 로고    scopus 로고
    • Incidence and prognostic influence of DNMT3A mutations in acute myeloid leukemia
    • Thol F, Damm F, Ludeking A, et al. Incidence and prognostic influence of DNMT3A mutations in acute myeloid leukemia. J Clin Oncol 2011, 29:2889-2896.
    • (2011) J Clin Oncol , vol.29 , pp. 2889-2896
    • Thol, F.1    Damm, F.2    Ludeking, A.3
  • 32
    • 67749086747 scopus 로고    scopus 로고
    • FLT3 mutations have no prognostic impact in elderly patients with acute myeloid leukemia and normal karyotype
    • Ferrara F, Criscuolo C, Riccardi C, et al. FLT3 mutations have no prognostic impact in elderly patients with acute myeloid leukemia and normal karyotype. Am J Hematol 2009, 84:532-535.
    • (2009) Am J Hematol , vol.84 , pp. 532-535
    • Ferrara, F.1    Criscuolo, C.2    Riccardi, C.3
  • 33
    • 0037114829 scopus 로고    scopus 로고
    • Prognostic significance of activating FLT3 mutations in younger adults (16 to 60 years) with acute myeloid leukemia and normal cytogenetics: a study of the AML Study Group Ulm
    • Frohling S, Schlenk RF, Breitruck J, et al. Prognostic significance of activating FLT3 mutations in younger adults (16 to 60 years) with acute myeloid leukemia and normal cytogenetics: a study of the AML Study Group Ulm. Blood 2002, 100:4372-4380.
    • (2002) Blood , vol.100 , pp. 4372-4380
    • Frohling, S.1    Schlenk, R.F.2    Breitruck, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.