000128816 001__ 128816 000128816 005__ 20240228143350.0 000128816 0247_ $$2doi$$a10.3324/haematol.2015.141622 000128816 0247_ $$2pmid$$apmid:27036160 000128816 0247_ $$2pmc$$apmc:PMC5004463 000128816 0247_ $$2ISSN$$a0390-6078 000128816 0247_ $$2ISSN$$a1592-8721 000128816 0247_ $$2altmetric$$aaltmetric:6428717 000128816 037__ $$aDKFZ-2017-04829 000128816 041__ $$aeng 000128816 082__ $$a610 000128816 1001_ $$aHütter-Krönke, Marie-Luise$$b0 000128816 245__ $$aSalvage therapy with high-dose cytarabine and mitoxantrone in combination with all-trans retinoic acid and gemtuzumab ozogamicin in acute myeloid leukemia refractory to first induction therapy. 000128816 260__ $$aPavia$$bFerrata Storti Foundation$$c2016 000128816 3367_ $$2DRIVER$$aarticle 000128816 3367_ $$2DataCite$$aOutput Types/Journal article 000128816 3367_ $$0PUB:(DE-HGF)16$$2PUB:(DE-HGF)$$aJournal Article$$bjournal$$mjournal$$s1522056644_26909 000128816 3367_ $$2BibTeX$$aARTICLE 000128816 3367_ $$2ORCID$$aJOURNAL_ARTICLE 000128816 3367_ $$00$$2EndNote$$aJournal Article 000128816 520__ $$aOutcome of patients with primary refractory acute myeloid leukemia remains unsatisfactory. We conducted a prospective phase II clinical trial with gemtuzumab ozogamicin (3 mg/m(2) intravenously on day 1), all-trans retinoic acid (45 mg/m(2) orally on days 4-6 and 15 mg/m(2) orally on days 7-28), high-dose cytarabine (3 g/m(2)/12 h intravenously on days 1-3) and mitoxantrone (12 mg/m(2) intravenously on days 2-3) in 93 patients aged 18-60 years refractory to one cycle of induction therapy. Primary end point of the study was response to therapy; secondary end points included evaluation of toxicities, in particular, rate of sinusoidal obstruction syndrome after allogeneic hematopoietic cell transplantation. Complete remission or complete remission with incomplete blood count recovery was achieved in 47 (51%) and partial remission in 10 (11%) patients resulting in an overall response rate of 61.5%; 33 (35.5%) patients had refractory disease and 3 patients (3%) died. Allogeneic hematopoietic cell transplantation was performed in 71 (76%) patients; 6 of the 71 (8.5%) patients developed moderate or severe sinusoidal obstruction syndrome after transplantation. Four-year overall survival rate was 32% (95% confidence interval 24%-43%). Patients responding to salvage therapy and undergoing allogeneic hematopoietic cell transplantation (n=51) had a 4-year survival rate of 49% (95% confidence intervaI 37%-64%). Patients with fms-like tyrosine kinase internal tandem duplication positive acute myeloid leukemia had a poor outcome despite transplantation. In conclusion, the described regimen is an effective and tolerable salvage therapy for patients who are primary refractory to one cycle of conventional intensive induction therapy. (clinicaltrials.gov identifier: 00143975). 000128816 536__ $$0G:(DE-HGF)POF3-313$$a313 - Cancer risk factors and prevention (POF3-313)$$cPOF3-313$$fPOF III$$x0 000128816 588__ $$aDataset connected to CrossRef, PubMed, 000128816 650_7 $$2NLM Chemicals$$aAminoglycosides 000128816 650_7 $$2NLM Chemicals$$aAntibodies, Monoclonal, Humanized 000128816 650_7 $$004079A1RDZ$$2NLM Chemicals$$aCytarabine 000128816 650_7 $$05688UTC01R$$2NLM Chemicals$$aTretinoin 000128816 650_7 $$093NS566KF7$$2NLM Chemicals$$agemtuzumab 000128816 650_7 $$0BZ114NVM5P$$2NLM Chemicals$$aMitoxantrone 000128816 7001_ $$0P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aBenner, Axel$$b1$$udkfz 000128816 7001_ $$aDöhner, Konstanze$$b2 000128816 7001_ $$aKrauter, Jürgen$$b3 000128816 7001_ $$aWeber, Daniela$$b4 000128816 7001_ $$aMoessner, Margit$$b5 000128816 7001_ $$aKöhne, Claus-Henning$$b6 000128816 7001_ $$aHorst, Heinz A$$b7 000128816 7001_ $$aSchmidt-Wolf, Ingo G H$$b8 000128816 7001_ $$aRummel, Mathias$$b9 000128816 7001_ $$aGötze, Katharina$$b10 000128816 7001_ $$aKoller, Elisabeth$$b11 000128816 7001_ $$aPetzer, Andreas L$$b12 000128816 7001_ $$aSalwender, Hans$$b13 000128816 7001_ $$aFiedler, Walter$$b14 000128816 7001_ $$aKirchen, Heinz$$b15 000128816 7001_ $$aHaase, Detlef$$b16 000128816 7001_ $$aKremers, Stephan$$b17 000128816 7001_ $$aTheobald, Matthias$$b18 000128816 7001_ $$aMatzdorff, Axel C$$b19 000128816 7001_ $$aGanser, Arnold$$b20 000128816 7001_ $$aDöhner, Hartmut$$b21 000128816 7001_ $$aSchlenk, Richard F$$b22 000128816 773__ $$0PERI:(DE-600)2805244-4$$a10.3324/haematol.2015.141622$$gVol. 101, no. 7, p. 839 - 845$$n7$$p839 - 845$$tHaematologica$$v101$$x1592-8721$$y2016 000128816 909CO $$ooai:inrepo02.dkfz.de:128816$$pVDB 000128816 9101_ $$0I:(DE-588b)2036810-0$$6P:(DE-He78)e15dfa1260625c69d6690a197392a994$$aDeutsches Krebsforschungszentrum$$b1$$kDKFZ 000128816 9131_ $$0G:(DE-HGF)POF3-313$$1G:(DE-HGF)POF3-310$$2G:(DE-HGF)POF3-300$$3G:(DE-HGF)POF3$$4G:(DE-HGF)POF$$aDE-HGF$$bGesundheit$$lKrebsforschung$$vCancer risk factors and prevention$$x0 000128816 9141_ $$y2016 000128816 915__ $$0StatID:(DE-HGF)0200$$2StatID$$aDBCoverage$$bSCOPUS 000128816 915__ $$0StatID:(DE-HGF)0300$$2StatID$$aDBCoverage$$bMedline 000128816 915__ $$0StatID:(DE-HGF)0310$$2StatID$$aDBCoverage$$bNCBI Molecular Biology Database 000128816 915__ $$0StatID:(DE-HGF)0501$$2StatID$$aDBCoverage$$bDOAJ Seal 000128816 915__ $$0StatID:(DE-HGF)0500$$2StatID$$aDBCoverage$$bDOAJ 000128816 915__ $$0LIC:(DE-HGF)CCBYNV$$2V:(DE-HGF)$$aCreative Commons Attribution CC BY (No Version)$$bDOAJ 000128816 915__ $$0StatID:(DE-HGF)0199$$2StatID$$aDBCoverage$$bThomson Reuters Master Journal List 000128816 915__ $$0StatID:(DE-HGF)0110$$2StatID$$aWoS$$bScience Citation Index 000128816 915__ $$0StatID:(DE-HGF)0150$$2StatID$$aDBCoverage$$bWeb of Science Core Collection 000128816 915__ $$0StatID:(DE-HGF)0111$$2StatID$$aWoS$$bScience Citation Index Expanded 000128816 915__ $$0StatID:(DE-HGF)1110$$2StatID$$aDBCoverage$$bCurrent Contents - Clinical Medicine 000128816 915__ $$0StatID:(DE-HGF)1030$$2StatID$$aDBCoverage$$bCurrent Contents - Life Sciences 000128816 915__ $$0StatID:(DE-HGF)1050$$2StatID$$aDBCoverage$$bBIOSIS Previews 000128816 9201_ $$0I:(DE-He78)C060-20160331$$kC060$$lBiostatistik$$x0 000128816 980__ $$ajournal 000128816 980__ $$aVDB 000128816 980__ $$aI:(DE-He78)C060-20160331 000128816 980__ $$aUNRESTRICTED