% IMPORTANT: The following is UTF-8 encoded. This means that in the presence % of non-ASCII characters, it will not work with BibTeX 0.99 or older. % Instead, you should use an up-to-date BibTeX implementation like “bibtex8” or % “biber”. @ARTICLE{HtterKrnke:128816, author = {M.-L. Hütter-Krönke and A. Benner$^*$ and K. Döhner and J. Krauter and D. Weber and M. Moessner and C.-H. Köhne and H. A. Horst and I. G. H. Schmidt-Wolf and M. Rummel and K. Götze and E. Koller and A. L. Petzer and H. Salwender and W. Fiedler and H. Kirchen and D. Haase and S. Kremers and M. Theobald and A. C. Matzdorff and A. Ganser and H. Döhner and R. F. Schlenk}, title = {{S}alvage 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.}, journal = {Haematologica}, volume = {101}, number = {7}, issn = {1592-8721}, address = {Pavia}, publisher = {Ferrata Storti Foundation}, reportid = {DKFZ-2017-04829}, pages = {839 - 845}, year = {2016}, abstract = {Outcome 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).}, keywords = {Aminoglycosides (NLM Chemicals) / Antibodies, Monoclonal, Humanized (NLM Chemicals) / Cytarabine (NLM Chemicals) / Tretinoin (NLM Chemicals) / gemtuzumab (NLM Chemicals) / Mitoxantrone (NLM Chemicals)}, cin = {C060}, ddc = {610}, cid = {I:(DE-He78)C060-20160331}, pnm = {313 - Cancer risk factors and prevention (POF3-313)}, pid = {G:(DE-HGF)POF3-313}, typ = {PUB:(DE-HGF)16}, pubmed = {pmid:27036160}, pmc = {pmc:PMC5004463}, doi = {10.3324/haematol.2015.141622}, url = {https://inrepo02.dkfz.de/record/128816}, }