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dc.contributor.authorIland, H.J.en
dc.contributor.authorBradstock, K.F.en
dc.contributor.authorSupple, S.G.en
dc.contributor.authorCatalano, A.en
dc.contributor.authorCollins, M.en
dc.contributor.authorHertzberg, M.en
dc.contributor.authorBrowett, P.en
dc.contributor.authorGrigg, A.en
dc.contributor.authorFirkin, F.en
dc.contributor.authorHugman, A.en
dc.contributor.authorReynolds, J.en
dc.contributor.authorDi Iulio, J.en
dc.contributor.authorTiley, Campbellen
dc.contributor.authorTaylor, K.en
dc.contributor.authorFilshie, R.en
dc.contributor.authorSeldon, M.en
dc.contributor.authorTaper, J.en
dc.contributor.authorSzer, J.en
dc.contributor.authorMoore, J.en
dc.contributor.authorBashford, J.en
dc.contributor.authorSeymour, J.F.en
dc.identifier.citationVolume 120, Issue 8, pp. 1570 - 1580en
dc.description.abstractThe treatment of acute promyelocytic leukemia has improved considerably after recognition of the effectiveness of all-trans-retinoic acid (ATRA), anthracycline-based chemotherapy, and arsenic trioxide (ATO). Here we report the use of all 3 agents in combination in an APML4 phase 2 protocol. For induction, ATO was superimposed on an ATRA and idarubicin backbone, with scheduling designed to exploit antileukemic synergy while minimizing cardiotoxicity and the severity of differentiation syndrome. Consolidation comprised 2 cycles of ATRA and ATO without chemotherapy, followed by 2 years of maintenance with ATRA, oral methotrexate, and 6-mercaptopurine. Of 124 evaluable patients, there were 4 (3.2%) early deaths, 118 (95%) hematologic complete remissions, and all 112 patients who commenced consolidation attained molecular complete remission. The 2-year rate for freedom from relapse is 97.5%, failure-free survival 88.1%, and overall survival 93.2%. These outcomes were not influenced by FLT3 mutation status, whereas failure-free survival was correlated with Sanz risk stratification (P[trend] = .03). Compared with our previously reported ATRA/idarubicin-based protocol (APML3), APML4 patients had statistically significantly improved freedom from relapse (P = .006) and failure-free survival (P = .01). In conclusion, the use of ATO in both induction and consolidation achieved excellent outcomes despite a substantial reduction in anthracycline exposure. This trial was registered at the Australian New Zealand Clinical Trials Registry ( as ACTRN12605000070639.en
dc.subjectDrug Therapyen
dc.titleAll-Trans-Retinoic Acid, Idarubicin, and IV Arsenic Trioxide as initial therapy in Acute Promyelocytic Leukemia (APML4)en
dc.typeJournal Articleen
dc.type.studyortrialClinical Trialen
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
Appears in Collections:Oncology / Cancer
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