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Title: All-Trans-Retinoic Acid, Idarubicin, and IV Arsenic Trioxide as initial therapy in Acute Promyelocytic Leukemia (APML4)
Authors: Iland, H.J.;Bradstock, K.F.;Supple, S.G.;Catalano, A.;Collins, M.;Hertzberg, M.;Browett, P.;Grigg, A.;Firkin, F.;Hugman, A.;Reynolds, J.;Di Iulio, J.;Tiley, Campbell ;Taylor, K.;Filshie, R.;Seldon, M.;Taper, J.;Szer, J.;Moore, J.;Bashford, J.;Seymour, J.F.
Issue Date: Aug-2012
Source: Volume 120, Issue 8, pp. 1570 - 1580
Journal title: Blood
Abstract: The 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.
DOI: 10.1182/blood-2012-02-410746
ISSN: 1528-0020
Publicaton type: Journal Article
Keywords: Cancer
Drug Therapy
Study or Trial: Clinical Trial
Appears in Collections:Oncology / Cancer

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