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Prepublished online as a Blood First Edition Paper on August 21, 2003; DOI 10.1182/blood-2003-05-1620.

Submitted May 29, 2003
Accepted July 26, 2003
Simultaneous administration of Mylotarg (Gemtuzumab Ozogamicin) with intensive chemotherapy in induction, and consolidation in younger patients with acute myeloid leukaemia: a feasibility study
William J Kell, Alan K Burnett*, Raj Chopra, John A L Yin, Richard E Clark, Ama Rohatiner, Dominic Culligan, Ann Hunter, Archie G Prentice, and Donald W Milligan
Department of Haematology, University of Wales College of Medicine, Cardiff, United Kingdom
Department of Medical Oncology, Christie Hospital, Manchester, United Kingdom
Department of Haematology, Manchester Royal Infirmary, Manchester, United Kingdom
Department of Haematology, Royal Liverpool Hospital, Liverpool, United Kingdom
Department of Haematology, St. Bartholomew's Hospital, London, United Kingdom
Department of Haematology, Aberdeen Royal Infirmary, Aberdeen, United Kingdom
Department of Haematology, Leicester Royal Infirmary, Leicester, United Kingdom
Department of Haematology, Derriford Hospital, Plymouth, United Kingdom
Department of Haematology, Heartlands Hospital, Birmingham, United Kingdom
* Corresponding author; email: BurnettAK{at}Cardiff.ac.uk.
The feasibility of combining Gemtuzumab Ozogamicin (GO, MylotargTM) with intensive chemotherapy as first line treatment of Acute Myeloid Leukaemia was assessed in 72 patients aged 17-59 years, as a prelude to the MRC AML15 Trial. Sixty-four patients received induction chemotherapy [DAT, DA or FLAG-Ida] with GO on day 1. It was possible to give GO 3mg/m2 with course 1, but 6mg/m2 with course 1 or GO in a dose of 3mg/m2, with consecutive courses was not feasible due to hepatotoxicity and delayed haemopoietic recovery. Thirty-one patients were treated in consolidation with MACE or MidAC and GO(3mg/m2), and 23 in induction and consolidation, tolerated GO (3mg/m2) well. Grade 4 liver toxicity and Sinusoidal Obstructive Syndrome was more common in thioguanine containing schedules (p=0.007). Remission with course 1 was seen in 86% of patients. DA and FLAG-Ida with GO in induction achieved CR in 91% of patients and 78% of these patients are in CCR at 8 months. GO given with induction [DA or FLAG-Ida] and consolidation [MACE or MidAC] was well tolerated. These schedules are now being compared in the MRC AML15 Trial in patients under 60 years.

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