Achievements (2009 - 2010)
In the EORTC 06991 trial, a report of the first results concerning induction was selected for oral presentation at the 2008 ASH meeting : R Willemze et al, “High Dose (HDAraC) Vs Standard Dose Cytosine Arabinoside (SDAraC) during Induction and Value of IL-2 during Maintenance in Acute Myelogenous Leukemia (AML): Impact of AraC Dose on Complete Remission Rate and Toxicity: Results on the first 1700 randomised patients of the AML-12 trial of EORTC and GIMEMA Leukemia Groups”, Blood (ASH Annual Meeting Abstracts), Nov 2008; 112: 134.
In elderly patients (> 60 years) with AML, the group completed the AML 17 (EORTC 06012) trial. In 61-75 year old patients in good physical condition, this trial assessed the anti-leukaemic activity of a sequential treatment with Mylotarg® (anti-CD33+calicheamycin) followed by “standard” chemotherapy with mitoxantrone, Ara-C and Etoposide as a front-line therapy in previously untreated AML. This regimen is compared to “standard” chemotherapy. The target sample size for this study was reached and the accrual was closed as of August 2007 with a total of 473 patients randomised. Patient follow-up and data collection is ongoing.
The first part of the EORTC 06031 trial, (“best schedule of Mylotarg”) was selected as an oral
presentation at the 2008 ASH meeting: Sergio Amadori et al: “Phase II–III Study of Gemtuzumab
Ozogamicin Monotherapy versus Best Supportive Care in Older Patients with Newly
Diagnosed AML Unfit for Intensive Chemotherapy: First Results of the EORTC-GIMEMA
AML-19 Trial” Blood (ASH Annual Meeting Abstracts), Nov 2008; 112: 762.
Myelodysplastic syndromes
The Decitabine study (EORTC 06011) was a randomised study of Decitabine vs. palliative supportive
care in elderly patients ineligible for intensive chemotherapy. The trial was closed to patient entry in
May 2007 having accrued 238 patients through a joint effort between the EORTC Leukaemia group
and the German MDS Study Group.
The final analysis was performed in 2008 and the final results were selected for an oral communication
at the 2008 ASH meeting: P Wijermans et al: “Low Dose Decitabine Versus Best Supportive
Care in Elderly Patients with Intermediate or High Risk MDS Not Eligible for Intensive
Chemotherapy: Final Results of the Randomized Phase III Study (06011) of the EORTC
Leukemia and German MDS Study Groups”. Blood (ASH Annual Meeting Abstracts), Nov 2008;
112: 226.
Acute lymphoblastic leukaemia (ALL)
A manuscript presenting the final results of the ALL-4 trial (EORTC 06951) is in preparation and will
soon be submitted for publication. This trial randomised 325 patients and compared the effects of
prednisone versus dexamethasone both in the remission induction and in the consolidation phase.
A second randomisation compares continuous intensive maintenance chemotherapy courses versus
autologous stem cell transplantation followed by low dose maintenance courses.