Arsenic Trioxide (ATO) and ATRA with Limited Chemotherapy (CT) in Newly Diagnosed Standard Risk APL in the Elderly. a Report By the French Belgian Swiss APL Group (APL 2006 trial)

Background.Treatment of APL in the elderly with conventional ATRA-anthracycline based CT regimens is associated, like in younger patients, with very few relapses, but high death rates (CR rate of 87.3%, 10-year CIR of 9.3%, 21.7% deaths in CR, and a 10-year OS of 58% in patients aged> 65 years in our previous APL trials ;Blood 2010 115:1690). Recent results have shown that, in standard risk APL, ATRA+ATO combinations (without CT) are at least as effective as classical ATRA + CT regimens while being less myelosuppressive (Lo Coco, NEJM 2014; Burnett, Lancet Oncol, 2015) thus constituting a very appealing approach for elderly patients. However, when our APL 2006 trial started, the feasibility of treatment of APL without CT was unknown. Furthermore, access to ATO still remains limited for frontline treatment of APL in most countries. We present results of APL 2006 trial, where we combined ATO to ATRA and reduced CT in patients aged older than 70 with standard risk APL (baseline WBC Methods. Between 2006 and 2015, newly diagnosed APL patients (pts)>70 years with WBC 1 G/L and platelets> 50G/l after the first consolidation course was 16.2 and 11.9 days in the original vs 5.6 and 4.0 days in the amended protocol (p Conclusion. In this very old patient population (>70 years) with standard risk APL, addition of ATO, that allowed reduction of the amount of CT administered, was associated with high CR rates, without any increase (and a possible reduction) in the relapse rate compared to our previous experience with ATRA-CT regimens. However, reduction of mortality in CR with this regimen was only seen when consolidation CT was reduced to one single day of Ida. This is further evidence of the role of ATO in a patient population in whom myelosuppression must be avoided. Disclosures Ades:Celgene, Takeda, Novartis, Astex: Consultancy, Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding. Thomas:Pfizer: Consultancy. Pigneux:Agios: Consultancy, Honoraria; Sunesis: Consultancy, Honoraria. Fenaux:Celgene, Novartis, Teva: Honoraria; Celgene, Janssen, Novartis, Astex, Teva: Research Funding.