Outcome of Relapsed AML Patients Aged between 50 and 70: The ALFA Group Experience (ALFA 9801 Study).

Background: Outcome of relapsing AML pts aged > 50 yrs is considered poor but remains incompletely studied and is important to analyse, especially with new therapeutic perspectives like targetted drugs and non myeloablative allogeneic SCT (ASCT).

Methods: we analyzed the outcome of pts included in ALFA 9801 trial (reported in detail in another abstract) who had relapsed. This trial included, between 2001 and 2006, de novo AML aged 50 to 70 years, randomized for induction to conventional dose AraC and high dose DNR or IDA, followed by 2 courses of intermediate dose AraC with the same anthr, and finally randomization between no maintenance or 1 year of IL2.

Results: 468 pts were included (median age: 60 years).360 (77%) achieved CR. With a median follow up of 40 months, 232 (64% of CR) pts had relapsed. Their median age was 60 years and M/F 132/100. Duration of first remission was ≤6 mo (41pts), >6mo and ≤12 mo (102 pts), >12 mo (89 pts). Treatment received for relapse was proposed at the discretion of physicians in charge of the patient: 97 (42%) pts received intensive chemotherapy (anthr-AraC, n=89, HD AraC n=5, FLAG, n= 3),) (IC group), 47 (20%) received Gemtuzumab (GO) alone (n= 25) or a GO containing regimen (n=22)(GO group), 12 patients (5%) received LD AraC, and 60 (28%) were treated with supportive care (SC). 8 pts were lost to follow up, 3 pts had CNS relapse, 1 pt received ASCT as relapse tratment, and 4 received investigational drugs. 52/110 pts aged < 60 received IC or GO combining regimen versus 39/122 pts> 60 (p<0.01). 46/122 pts aged > 60 were treated with SC versus 12/110 pts<60 (p<0.001). GO alone was given to 22/110 and 20/122 pts aged < or > than 60 (NS). 18 patients (median age 53 years) received allo SCT (13 “classical” and 5 non myeloablative SCT) in second CR, including only 1 pt aged > 60. A second CR was obtained in 39%: 57% in the IC group, 59% in the GO group (60% for pts treated with GO alone), 25% in the LDAraC group and none in the SC group. Median duration of second CR was 260 days. Median overall survival of the 232 patients from first relapse was 233 days (IC95%:202–281). Age < 60 years (p= 0.02), duration of first CR> 12 months (median 451 d vs 205 d for 1st CR< 12 months, p=0.001), salvage with IC or GO (median 340 days vs 140 for non IC +GO group, p<0.001) predicted for longer survival. There was no difference in survival for pts in the intermediate (N:144) and defav (N:43) cytogenetic groups (according to results of cytogenetics at diagnosis). The 12 pts in the fav cytogenetic group had significant better outcome. Survival from first relapse was similar for pts with a duration of 1st remission <6 months or 6 to 12 months. Of the 18 pts allografted in 2^nd CR: 9 were alive in CR (4 + to 60 +: median:30 months).

Conclusion: In this relatively old relapsing AML population (median age of 60), 62% of the 232 pts were able to receive intensive treatment for their relapse (chemotherapy and/or GO). 39% pts overall obtained a 2^nd CR, including 57% of those treated intensively.17% of CR2 pts received allogeneic SCT, a proportion that may increase if more non myeloablative allo SCT are performed.