904P The role of arginine/citrulline cycle disorders in the liver injury pathogenesis in acute myeloid leukemia patients with concomitant obesity

Abstract

Background: At present there is no cure for RRMM, yet pts have prolonged survival due to improved treatments, and therefore ensuring acceptable QoL throughout treatment is worthwhile. We aimed to evaluate QoL, safety and response to treatment with IRd as ! 2nd line in RRMM pts in a real world setting.Methods: Adult pts with RRMM who have been assigned IRd as !2nd line treatment were enrolled in multicenter observational prospective study. Treatment response was evaluated by IMWG 2011, adverse events (AEs) e by CTCAE v.4.0. Pts filled out SF-36 and ESAS-R at baseline and during IRd treatment. Descriptive statistics and paired t-test were employed.Results: At time of analysis 32 pts with RRMM were enrolled: median age e 65 yrs, 72% females, DurieeSalmon stage III e 56%, ECOG status 2/3 e 28%. Half of pts had 3-7 lines of prior therapy. The median number of cycles administered is 4, median follow-up e 4.5 (0.4-10.5) mos. Treatment response was not evaluated in 9 pts: 1 e death (at 3 months), 1e refusal, 7 e too early for evaluation. Out of 23 pts 6 achieved partial response, 10 e minor response, yielding a clinical benefit rate of 67%. AEs were revealed in 43% pts: grades 1-2 AEs e 9 pts; grades 3-4 AEs e 4 pts; SAEs e 3 pts (neurological toxicity, gastric bleeding, hypotension). Baseline QoL was dramatically impaired by the majority of SF-36 scales with significant QoL impairment in 50% pts. 88% pts had moderate-to severe symptoms (!4 scores on the scale from 0 to 10); moderate-to severe tiredness, pain or shortness of breath had 72%, 59% and 50% pts, respectively. At 1 month of IRd treatment QoL improved or was stable (without significant impairment) in 53% pts, at 3 months e in 45% pts. Better general and mental health were observed 1 month after treatment start (p¼0.01). At 1 month of treatment meaningful decrease of shortness of breath (in 60% pts), tiredness and pain (in 30% pts) was revealed; this proportion decreased twice at 3 months. Conclusions:The first results of our real-world study demonstrate significant clinical benefits of IRd regimen in RRMM pts. The treatment has acceptable safety profile and is accompanied with QoL maintenance and satisfactory symptom control in this heavily pretreated patients' cohort.