PF182 CLINICOBIOLOGIC CHARACTERISTICS AND OUTCOME OF ELDERLY FRAIL PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA INCLUDED IN A SPECIFIC PROTOCOL (ALL‐07FRAIL)

Abstract

Background:Elderly patients with ALL are frequently excluded from clinical studies, especially if they have criteria of frailty. Treatment of these patients is considered palliative, but here are scarce studies analysing the tolerability and outcome of elderly frail patients included in specific trials.Aims:Here we present the clinicobiologic characteristics and outcome of elderly frail patients with Philadelphia chromosome‐negative (Ph‐neg) ALL included in the ALL‐07FRAIL (NCT01358201) study from the Spanish PETHEMA Group.Methods:Older (55–65 yrs.) and elderly (>65 yrs.) patients with Ph‐neg ALL with Charlson comorbidity index >3 were included in this study. Treatment schedule: pre‐phase (dexamethasone [DXM] for 1 week + triple intrathecal therapy [TIT]). Induction: vincristine (VCR) 1 mg/week x 4 wks and DXM (10 mg/m2/d x 28d) and TIT (d1 and d35). No consolidation. Maintenance: mercaptopurine (MP) (50 mg/m2/d) and methotrexate (MTX) (20 mg/m2/wk) for 2 years from CR, with monthly reinductions with VCR (1 mg), DXM (40 mg/m2, d1,2) and TIT during the 1st year.Results:From 2008 to 2018, 58 patients (pts) were included in the ALL FRAIL07 study. Mean (SD) age 73 (7) yrs., 42 pts (72%) over 70 yrs., 38 males (66%), median WBC count 8.2 x109/L (0.3–475), CNS involvement 5 pts (9%), B‐cell precursor ALL 48/56 (86%)(pro‐B [n = 12], common [n = 23], pre‐B [n = 12], non‐specified [n = 1]), T‐ALL 8/56 (14%)(pro‐T [n = 1], pre‐T [n = 4], mature T [n = 1], non‐specified [n = 2]). Results of induction treatment (n = 57, 1 on treatment): early death 9 (16%), failure 17 (30%), complete remission 31 (54%). The most frequent Grade 3–4 toxicities in induction were: neutropenia 39/51 pts (77%), thrombocytopenia 30/51 (59%), infection 11/51 (22%), neurologic 4/49 (8%) and gastrointestinal 2/49 (4%). Outcome of CR patients: treatment‐related mortality 6 (19%), withdrawn from study 2 (6%), relapse 20 (65%), persistent CR1 3 (10%). The cumulative incidence of relapse at 3‐yrs was 80% (median: 11.1 months [95%CI: 5.2–25.9]). With a median follow‐up of 23.7 months (0.1–53.7), 4 patients are alive, with a median OS of 7.7 months (95% CI, 5.6–9.9)(Figure 1).Summary/Conclusion:Older and elderly frail patients with Ph‐neg ALL can benefit from a structured study using non‐genotoxic drugs, with good tolerability and acceptable CR rate and survival. These results could serve as control for strategies including new drugs in this difficult‐to‐treat population.image