A Retrospective Real-Life Report on Newly Diagnosed Adult Ph plus Acute Lymphoblastic Leukemia (Ph plus ALL) Patients Treated in Italy - The CAMPUS-ALL Experience

Background The unfavorable prognosis of Ph+ ALL has improved following the introduction of tyrosine kinase inhibitors (TKIs). While the GIMEMA trials are based on a chemo-free induction strategy, information is lacking on long-term follow-up of enrolled patients, and of patients treated outside of clinical trials. Aims and methods To evaluate the real-life experience on newly diagnosed adult Ph+ ALL patients treated with TKIs in Italy, we retrospectively collected data from 7 centers from 1/2000 to 12/2017 within the Campus ALL program. Results 158 patients (mean age: 51.8 years) were included; 69 were treated within GIMEMA trials. Induction therapy was: TKI+steroids (n=91), TKI+chemotherapy (n=39), and chemotherapy alone (n=28). A complete hematologic remission (CHR) was achieved in 99%, 100%, and 87% of patients, respectively. Minimal residual disease (MRD) at 3 months was available in 92 patients (52 outside of a clinical trial): 75% had MRD levels \u003e 0.01 and 25% ≤0.01. Fifty-five patients received TKIs as consolidation and 77 chemotherapy. Seventy patients underwent an allogeneic and 5 an autologous transplant, 41 in first CHR. Of the allografted patients, 19/75 (25%) relapsed; 32 received TKIs post-transplant. Among the 77 non-transplanted cases, 35 (45%) relapsed; the majority (71%) continued TKI treatment: among those still alive, 3 stopped it. With a median follow-up of 61.8 months, overall survival (OS) and disease-free survival (DFS) at 5 years are 50% and 59% (median not reached). Prognostic factors for OS were transplantation (HR 0.44, p 65 yo; HR 2.14, p 40% of cases; nevertheless, the lack of its impact suggests that in MRD+ cases, salvage with novel treatments (i.e., newer generation TKIs and immunotherapy) can improve the outcome of Ph+ ALL. Conclusions We provide an overview of the long-term outcome of an unselected cohort of patients treated between 2000 and 2017, which documents the improved prognosis of Ph+ ALL also in the real-life setting. Further cases are being collected.