TREATMENT, RESPONSE, AND OUTCOME IN UNSELECTED ELDERLY PATIENTS WITH NEWLY DIAGNOSED, CHRONIC PHASE (CP), PHILADELPHIA CHROMOSOME-POSITIVE (PH plus ) CHRONIC MYELOID LEUKEMIA

leukemia (CML) patients (22% in a population-based registry study performed in Europe) (Hoffman V et al., Leukemia 2015;29:1336-43) but are under-represented and selected in academic and commercial studies. Their treatment and their outcome are poorly known. Aims: To investigate the treatment, response and outcome in an unselected cohort of elderly patients with newly diagnosed chronic phase (CP) CML. Methods: In a cohort of 337 newly diagnosed, adult, CP, Ph+,BCR-ABL1+, CML patients who were registered according to the population-based criteria in two Italian Regions (Emilia-Romagna and Sicily) between 2008 and 2012, we identified 85 patients (25%) who were ≥70 years old. Five of them were treated only with hydroxyurea (HU); 17 of them were treated in first-line with nilotinib. We report here on the 63 patients who were treated in first-line with imatinib, 400 mg once daily. Results: Males were 54%. Median age at diagnosis was 77 years (range 70- 95). Median follow-up was 48 months (range 30-65), so that median patients age at data analysis was 81 years. Sokal risk distribution was 3% low, 56% intermediate, and 41% high. 41 patients (65%) received only imatinib. 14 patients (22%) were switched to a 2nd generation TKI for failure. 8 patients were switched to a 2nd generaion TKI (n=5) or to HU (n=3) for toxicity. Responses and outcomes are shown in the Table 1. Molecular responses (early molecular response, major molecular response, and deeper molecular response) were in the range reported for younger patients in prospective studies of treatment. Overall survival was poorer, because 19% of patients died in MMR or in CP without any evidence of progression, due to age-related complications, mainly cardiovascular and cerebrovascular