ASH Clinical News July 2017 V2 - Page 21

Rates of Myeloid Neoplasms in Patients With Unexplained Cytopenias 5.5” .25” G:.5” Patients with unexplained cytopenias may never receive a definitive diagnosis, or may eventually be classified as having myelodysplastic syndromes (MDS, a myelo- proliferative neoplasm [MPN] or, if their cytopenias persist, as having idiopathic cytopenia of undetermined significance [ICUS]). Adding mutational profiling to the evaluation of patients with unexplained cytopenias could help identify individuals who have or are at risk of developing a myeloid malignancy, according to results of a prospective cohort study published in Blood. Lead author Luca Malcovati, MD, from the Department of Molecular Medicine at the University of Pavia in Italy, and colleagues looked for somatic mu- tations in 40 genes known to be recurrently mutated S:6.75” in myeloid malignancies to determine their predic- tive value for identifying patients with, or at high risk of developing, a myeloid neoplasm. The researchers found that carrying one or more of these somatic mutations was associated with a high probability of de- veloping a myeloid neoplasm during follow-up (hazard ratio [HR] = 13.9; p<0.001). “Mutation profiling on peripheral blood cells has a high predictive value for identifying individuals at high risk of developing MPNs,” Dr. Malcovati told ASH Clinical News. “Mutation analyses may be a valuable complement BOSULIF offers proven efficacy for patients with resistance or intolerance to prior therapy 2 In 2nd-line treatment, after imatinib (n=266 evaluable) a 34 % of patients 53 % of patients achieved MCyR at 6 months achieved MCyR with a minimum follow-up of 23 months (95% CI: 28.2, 39.9) Median duration of MCyR was not reached at the time of analysis 53% of patients with MCyR maintained MCyR for at least 18 months (with a minimum follow-up of 23 months) In 3rd-line treatment, after imatinib followed by nilotinib and/or dasatinib therapy (n=108 evaluable) • 27% of patients achieved MCyR by 6 months (95% CI: 18.8, 36.2) • 32% of patients achieved MCyR with a minimum follow-up of 13 months • Median duration of MCyR was not reached at the time of analysis — 51% of patients with MCyR maintained MCyR for at least 9 months (with a minimum follow-up of 13 months) BOSULIF has a distinct safety and tolerability profile 2 Warnings and precautions include: gastrointestinal toxicity, myelosuppression, hepatic toxicity, fluid retention, renal toxicity, and embryofetal toxicity. Please see Important Safety Information below for more detail. Most common adverse reactions observed in >20% of patients in the Phase 1/2 safety population (N=546) Most common Grade 3/4 adverse reactions observed in ≥10% of patients All grades (%) Grade 3/4 (%) Nausea (46) Anemia (27) Anemia (13) Thrombocytopenia (41) Pyrexia (26) Neutropenia (12) Vomiting (39) Fatigue (24) Abdominal pain (37) a Median duration of treatment was 22 months for evaluable patients. MCyR=major cytogenetic response. For more information on BOSULIF, visit www.BosulifHCP.com. Embryofetal Toxicity: BOSULIF may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving BOSULIF. Adverse Reactions: The most common adverse reactions observed in greater than 20% of patients in the Phase 1/2 safety population (N=546) were diarrhea, nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and fatigue. The most common Grade 3/4 adverse reactions and laboratory abnorma