ASH Clinical News October 2016 | Page 21

CLINICAL NEWS
• prednisone ( n = 46 ; 92 %; median initial dose = 50 mg / day )
• dexamethasone ( n = 4 ; 7.8 %; 40 mg / day )
• both prednisone and dexamethasone ( n = 1 ; 2 %)
A total of 231 neonates were alive at
birth ; of the 235 pregnancies , 161 had one baby ( 83 %), 28 had two babies ( 14 %), and six had three babies ( 3 %). Four of the 235 pregnancies ended in intra-uterine deaths ; 56 ( 28 %) had a platelet count < 150x10 9 / L and 18 ( 9 %) had a platelet count < 50x10 9 / L , though , the authors reported , “ there was no correlation between maternal platelet count at delivery and the nadir neonatal platelet count .”
“ There was no difference in maternal platelet counts at delivery between those treated with IVIg and those treated with corticosteroids as the initial agent ( 69x10 9 / L and 77x10 9 / L ; p = 0.71 ),” Dr . Sun and colleagues wrote . A rise in platelet count occurred in 18 of 47 pregnancies initially treated with IVIg ( 38 %) and 20 of 51 pregnancies initially treated with corticosteroids ( 39 %; p = 0.85 ).
“ The sole difference between the treatments was a higher [ rate of ] maternal composite outcome [ consisting of higher rates of postpartum hemorrhage , pre-delivery platelet transfusion , peripartum transfusion of any blood product , or postpartum reduction in the hemoglobin concentration of 30g / L or more ] noted in the IVIg group ,” the authors added . Rates among IVIg- and corticosteroids-treated

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 % 53 % of patients of patients achieved MCyR at 6 months ( 95 % CI : 28.2 , 39.9 ) achieved MCyR with a minimum follow-up of 23 months

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 )
All grades (%) Diarrhea ( 82 ) Rash ( 35 )
Nausea ( 46 )
Anemia ( 27 )
Thrombocytopenia ( 41 )
Pyrexia ( 26 )
Vomiting ( 39 ) Fatigue ( 24 ) Abdominal pain ( 37 )
For more information on BOSULIF , visit www . BosulifHCP . com .
Most common Grade 3 / 4 adverse reactions observed in ≥10 % of patients
Grade 3 / 4 (%) Thrombocytopenia ( 29 ) Anemia ( 13 ) Neutropenia ( 12 ) a
Median duration of treatment was 22 months for evaluable patients . MCyR = major cytogenetic response .
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 abnormalities observed in greater than 10 % of patients were thrombocytopenia , anemia , and neutropenia .
CYP3A Inhibitors and Inducers : Avoid concurrent use with strong or moderate CYP3A inhibitors or inducers .
Proton Pump Inhibitors : Consider using short-acting antacids or H2 blockers instead of PPIs to avoid a reduction in BOSULIF exposure . Separate antacid or H2 blocker dosing and BOSULIF dosing by more than 2 hours .
Nursing Mothers : Given the potential for serious adverse reactions in nursing infants , a decision should be made whether to discontinue nursing or BOSULIF , taking into account the importance of the drug to the mother .
References : 1 . Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology ( NCCN Guidelines ®) for Chronic Myelogenous Leukemia V . 1.2016 . © National Comprehensive Cancer Network , Inc . 2015 . All rights reserved . Accessed October 27 , 2015 . To view the most recent and complete version of the guideline , go online to NCCN . org . NATIONAL COMPREHENSIVE CANCER NETWORK ®, NCCN ®, NCCN GUIDELINES ®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network , Inc . 2 . BOSULIF Prescribing Information . New York , NY : Pfizer Inc .
Please see brief summary of full Prescribing Information on the following pages .
PP-BOS-USA-0288-01 © 2016 Pfizer Inc . All rights reserved . July 2016