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CLINICAL NEWS |
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including 102 ( 85 %) of those assigned to TAD-HAM and 90 ( 75 %) to HAM-HAM ( p = 0.053 ).
Compliance rates were similar between the younger and older cohorts ( p = 0.44 and p = 0.70 , respectively ).
A total of 264 patients ( 83 %) who achieved CR after induction therapy then received TAD consolidation therapy , including 107 ( 78 %) in the younger patient cohort and 157 ( 86 %) in the older patient
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cohort ( p = 0.04 ).
Therapy intensity , measured by comparing the numbers of protocol-defined induction and consolidation cycles received by the two cohorts , varied between the younger and older cohorts :
• 16 % and 25 % received only one treatment course
• 33 % and 46 % received two courses
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• 51 % and 29 % received three courses ( p≤0.01 for all )
Within the younger cohort , CR was achieved in 64 percent of those treated with TAD-HAM ( 95 % CI 54-72 ) compared with 55 percent in those assigned to receive HAM-HAM ( 95 % CI 46-65 ; p = 0.2 ). Comparatively , in the older cohort , CR was achieved in 56 percent of those treated with TAD-HAM ( 95 % CI 48-64 )
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compared with 57 percent of those treated with HAM-HAM ( 95 % CI 49-65 ; p = 0.9 ). Monthly maintenance therapy was associated with lower five-year cumulative incidence of relapse ( CIR ) among younger patients who received high-dose therapy and AHCT : 60 percent ( 95 % CI 46-72 ) versus 73 percent ( 95 % CI 59-83 ; p = 0.21 ). Similarly , five-year survival rates were 32 percent ( 95 % CI 21-43 ) and 27 percent ( 95 % CI 15-39 ; p = 0.85 ), respectively . |
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-0154-01 © 2016 Pfizer Inc . All rights reserved . March 2016