LONG-TERM safety data : BOSULIF ® has a distinct safety profile that was established in 5- and 4-year follow-up 2
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CLINICAL NEWS |
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p < 0.001 ). Also , fewer RCT-ineligible patients received autologous hematopoietic cell transplantation ( AHCT ; 28.4 % vs . 38.0 %; p < 0.001 ).
At data cut-off ( January 7 , 2016 ), the median follow-up of patients enrolled in the registry was 39.3 months ( range not provided ). The three-year overall survival ( OS ) rate appeared to be lower in RCTineligible patients , compared with RCTeligible patients ( 63 % vs . 70 %; p < 0.05 ).
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However , undergoing AHCT seemed to equalize three-year OS rates , regardless of RCT eligibility ( 81 % for ineligible and 78 % for eligible patients ). Among patients who did not undergo AHCT , three-year OS rates remained higher for RCT-eligible patients ( 66 % vs . 54 %).
Three-year OS rates also were higher in RCT-ineligible patients who received novel therapies ( including bortezomib , carfilzomib , lenalidomide ,
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or pomalidomide ), compared with RCTeligible patients ( 63 % vs . 70 %); rates were similar among patients who did not receive novel therapy ( 59 % vs . 80 % percent , respectively ).
In univariate analyses , the authors determined that the following factors were associated with increased risk of death and , therefore , could potentially serve as more meaningful exclusion criteria :
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• platelet count ≤1.5 × 10 9 / L
• creatinine level > 2.5 mg / dL
• previous invasive malignancy
• International Staging System ( ISS ; I-II vs . III )
• ECOG score ( 3 or 4 vs . < 3 )
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LONG-TERM efficacy data in both the 2nd- and 3rd-line settings 2
In 2nd-line treatment , after imatinib ( n = 262 evaluable ) a
40 % of patients achieved MCyR by 6 months ( 95 % CI : 34.1 , 46.3 )
60 % of patients achieved MCyR at any time during a minimum follow-up of 60 months ( 95 % CI : 53.3 , 65.5 )
• 65 % of responders had an MCyR lasting at least 18 months
• 43 % of responders had an MCyR lasting at least 54 months
Median duration of MCyR was not reached at the time of analysis In 3rd-line treatment , after imatinib followed by nilotinib or dasatinib therapy ( n = 112 evaluable ) b
• 26 % of patients achieved MCyR by 6 months ( 95 % CI : 18.1 , 35.0 )
• 40 % of patients achieved MCyR at any time during a minimum follow-up of 48 months ( 95 % CI : 31.0 , 49.9 ) — 64 % of responders had an MCyR lasting at least 9 months — 36 % of responders had an MCyR lasting at least 42 months
• Median duration of MCyR was not reached at the time of analysis
LONG-TERM safety data : BOSULIF ® has a distinct safety profile that was established in 5- and 4-year follow-up 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 .
Adverse reactions observed in ≥20 % of patients in the Phase 1 / 2 safety population ( N = 546 ) Print-only content
All grades (%) Diarrhea ( 82 ) |
Abdominal pain ( 39 ) |
Fatigue ( 25 ) |
Nausea ( 47 ) |
Respiratory tract infection ( 39 ) |
Cough ( 22 ) |
Thrombocytopenia ( 42 ) |
Anemia ( 30 ) |
Headache ( 20 ) |
Rash ( 41 ) |
Pyrexia ( 27 ) |
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Vomiting ( 39 ) |
Liver test abnormalities ( 24 ) |
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a
Median duration of treatment was 26 months for evaluable patients . b
Median duration of treatment was 9 months for evaluable patients .
CI = confidence interval ; MCyR = major cytogenetic response .
For more information on BOSULIF , visit www . BosulifHCP . com . potential hazard to the fetus . Advise females of reproductive potential to use effective contraceptive measures to prevent pregnancy while being treated with BOSULIF and for at least 30 days after the final dose .
Adverse Reactions : The most common adverse reactions observed in greater than or equal to 20 % of patients in the Phase 1 / 2 safety population ( N = 546 ) were diarrhea , nausea , thrombocytopenia , rash , vomiting , abdominal pain , respiratory tract infection , anemia , pyrexia , liver test abnormalities , fatigue , cough , and headache . The most common Grade 3 / 4 adverse reactions and laboratory abnormalities observed in greater than 10 % of patients were thrombocytopenia , neutropenia , and anemia .
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 Myeloid Leukemia V . 1.2018 . © National Comprehensive Cancer Network , Inc . 2017 . All rights reserved . Accessed August 8 , 2017 . To view the most recent and complete version of the guideline , go online to NCCN . org . NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way . 2 . BOSULIF Prescribing Information . New York , NY : Pfizer Inc .
Please see brief summary of full Prescribing Information on the following pages .
PP-BOS-USA-0415-01 © 2017 Pfizer Inc . All rights reserved . Printed in USA / September 2017