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CML Treatment Goals | BOSULIF® (bosutinib) Tablets | Safety Info

What is the goal of treatment for CML?

What is the goal of treatment for CML?

Stages of CML

Stages of CML

Chronic myelogenous leukemia (CML) has 3 phases: CP, AP, and BP. Most patients are diagnosed in CP, so the goal of treatment is to control the disease in CP and keep it from getting worse for as long as possible. To do this, tyrosine kinase inhibitors (TKIs) are used to slow the growth of CML cells.

There are 3 types of responses measured to see if you are meeting treatment goals:

Types of responses in CML

Hematologic response Cytogenetic response Molecular response
A return of blood cells to normal levels, a decrease of immature cells in peripheral blood (blood outside the bones), and no signs or symptoms of the disease A decrease in the number of Philadelphia (Ph+) chromosomes in blood or bone marrow cells A decrease in the amount of
Bcr-Abl
messenger ribonucleic acid (mRNA) in blood or bone marrow cells

Response to treatment is measured using a number of different types of tests. You can learn more here about how these tests are important ways of monitoring your response to your CML therapy.

Treatment milestones for CML

The following is a general set of recommendations for monitoring CML treatment that may be used for some patients. These are based on the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for Chronic Myelogenous Leukemia (V.1.2016).a


Follow-up point Treatment goal
3 months 10% or less of Bcr-Abl detected by QPCR
OR
Partial cytogenetic response in bone marrow
  • 1% to 35% Ph+ chromosomes detected in the bone marrow
6 months 10% or less of Bcr-Abl detected by QPCR
OR
Partial or complete cytogenetic response in bone marrow
  • 0% to 35% Ph+ chromosomes detected in the bone marrow
12 months and beyond Complete cytogenetic response
  • No Ph+ chromosomes detected
    in the bone marrow
OR
1% or less, but more than 0.1% of Bcr-Abl detected by QPCR

aReferenced 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.

b6-month evaluation not needed if 3-month milestone is achieved.

aReferenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myelogenous Leukemia V.1.2015. © 2014 National Comprehensive Cancer Network, Inc. All rights reserved. Accessed November 5, 2014. To view the most recent and complete version of the NCCN Guidelines, go online to www.nccn.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.

Scroll for Important Safety Information for patients and Indication.

BOSULIF may cause serious side effects, including:

  • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, or vomiting. Tell your doctor about any stomach problems
  • Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection
  • Liver problems. BOSULIF may cause liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark “tea color” urine
  • Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • – shortness of breath and cough
    • – chest pain
    • – swelling in your hands, ankles, or feet
    • – swelling all over your body
    • – weight gain
  • Kidney problems. BOSULIF may cause kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • you urinate more or less often than normal
    • you make a much larger or smaller amount of urine than normal
  • The most common side effects of BOSULIF include:
    • – diarrhea
    • – nausea
    • – low blood cell counts
    • – vomiting
    • – stomach pain
    • – rash
    • – fever
    • – tiredness or weakness

Before you take BOSULIF, tell your doctor if you:

  • have liver problems
  • have heart problems
  • have kidney problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. You should not become pregnant while taking BOSULIF. Tell your doctor right away if you become pregnant while taking BOSULIF
  • are a woman who may become pregnant. Use effective contraception (birth control) during and for at least 30 days after completing treatment with BOSULIF. Talk to your doctor about forms of birth control
  • are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. You and your doctor should decide if you will take BOSULIF or breastfeed. You should not do both

Scroll for Important Safety Information for patients and Indication.

BOSULIF may cause serious side effects, including:

  • Stomach problems. BOSULIF may cause stomach (abdomen) pain, nausea, diarrhea, or vomiting. Tell your doctor about any stomach problems
  • Low blood cell counts. BOSULIF may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia) and low white blood cell counts (neutropenia). Your doctor should do blood tests to check your blood cell counts regularly during your treatment with BOSULIF. Call your doctor right away if you have unexpected bleeding or bruising, blood in your urine or stools, fever, or any signs of an infection
  • Liver problems. BOSULIF may cause liver problems. Your doctor should do blood tests to check your liver function regularly during your treatment with BOSULIF. Call your doctor right away if your skin or the white part of your eyes turns yellow (jaundice) or you have dark “tea color” urine
  • Your body may hold too much fluid (fluid retention). Fluid may build up in the lining of your lungs, the sac around your heart, or your stomach cavity. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • – shortness of breath and cough
    • – chest pain
    • – swelling in your hands, ankles, or feet
    • – swelling all over your body
    • – weight gain
  • Kidney problems. BOSULIF may cause kidney problems. Your doctor should do tests to check your kidney function when you start treatment with BOSULIF and during your treatment. Call your doctor right away if you get any of the following symptoms during your treatment with BOSULIF:
    • – you urinate more or less often than normal
    • – you make a much larger or smaller amount of urine than normal
  • The most common side effects of BOSULIF include:
    • – diarrhea
    • – nausea
    • – low blood cell counts
    • – vomiting
    • – stomach pain
    • – rash
    • – fever
    • – tiredness or weakness

Before you take BOSULIF, tell your doctor if you:

  • have liver problems
  • have heart problems
  • have kidney problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. BOSULIF can harm your unborn baby. You should not become pregnant while taking BOSULIF. Tell your doctor right away if you become pregnant while taking BOSULIF
  • are a woman who may become pregnant. Use effective contraception (birth control) during and for at least 30 days after completing treatment with BOSULIF. Talk to your doctor about forms of birth control
  • are breastfeeding or plan to breastfeed. It is not known if BOSULIF passes into your breast milk or if it can harm your baby. You and your doctor should decide if you will take BOSULIF or breastfeed. You should not do both