Chronic Myeloid Leukaemia
Conditions
Keywords
Bosutinib, chronic myeloid leukaemia, retrospective, observational
Brief summary
The purpose of this study is to describe the efficacy and safety of bosutinib in patients with chronic myeloid leukaemia used in a real world setting
Interventions
DRUGBosutinib
Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)
Sponsors
pH Associates
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Ph+ CML aged ≥18 years at bosutinib initiation. * Prescribed bosutinib (irrespective of the phase of their disease) EITHER in normal clinical practice since it received marketing authorisation (27th March 2013) by the EMA11 OR via the compassionate use programme prior to marketing authorization. * Where required, evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
* Prescribed bosutinib as part of an interventional clinical trial programme. * Initiated on bosutinib less than 3 months prior to data collection taking place.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Cumulative Complete Haematological Response (CHR) | Baseline up to 5.5 years | Haematological response used blood sample of the participants to evaluate response to treatment for CML. Based on the European LeukemiaNet (ELN) 2013 definition: CHR is defined as platelet count less than (\<) 450\*10\^9 per liter, white blood cells count \<10\*10\^9 per liter, no immature granulocytes and \<5 percent (%) basophils on differential and a non-palpable spleen. |
| Percentage of Participants With Cumulative Partial Haematological Response (PHR) | Baseline up to 5.5 years | Haematological response used blood sample of the participants to evaluate response to treatment for CML. |
| Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) | Baseline up to 5.5 years | Cytogenetic response (CyR) used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by chromosome banding analysis (CBA) or fluorescence in situ hybridisation (FISH). CCyR was indicated by absence of Philadelphia chromosome positive (Ph+) cells metaphases from FISH of blood interphase cell nuclei. |
| Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) | Baseline up to 5.5 years | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. MCyR was indicated by presence of 36-65% Ph+ cells from CBA of bone marrow metaphases. |
| Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) | Baseline up to 5.5 years | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. mCyR was indicated by presence of 66-95% Ph+ cells from CBA of bone marrow metaphases. |
| Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) | Baseline up to 5.5 years | CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. PCyR was indicated by presence of 1-35% Ph+ cells from CBA of bone marrow metaphases. |
| Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) | Baseline up to 5.5 years | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.0 was defined and recorded as detectable disease with \<0.01% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with greater than (\>) 10,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts. |
| Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) | Baseline up to 5.5 years | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.5 was defined and recorded as detectable disease with \<0.0032% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with \>32,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts. |
| Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) | Baseline up to 5.5 years | Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MMR was defined as a BCR-ABL1 to ABL1 less than or equal to (\<=) 0.1% on the IS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Related Adverse Events (AEs) | Baseline up to 5.5 years | Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. Relatedness to Bosutinib was assessed by the investigator. |
| Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3 | Baseline up to 5.5 years | Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death. |
| Progression-free Survival (PFS) | Year 1, 2, 3 | PFS was defined as the duration between initiation of Bosutinib therapy and date of progression estimated by the treating physician or death of participant (all causes combined). Progression was defined as change from chronic phase of CML (CP-CML) to accelerated phase of CML (AP-CML) or to blast crisis of CML (BC-CML). CP-CML is frequently asymptomatic and diagnosed with \<10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes \>30%, with blasts \<30% in blood or bone marrow, platelet count \<100\*10\^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow \>=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. Participants who were alive at the date of last assessment were censored on the date of data collection. |
| Overall Survival (OS) | From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3 | OS was defined as the duration from initiation of Bosutinib therapy to date of death (all causes combined). For participants who were alive or lost to follow-up (LTFU), overall survival was censored on the date of data collection or date LTFU, respectively. |
| Percentage of Participants With Disease Progression | Year 1, 2, 3 | Progression was defined as change from CP-CML to AP-CML or to BC-CML. CP-CML is frequently asymptomatic and diagnosed with \<10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes \>30%, with blasts \<30% in blood or bone marrow, platelet count \<100\*10\^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow \>=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. |
| Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Baseline up to 5.5 years | — |
| Cross-Intolerance Between Bosutinib and Previous Therapy | Baseline up to 5.5 years | Cross-intolerance was defined as percentage of participants who permanently discontinued bosutinib due to an adverse event which also resulted in discontinuation of a previous treatment (imatinib, dasatinib, nilotinib). |
| Mean Dose of Bosutinib at Initiation of Treatment | Baseline up to 5.5 years | — |
| Relative Bosutinib Dose Intensity | Baseline up to 5.5 years | Relative dose intensity was defined as the percentage of daily dose received over the expected daily dose of the study drug. |
| Duration of Bosutinib Therapy | Baseline up to 5.5 years | The duration from initiation of Bosutinib therapy up to the end of Bosutinib therapy was reported in this outcome measure. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bosutinib Participants with Philadelphia chromosome-positive CML receiving imatinib, dasatinib or nilotinib prior to enrollment in the study, who were treated with single daily oral dose of Bosutinib 100 to 500 mg, were observed up to a maximum duration of 5.5 years. Dosage and use of Bosutinib was based on treating physician, according to approved SmPC. | 87 |
| Total | 87 |
Baseline characteristics
| Characteristic | Bosutinib |
|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 14.3 |
| Sex/Gender, Customized Female | 40 Participants |
| Sex/Gender, Customized Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 81 / 87 |
| serious Total, serious adverse events | 17 / 87 |
Outcome results
Primary
Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR)
Cytogenetic response (CyR) used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by chromosome banding analysis (CBA) or fluorescence in situ hybridisation (FISH). CCyR was indicated by absence of Philadelphia chromosome positive (Ph+) cells metaphases from FISH of blood interphase cell nuclei.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Complete Cytogenetic Response (CCyR) | 67 percentage of participants |
Primary
Percentage of Participants With Cumulative Complete Haematological Response (CHR)
Haematological response used blood sample of the participants to evaluate response to treatment for CML. Based on the European LeukemiaNet (ELN) 2013 definition: CHR is defined as platelet count less than (\<) 450\*10\^9 per liter, white blood cells count \<10\*10\^9 per liter, no immature granulocytes and \<5 percent (%) basophils on differential and a non-palpable spleen.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Complete Haematological Response (CHR) | 93 percentage of participants |
Primary
Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0)
Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.0 was defined and recorded as detectable disease with \<0.01% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with greater than (\>) 10,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Complete Molecular Response 4.0 (MR4.0) | 33 percentage of participants |
Primary
Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5)
Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MR4.5 was defined and recorded as detectable disease with \<0.0032% BCR-ABL1 transcripts on IS or undetectable disease in cDNA with \>32,000 ABL1 transcripts in the same volume of cDNA used to test for BCR-ABL1 transcripts.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Complete Molecular Response 4.5 (MR4.5) | 27 percentage of participants |
Primary
Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0)
Molecular response used blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: Molecular response used breakpoint cluster region/Abelson (BCR-ABL1) transcript measured by real time quantitative polymerase chain reaction (RT-Q-PCR). Evaluation was expressed as percentage of ratio of BCR-ABL1 transcripts to ABL1 transcripts according to the international scale (IS) or the ratio of BCR/ABL1 transcripts to other internationally recognized control transcripts levels. MMR was defined as a BCR-ABL1 to ABL1 less than or equal to (\<=) 0.1% on the IS.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Major Molecular Response (MMR)/Molecular Response 3.0 (MR3.0) | 55 percentage of participants |
Primary
Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR)
CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. mCyR was indicated by presence of 66-95% Ph+ cells from CBA of bone marrow metaphases.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Minimal Cytogenetic Response (mCyR) | 80 percentage of participants |
Primary
Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR)
CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. MCyR was indicated by presence of 36-65% Ph+ cells from CBA of bone marrow metaphases.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Minor Cytogenetic Response (MCyR) | 77 percentage of participants |
Primary
Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR)
CyR used bone marrow/blood sample of the participants to evaluate response to treatment for CML. Based on the ELN 2013 definition: CyR was measured by CBA or FISH. PCyR was indicated by presence of 1-35% Ph+ cells from CBA of bone marrow metaphases.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Partial Cytogenetic Response (PCyR) | 77 percentage of participants |
Primary
Percentage of Participants With Cumulative Partial Haematological Response (PHR)
Haematological response used blood sample of the participants to evaluate response to treatment for CML.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Cumulative Partial Haematological Response (PHR) | 94 percentage of participants |
Secondary
Cross-Intolerance Between Bosutinib and Previous Therapy
Cross-intolerance was defined as percentage of participants who permanently discontinued bosutinib due to an adverse event which also resulted in discontinuation of a previous treatment (imatinib, dasatinib, nilotinib).
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Cross-Intolerance Between Bosutinib and Previous Therapy | 1.1 percentage of participants |
Secondary
Duration of Bosutinib Therapy
The duration from initiation of Bosutinib therapy up to the end of Bosutinib therapy was reported in this outcome measure.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bosutinib | Duration of Bosutinib Therapy | 15.6 months |
Secondary
Mean Dose of Bosutinib at Initiation of Treatment
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bosutinib | Mean Dose of Bosutinib at Initiation of Treatment | 331.0 milligram per day | Standard Deviation 126.6 |
Secondary
Overall Survival (OS)
OS was defined as the duration from initiation of Bosutinib therapy to date of death (all causes combined). For participants who were alive or lost to follow-up (LTFU), overall survival was censored on the date of data collection or date LTFU, respectively.
Time frame: From baseline up to 1 Year, baseline up to Year 2, baseline up to Year 3
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bosutinib | Overall Survival (OS) | NA years |
Secondary
Percentage of Participants With Disease Progression
Progression was defined as change from CP-CML to AP-CML or to BC-CML. CP-CML is frequently asymptomatic and diagnosed with \<10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes \>30%, with blasts \<30% in blood or bone marrow, platelet count \<100\*10\^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow \>=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy.
Time frame: Year 1, 2, 3
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib. Here, N signifies those participants who were evaluable for this outcome measure and number analyzed (n) signifies those participants who were evaluable at specified time points only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bosutinib | Percentage of Participants With Disease Progression | 1 year | 3 percentage of participants |
| Bosutinib | Percentage of Participants With Disease Progression | 2 year | 3 percentage of participants |
| Bosutinib | Percentage of Participants With Disease Progression | 3 year | 0 percentage of participants |
Secondary
Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bosutinib | Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Adverse event | 14 percentage of participants |
| Bosutinib | Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Loss of response | 5 percentage of participants |
| Bosutinib | Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Treatment failure | 11 percentage of participants |
| Bosutinib | Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Participant request | 2 percentage of participants |
| Bosutinib | Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Death | 2 percentage of participants |
| Bosutinib | Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Disease progression | 1 percentage of participants |
| Bosutinib | Percentage of Participants With Permanent Discontinuation From Bosutinib Therapy | Other | 2 percentage of participants |
Secondary
Percentage of Participants With Treatment Related Adverse Events (AEs)
Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. Relatedness to Bosutinib was assessed by the investigator.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Treatment Related Adverse Events (AEs) | 94 percentage of participants |
Secondary
Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3
Treatment-related AE was any untoward medical occurrence attributed to Bosutinib in a participant who received Bosutinib. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Percentage of Participants With Treatment Related Adverse Events (AEs) Greater Than or Equal to Grade 3 | 21 percentage of participants |
Secondary
Progression-free Survival (PFS)
PFS was defined as the duration between initiation of Bosutinib therapy and date of progression estimated by the treating physician or death of participant (all causes combined). Progression was defined as change from chronic phase of CML (CP-CML) to accelerated phase of CML (AP-CML) or to blast crisis of CML (BC-CML). CP-CML is frequently asymptomatic and diagnosed with \<10% blasts. Based on the ELN 2013 definition: AP-CML was defined by the presence of blast cells between 15-29% or blast cells plus promyelocytes \>30%, with blasts \<30% in blood or bone marrow, platelet count \<100\*10\^9 or clonal chromosome abnormalities in Ph+ cells. BC-CML was defined as blasts in blood or bone marrow \>=30%, extramedullary blast proliferation (excluding spleen), large foci or clusters of blasts in bone marrow biopsy. Participants who were alive at the date of last assessment were censored on the date of data collection.
Time frame: Year 1, 2, 3
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bosutinib | Progression-free Survival (PFS) | NA years |
Secondary
Relative Bosutinib Dose Intensity
Relative dose intensity was defined as the percentage of daily dose received over the expected daily dose of the study drug.
Time frame: Baseline up to 5.5 years
Population: All enrolled participants with Philadephia chromosome positive CML in chronic phase received at least 1 dose of Bosutinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bosutinib | Relative Bosutinib Dose Intensity | 66 percentage of daily dose |