Chronic Myeloid Leukaemia
Conditions
Keywords
tyrosine kinase inhibitor (TKI)
Brief summary
The objectives of this study are to describe patient demographics, clinical and disease characteristics and treatment patterns of Chronic Lymphoid Leukaemia (CML) in Hungary. The primary endpoint of this study is the overall survival of CML patients treated with tyrosine kinase inhibitors in Hungary. The Overall Survival (OS) of all enrolled patients, OS by sequence pattern and by the number of treatment lines will be analyzed. Secondary objectives are description of the treatment length in 1st and later lines, incidence and prevalence of CML, the patient demographics (as age, gender, comorbidities), average number of patients' comorbidities, most frequent comorbidities and patient number with comorbidities at baseline and at different treatment lines by investigated Thyrosine Kinase Inhibitor (TKI), distribution of the investigated TKI therapies by treatment lines
Interventions
DRUGBosutinib
Bosutinib as prescribed in real world
DRUGImatinib
Imatinib as prescribed in real world
DRUGNilotinib
Nilotinib as prescribed in real world
DRUGDasatinib
Dasatinib as prescribed in real world
DRUGPonatinib
Ponatinib as prescribed in real world
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Female and male patients diagnosed with chronic myeloid leukemia * Patients receiving tyrosine kinase inhibitor therapy under the terms of the current marketing authorization
Exclusion criteria
* Patients receiving TKI for non-CML diagnoses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Rate: All Participants | 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years) | Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve. |
| Overall Survival Rate: Type of First Line TKI | 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years) | Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve. |
| Overall Survival Rate: Type of Second Line TKI | 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years) | Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve. |
| Overall Survival Rate: Per Sequence of Treatment | 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years) | Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve. |
Countries
Hungary
Participant flow
Recruitment details
Data of participants, who received tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) anytime from 01 January 2009 to 30 June 2020, under the terms of the current marketing authorization, inclusion criteria, for treatment of chronic myeloid leukemia (CML), was retrieved from database National Health Insurance Fund (NHIF) of Hungary.
Participants by arm
| Arm | Count |
|---|---|
| Participants With CML Participants who received their first tyrosine kinase inhibitors (imatinib, dasatinib, nilotinib, bosutinib or ponatinib) to treat CML (from 01 January 2011 - 30 June 2020) under standard real world clinical practice in Hungary (under the terms of the current marketing authorization). Data collection started 2 years before (01 January 2009), as reference years in order to detect only the real starting therapies from 2011. | 1,484 |
| Total | 1,484 |
Baseline characteristics
| Characteristic | Participants With CML | — |
|---|---|---|
| Age, Continuous | 56.14 Years STANDARD_DEVIATION 17.13 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 704 Participants | — |
| Sex: Female, Male Male | 780 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Overall Survival Rate: All Participants
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Time frame: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
Population: Analysis set included all participants initiated with first line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With CML | Overall Survival Rate: All Participants | 77.1 Percentage of participants |
Primary
Overall Survival Rate: Per Sequence of Treatment
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Time frame: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
Population: NHIF did not provide data for event below 10 participants. Apart from 2 sequences all rest sequences had low yearly participants during the whole studied period (less than 10 participants). Hence data for analysis for Overall Survival rate by sequence was not collected and analyzed for whole population.
Primary
Overall Survival Rate: Type of First Line TKI
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Time frame: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
Population: Analysis set included all participants initiated with first line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With CML | Overall Survival Rate: Type of First Line TKI | 77.1 Percentage of participants |
Primary
Overall Survival Rate: Type of Second Line TKI
Overall survival rate in this study was defined as percentage of participants alive during analysis period of 01-January-2011 till 30-June-2020. 5 years overall survival rate was demonstrated with Kaplan-Meier curve.
Time frame: 5 years, during analysis period from 01-January-2011 till 30-June-2020 (retrieved data assessed in this observational study for approximately 1.2 years)
Population: Analysis set included all participants initiated with second line tyrosine kinase inhibitors based on chronic myeloid leukemia diagnosis between 01 January 2011 to 30 June 2020. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With CML | Overall Survival Rate: Type of Second Line TKI | 71.5 Percentage of participants |