AN ASSESSMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO ARE ELIGIBLE FOR FIRST-LINE THERAPY BUT UNSUITABLE FOR FULL-DOSE FLUDARABINE.
(Abstract release date: 05/19/16)
EHA Library. Jeyakumaran D. 06/09/16; 134690; PB1790
Mrs. Dusha Jeyakumaran
Contributions
Contributions
Abstract
Abstract: PB1790
Type: Publication Only
Background
Chronic Lymphocytic Leukemia (CLL) is a rare disease which has been granted orphan designation by the EMA. Treatment of CLL is only initiated in patients with symptomatic, active disease and treatment options are dependent on patient characteristics. The European Society for Medical Oncology (ESMO) identifies three subgroups of symptomatic CLL patients who are eligible for front-line treatment; physically fit patients, elderly patients or those with major comorbidities, and patients with del17p/TP53 mutation. Older patients and those with severe comorbidities are less able to tolerate the full-dose fludarabine treatments prescribed to physically fit patients. Fludarabine-based therapies are also considered unsuitable for patients with the del17p/TP53 mutation. These patient subgroups may thus benefit from the introduction of newer, less aggressive therapies.
Aims
The aim of this analysis is to estimate the number of CLL patients who require treatment initiation but who are unsuitable for treatment with full-dose fludarabine, namely those who are elderly (≥70 years), or those who are younger but have comorbidities (aged between 65 and 69 with comorbidities). It also identifies the number of patients with the del17p/TP53 mutation. To our knowledge this is the first study to stratify the total symptomatic, treatment naïve CLL patient population by these patient characteristics which influence treatment decisions.
Methods
A targeted literature review was conducted in Medline and Embase, as well as in cancer-related statistical sources in nine European countries (Belgium, France, Germany, Italy, Spain, UK, Netherlands, Poland and Sweden), applying all relevant keywords related to the disease and to the parameters to be assessed (incidence, prevalence, mortality, survival, asymptomatic, symptomatic, age, fitness, comorbidities). Based on relevant articles extracted and reviewed, the annual number of patients unsuitable for full-dose fludarabine is estimated.
Results
Patients eligible for first-line therapy comprise all newly diagnosed symptomatic CLL patients as well as patients who have transitioned from an asymptomatic disease state to an active disease state. The crude incidence rate of CLL was found to range from 3.88 per 100,000 in Germany to 6.9 per 100,000 in the UK. Of these newly diagnosed patients, between 51.9% and 75.6% are asymptomatic. Approximately 5.0% to 7.8% of previously diagnosed patients transition from an asymptomatic state to a symptomatic state every year. Assuming a mean CLL incidence rate of 4.94 per 100,000 and a mean yearly transition rate of 6.4%, the total estimated number of patients eligible for front-line treatment in 2015, across the nine European countries considered, was 12,370. Of these symptomatic patients, 986 (8.0%) had the del17p/TP53 mutation. Among symptomatic patients without the del17p/TP53 mutation, 56.5% were aged ≥70, and 6.7% were aged between 65 and 69 with major comorbidities. Thus in 2015, across the nine European countries considered, there were an estimated 7,191 symptomatic CLL patients aged ≥70 or aged between 65 and 69 with major comorbidities, who were eligible for first-line treatment but not suitable for full-dose fludarabine.
Conclusion
This study provides an in-depth overview of the treatment-naïve CLL patient population across nine European countries and provides an estimate of the number of patients unsuitable for full-dose fludarabine and fludarabine-based therapies, and who could potentially benefit from newer, more tolerable therapies.
Session topic: E-poster
Keyword(s): Chronic lymphocytic leukemia, Comorbidities, Elderly, Incidence
Type: Publication Only
Background
Chronic Lymphocytic Leukemia (CLL) is a rare disease which has been granted orphan designation by the EMA. Treatment of CLL is only initiated in patients with symptomatic, active disease and treatment options are dependent on patient characteristics. The European Society for Medical Oncology (ESMO) identifies three subgroups of symptomatic CLL patients who are eligible for front-line treatment; physically fit patients, elderly patients or those with major comorbidities, and patients with del17p/TP53 mutation. Older patients and those with severe comorbidities are less able to tolerate the full-dose fludarabine treatments prescribed to physically fit patients. Fludarabine-based therapies are also considered unsuitable for patients with the del17p/TP53 mutation. These patient subgroups may thus benefit from the introduction of newer, less aggressive therapies.
Aims
The aim of this analysis is to estimate the number of CLL patients who require treatment initiation but who are unsuitable for treatment with full-dose fludarabine, namely those who are elderly (≥70 years), or those who are younger but have comorbidities (aged between 65 and 69 with comorbidities). It also identifies the number of patients with the del17p/TP53 mutation. To our knowledge this is the first study to stratify the total symptomatic, treatment naïve CLL patient population by these patient characteristics which influence treatment decisions.
Methods
A targeted literature review was conducted in Medline and Embase, as well as in cancer-related statistical sources in nine European countries (Belgium, France, Germany, Italy, Spain, UK, Netherlands, Poland and Sweden), applying all relevant keywords related to the disease and to the parameters to be assessed (incidence, prevalence, mortality, survival, asymptomatic, symptomatic, age, fitness, comorbidities). Based on relevant articles extracted and reviewed, the annual number of patients unsuitable for full-dose fludarabine is estimated.
Results
Patients eligible for first-line therapy comprise all newly diagnosed symptomatic CLL patients as well as patients who have transitioned from an asymptomatic disease state to an active disease state. The crude incidence rate of CLL was found to range from 3.88 per 100,000 in Germany to 6.9 per 100,000 in the UK. Of these newly diagnosed patients, between 51.9% and 75.6% are asymptomatic. Approximately 5.0% to 7.8% of previously diagnosed patients transition from an asymptomatic state to a symptomatic state every year. Assuming a mean CLL incidence rate of 4.94 per 100,000 and a mean yearly transition rate of 6.4%, the total estimated number of patients eligible for front-line treatment in 2015, across the nine European countries considered, was 12,370. Of these symptomatic patients, 986 (8.0%) had the del17p/TP53 mutation. Among symptomatic patients without the del17p/TP53 mutation, 56.5% were aged ≥70, and 6.7% were aged between 65 and 69 with major comorbidities. Thus in 2015, across the nine European countries considered, there were an estimated 7,191 symptomatic CLL patients aged ≥70 or aged between 65 and 69 with major comorbidities, who were eligible for first-line treatment but not suitable for full-dose fludarabine.
Conclusion
This study provides an in-depth overview of the treatment-naïve CLL patient population across nine European countries and provides an estimate of the number of patients unsuitable for full-dose fludarabine and fludarabine-based therapies, and who could potentially benefit from newer, more tolerable therapies.
Session topic: E-poster
Keyword(s): Chronic lymphocytic leukemia, Comorbidities, Elderly, Incidence
Abstract: PB1790
Type: Publication Only
Background
Chronic Lymphocytic Leukemia (CLL) is a rare disease which has been granted orphan designation by the EMA. Treatment of CLL is only initiated in patients with symptomatic, active disease and treatment options are dependent on patient characteristics. The European Society for Medical Oncology (ESMO) identifies three subgroups of symptomatic CLL patients who are eligible for front-line treatment; physically fit patients, elderly patients or those with major comorbidities, and patients with del17p/TP53 mutation. Older patients and those with severe comorbidities are less able to tolerate the full-dose fludarabine treatments prescribed to physically fit patients. Fludarabine-based therapies are also considered unsuitable for patients with the del17p/TP53 mutation. These patient subgroups may thus benefit from the introduction of newer, less aggressive therapies.
Aims
The aim of this analysis is to estimate the number of CLL patients who require treatment initiation but who are unsuitable for treatment with full-dose fludarabine, namely those who are elderly (≥70 years), or those who are younger but have comorbidities (aged between 65 and 69 with comorbidities). It also identifies the number of patients with the del17p/TP53 mutation. To our knowledge this is the first study to stratify the total symptomatic, treatment naïve CLL patient population by these patient characteristics which influence treatment decisions.
Methods
A targeted literature review was conducted in Medline and Embase, as well as in cancer-related statistical sources in nine European countries (Belgium, France, Germany, Italy, Spain, UK, Netherlands, Poland and Sweden), applying all relevant keywords related to the disease and to the parameters to be assessed (incidence, prevalence, mortality, survival, asymptomatic, symptomatic, age, fitness, comorbidities). Based on relevant articles extracted and reviewed, the annual number of patients unsuitable for full-dose fludarabine is estimated.
Results
Patients eligible for first-line therapy comprise all newly diagnosed symptomatic CLL patients as well as patients who have transitioned from an asymptomatic disease state to an active disease state. The crude incidence rate of CLL was found to range from 3.88 per 100,000 in Germany to 6.9 per 100,000 in the UK. Of these newly diagnosed patients, between 51.9% and 75.6% are asymptomatic. Approximately 5.0% to 7.8% of previously diagnosed patients transition from an asymptomatic state to a symptomatic state every year. Assuming a mean CLL incidence rate of 4.94 per 100,000 and a mean yearly transition rate of 6.4%, the total estimated number of patients eligible for front-line treatment in 2015, across the nine European countries considered, was 12,370. Of these symptomatic patients, 986 (8.0%) had the del17p/TP53 mutation. Among symptomatic patients without the del17p/TP53 mutation, 56.5% were aged ≥70, and 6.7% were aged between 65 and 69 with major comorbidities. Thus in 2015, across the nine European countries considered, there were an estimated 7,191 symptomatic CLL patients aged ≥70 or aged between 65 and 69 with major comorbidities, who were eligible for first-line treatment but not suitable for full-dose fludarabine.
Conclusion
This study provides an in-depth overview of the treatment-naïve CLL patient population across nine European countries and provides an estimate of the number of patients unsuitable for full-dose fludarabine and fludarabine-based therapies, and who could potentially benefit from newer, more tolerable therapies.
Session topic: E-poster
Keyword(s): Chronic lymphocytic leukemia, Comorbidities, Elderly, Incidence
Type: Publication Only
Background
Chronic Lymphocytic Leukemia (CLL) is a rare disease which has been granted orphan designation by the EMA. Treatment of CLL is only initiated in patients with symptomatic, active disease and treatment options are dependent on patient characteristics. The European Society for Medical Oncology (ESMO) identifies three subgroups of symptomatic CLL patients who are eligible for front-line treatment; physically fit patients, elderly patients or those with major comorbidities, and patients with del17p/TP53 mutation. Older patients and those with severe comorbidities are less able to tolerate the full-dose fludarabine treatments prescribed to physically fit patients. Fludarabine-based therapies are also considered unsuitable for patients with the del17p/TP53 mutation. These patient subgroups may thus benefit from the introduction of newer, less aggressive therapies.
Aims
The aim of this analysis is to estimate the number of CLL patients who require treatment initiation but who are unsuitable for treatment with full-dose fludarabine, namely those who are elderly (≥70 years), or those who are younger but have comorbidities (aged between 65 and 69 with comorbidities). It also identifies the number of patients with the del17p/TP53 mutation. To our knowledge this is the first study to stratify the total symptomatic, treatment naïve CLL patient population by these patient characteristics which influence treatment decisions.
Methods
A targeted literature review was conducted in Medline and Embase, as well as in cancer-related statistical sources in nine European countries (Belgium, France, Germany, Italy, Spain, UK, Netherlands, Poland and Sweden), applying all relevant keywords related to the disease and to the parameters to be assessed (incidence, prevalence, mortality, survival, asymptomatic, symptomatic, age, fitness, comorbidities). Based on relevant articles extracted and reviewed, the annual number of patients unsuitable for full-dose fludarabine is estimated.
Results
Patients eligible for first-line therapy comprise all newly diagnosed symptomatic CLL patients as well as patients who have transitioned from an asymptomatic disease state to an active disease state. The crude incidence rate of CLL was found to range from 3.88 per 100,000 in Germany to 6.9 per 100,000 in the UK. Of these newly diagnosed patients, between 51.9% and 75.6% are asymptomatic. Approximately 5.0% to 7.8% of previously diagnosed patients transition from an asymptomatic state to a symptomatic state every year. Assuming a mean CLL incidence rate of 4.94 per 100,000 and a mean yearly transition rate of 6.4%, the total estimated number of patients eligible for front-line treatment in 2015, across the nine European countries considered, was 12,370. Of these symptomatic patients, 986 (8.0%) had the del17p/TP53 mutation. Among symptomatic patients without the del17p/TP53 mutation, 56.5% were aged ≥70, and 6.7% were aged between 65 and 69 with major comorbidities. Thus in 2015, across the nine European countries considered, there were an estimated 7,191 symptomatic CLL patients aged ≥70 or aged between 65 and 69 with major comorbidities, who were eligible for first-line treatment but not suitable for full-dose fludarabine.
Conclusion
This study provides an in-depth overview of the treatment-naïve CLL patient population across nine European countries and provides an estimate of the number of patients unsuitable for full-dose fludarabine and fludarabine-based therapies, and who could potentially benefit from newer, more tolerable therapies.
Session topic: E-poster
Keyword(s): Chronic lymphocytic leukemia, Comorbidities, Elderly, Incidence
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