INITIAL RESULTS FROM UKALL60+, A UK/HOVON COLLABORATIVE PHASE 2 STUDY IN ELDERLY PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKAEMIA.
(Abstract release date: 05/19/16)
EHA Library. MORLEY N. 06/10/16; 133159; P171
Dr. Nick MORLEY
Contributions
Contributions
Abstract
Abstract: P171
Type: Poster Presentation
Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45
Location: Poster area (Hall H)
Background
The outcome for older adults with acute lymphoblastic leukaemia (ALL) is generally poor. The UKALL12/ECOG2993 study reported a greater incidence of high risk cytogenetic abnormalities, increased toxicity (e.g. 18% Induction death rate) and poorer outcomes (CR rate 73% and 5 year overall survival 21%) in those 55- 65 years of age. There is a dearth of studies which focus on patients at the very oldest end of the age spectrum despite an increasing incidence with age.
Aims
We aimed to conduct a pragmatic study intended to establish baseline chemotherapy from which to design widely-applicable studies of novel agents in older people.
Methods
We established UKALL60+ as a collaboration between the UK National Cancer Research Institute Adult ALL Group and HOVON to study treatment choice and outcomes in patients aged 60 years and over (or 55 years and over with co-morbidities) with ALL. The study offers five ‘arms’ to be decided by investigator and patient choice; Non-intensive (designed to be delivered primarily out of hospital), Intensive, Intensive+, Philadelphia positive (Ph+) and Registration only ( in which treatment is at investigators discretion, including no active therapy). Any elderly patient with newly diagnosed ALL is eligible. There are no exclusions for co-morbidities, including prior malignancies. Baseline characteristics of each group including Charlson index, ECOG, Karnofsky and CRASH scores are being collected with the aim of determining why each regimen was allocated. The primary endpoint is the rate of complete remission (CR) after 2 phases of induction. Secondary objectives include determination of MRD status at 3 time points, EFS and OS at 1 year, treatment related mortality and quality of life assessments.
Results
Since activation in December 2012 81 patients (84% of those screened) with a median age of 67 years (Range 55 – 83) have been enrolled. Median follow up is 9.4 months (Range 1 day to 29.8 months). ECOG performance status was 1 in 33 (40%), 2 in 37 (45%) and ≥3 in 13 (15%). Treatment allocation has been non-Intensive n=11, Intensive n=34, Intensive+ n=7, Ph+ n=18 and Registration only n=11 patients. It is too early to perform a full analysis of the reasons given for choosing each regimen but age appears to be a major factor for Ph-ve patients, with the average age 74 years (Range 64-82) in the non-Intensive arm compared with 66 years (Range 56 -76) in the Intensive and Intensive+ arms. A total of 32/80 patients (40%) had high risk cytogenetics including BCR-ABL1 (n=18), low hypodiploidy (n=10), complex karyotype (n=2) and KMT2A-AFF1 (aka MLL-AF4) (n=1).So far forty-eight patients have completed 2 phases of induction chemotherapy with 37 of these attaining CR (77%). Failure to complete this was very common (n=17); reasons include inadequate response/relapse=8, death=5, clinician or patient decision=4. Baseline MRD samples were received for 62 patients, 43 of which have been evaluated to date by immunoglobulin heavy chain/T cell receptor re-arrangement quantification or BCR-ABL quantification. Only 3 of these patients were MRD negative following the first cycle of induction chemotherapy.Grade 3/4 AEs were seen in 54/58 assessable patients. The most common toxicities were haematological (71%) and infections (38%). To date 28 deaths have been reported; 18 patients died of ALL, 5 infection, 1 cardiac, 1 multi-organ failure and 3 data outstanding. Quality of life data has been collected and the results are anticipated.
Conclusion
ALL in older patients is difficult to treat with a delicate balance between efficacy and toxicity. Treatment choices currently vary widely. The goal of our trial is to provide a representative view of elderly ALL treatment, to identify a group where the current therapeutic approaches need improvement and to pave the way for older individuals to be at the forefront of development of novel approaches in de novo ALL.
Session topic: Acute lymphoblastic leukemia - Clinical 1
Keyword(s): Acute lymphoblastic leukemia, Clinical trial, Elderly, Treatment
Type: Poster Presentation
Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45
Location: Poster area (Hall H)
Background
The outcome for older adults with acute lymphoblastic leukaemia (ALL) is generally poor. The UKALL12/ECOG2993 study reported a greater incidence of high risk cytogenetic abnormalities, increased toxicity (e.g. 18% Induction death rate) and poorer outcomes (CR rate 73% and 5 year overall survival 21%) in those 55- 65 years of age. There is a dearth of studies which focus on patients at the very oldest end of the age spectrum despite an increasing incidence with age.
Aims
We aimed to conduct a pragmatic study intended to establish baseline chemotherapy from which to design widely-applicable studies of novel agents in older people.
Methods
We established UKALL60+ as a collaboration between the UK National Cancer Research Institute Adult ALL Group and HOVON to study treatment choice and outcomes in patients aged 60 years and over (or 55 years and over with co-morbidities) with ALL. The study offers five ‘arms’ to be decided by investigator and patient choice; Non-intensive (designed to be delivered primarily out of hospital), Intensive, Intensive+, Philadelphia positive (Ph+) and Registration only ( in which treatment is at investigators discretion, including no active therapy). Any elderly patient with newly diagnosed ALL is eligible. There are no exclusions for co-morbidities, including prior malignancies. Baseline characteristics of each group including Charlson index, ECOG, Karnofsky and CRASH scores are being collected with the aim of determining why each regimen was allocated. The primary endpoint is the rate of complete remission (CR) after 2 phases of induction. Secondary objectives include determination of MRD status at 3 time points, EFS and OS at 1 year, treatment related mortality and quality of life assessments.
Results
Since activation in December 2012 81 patients (84% of those screened) with a median age of 67 years (Range 55 – 83) have been enrolled. Median follow up is 9.4 months (Range 1 day to 29.8 months). ECOG performance status was 1 in 33 (40%), 2 in 37 (45%) and ≥3 in 13 (15%). Treatment allocation has been non-Intensive n=11, Intensive n=34, Intensive+ n=7, Ph+ n=18 and Registration only n=11 patients. It is too early to perform a full analysis of the reasons given for choosing each regimen but age appears to be a major factor for Ph-ve patients, with the average age 74 years (Range 64-82) in the non-Intensive arm compared with 66 years (Range 56 -76) in the Intensive and Intensive+ arms. A total of 32/80 patients (40%) had high risk cytogenetics including BCR-ABL1 (n=18), low hypodiploidy (n=10), complex karyotype (n=2) and KMT2A-AFF1 (aka MLL-AF4) (n=1).So far forty-eight patients have completed 2 phases of induction chemotherapy with 37 of these attaining CR (77%). Failure to complete this was very common (n=17); reasons include inadequate response/relapse=8, death=5, clinician or patient decision=4. Baseline MRD samples were received for 62 patients, 43 of which have been evaluated to date by immunoglobulin heavy chain/T cell receptor re-arrangement quantification or BCR-ABL quantification. Only 3 of these patients were MRD negative following the first cycle of induction chemotherapy.Grade 3/4 AEs were seen in 54/58 assessable patients. The most common toxicities were haematological (71%) and infections (38%). To date 28 deaths have been reported; 18 patients died of ALL, 5 infection, 1 cardiac, 1 multi-organ failure and 3 data outstanding. Quality of life data has been collected and the results are anticipated.
Conclusion
ALL in older patients is difficult to treat with a delicate balance between efficacy and toxicity. Treatment choices currently vary widely. The goal of our trial is to provide a representative view of elderly ALL treatment, to identify a group where the current therapeutic approaches need improvement and to pave the way for older individuals to be at the forefront of development of novel approaches in de novo ALL.
Session topic: Acute lymphoblastic leukemia - Clinical 1
Keyword(s): Acute lymphoblastic leukemia, Clinical trial, Elderly, Treatment
Abstract: P171
Type: Poster Presentation
Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45
Location: Poster area (Hall H)
Background
The outcome for older adults with acute lymphoblastic leukaemia (ALL) is generally poor. The UKALL12/ECOG2993 study reported a greater incidence of high risk cytogenetic abnormalities, increased toxicity (e.g. 18% Induction death rate) and poorer outcomes (CR rate 73% and 5 year overall survival 21%) in those 55- 65 years of age. There is a dearth of studies which focus on patients at the very oldest end of the age spectrum despite an increasing incidence with age.
Aims
We aimed to conduct a pragmatic study intended to establish baseline chemotherapy from which to design widely-applicable studies of novel agents in older people.
Methods
We established UKALL60+ as a collaboration between the UK National Cancer Research Institute Adult ALL Group and HOVON to study treatment choice and outcomes in patients aged 60 years and over (or 55 years and over with co-morbidities) with ALL. The study offers five ‘arms’ to be decided by investigator and patient choice; Non-intensive (designed to be delivered primarily out of hospital), Intensive, Intensive+, Philadelphia positive (Ph+) and Registration only ( in which treatment is at investigators discretion, including no active therapy). Any elderly patient with newly diagnosed ALL is eligible. There are no exclusions for co-morbidities, including prior malignancies. Baseline characteristics of each group including Charlson index, ECOG, Karnofsky and CRASH scores are being collected with the aim of determining why each regimen was allocated. The primary endpoint is the rate of complete remission (CR) after 2 phases of induction. Secondary objectives include determination of MRD status at 3 time points, EFS and OS at 1 year, treatment related mortality and quality of life assessments.
Results
Since activation in December 2012 81 patients (84% of those screened) with a median age of 67 years (Range 55 – 83) have been enrolled. Median follow up is 9.4 months (Range 1 day to 29.8 months). ECOG performance status was 1 in 33 (40%), 2 in 37 (45%) and ≥3 in 13 (15%). Treatment allocation has been non-Intensive n=11, Intensive n=34, Intensive+ n=7, Ph+ n=18 and Registration only n=11 patients. It is too early to perform a full analysis of the reasons given for choosing each regimen but age appears to be a major factor for Ph-ve patients, with the average age 74 years (Range 64-82) in the non-Intensive arm compared with 66 years (Range 56 -76) in the Intensive and Intensive+ arms. A total of 32/80 patients (40%) had high risk cytogenetics including BCR-ABL1 (n=18), low hypodiploidy (n=10), complex karyotype (n=2) and KMT2A-AFF1 (aka MLL-AF4) (n=1).So far forty-eight patients have completed 2 phases of induction chemotherapy with 37 of these attaining CR (77%). Failure to complete this was very common (n=17); reasons include inadequate response/relapse=8, death=5, clinician or patient decision=4. Baseline MRD samples were received for 62 patients, 43 of which have been evaluated to date by immunoglobulin heavy chain/T cell receptor re-arrangement quantification or BCR-ABL quantification. Only 3 of these patients were MRD negative following the first cycle of induction chemotherapy.Grade 3/4 AEs were seen in 54/58 assessable patients. The most common toxicities were haematological (71%) and infections (38%). To date 28 deaths have been reported; 18 patients died of ALL, 5 infection, 1 cardiac, 1 multi-organ failure and 3 data outstanding. Quality of life data has been collected and the results are anticipated.
Conclusion
ALL in older patients is difficult to treat with a delicate balance between efficacy and toxicity. Treatment choices currently vary widely. The goal of our trial is to provide a representative view of elderly ALL treatment, to identify a group where the current therapeutic approaches need improvement and to pave the way for older individuals to be at the forefront of development of novel approaches in de novo ALL.
Session topic: Acute lymphoblastic leukemia - Clinical 1
Keyword(s): Acute lymphoblastic leukemia, Clinical trial, Elderly, Treatment
Type: Poster Presentation
Presentation during EHA21: On Friday, June 10, 2016 from 17:15 - 18:45
Location: Poster area (Hall H)
Background
The outcome for older adults with acute lymphoblastic leukaemia (ALL) is generally poor. The UKALL12/ECOG2993 study reported a greater incidence of high risk cytogenetic abnormalities, increased toxicity (e.g. 18% Induction death rate) and poorer outcomes (CR rate 73% and 5 year overall survival 21%) in those 55- 65 years of age. There is a dearth of studies which focus on patients at the very oldest end of the age spectrum despite an increasing incidence with age.
Aims
We aimed to conduct a pragmatic study intended to establish baseline chemotherapy from which to design widely-applicable studies of novel agents in older people.
Methods
We established UKALL60+ as a collaboration between the UK National Cancer Research Institute Adult ALL Group and HOVON to study treatment choice and outcomes in patients aged 60 years and over (or 55 years and over with co-morbidities) with ALL. The study offers five ‘arms’ to be decided by investigator and patient choice; Non-intensive (designed to be delivered primarily out of hospital), Intensive, Intensive+, Philadelphia positive (Ph+) and Registration only ( in which treatment is at investigators discretion, including no active therapy). Any elderly patient with newly diagnosed ALL is eligible. There are no exclusions for co-morbidities, including prior malignancies. Baseline characteristics of each group including Charlson index, ECOG, Karnofsky and CRASH scores are being collected with the aim of determining why each regimen was allocated. The primary endpoint is the rate of complete remission (CR) after 2 phases of induction. Secondary objectives include determination of MRD status at 3 time points, EFS and OS at 1 year, treatment related mortality and quality of life assessments.
Results
Since activation in December 2012 81 patients (84% of those screened) with a median age of 67 years (Range 55 – 83) have been enrolled. Median follow up is 9.4 months (Range 1 day to 29.8 months). ECOG performance status was 1 in 33 (40%), 2 in 37 (45%) and ≥3 in 13 (15%). Treatment allocation has been non-Intensive n=11, Intensive n=34, Intensive+ n=7, Ph+ n=18 and Registration only n=11 patients. It is too early to perform a full analysis of the reasons given for choosing each regimen but age appears to be a major factor for Ph-ve patients, with the average age 74 years (Range 64-82) in the non-Intensive arm compared with 66 years (Range 56 -76) in the Intensive and Intensive+ arms. A total of 32/80 patients (40%) had high risk cytogenetics including BCR-ABL1 (n=18), low hypodiploidy (n=10), complex karyotype (n=2) and KMT2A-AFF1 (aka MLL-AF4) (n=1).So far forty-eight patients have completed 2 phases of induction chemotherapy with 37 of these attaining CR (77%). Failure to complete this was very common (n=17); reasons include inadequate response/relapse=8, death=5, clinician or patient decision=4. Baseline MRD samples were received for 62 patients, 43 of which have been evaluated to date by immunoglobulin heavy chain/T cell receptor re-arrangement quantification or BCR-ABL quantification. Only 3 of these patients were MRD negative following the first cycle of induction chemotherapy.Grade 3/4 AEs were seen in 54/58 assessable patients. The most common toxicities were haematological (71%) and infections (38%). To date 28 deaths have been reported; 18 patients died of ALL, 5 infection, 1 cardiac, 1 multi-organ failure and 3 data outstanding. Quality of life data has been collected and the results are anticipated.
Conclusion
ALL in older patients is difficult to treat with a delicate balance between efficacy and toxicity. Treatment choices currently vary widely. The goal of our trial is to provide a representative view of elderly ALL treatment, to identify a group where the current therapeutic approaches need improvement and to pave the way for older individuals to be at the forefront of development of novel approaches in de novo ALL.
Session topic: Acute lymphoblastic leukemia - Clinical 1
Keyword(s): Acute lymphoblastic leukemia, Clinical trial, Elderly, Treatment
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