ACHIEVING EARLY OPTIMAL RESPONSE IS ASSOCIATED WITH BETTER HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA TREATED WITH IMATINIB OR NILOTINIB AS FRONTLINE THERAPY
(Abstract release date: 05/21/15)
EHA Library. Qian J. 06/12/15; 102913; PB1761
Disclosure(s): Peking University People's Hospital, Peking University Institute of Hematology
Dr. Jiang Qian
Contributions
Contributions
Abstract
Abstract: PB1761
Type: Publication Only
Background
Tyrosine kinase inhibitors (TKIs) as the first-line therapy have improved the outcome of patients with chronic myeloid leukemia in chronic phase (CML-CP). Health-related quality of life (HRQoL) is becoming increasingly recognized as an important component of the management of CML.
Aims
To prospectively assess the HRQoL in newly-diagnosed patients with CML-CP treated with imatinib or nilotinib and to identify the factors associated with the HRQoL outcomes.
Methods
From June 2011 to July 2011, 59 newly-diagnosed patients with CML-CP from Peking University People’s Hospital, who were enrolled in the ENESTchina trial, were randomly assigned to receive imatinib 400 mg daily (n=27) or nilotinib 300 mg BID (n=32). Response to first-line TKI therapy was assessed according to European LeukemiaNet 2013 recommendations for the management of CML. HRQoL was measured with the Short Form 36 Health Survey (SF-36) at baseline and every 3 months during the 3 years follow-up. Fisher Exact tests or chi-square tests were used to compare subjects treated with imatinib or nilotinib. The Kaplan-Meier method was used to assess statistical significance in the time-to-event analyses. The longitudinal change in HRQoL was further analyzed in a mixed model approach to linear regression for repeated measurements.
Results
Among the 59 patients (35 man and 22 women), the median age was 37 years (range, 18-74 years). Patients in the two treatment arms were comparable in terms of demographics (e.g. gender, age, education and house register), clinical characteristics (e.g. Sokal risk score and interval from diagnosis to treatment) and HRQoL scores at baseline. With a median follow-up of 37 months (range, 11-38 months), patients in the nilotinib arm had significant higher cumulative incidences of complete cytogenetic response (P=0.0077) and major molecular response (P=0.0248) compared with those in the imatinib arm. Higher proportions of optimal responses at 3 months (81.5% vs. 68.8%, P=0.263), 6 months (77.8% vs. 62.5%, P=0.204) and 12 months (51.9% vs. 37.5%, P=0.269) were also observed in the nilotinib arm, but without statistical significance. Patients in the two arms had similar rates of event-free survival (84.4% vs. 85.2%, P=0.958), progression-free survival (88. 9% vs. 87.5%, P=0.893) and overall survival (100% vs. 90.6%, P=0.199?at 3 years. Regarding HRQoL, although there was no difference on the SF-36 physical and mental assessments between patients in the two arms during the follow-up, role-physical functioning subscale was improved in patients treated with imatinib (P=0.0421) over time, furthermore, social functioning (P=0.0293) and mental component summary (P=0.0043) were improved in those treated with nilotinib. In total population, patient characteristics at baseline (including gender, age, education, house register and Sokal risk score), TKI used (imatinib vs. nilotinib) and early responses to TKI therapy (optimal response vs. non-optimal response) at 3, 6 and 12 months was analyzed in order to identify the independent factors affecting the HRQoL. Multivariable analyses by mixed model showed that patients with university graduate or above was associated with better vitality (P=0.0468), achieving optimal response at 3 months improved physical functioning dramatically (P<0.0001), and achieving optimal response at 6 months (P=0.0432) or 12 months (P=0.0483) improved social functioning remarkably.
Summary
Imatinib or nilotinib as the first-line therapy improved the HRQoL of CML-CP patients significantly, especially for those achieving optimal response at 3 months, 6 months or 12 months.
Keyword(s): Chronic, Imatinib, Quality of life
Session topic: Publication Only
Type: Publication Only
Background
Tyrosine kinase inhibitors (TKIs) as the first-line therapy have improved the outcome of patients with chronic myeloid leukemia in chronic phase (CML-CP). Health-related quality of life (HRQoL) is becoming increasingly recognized as an important component of the management of CML.
Aims
To prospectively assess the HRQoL in newly-diagnosed patients with CML-CP treated with imatinib or nilotinib and to identify the factors associated with the HRQoL outcomes.
Methods
From June 2011 to July 2011, 59 newly-diagnosed patients with CML-CP from Peking University People’s Hospital, who were enrolled in the ENESTchina trial, were randomly assigned to receive imatinib 400 mg daily (n=27) or nilotinib 300 mg BID (n=32). Response to first-line TKI therapy was assessed according to European LeukemiaNet 2013 recommendations for the management of CML. HRQoL was measured with the Short Form 36 Health Survey (SF-36) at baseline and every 3 months during the 3 years follow-up. Fisher Exact tests or chi-square tests were used to compare subjects treated with imatinib or nilotinib. The Kaplan-Meier method was used to assess statistical significance in the time-to-event analyses. The longitudinal change in HRQoL was further analyzed in a mixed model approach to linear regression for repeated measurements.
Results
Among the 59 patients (35 man and 22 women), the median age was 37 years (range, 18-74 years). Patients in the two treatment arms were comparable in terms of demographics (e.g. gender, age, education and house register), clinical characteristics (e.g. Sokal risk score and interval from diagnosis to treatment) and HRQoL scores at baseline. With a median follow-up of 37 months (range, 11-38 months), patients in the nilotinib arm had significant higher cumulative incidences of complete cytogenetic response (P=0.0077) and major molecular response (P=0.0248) compared with those in the imatinib arm. Higher proportions of optimal responses at 3 months (81.5% vs. 68.8%, P=0.263), 6 months (77.8% vs. 62.5%, P=0.204) and 12 months (51.9% vs. 37.5%, P=0.269) were also observed in the nilotinib arm, but without statistical significance. Patients in the two arms had similar rates of event-free survival (84.4% vs. 85.2%, P=0.958), progression-free survival (88. 9% vs. 87.5%, P=0.893) and overall survival (100% vs. 90.6%, P=0.199?at 3 years. Regarding HRQoL, although there was no difference on the SF-36 physical and mental assessments between patients in the two arms during the follow-up, role-physical functioning subscale was improved in patients treated with imatinib (P=0.0421) over time, furthermore, social functioning (P=0.0293) and mental component summary (P=0.0043) were improved in those treated with nilotinib. In total population, patient characteristics at baseline (including gender, age, education, house register and Sokal risk score), TKI used (imatinib vs. nilotinib) and early responses to TKI therapy (optimal response vs. non-optimal response) at 3, 6 and 12 months was analyzed in order to identify the independent factors affecting the HRQoL. Multivariable analyses by mixed model showed that patients with university graduate or above was associated with better vitality (P=0.0468), achieving optimal response at 3 months improved physical functioning dramatically (P<0.0001), and achieving optimal response at 6 months (P=0.0432) or 12 months (P=0.0483) improved social functioning remarkably.
Summary
Imatinib or nilotinib as the first-line therapy improved the HRQoL of CML-CP patients significantly, especially for those achieving optimal response at 3 months, 6 months or 12 months.
Keyword(s): Chronic, Imatinib, Quality of life
Session topic: Publication Only
Abstract: PB1761
Type: Publication Only
Background
Tyrosine kinase inhibitors (TKIs) as the first-line therapy have improved the outcome of patients with chronic myeloid leukemia in chronic phase (CML-CP). Health-related quality of life (HRQoL) is becoming increasingly recognized as an important component of the management of CML.
Aims
To prospectively assess the HRQoL in newly-diagnosed patients with CML-CP treated with imatinib or nilotinib and to identify the factors associated with the HRQoL outcomes.
Methods
From June 2011 to July 2011, 59 newly-diagnosed patients with CML-CP from Peking University People’s Hospital, who were enrolled in the ENESTchina trial, were randomly assigned to receive imatinib 400 mg daily (n=27) or nilotinib 300 mg BID (n=32). Response to first-line TKI therapy was assessed according to European LeukemiaNet 2013 recommendations for the management of CML. HRQoL was measured with the Short Form 36 Health Survey (SF-36) at baseline and every 3 months during the 3 years follow-up. Fisher Exact tests or chi-square tests were used to compare subjects treated with imatinib or nilotinib. The Kaplan-Meier method was used to assess statistical significance in the time-to-event analyses. The longitudinal change in HRQoL was further analyzed in a mixed model approach to linear regression for repeated measurements.
Results
Among the 59 patients (35 man and 22 women), the median age was 37 years (range, 18-74 years). Patients in the two treatment arms were comparable in terms of demographics (e.g. gender, age, education and house register), clinical characteristics (e.g. Sokal risk score and interval from diagnosis to treatment) and HRQoL scores at baseline. With a median follow-up of 37 months (range, 11-38 months), patients in the nilotinib arm had significant higher cumulative incidences of complete cytogenetic response (P=0.0077) and major molecular response (P=0.0248) compared with those in the imatinib arm. Higher proportions of optimal responses at 3 months (81.5% vs. 68.8%, P=0.263), 6 months (77.8% vs. 62.5%, P=0.204) and 12 months (51.9% vs. 37.5%, P=0.269) were also observed in the nilotinib arm, but without statistical significance. Patients in the two arms had similar rates of event-free survival (84.4% vs. 85.2%, P=0.958), progression-free survival (88. 9% vs. 87.5%, P=0.893) and overall survival (100% vs. 90.6%, P=0.199?at 3 years. Regarding HRQoL, although there was no difference on the SF-36 physical and mental assessments between patients in the two arms during the follow-up, role-physical functioning subscale was improved in patients treated with imatinib (P=0.0421) over time, furthermore, social functioning (P=0.0293) and mental component summary (P=0.0043) were improved in those treated with nilotinib. In total population, patient characteristics at baseline (including gender, age, education, house register and Sokal risk score), TKI used (imatinib vs. nilotinib) and early responses to TKI therapy (optimal response vs. non-optimal response) at 3, 6 and 12 months was analyzed in order to identify the independent factors affecting the HRQoL. Multivariable analyses by mixed model showed that patients with university graduate or above was associated with better vitality (P=0.0468), achieving optimal response at 3 months improved physical functioning dramatically (P<0.0001), and achieving optimal response at 6 months (P=0.0432) or 12 months (P=0.0483) improved social functioning remarkably.
Summary
Imatinib or nilotinib as the first-line therapy improved the HRQoL of CML-CP patients significantly, especially for those achieving optimal response at 3 months, 6 months or 12 months.
Keyword(s): Chronic, Imatinib, Quality of life
Session topic: Publication Only
Type: Publication Only
Background
Tyrosine kinase inhibitors (TKIs) as the first-line therapy have improved the outcome of patients with chronic myeloid leukemia in chronic phase (CML-CP). Health-related quality of life (HRQoL) is becoming increasingly recognized as an important component of the management of CML.
Aims
To prospectively assess the HRQoL in newly-diagnosed patients with CML-CP treated with imatinib or nilotinib and to identify the factors associated with the HRQoL outcomes.
Methods
From June 2011 to July 2011, 59 newly-diagnosed patients with CML-CP from Peking University People’s Hospital, who were enrolled in the ENESTchina trial, were randomly assigned to receive imatinib 400 mg daily (n=27) or nilotinib 300 mg BID (n=32). Response to first-line TKI therapy was assessed according to European LeukemiaNet 2013 recommendations for the management of CML. HRQoL was measured with the Short Form 36 Health Survey (SF-36) at baseline and every 3 months during the 3 years follow-up. Fisher Exact tests or chi-square tests were used to compare subjects treated with imatinib or nilotinib. The Kaplan-Meier method was used to assess statistical significance in the time-to-event analyses. The longitudinal change in HRQoL was further analyzed in a mixed model approach to linear regression for repeated measurements.
Results
Among the 59 patients (35 man and 22 women), the median age was 37 years (range, 18-74 years). Patients in the two treatment arms were comparable in terms of demographics (e.g. gender, age, education and house register), clinical characteristics (e.g. Sokal risk score and interval from diagnosis to treatment) and HRQoL scores at baseline. With a median follow-up of 37 months (range, 11-38 months), patients in the nilotinib arm had significant higher cumulative incidences of complete cytogenetic response (P=0.0077) and major molecular response (P=0.0248) compared with those in the imatinib arm. Higher proportions of optimal responses at 3 months (81.5% vs. 68.8%, P=0.263), 6 months (77.8% vs. 62.5%, P=0.204) and 12 months (51.9% vs. 37.5%, P=0.269) were also observed in the nilotinib arm, but without statistical significance. Patients in the two arms had similar rates of event-free survival (84.4% vs. 85.2%, P=0.958), progression-free survival (88. 9% vs. 87.5%, P=0.893) and overall survival (100% vs. 90.6%, P=0.199?at 3 years. Regarding HRQoL, although there was no difference on the SF-36 physical and mental assessments between patients in the two arms during the follow-up, role-physical functioning subscale was improved in patients treated with imatinib (P=0.0421) over time, furthermore, social functioning (P=0.0293) and mental component summary (P=0.0043) were improved in those treated with nilotinib. In total population, patient characteristics at baseline (including gender, age, education, house register and Sokal risk score), TKI used (imatinib vs. nilotinib) and early responses to TKI therapy (optimal response vs. non-optimal response) at 3, 6 and 12 months was analyzed in order to identify the independent factors affecting the HRQoL. Multivariable analyses by mixed model showed that patients with university graduate or above was associated with better vitality (P=0.0468), achieving optimal response at 3 months improved physical functioning dramatically (P<0.0001), and achieving optimal response at 6 months (P=0.0432) or 12 months (P=0.0483) improved social functioning remarkably.
Summary
Imatinib or nilotinib as the first-line therapy improved the HRQoL of CML-CP patients significantly, especially for those achieving optimal response at 3 months, 6 months or 12 months.
Keyword(s): Chronic, Imatinib, Quality of life
Session topic: Publication Only
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