LONG-TERM OUTCOME OF ELDERLY PATIENTS WITH ACUTE PROMYELOCYTIC LEUKEMIA TREATED WITH ANTHRACYCLINE MONOTHERAPY AND ATRA-BASED PETHEMA PROTOCOLS
(Abstract release date: 05/19/16)
EHA Library. Martinez-Cuadron D. 06/11/16; 135242; S486
Dr. David Martinez-Cuadron
Contributions
Contributions
Abstract
Abstract: S486
Type: Oral Presentation
Presentation during EHA21: On Saturday, June 11, 2016 from 17:00 - 17:15
Location: Hall A2
Background
Outcomes of elderly patients with acute promyelocytic leukemia (APL) have been reported as less effective than in younger patients because of lower compliance and higher mortality rate related to toxicity of the treatment. This fact has led to design the risk-adapted and age-adapted PETHEMA LPA2005 protocol, in which the anthracycline dose in second consolidation was reduced with respect to previous protocols.
Aims
This study aims at comparing elderly patients (age ≥ 60 years old) who were treated according to PETHEMA LPA2005 schedule and those who were included in the more intensive previous protocols (LP96&LP99 trials).
Methods
Elderly patients (age equal or greater than 60) who were reported to the multicenter PETHEMA APL registry, diagnosed with APL and demonstration of the t(15;17) or PML/RARA rearrangement were included in this study. They were excluded if they met any of the following criteria: 1) Eastern Cooperative Oncology Group (ECOG) performance status at presentation of more than three, 2) severe medical comorbidities limiting the administration of chemotherapy in opinion of the treating physician, 3) antecedents of primary malignancy or previous therapy with leukemogenic agents, and 4) protocol violation. Elderly patients who received treatment according to the risk and age-adapted protocol LPA2005 were compared to those included in LPA96&LPA99 protocols.
Results
From November 1996 to November 2014, 389 elderly patients were reported to PETHEMA APL registry and 268 (69%) were considered as eligible. Causes of ineligibility were secondary APL (19%), ECOG 4/unfit for intensive chemotherapy (11%), and protocol violation (1%). Median age of eligible patients was 67 years (range, 60-84), and the distribution of relapse-risk categories was low (29%), intermediate (50%), and high (21%). Two-hundred sixteen out of 268 eligible patients (81%) achieved complete remission and 52 (19%) died during induction treatment due to hemorrhage and infection, mainly. Leukemic resistance was not observed. Comparing patients according to protocol, no differences in biological and clinical characteristics at diagnosis were identified between the LPA96&99 and LPA2005 cohorts. The median follow-up of patients alive was 62 months (range 2-191). Patients treated with the less intense schedule (LPA2005 trial) had lower toxicity, with a lower duration of neutropenia and thrombocytopenia during the second consolidation and fewer days of hospitalization, resulting in reduced 5-year non-relapse mortality compared with the LPA96&99 trials (5% vs. 18%, P=0.02). At 5 years, patients treated according to LPA2005 protocol had higher overall survival (74% vs. 60%, P=0.02), and higher disease-free survival (87% vs. 69%, P=0.009) than patients who received LPA96&99 protocols. There were no differences in the cumulative incidence of relapse between the two groups (P=0.25).
Conclusion
Anthracycline dose reduction during consolidation for elderly patients with APL treated with the PETHEMA LPA2005 trial resulted in lower toxicity and non-relapse mortality, while maintaining a high antileukemic activity.
Session topic: Standard Treatment Results in AML
Keyword(s): Acute promyelocytic leukemia, ALL-trans retinoic acid (ATRA), Anthracycline, Elderly
Type: Oral Presentation
Presentation during EHA21: On Saturday, June 11, 2016 from 17:00 - 17:15
Location: Hall A2
Background
Outcomes of elderly patients with acute promyelocytic leukemia (APL) have been reported as less effective than in younger patients because of lower compliance and higher mortality rate related to toxicity of the treatment. This fact has led to design the risk-adapted and age-adapted PETHEMA LPA2005 protocol, in which the anthracycline dose in second consolidation was reduced with respect to previous protocols.
Aims
This study aims at comparing elderly patients (age ≥ 60 years old) who were treated according to PETHEMA LPA2005 schedule and those who were included in the more intensive previous protocols (LP96&LP99 trials).
Methods
Elderly patients (age equal or greater than 60) who were reported to the multicenter PETHEMA APL registry, diagnosed with APL and demonstration of the t(15;17) or PML/RARA rearrangement were included in this study. They were excluded if they met any of the following criteria: 1) Eastern Cooperative Oncology Group (ECOG) performance status at presentation of more than three, 2) severe medical comorbidities limiting the administration of chemotherapy in opinion of the treating physician, 3) antecedents of primary malignancy or previous therapy with leukemogenic agents, and 4) protocol violation. Elderly patients who received treatment according to the risk and age-adapted protocol LPA2005 were compared to those included in LPA96&LPA99 protocols.
Results
From November 1996 to November 2014, 389 elderly patients were reported to PETHEMA APL registry and 268 (69%) were considered as eligible. Causes of ineligibility were secondary APL (19%), ECOG 4/unfit for intensive chemotherapy (11%), and protocol violation (1%). Median age of eligible patients was 67 years (range, 60-84), and the distribution of relapse-risk categories was low (29%), intermediate (50%), and high (21%). Two-hundred sixteen out of 268 eligible patients (81%) achieved complete remission and 52 (19%) died during induction treatment due to hemorrhage and infection, mainly. Leukemic resistance was not observed. Comparing patients according to protocol, no differences in biological and clinical characteristics at diagnosis were identified between the LPA96&99 and LPA2005 cohorts. The median follow-up of patients alive was 62 months (range 2-191). Patients treated with the less intense schedule (LPA2005 trial) had lower toxicity, with a lower duration of neutropenia and thrombocytopenia during the second consolidation and fewer days of hospitalization, resulting in reduced 5-year non-relapse mortality compared with the LPA96&99 trials (5% vs. 18%, P=0.02). At 5 years, patients treated according to LPA2005 protocol had higher overall survival (74% vs. 60%, P=0.02), and higher disease-free survival (87% vs. 69%, P=0.009) than patients who received LPA96&99 protocols. There were no differences in the cumulative incidence of relapse between the two groups (P=0.25).
Conclusion
Anthracycline dose reduction during consolidation for elderly patients with APL treated with the PETHEMA LPA2005 trial resulted in lower toxicity and non-relapse mortality, while maintaining a high antileukemic activity.
Session topic: Standard Treatment Results in AML
Keyword(s): Acute promyelocytic leukemia, ALL-trans retinoic acid (ATRA), Anthracycline, Elderly
Abstract: S486
Type: Oral Presentation
Presentation during EHA21: On Saturday, June 11, 2016 from 17:00 - 17:15
Location: Hall A2
Background
Outcomes of elderly patients with acute promyelocytic leukemia (APL) have been reported as less effective than in younger patients because of lower compliance and higher mortality rate related to toxicity of the treatment. This fact has led to design the risk-adapted and age-adapted PETHEMA LPA2005 protocol, in which the anthracycline dose in second consolidation was reduced with respect to previous protocols.
Aims
This study aims at comparing elderly patients (age ≥ 60 years old) who were treated according to PETHEMA LPA2005 schedule and those who were included in the more intensive previous protocols (LP96&LP99 trials).
Methods
Elderly patients (age equal or greater than 60) who were reported to the multicenter PETHEMA APL registry, diagnosed with APL and demonstration of the t(15;17) or PML/RARA rearrangement were included in this study. They were excluded if they met any of the following criteria: 1) Eastern Cooperative Oncology Group (ECOG) performance status at presentation of more than three, 2) severe medical comorbidities limiting the administration of chemotherapy in opinion of the treating physician, 3) antecedents of primary malignancy or previous therapy with leukemogenic agents, and 4) protocol violation. Elderly patients who received treatment according to the risk and age-adapted protocol LPA2005 were compared to those included in LPA96&LPA99 protocols.
Results
From November 1996 to November 2014, 389 elderly patients were reported to PETHEMA APL registry and 268 (69%) were considered as eligible. Causes of ineligibility were secondary APL (19%), ECOG 4/unfit for intensive chemotherapy (11%), and protocol violation (1%). Median age of eligible patients was 67 years (range, 60-84), and the distribution of relapse-risk categories was low (29%), intermediate (50%), and high (21%). Two-hundred sixteen out of 268 eligible patients (81%) achieved complete remission and 52 (19%) died during induction treatment due to hemorrhage and infection, mainly. Leukemic resistance was not observed. Comparing patients according to protocol, no differences in biological and clinical characteristics at diagnosis were identified between the LPA96&99 and LPA2005 cohorts. The median follow-up of patients alive was 62 months (range 2-191). Patients treated with the less intense schedule (LPA2005 trial) had lower toxicity, with a lower duration of neutropenia and thrombocytopenia during the second consolidation and fewer days of hospitalization, resulting in reduced 5-year non-relapse mortality compared with the LPA96&99 trials (5% vs. 18%, P=0.02). At 5 years, patients treated according to LPA2005 protocol had higher overall survival (74% vs. 60%, P=0.02), and higher disease-free survival (87% vs. 69%, P=0.009) than patients who received LPA96&99 protocols. There were no differences in the cumulative incidence of relapse between the two groups (P=0.25).
Conclusion
Anthracycline dose reduction during consolidation for elderly patients with APL treated with the PETHEMA LPA2005 trial resulted in lower toxicity and non-relapse mortality, while maintaining a high antileukemic activity.
Session topic: Standard Treatment Results in AML
Keyword(s): Acute promyelocytic leukemia, ALL-trans retinoic acid (ATRA), Anthracycline, Elderly
Type: Oral Presentation
Presentation during EHA21: On Saturday, June 11, 2016 from 17:00 - 17:15
Location: Hall A2
Background
Outcomes of elderly patients with acute promyelocytic leukemia (APL) have been reported as less effective than in younger patients because of lower compliance and higher mortality rate related to toxicity of the treatment. This fact has led to design the risk-adapted and age-adapted PETHEMA LPA2005 protocol, in which the anthracycline dose in second consolidation was reduced with respect to previous protocols.
Aims
This study aims at comparing elderly patients (age ≥ 60 years old) who were treated according to PETHEMA LPA2005 schedule and those who were included in the more intensive previous protocols (LP96&LP99 trials).
Methods
Elderly patients (age equal or greater than 60) who were reported to the multicenter PETHEMA APL registry, diagnosed with APL and demonstration of the t(15;17) or PML/RARA rearrangement were included in this study. They were excluded if they met any of the following criteria: 1) Eastern Cooperative Oncology Group (ECOG) performance status at presentation of more than three, 2) severe medical comorbidities limiting the administration of chemotherapy in opinion of the treating physician, 3) antecedents of primary malignancy or previous therapy with leukemogenic agents, and 4) protocol violation. Elderly patients who received treatment according to the risk and age-adapted protocol LPA2005 were compared to those included in LPA96&LPA99 protocols.
Results
From November 1996 to November 2014, 389 elderly patients were reported to PETHEMA APL registry and 268 (69%) were considered as eligible. Causes of ineligibility were secondary APL (19%), ECOG 4/unfit for intensive chemotherapy (11%), and protocol violation (1%). Median age of eligible patients was 67 years (range, 60-84), and the distribution of relapse-risk categories was low (29%), intermediate (50%), and high (21%). Two-hundred sixteen out of 268 eligible patients (81%) achieved complete remission and 52 (19%) died during induction treatment due to hemorrhage and infection, mainly. Leukemic resistance was not observed. Comparing patients according to protocol, no differences in biological and clinical characteristics at diagnosis were identified between the LPA96&99 and LPA2005 cohorts. The median follow-up of patients alive was 62 months (range 2-191). Patients treated with the less intense schedule (LPA2005 trial) had lower toxicity, with a lower duration of neutropenia and thrombocytopenia during the second consolidation and fewer days of hospitalization, resulting in reduced 5-year non-relapse mortality compared with the LPA96&99 trials (5% vs. 18%, P=0.02). At 5 years, patients treated according to LPA2005 protocol had higher overall survival (74% vs. 60%, P=0.02), and higher disease-free survival (87% vs. 69%, P=0.009) than patients who received LPA96&99 protocols. There were no differences in the cumulative incidence of relapse between the two groups (P=0.25).
Conclusion
Anthracycline dose reduction during consolidation for elderly patients with APL treated with the PETHEMA LPA2005 trial resulted in lower toxicity and non-relapse mortality, while maintaining a high antileukemic activity.
Session topic: Standard Treatment Results in AML
Keyword(s): Acute promyelocytic leukemia, ALL-trans retinoic acid (ATRA), Anthracycline, Elderly
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