ACUTE MYELOID LEUKEMIA (AML) IN ELDERLY PATIENTS (≥70 YRS): SEMI-INTENSIVE INDUCTION AND CONSOLIDATION WITH MAINTENANCE TREATMENT (1-YR) IN OUTPATIENT BASIS
(Abstract release date: 05/19/16)
EHA Library. Vives Polo S. 06/09/16; 132471; E922
Dr. Susana Vives Polo
Contributions
Contributions
Abstract
Abstract: E922
Type: Eposter Presentation
Background
The results of AML treatment in patients’ ≥ 70 years are disappointing. Finding tolerable and efficacious treatments remains a major challenge. Intermediate dose cytarabine schedules in combination with other drugs allow treating patients in an outpatient basis.
Aims
The CETLAM04LAM70 semi-intensive protocol (Eur J Haematol. 2015;95:576-82) aimed to achieve a significant proportion of durable remissions in elderly (≥ 70 years) patients with AML based on reduction of the toxicity of full dose cytarabine. Despite this, toxicity and deaths in consolidation were of concern. In the current protocol (CETLAM11LAM70) intensive consolidations were substituted by 1 year of 5-azacitidine treatment. The aim of this study was to evaluate the tolerability and efficacy of the CETLAM11LAM70 protocol and to compare the outcomes with those from CETLAM04LAM70 protocol.
Methods
Eligible patients: 70 years of age or older with a newly diagnosed AML excluding t(15;17), biphenotypic leukemia with t(9;22) or blast crisis of chronic myeloid leukemia, ECOG 0-3 and able to attend weekly hospital visits at baseline. Treatment regimen: Induction-1 with FAG (fludarabine 25 mg/m2 PO days 2-5, cytarabine 100 mg/m2 SC days 2-8, filgrastim 300µg SC days 1-8), induction-2 or consolidation with IAG (idarubicin 20 mg/m2 PO days 2-4, cytarabine 100 mg/m2 SC days 2-8, filgrastim 300µg SC days 1-8) followed by 12 courses of AZA (5-azacitidine 75 mg/m2 SC days 1-5 every 28 days). The main differences with the CETLAM04LAM70 protocol were the cytarabine dose (200 mg/m2 vs. 100 mg/m2), the number induction/consolidation cycles and the 12 months maintenance.
Results
From January 2011 to June 2015, 44 patients were included (target 50 patients). Median age 74[70;87] years, 23 males (52%). AML characteristics: poor-risk cytogenetics 15 (34%), trilineage dysplasia 14/42 (33%), FLT3 ITD 6/33 (18%), mutation of NPM1 9/31 (29%). Outcomes: induction-related deaths 8 (18%), overall response to induction-1 26 (59%)(11/44 CR and 15/44 PR), consolidation-related deaths 3 (12%) and deaths during AZA treatment 2 (14%). Fourteen patients (32%) completed the scheduled treatment. The 1 and 2-yr (95%CI) OS, DFS and response duration are summarized in Table 1. Toxicities: Median duration of thrombocytopenia (<20x109/L) and neutropenia (<1x109/L) were 3 weeks (range 1-6) without differences between induction and consolidation. Fever in induction was observed in 30 patients (68%) and 34 (77%) were hospitalized; the median hospital stay was 15 days (1-45). Ten patients (23%) during induction and 8 (31%) during consolidation could be managed completely as outpatients. No toxicities grade > 2 were observed during azacitidine treatment. No differences in OS, CR duration and DFS were observed on comparison of the two protocols (Table 1).
Conclusion
The CETLAM11LAM70 protocol for elderly AML patients ≥ 70 years is tolerable, feasible and effective with reasonable response and induction mortality rates. Despite azaciditine was less toxic than previous consolidation strategies, the modification of the protocol did not help to improve OS. Supported: grants PI10/01417 and PI14/00450 from FIS, RD12/0036/0029 from Instituto Carlos III and 2014SGR225(GRE) from Generalitat de Catalunya, Spain.
Session topic: E-poster
Keyword(s): AML, Ara-C (cytarabine), Elderly, Maintenance
Type: Eposter Presentation
Background
The results of AML treatment in patients’ ≥ 70 years are disappointing. Finding tolerable and efficacious treatments remains a major challenge. Intermediate dose cytarabine schedules in combination with other drugs allow treating patients in an outpatient basis.
Aims
The CETLAM04LAM70 semi-intensive protocol (Eur J Haematol. 2015;95:576-82) aimed to achieve a significant proportion of durable remissions in elderly (≥ 70 years) patients with AML based on reduction of the toxicity of full dose cytarabine. Despite this, toxicity and deaths in consolidation were of concern. In the current protocol (CETLAM11LAM70) intensive consolidations were substituted by 1 year of 5-azacitidine treatment. The aim of this study was to evaluate the tolerability and efficacy of the CETLAM11LAM70 protocol and to compare the outcomes with those from CETLAM04LAM70 protocol.
Methods
Eligible patients: 70 years of age or older with a newly diagnosed AML excluding t(15;17), biphenotypic leukemia with t(9;22) or blast crisis of chronic myeloid leukemia, ECOG 0-3 and able to attend weekly hospital visits at baseline. Treatment regimen: Induction-1 with FAG (fludarabine 25 mg/m2 PO days 2-5, cytarabine 100 mg/m2 SC days 2-8, filgrastim 300µg SC days 1-8), induction-2 or consolidation with IAG (idarubicin 20 mg/m2 PO days 2-4, cytarabine 100 mg/m2 SC days 2-8, filgrastim 300µg SC days 1-8) followed by 12 courses of AZA (5-azacitidine 75 mg/m2 SC days 1-5 every 28 days). The main differences with the CETLAM04LAM70 protocol were the cytarabine dose (200 mg/m2 vs. 100 mg/m2), the number induction/consolidation cycles and the 12 months maintenance.
Results
From January 2011 to June 2015, 44 patients were included (target 50 patients). Median age 74[70;87] years, 23 males (52%). AML characteristics: poor-risk cytogenetics 15 (34%), trilineage dysplasia 14/42 (33%), FLT3 ITD 6/33 (18%), mutation of NPM1 9/31 (29%). Outcomes: induction-related deaths 8 (18%), overall response to induction-1 26 (59%)(11/44 CR and 15/44 PR), consolidation-related deaths 3 (12%) and deaths during AZA treatment 2 (14%). Fourteen patients (32%) completed the scheduled treatment. The 1 and 2-yr (95%CI) OS, DFS and response duration are summarized in Table 1. Toxicities: Median duration of thrombocytopenia (<20x109/L) and neutropenia (<1x109/L) were 3 weeks (range 1-6) without differences between induction and consolidation. Fever in induction was observed in 30 patients (68%) and 34 (77%) were hospitalized; the median hospital stay was 15 days (1-45). Ten patients (23%) during induction and 8 (31%) during consolidation could be managed completely as outpatients. No toxicities grade > 2 were observed during azacitidine treatment. No differences in OS, CR duration and DFS were observed on comparison of the two protocols (Table 1).
| CETLAM04LAM70 (%) | CETLAM11LAM70 (%) | |
| 1 yr OS (95%CI) | 30 (14-46) | 40 (25-55) |
| 2 yr OS (95%CI) | 23 (12-35) | 24 (10-38) |
| 1 yr response duration (95%CI) | 50 (23-77) | 67 (46-88) |
| 2 yr response duration (95%CI) | 41 (14-68) | 38 (13-63) |
| 1yr-DFS (95%CI) | 35 (12-58) | 43 (24-62) |
| 2yr-DFS (95%CI) | 29 (5-47) | 21 (5-37) |
Conclusion
The CETLAM11LAM70 protocol for elderly AML patients ≥ 70 years is tolerable, feasible and effective with reasonable response and induction mortality rates. Despite azaciditine was less toxic than previous consolidation strategies, the modification of the protocol did not help to improve OS. Supported: grants PI10/01417 and PI14/00450 from FIS, RD12/0036/0029 from Instituto Carlos III and 2014SGR225(GRE) from Generalitat de Catalunya, Spain.
Session topic: E-poster
Keyword(s): AML, Ara-C (cytarabine), Elderly, Maintenance
Abstract: E922
Type: Eposter Presentation
Background
The results of AML treatment in patients’ ≥ 70 years are disappointing. Finding tolerable and efficacious treatments remains a major challenge. Intermediate dose cytarabine schedules in combination with other drugs allow treating patients in an outpatient basis.
Aims
The CETLAM04LAM70 semi-intensive protocol (Eur J Haematol. 2015;95:576-82) aimed to achieve a significant proportion of durable remissions in elderly (≥ 70 years) patients with AML based on reduction of the toxicity of full dose cytarabine. Despite this, toxicity and deaths in consolidation were of concern. In the current protocol (CETLAM11LAM70) intensive consolidations were substituted by 1 year of 5-azacitidine treatment. The aim of this study was to evaluate the tolerability and efficacy of the CETLAM11LAM70 protocol and to compare the outcomes with those from CETLAM04LAM70 protocol.
Methods
Eligible patients: 70 years of age or older with a newly diagnosed AML excluding t(15;17), biphenotypic leukemia with t(9;22) or blast crisis of chronic myeloid leukemia, ECOG 0-3 and able to attend weekly hospital visits at baseline. Treatment regimen: Induction-1 with FAG (fludarabine 25 mg/m2 PO days 2-5, cytarabine 100 mg/m2 SC days 2-8, filgrastim 300µg SC days 1-8), induction-2 or consolidation with IAG (idarubicin 20 mg/m2 PO days 2-4, cytarabine 100 mg/m2 SC days 2-8, filgrastim 300µg SC days 1-8) followed by 12 courses of AZA (5-azacitidine 75 mg/m2 SC days 1-5 every 28 days). The main differences with the CETLAM04LAM70 protocol were the cytarabine dose (200 mg/m2 vs. 100 mg/m2), the number induction/consolidation cycles and the 12 months maintenance.
Results
From January 2011 to June 2015, 44 patients were included (target 50 patients). Median age 74[70;87] years, 23 males (52%). AML characteristics: poor-risk cytogenetics 15 (34%), trilineage dysplasia 14/42 (33%), FLT3 ITD 6/33 (18%), mutation of NPM1 9/31 (29%). Outcomes: induction-related deaths 8 (18%), overall response to induction-1 26 (59%)(11/44 CR and 15/44 PR), consolidation-related deaths 3 (12%) and deaths during AZA treatment 2 (14%). Fourteen patients (32%) completed the scheduled treatment. The 1 and 2-yr (95%CI) OS, DFS and response duration are summarized in Table 1. Toxicities: Median duration of thrombocytopenia (<20x109/L) and neutropenia (<1x109/L) were 3 weeks (range 1-6) without differences between induction and consolidation. Fever in induction was observed in 30 patients (68%) and 34 (77%) were hospitalized; the median hospital stay was 15 days (1-45). Ten patients (23%) during induction and 8 (31%) during consolidation could be managed completely as outpatients. No toxicities grade > 2 were observed during azacitidine treatment. No differences in OS, CR duration and DFS were observed on comparison of the two protocols (Table 1).
Conclusion
The CETLAM11LAM70 protocol for elderly AML patients ≥ 70 years is tolerable, feasible and effective with reasonable response and induction mortality rates. Despite azaciditine was less toxic than previous consolidation strategies, the modification of the protocol did not help to improve OS. Supported: grants PI10/01417 and PI14/00450 from FIS, RD12/0036/0029 from Instituto Carlos III and 2014SGR225(GRE) from Generalitat de Catalunya, Spain.
Session topic: E-poster
Keyword(s): AML, Ara-C (cytarabine), Elderly, Maintenance
Type: Eposter Presentation
Background
The results of AML treatment in patients’ ≥ 70 years are disappointing. Finding tolerable and efficacious treatments remains a major challenge. Intermediate dose cytarabine schedules in combination with other drugs allow treating patients in an outpatient basis.
Aims
The CETLAM04LAM70 semi-intensive protocol (Eur J Haematol. 2015;95:576-82) aimed to achieve a significant proportion of durable remissions in elderly (≥ 70 years) patients with AML based on reduction of the toxicity of full dose cytarabine. Despite this, toxicity and deaths in consolidation were of concern. In the current protocol (CETLAM11LAM70) intensive consolidations were substituted by 1 year of 5-azacitidine treatment. The aim of this study was to evaluate the tolerability and efficacy of the CETLAM11LAM70 protocol and to compare the outcomes with those from CETLAM04LAM70 protocol.
Methods
Eligible patients: 70 years of age or older with a newly diagnosed AML excluding t(15;17), biphenotypic leukemia with t(9;22) or blast crisis of chronic myeloid leukemia, ECOG 0-3 and able to attend weekly hospital visits at baseline. Treatment regimen: Induction-1 with FAG (fludarabine 25 mg/m2 PO days 2-5, cytarabine 100 mg/m2 SC days 2-8, filgrastim 300µg SC days 1-8), induction-2 or consolidation with IAG (idarubicin 20 mg/m2 PO days 2-4, cytarabine 100 mg/m2 SC days 2-8, filgrastim 300µg SC days 1-8) followed by 12 courses of AZA (5-azacitidine 75 mg/m2 SC days 1-5 every 28 days). The main differences with the CETLAM04LAM70 protocol were the cytarabine dose (200 mg/m2 vs. 100 mg/m2), the number induction/consolidation cycles and the 12 months maintenance.
Results
From January 2011 to June 2015, 44 patients were included (target 50 patients). Median age 74[70;87] years, 23 males (52%). AML characteristics: poor-risk cytogenetics 15 (34%), trilineage dysplasia 14/42 (33%), FLT3 ITD 6/33 (18%), mutation of NPM1 9/31 (29%). Outcomes: induction-related deaths 8 (18%), overall response to induction-1 26 (59%)(11/44 CR and 15/44 PR), consolidation-related deaths 3 (12%) and deaths during AZA treatment 2 (14%). Fourteen patients (32%) completed the scheduled treatment. The 1 and 2-yr (95%CI) OS, DFS and response duration are summarized in Table 1. Toxicities: Median duration of thrombocytopenia (<20x109/L) and neutropenia (<1x109/L) were 3 weeks (range 1-6) without differences between induction and consolidation. Fever in induction was observed in 30 patients (68%) and 34 (77%) were hospitalized; the median hospital stay was 15 days (1-45). Ten patients (23%) during induction and 8 (31%) during consolidation could be managed completely as outpatients. No toxicities grade > 2 were observed during azacitidine treatment. No differences in OS, CR duration and DFS were observed on comparison of the two protocols (Table 1).
| CETLAM04LAM70 (%) | CETLAM11LAM70 (%) | |
| 1 yr OS (95%CI) | 30 (14-46) | 40 (25-55) |
| 2 yr OS (95%CI) | 23 (12-35) | 24 (10-38) |
| 1 yr response duration (95%CI) | 50 (23-77) | 67 (46-88) |
| 2 yr response duration (95%CI) | 41 (14-68) | 38 (13-63) |
| 1yr-DFS (95%CI) | 35 (12-58) | 43 (24-62) |
| 2yr-DFS (95%CI) | 29 (5-47) | 21 (5-37) |
Conclusion
The CETLAM11LAM70 protocol for elderly AML patients ≥ 70 years is tolerable, feasible and effective with reasonable response and induction mortality rates. Despite azaciditine was less toxic than previous consolidation strategies, the modification of the protocol did not help to improve OS. Supported: grants PI10/01417 and PI14/00450 from FIS, RD12/0036/0029 from Instituto Carlos III and 2014SGR225(GRE) from Generalitat de Catalunya, Spain.
Session topic: E-poster
Keyword(s): AML, Ara-C (cytarabine), Elderly, Maintenance
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