DECITABINE AS THE FIRST-LINE TREATMENT FOR ELDERLY PATIENTS WITH ACUTE MYELOID LEUKEMIA; A SINGLE CENTER EXPERIENCE IN KOREA
(Abstract release date: 05/21/15)
EHA Library. Lee J. 06/12/15; 102692; PB1653
Jungyeon Lee
Contributions
Contributions
Abstract
Abstract: PB1653
Type: Publication Only
Background
Decitabine, a DNA hypomethylating agent, was approved by the European Union for the treatment of elderly patients with acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy in 2012, but the role of decitabine for remission induction is still controversial. Recently, Korean Food and Drug Administration also approved decitabine as the first-line treatment for as same indication as of EU.
Aims
Through this study, we want to share our recent experience of decitabine for the treatment of elderly AML patients.
Methods
Among patients who were diagnosed with AML except acute promyelocytic leukemia from Jan. 2014 at Severance hospital in Korea, 16 patients treated with decitabine as the first-line therapy for remission induction were evaluated retrospectively. All patients were treated with at least one course of decitaibine at an initial dose of 20 mg/m2 intravenously daily for 5 days in 28-day cycles. Patients showing complete response (CR) or partial response (PR) could continue to decitabine therapy, and those showing no response (NR) or loss of response (LOR) could be considered treatment failure and received second-line treatment.
Results
The median age of total patients was 73.5 (range, 68-82) years, with 9 patients 65–74 years and 7 over 75 years. Cytogenetic risk assignment based on the National Comprehensive Cancer Network criteria was favorable in 3 patients (18.8%), normal karyotype or other intermediate-risk in 11 (68.8%), poor-risk in 1 (6.3%) and unknown in one. The median follow-up duration after diagnosis was 138 (range, 39-310) days. Median and mean number of cycle was 3 and 3.75 (range, 1-8), respectively, and 2 patients received total 8 cycles. Fifteen (93.8%) patients completed the second cycle, and 9 were evaluated for response. CR was achieved in 2 patients (22.2%) after the second cycle and in additional 2 patients after the fourth cycle, for an overall response rate (ORR) of 33.3%. LOR was shown in 2 patients. Eight patients discontinued decitabine treatment due to NR or LOS in 5 (62.5%) and side effects in 3 (37.5%). Grade 3-4 febrile neutropenia was developed in 7 (43.8%), grade 2-3 fatigues in 3 (18.8%), and grade 3-4 heart failure in 1 (6.25%). The estimated median overall survival (OS) was 302 (95% CI, 83.5-520.5) days. The pretreatment characteristics that differed significantly between responders and non-responders was age (p = 0.042) and serum ferritin level (p = 0.016). Age and serum ferritin level were younger and lower in responder than in non-responder.
Summary
In our experience, 5-day decitabine treatment has efficacy in elderly patients with AML considered unfit for conventional chemotherapy with 33.3% of CR rate and 10 months of median OS. Further study will be objected to discover good clinical determinants and biomarker to select patients who may drive greater benefit from decitabine.
Keyword(s): Acute myeloid leukemia, Decitabine, Elderly
Type: Publication Only
Background
Decitabine, a DNA hypomethylating agent, was approved by the European Union for the treatment of elderly patients with acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy in 2012, but the role of decitabine for remission induction is still controversial. Recently, Korean Food and Drug Administration also approved decitabine as the first-line treatment for as same indication as of EU.
Aims
Through this study, we want to share our recent experience of decitabine for the treatment of elderly AML patients.
Methods
Among patients who were diagnosed with AML except acute promyelocytic leukemia from Jan. 2014 at Severance hospital in Korea, 16 patients treated with decitabine as the first-line therapy for remission induction were evaluated retrospectively. All patients were treated with at least one course of decitaibine at an initial dose of 20 mg/m2 intravenously daily for 5 days in 28-day cycles. Patients showing complete response (CR) or partial response (PR) could continue to decitabine therapy, and those showing no response (NR) or loss of response (LOR) could be considered treatment failure and received second-line treatment.
Results
The median age of total patients was 73.5 (range, 68-82) years, with 9 patients 65–74 years and 7 over 75 years. Cytogenetic risk assignment based on the National Comprehensive Cancer Network criteria was favorable in 3 patients (18.8%), normal karyotype or other intermediate-risk in 11 (68.8%), poor-risk in 1 (6.3%) and unknown in one. The median follow-up duration after diagnosis was 138 (range, 39-310) days. Median and mean number of cycle was 3 and 3.75 (range, 1-8), respectively, and 2 patients received total 8 cycles. Fifteen (93.8%) patients completed the second cycle, and 9 were evaluated for response. CR was achieved in 2 patients (22.2%) after the second cycle and in additional 2 patients after the fourth cycle, for an overall response rate (ORR) of 33.3%. LOR was shown in 2 patients. Eight patients discontinued decitabine treatment due to NR or LOS in 5 (62.5%) and side effects in 3 (37.5%). Grade 3-4 febrile neutropenia was developed in 7 (43.8%), grade 2-3 fatigues in 3 (18.8%), and grade 3-4 heart failure in 1 (6.25%). The estimated median overall survival (OS) was 302 (95% CI, 83.5-520.5) days. The pretreatment characteristics that differed significantly between responders and non-responders was age (p = 0.042) and serum ferritin level (p = 0.016). Age and serum ferritin level were younger and lower in responder than in non-responder.
Summary
In our experience, 5-day decitabine treatment has efficacy in elderly patients with AML considered unfit for conventional chemotherapy with 33.3% of CR rate and 10 months of median OS. Further study will be objected to discover good clinical determinants and biomarker to select patients who may drive greater benefit from decitabine.
Keyword(s): Acute myeloid leukemia, Decitabine, Elderly
Abstract: PB1653
Type: Publication Only
Background
Decitabine, a DNA hypomethylating agent, was approved by the European Union for the treatment of elderly patients with acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy in 2012, but the role of decitabine for remission induction is still controversial. Recently, Korean Food and Drug Administration also approved decitabine as the first-line treatment for as same indication as of EU.
Aims
Through this study, we want to share our recent experience of decitabine for the treatment of elderly AML patients.
Methods
Among patients who were diagnosed with AML except acute promyelocytic leukemia from Jan. 2014 at Severance hospital in Korea, 16 patients treated with decitabine as the first-line therapy for remission induction were evaluated retrospectively. All patients were treated with at least one course of decitaibine at an initial dose of 20 mg/m2 intravenously daily for 5 days in 28-day cycles. Patients showing complete response (CR) or partial response (PR) could continue to decitabine therapy, and those showing no response (NR) or loss of response (LOR) could be considered treatment failure and received second-line treatment.
Results
The median age of total patients was 73.5 (range, 68-82) years, with 9 patients 65–74 years and 7 over 75 years. Cytogenetic risk assignment based on the National Comprehensive Cancer Network criteria was favorable in 3 patients (18.8%), normal karyotype or other intermediate-risk in 11 (68.8%), poor-risk in 1 (6.3%) and unknown in one. The median follow-up duration after diagnosis was 138 (range, 39-310) days. Median and mean number of cycle was 3 and 3.75 (range, 1-8), respectively, and 2 patients received total 8 cycles. Fifteen (93.8%) patients completed the second cycle, and 9 were evaluated for response. CR was achieved in 2 patients (22.2%) after the second cycle and in additional 2 patients after the fourth cycle, for an overall response rate (ORR) of 33.3%. LOR was shown in 2 patients. Eight patients discontinued decitabine treatment due to NR or LOS in 5 (62.5%) and side effects in 3 (37.5%). Grade 3-4 febrile neutropenia was developed in 7 (43.8%), grade 2-3 fatigues in 3 (18.8%), and grade 3-4 heart failure in 1 (6.25%). The estimated median overall survival (OS) was 302 (95% CI, 83.5-520.5) days. The pretreatment characteristics that differed significantly between responders and non-responders was age (p = 0.042) and serum ferritin level (p = 0.016). Age and serum ferritin level were younger and lower in responder than in non-responder.
Summary
In our experience, 5-day decitabine treatment has efficacy in elderly patients with AML considered unfit for conventional chemotherapy with 33.3% of CR rate and 10 months of median OS. Further study will be objected to discover good clinical determinants and biomarker to select patients who may drive greater benefit from decitabine.
Keyword(s): Acute myeloid leukemia, Decitabine, Elderly
Type: Publication Only
Background
Decitabine, a DNA hypomethylating agent, was approved by the European Union for the treatment of elderly patients with acute myeloid leukemia (AML) who are not candidates for standard induction chemotherapy in 2012, but the role of decitabine for remission induction is still controversial. Recently, Korean Food and Drug Administration also approved decitabine as the first-line treatment for as same indication as of EU.
Aims
Through this study, we want to share our recent experience of decitabine for the treatment of elderly AML patients.
Methods
Among patients who were diagnosed with AML except acute promyelocytic leukemia from Jan. 2014 at Severance hospital in Korea, 16 patients treated with decitabine as the first-line therapy for remission induction were evaluated retrospectively. All patients were treated with at least one course of decitaibine at an initial dose of 20 mg/m2 intravenously daily for 5 days in 28-day cycles. Patients showing complete response (CR) or partial response (PR) could continue to decitabine therapy, and those showing no response (NR) or loss of response (LOR) could be considered treatment failure and received second-line treatment.
Results
The median age of total patients was 73.5 (range, 68-82) years, with 9 patients 65–74 years and 7 over 75 years. Cytogenetic risk assignment based on the National Comprehensive Cancer Network criteria was favorable in 3 patients (18.8%), normal karyotype or other intermediate-risk in 11 (68.8%), poor-risk in 1 (6.3%) and unknown in one. The median follow-up duration after diagnosis was 138 (range, 39-310) days. Median and mean number of cycle was 3 and 3.75 (range, 1-8), respectively, and 2 patients received total 8 cycles. Fifteen (93.8%) patients completed the second cycle, and 9 were evaluated for response. CR was achieved in 2 patients (22.2%) after the second cycle and in additional 2 patients after the fourth cycle, for an overall response rate (ORR) of 33.3%. LOR was shown in 2 patients. Eight patients discontinued decitabine treatment due to NR or LOS in 5 (62.5%) and side effects in 3 (37.5%). Grade 3-4 febrile neutropenia was developed in 7 (43.8%), grade 2-3 fatigues in 3 (18.8%), and grade 3-4 heart failure in 1 (6.25%). The estimated median overall survival (OS) was 302 (95% CI, 83.5-520.5) days. The pretreatment characteristics that differed significantly between responders and non-responders was age (p = 0.042) and serum ferritin level (p = 0.016). Age and serum ferritin level were younger and lower in responder than in non-responder.
Summary
In our experience, 5-day decitabine treatment has efficacy in elderly patients with AML considered unfit for conventional chemotherapy with 33.3% of CR rate and 10 months of median OS. Further study will be objected to discover good clinical determinants and biomarker to select patients who may drive greater benefit from decitabine.
Keyword(s): Acute myeloid leukemia, Decitabine, Elderly
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