Contributions
Abstract: PB1741
Type: Publication Only
Background
Acute myeloid leukemia (AML) is a rare aggressive hematologic disease that occurs most often in the elderly and treatments for these patients are limited, particularly in those with poor performance status (PS) and comorbidities. Poor prognosis of elderly AML patients is due to several factors, including comorbidities, decreased organ function, poor performance status and a higher incidence of adverse karyotype. Although intensive chemotherapy can bring a high rate of complete remission (CR) in elderly AML patients, the toxicity and fatal side effects limit its extensive application in elderly unfit patients.
Recent updated on AML treatment recommendations include hypomethylating agents 5-azacytidine (AZA) and decitabine.
Aims
The aims of this study were the comparison the two hypomethylating agents and the evaluation of the overall survival (OS) of Azacitidine and Decitabine in patients with AML, not eligible for intensive chemotherapy.
Methods
A retrospective analysis was performed on 64 patients with AML, 39 treated with Azacitidine and 25 treated with Decitabine, followed at Padua University Hospital from April 2012 to February 2018. The diagnosis was made according to 2016 WHO criteria. Thirty-nine patients received s.c. 5-Azacitidine 75 mg/m2 for 7 days every 4 weeks until disease progression, and twenty-five patients received e.v. Decitabine 20 mg/m2 for 5 days every 4 weeks until disease progression.
Results
The median age at diagnosis was 70 years (range 49-83). Eighteen patients (46%) were considered at high, 19 (48%) intermediate and 2 (6%) low-cytogenetic risk in the AZA group, while twelve (80%) patients were considered at high, 3 (12%) intermediate and 2 (8%) low-cytogenetic risk in the Decitabine group. The complete remission was reached in 37% patients in AZA group, and in 30% in Decitabine group. The median OS for the AZA cohort was 10.7 months, while the median OS for the Decitabine cohort was 6.9 months, without any difference (p=0.9980). The median PFS for the AZA cohort was 4.4 months, while 11 months for Decitabine cohort, without any difference (p=0.2469). In univariate analysis, the variable associated with increased OS was adverse cytogenetic-risk (p=0.0367) in AZA cohort, not reaching in Decitabine cohort. No significant differences comparing the two treatments in patients with and without unfavorable cytogenetics-risk were found. Myelosuppression was the most common toxicity observed in decitabine treated patients. Infection-related complications occurred in 35 patients, 21 (54%) patients in azacitidine cohort and 18 (72%) patients in decitabine cohort. Pneumonia (62%) and sepsis (9%) were the most frequent infectious complications. These latters may occur during any cycle of therapy.
Conclusion
In conclusion, in our study there were no significant differences between azacitidine and decitabine. These agents are an effective and well-tolerated therapeutic alternative with acceptable side effects in elderly AML patients.
Session topic: 4. Acute myeloid leukemia - Clinical
Keyword(s): acute leukemia, Azacitidine, Decitabine
Abstract: PB1741
Type: Publication Only
Background
Acute myeloid leukemia (AML) is a rare aggressive hematologic disease that occurs most often in the elderly and treatments for these patients are limited, particularly in those with poor performance status (PS) and comorbidities. Poor prognosis of elderly AML patients is due to several factors, including comorbidities, decreased organ function, poor performance status and a higher incidence of adverse karyotype. Although intensive chemotherapy can bring a high rate of complete remission (CR) in elderly AML patients, the toxicity and fatal side effects limit its extensive application in elderly unfit patients.
Recent updated on AML treatment recommendations include hypomethylating agents 5-azacytidine (AZA) and decitabine.
Aims
The aims of this study were the comparison the two hypomethylating agents and the evaluation of the overall survival (OS) of Azacitidine and Decitabine in patients with AML, not eligible for intensive chemotherapy.
Methods
A retrospective analysis was performed on 64 patients with AML, 39 treated with Azacitidine and 25 treated with Decitabine, followed at Padua University Hospital from April 2012 to February 2018. The diagnosis was made according to 2016 WHO criteria. Thirty-nine patients received s.c. 5-Azacitidine 75 mg/m2 for 7 days every 4 weeks until disease progression, and twenty-five patients received e.v. Decitabine 20 mg/m2 for 5 days every 4 weeks until disease progression.
Results
The median age at diagnosis was 70 years (range 49-83). Eighteen patients (46%) were considered at high, 19 (48%) intermediate and 2 (6%) low-cytogenetic risk in the AZA group, while twelve (80%) patients were considered at high, 3 (12%) intermediate and 2 (8%) low-cytogenetic risk in the Decitabine group. The complete remission was reached in 37% patients in AZA group, and in 30% in Decitabine group. The median OS for the AZA cohort was 10.7 months, while the median OS for the Decitabine cohort was 6.9 months, without any difference (p=0.9980). The median PFS for the AZA cohort was 4.4 months, while 11 months for Decitabine cohort, without any difference (p=0.2469). In univariate analysis, the variable associated with increased OS was adverse cytogenetic-risk (p=0.0367) in AZA cohort, not reaching in Decitabine cohort. No significant differences comparing the two treatments in patients with and without unfavorable cytogenetics-risk were found. Myelosuppression was the most common toxicity observed in decitabine treated patients. Infection-related complications occurred in 35 patients, 21 (54%) patients in azacitidine cohort and 18 (72%) patients in decitabine cohort. Pneumonia (62%) and sepsis (9%) were the most frequent infectious complications. These latters may occur during any cycle of therapy.
Conclusion
In conclusion, in our study there were no significant differences between azacitidine and decitabine. These agents are an effective and well-tolerated therapeutic alternative with acceptable side effects in elderly AML patients.
Session topic: 4. Acute myeloid leukemia - Clinical
Keyword(s): acute leukemia, Azacitidine, Decitabine