Abstract
Simple SummaryThis Italian real-life study conducted between 2013 and 2021 and including 199 acute myeloid leukemia (AML) patients demonstrates, after a median follow-up of almost 3 years, how decitabine administered to AML patients not suitable for intensive chemotherapy is effective and well tolerated, even in a population of truly elderly patients with frequent comorbidities.Decitabine, a DNA hypomethylating agent, was approved for use in adults with acute myeloid leukemia (AML) not eligible for standard chemotherapy and is now widely accepted as standard treatment. Although a number of clinical trials demonstrated its benefits in elderly AML patients, older adults and patients with frequent comorbidities are typically under-represented in such settings. Thus, the aim of the present study is to evaluate, in a real-world setting, the effectiveness and toxicity of decitabine administered as a single agent in unselected previously untreated elderly AML patients not eligible for intensive chemotherapy. In nine hematological departments of the Apulian Hematological Network (REP), we enrolled 199 patients (median age: 75.4 years; range: 61–91) with de novo (n = 94) or secondary/therapy-related (n = 105) AML treated with decitabine 20 mg/m2 for five days every 4 weeks. Hazard ratios (HR) and their 95% confidence intervals (CI) were estimated using multivariate Cox regression. The average number of cycles administered per patient was 6.3 (SD: 6.0; median: 5 cycles). Complete response was achieved by 31 patients (15.6%) and partial response by 57 (28.6%), for a total of 88 responders overall (44.2%). After a median follow-up of 33.6 months, median OS was 8.7 months (95% CI: 7.4–10.3), and the 6-month, 1-year, and 3-year OS rates were 62.7%, 37.0%, and 7.1%, respectively. Mortality was increased in AML patients with ≥3 comorbidities (HR = 2.45; 95% CI: 1.18–5.08) vs. no comorbidities and in those with adverse karyotype (HR = 1.58; 95% CI: 1.05–2.38) vs. favourable or intermediate profile. Infection was the main registered adverse event (46.0%). In conclusion, this REP real-life study demonstrates, after a follow-up of almost 3 years, how decitabine administered to AML patients not suitable for intensive chemotherapy is effective and well tolerated, even in a population of truly elderly patients with frequent comorbidities.
Highlights
According to the IARC GLOBOCAN, over 450,000 incident cases of leukemia are diagnosed worldwide, and over 300,000 patients die of this cancer every year [1]
The treatment of elderly acute myeloid leukemia (AML) patients or those unfit for intensive induction chemotherapy remains a challenge for hematologists, though the survival of these patients significantly improved with the advent of low-intensity therapeutic regimens, comprising hypomethylating agents such as decitabine or azacytidine
It is well known that older adults or those with comorbidities are underrepresented in clinical trials as compared with populations of AML patients seen daily in clinical practice
Summary
According to the IARC GLOBOCAN, over 450,000 incident cases of leukemia are diagnosed worldwide, and over 300,000 patients die of this cancer every year [1]. In patients aged 65 years or older, the 5-year relative survival rate in the USA is still only 12.5%, there has been a trend to improvements in survival over time [4]. The latter is, at least in part, explained by the more frequent decision to treat (older) AML patients [4], as well as by an increasing range of available treatment options. Treatment selection for older patients is challenging, and requires a comprehensive consideration of disease-specific characteristics, as well as full evaluations of comorbidities and functional status, which influence treatment tolerance and efficacy [5,6]
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