Abstract
Numerous studies have analysed the clinical efficacies of hypomethylating agents (HMAs) in patients with myelodysplastic syndromes (MDS). However, reports that compare the two HMAs, decitabine and azacitidine, in patients with lower-risk (low and intermediate-1) MDS are limited. We compared 5-day decitabine and 7-day azacitidine regimens in terms of treatment responses, survival outcomes, and adverse events in patients with lower-risk MDS with poor prognostic features. The overall response rates (ORRs) were 67.2% and 44.0% in the patients treated with decitabine and azacitidine, respectively (P = 0.014). While the median progression-free survival (PFS) was significantly better in the patients treated with decitabine than in those treated with azacitidine (P = 0.019), no significant differences in event-free and overall survival rates were observed between the two groups. Multivariate analysis revealed that compared with azacitidine treatment, decitabine treatment is significantly associated with a higher ORR (P = 0.026) and longer PFS (P = 0.037). No significant differences were observed in the incidence of grade 3 or higher haematologic adverse events in response to the two HMAs. In conclusion, in lower-risk MDS, especially with poor prognostic features, ORR and PFS were significantly better with 5-day decitabine treatment than with 7-day azacitidine treatment, with comparable safety.
Highlights
Numerous studies have analysed the clinical efficacies of hypomethylating agents (HMAs) in patients with myelodysplastic syndromes (MDS)
Count, red blood cells (RBCs)- and PLT-transfusion dependency, bone marrow (BM) blasts, cytogenetics, and risk groups based on the International Prognostic Scoring System (IPSS)-R and Lower Risk Prognostic Scoring System (LR-PSS), we found that treatment with decitabine (HR, 0.496; 95% CI, 0.257–0.957; P = 0.037) and achievement of complete remission (CR) (HR, 0.122; 95% CI, 0.015–0.993; P = 0.049) were significant prognostic factors for better survival, whereas absolute neutrophil count (ANC) below 0.8 × 109/L (HR, 1.905; 95% CI, 1.032–3.515; P = 0.039) was a significant poor prognostic factor
In our retrospective cohort analysis of lower-risk MDS patients with poor prognostic features, higher overall response rates (ORRs) and haematologic improvement (HI)-E rates were observed after treatment with a 5-day decitabine regimen (20 mg/m2 daily every 4 weeks) than after treatment with a 7-day azacitidine regimen (75 mg/m2 daily every 4 weeks) (ORR, 67.2% vs 44.0%; P = 0.014 and HI-E, 68.3% vs 44.2%; P = 0.014)
Summary
Numerous studies have analysed the clinical efficacies of hypomethylating agents (HMAs) in patients with myelodysplastic syndromes (MDS). A retrospective multicentre study conducted prognostic factor analysis that included the type of HMA; no significant association was found on treatment response and survival outcomes between decitabine and azacitidine[19] Another retrospective analysis found better survival outcomes in patients with lower-risk MDS treated with a 5-day decitabine regimen than in those treated with a 7-day azacitidine regimen, these results did not reach statistical significance[20]. A randomised phase 2 study demonstrated that low-dose decitabine therapy (20 mg/m2 daily for 3 days, intravenous [IV]) resulted in better response rates than low-dose azacitidine therapy (75 mg/m2 daily for 3 days, IV) in patients with lower-risk MDS, especially in those with a poor prognostic feature, i.e., ≥5% bone marrow (BM) blasts[21]. The hypothesis of this study is that 5 days of decitabine might have greater potential benefits in lower-risk patients with poor prognostic factors than 7 days of azacitidine
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
