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Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy.
- Source :
-
Hematological oncology [Hematol Oncol] 2019 Oct; Vol. 37 (4), pp. 447-455. Date of Electronic Publication: 2019 Aug 20. - Publication Year :
- 2019
-
Abstract
- Despite widespread use of decitabine to treat acute myeloid leukaemia (AML), data on its effectiveness and safety in the real-world setting are scanty. Thus, to analyze the performance of decitabine in clinical practice, we pooled together patient-level data of three multicentric observational studies conducted since 2013 throughout Italy, including 306 elderly AML patients (median age 75 years), unfit for intensive chemotherapy, treated with first-line decitabine therapy at the registered schedule of 20 mg/m <superscript>2</superscript> /iv daily for 5 days every 4 weeks. Overall response rate (ORR), overall survival (OS) curves, and multivariate hazard ratios (HRs) of all-cause mortality were computed. Overall, 1940 cycles of therapy were administered (median, 5 cycles/patient). A total of 148 subjects were responders and, therefore, ORR was 48.4%. Seventy-one patients (23.2%) had complete remission, 32 (10.5%) had partial remission, and 45 (14.7%) had haematologic improvement. Median OS was 11.6 months for patients with favourable-intermediate cytogenetic risk and 7.9 months for those with adverse cytogenetic risk. Median relapse-free survival after CR was 10.9 months (95% confidence interval [CI]: 8.7-16.0). In multivariate analysis, mortality was higher in patients with adverse cytogenetic risk (HR=1.58; 95% CI: 1.13-2.21) and increased continuously with white blood cell (WBC) count (HR=1.12; 95% CI: 1.06-1.18). A total of 183 infectious adverse events occurred in 136 patients mainly (>90%) within the first five cycles of therapy. This pooled analysis of clinical care studies confirmed, outside of clinical trials, the effectiveness of decitabine as first-line therapy for AML in elderly patients unfit for intensive chemotherapy. An adverse cytogenetic profile and a higher WBC count at diagnosis were, in this real life setting, unfavourable predictors of survival.<br /> (© 2019 John Wiley & Sons, Ltd.)
- Subjects :
- Aged
Aged, 80 and over
Antimetabolites, Antineoplastic adverse effects
Antimetabolites, Antineoplastic therapeutic use
Cause of Death
Decitabine adverse effects
Disease Progression
Female
Humans
Infections etiology
Kaplan-Meier Estimate
Leukemia, Myeloid, Acute mortality
Male
Multicenter Studies as Topic statistics & numerical data
Observational Studies as Topic statistics & numerical data
Prognosis
Proportional Hazards Models
Risk Factors
Treatment Outcome
Decitabine therapeutic use
Leukemia, Myeloid, Acute drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1099-1069
- Volume :
- 37
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Hematological oncology
- Publication Type :
- Academic Journal
- Accession number :
- 31385337
- Full Text :
- https://doi.org/10.1002/hon.2663