Standard dose and prolonged administration of azacitidine are associated with improved efficacy in a real-world group of patients with myelodysplastic syndrome or low blast count acute myeloid leukemia

2015 ◽  
Vol 96 (4) ◽  
pp. 344-351 ◽  
Author(s):  
Maria Teresa Voso ◽  
Pasquale Niscola ◽  
Alfonso Piciocchi ◽  
Luana Fianchi ◽  
Luca Maurillo ◽  
...  
Leukemia ◽  
1997 ◽  
Vol 11 (2) ◽  
pp. 206-211 ◽  
Author(s):  
GCF Chan ◽  
WC Wang ◽  
SC Raimondi ◽  
FG Behm ◽  
RA Krance ◽  
...  

Haematologica ◽  
2019 ◽  
Vol 104 (8) ◽  
pp. 1565-1571 ◽  
Author(s):  
Marie Sébert ◽  
Aline Renneville ◽  
Cécile Bally ◽  
Pierre Peterlin ◽  
Odile Beyne-Rauzy ◽  
...  

2016 ◽  
Vol 23 (12) ◽  
pp. 3025-3034 ◽  
Author(s):  
Françoise Solly ◽  
Catherine Koering ◽  
Aminetou Mint Mohamed ◽  
Delphine Maucort-Boulch ◽  
Guillaume Robert ◽  
...  

2014 ◽  
Vol 32 (12) ◽  
pp. 1242-1248 ◽  
Author(s):  
Thomas Prebet ◽  
Zhuoxin Sun ◽  
Maria E. Figueroa ◽  
Rhett Ketterling ◽  
Ari Melnick ◽  
...  

Purpose Although azacitidine (AZA) improves survival in patients with high-risk myelodysplastic syndrome, the overall response remains approximately 50%. Entinostat is a histone deacetylase inhibitor that has been combined with AZA with significant clinical activity in a previous phase I dose finding study. Design Open label phase II randomized trial comparing AZA 50 mg/m2/d given for 10 days ± entinostat 4 mg/m2/d day 3 and day 10. All subtypes of myelodysplasia, chronic myelomonocytic leukemia, and acute myeloid leukemia with myelodysplasia-related changes were eligible for the study. The primary objective was the rate of hematologic normalization (HN; complete remission + partial remission + trilineage hematological improvement). Results One hundred forty-nine patients were analyzed, including 97 patients with myelodysplastic syndrome and 52 patients with acute myeloid leukemia. In the AZA group, 32% (95% CI, 22% to 44%) experienced HN and 27% (95% CI, 17% to 39%) in the AZA + entinostat group. Both arms exceeded the HN rate of historical control (Cancer and Leukemia Group B 9221 trial), but only the AZA group fulfilled the primary objective of the study. Rates of overall hematologic response were 46% and 44%, respectively. Median overall survivals were 18 months for the AZA group and 13 months for the AZA + entinostat group. The combination arm led to less demethylation compared with the monotherapy arm, suggesting pharmacodynamic antagonism. Conclusion Addition of entinostat to AZA did not increase clinical response as defined by the protocol and was associated with pharmacodynamic antagonism. However, the prolonged administration of AZA by itself seems to increase HN rate compared with standard dosing and warrants additional investigation.


2020 ◽  
pp. OP.20.00446
Author(s):  
Lee Mozessohn ◽  
Matthew C. Cheung ◽  
Nicole Mittmann ◽  
Craig C. Earle ◽  
Ning Liu ◽  
...  

PURPOSE: Azacitidine (AZA) is a standard of care for higher-risk myelodysplastic syndrome (MDS)/low blast–count acute myeloid leukemia (AML). Despite this, there is a paucity of data on the real-world health care resource utilization costs of AZA in this population. METHODS: We linked the Ontario AZA MDS registry—higher-risk MDS/low blast–count AML—to population-based health system administrative databases. Patients were observed for 24 months after first AZA and censored at the earliest of 90 days after last AZA, date of death, time of AML induction/stem-cell transplantation, or March 31, 2016. Costs (2015 Canadian dollars) were expressed as standardized mean and median 28-day costs. Univariable quantile regression was used to explore the association of baseline patient and disease characteristics and median cost. Multivariable quantile regression was used to explore predictors of median costs. RESULTS: Among 877 patients in the registry, mean standardized 28-day cost per patient was $17,638 (median, $15,272; interquartile range [IQR], $11,869-$19,580) and $13,450 (median, $11,043; IQR, $7,981-$14,882) excluding the cost of AZA. Major nondrug drivers of cost were cancer clinic visits and inpatient care (mean standardized 28-day cost, $4,631; median, $1,558; IQR, $238-$4,961). Transfusion dependence at AZA initiation ( P = .001) and greater comorbid disease burden ( P = .009) were independently associated with increased cost. CONCLUSION: Our cohort of patients with uniformly higher-risk MDS/low blast–count AML treated with AZA demonstrates substantial costs of care above and beyond the cost of AZA alone. These results provide insight into the costs of AZA in the real world with implications for resource allocation.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5574-5574
Author(s):  
Nicole Fulcher ◽  
Rahul A. Shenolikar ◽  
Emily Durden ◽  
Kathleen N. Moore

5574 Background: Limited real-world data are available on cancer patients withsecondary malignancies such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) caused by use of certain chemotherapeutic agents that interfere with DNA. This study assessedthe incidence of secondary MDS and AML in patients (pts) with ovarian cancer (OC) or breast cancer (BC), including subcohorts tested for BRCA mutations and those exposed to DNA damaging therapy. Methods: Adult females with OC or BC between 1/1/2000 and 6/30/2014 (first observed diagnosis of OC or BC = index date) were identified from the MarketScan Commercial and Medicare claims databases. Patients had ≥12 months of pre- and ≥1 month of post-index continuous health plan enrollment. The incidence of MDS and AML (per 1000 person-years [PY]) was assessed using ICD-9 codes over a variable-length post-index period for each cancer cohort and separately for pts with BRCA testing and those exposed to DNA damaging therapy. Results: The study identified 23,862 OC pts (mean [SD] follow-up: 35.8 [31.4] months), and 281,473 BC pts (mean [SD] follow-up: 46.0 [37.2] months). Among OC pts, 10.9% had BRCA testing (OC- BRCA) and 56.6% had exposure to DNA damaging therapy (OC-DNA); 12.9% of BC pts were BRCA tested (BC- BRCA) and 28.1% had exposure to DNA damaging therapy (BC-DNA). The incidence of MDS and AML expressed as cases per 1,000 PY in the OC cohort was 0.51 (0.2%) and 0.39 (0.1%); in OC- BRCA pts, 0.62 and 0.25; and in OC-DNA pts, 0.68 and 0.41. In the BC cohort, the incidence of MDS and AML was 0.33 (0.1%) and 0.19 (0.1%); in BC- BRCA pts, 0.07 and 0.15; and in BC-DNA pts, 0.60 and 0.50. Conclusions: In addition to providing background rates in OC and BC pts, these data suggest that the incidence of MDS and AML in OC and BC pts was higher in patient subcohorts exposed to DNA damaging agents than in the overall cohort.


2012 ◽  
Vol 54 (7) ◽  
pp. 1538-1540 ◽  
Author(s):  
Thomas Prebet ◽  
Aude Charbonnier ◽  
Véronique Gelsi-Boyer ◽  
Marie Joelle Mozziconacci ◽  
Didier Blaise ◽  
...  

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