Page 128 - Haematologica March 2020

M. Hoeks et al.
International Working Group (IWG) criteria.24 Ferritin responses were defined as a decrease of ≥1000 mg/L or a drop of the serum ferritin value below 1000 mg/L.
All analyses were undertaken in Stata 15 (StataCorp, College Station, TX, USA).
Results
Patient population
Data were extracted from the EUMDS registry on July 5th 2017, 2,200 patients, diagnosed between December 3rd
Table 1. Baseline characteristics of non-chelated and chelated patients at the check-up prior to reaching the eligibility criteria and estimates of overall survival.
Non-chelated Chelated Deferasirox Deferoxamine Deferiprone
Total 490 199 150 36 13
N.ofcountrieswithchelatedpatients 17/17 17/17 14/17 9/17 6/17
Meanageateligible(SD)
Time from diagnosis (months)
Inclusion,median(p10-p90) Inclusion,mean(SD) Chelationmedian(p10-p90) Chelationmean(SD)
Number of units transfused Median(range) Medianatstartofchelation(range)
Ferritin (μg/L) Median (p10-p90)
Median at start of chelation (p10-p90)
Comorbidity (MDSCI) Low risk Intermediate risk High risk
Performance status
Unable to care for self
Unable to work
Able to work and normal activity
Prognostic indicator (IPSS-R)
Reaching criteria (LOCF***)
Very low Low Intermediate High
Very high
76 (10)
7 (0-35) 14 (16)
NA
NA
4.0 (1.0–33.0) NA
547.0 (116.0 – 1384.0) NA
308 63.2% 149 30.6% 30 6.2%
8 2.0% 132 32.3% 269 65.8%
48 13.4% 199 55.6% 111 31.0%
38 10.6%
3 0.8% NA
312 63.7%
178 36.3%
460 93.9% 30 6.1%
467 95.3%
23 4.7% 1
1
70 (9)
8 (0-32) 13 (15)
17 (4-46) 21 (17)
2.0 (0.0–28.0) 13.0 (2.0–91.0)
675.0 (256.0 – 1573.0)
1221.0
(475.8 – 3000.0)
150 75.8% 43 21.7% 5 2.5%
1 0.6% 36 20.2% 141 79.2%
22 13.5% 95 58.3% 46 28.2% 9 5.5%
1 0.6% 13 (3-41)
115 57.8%
84 42.2%
184 92.5% 15 7.5%
179 89.9%
20 10.1% 0.57 (0.45 – 0.73)
0.50 (0.34–0.74)
70 (9)
9 (0-36) 14 (16)
17 (4-47) 21 (18)
2.5 (0.0–28.0) 12.0 (2.0–75.0)
683.0 (264.0 – 1600.0) 1210.0
(449.3 – 2832.0)
118 79.2% 28 18.8% 3 2.0%
1 0.8% 21 15.9% 110 83.3%
18 14.6% 66 53.7% 39 31.7% 6 4.9%
1 0.8% 14 (3-41)
85 56.7%
65 43.3%
136 90.7% 14 9.3%
136 90.7%
14 9.3% 1
1
72 (9)
6 (0-30)
9 (11)
13 (2-39) 17 (13)
3.0 (0.0–18.0) 10.5 (2.0–75.0)
682.0 (256.0 – 1920.0) 1173.0
(335.0 – 3000.0)
23 63.9% 11 30.6% 2 5.6%
0 0.0% 12 34.3% 23 65.7%
2 6.9% 21 72.4% 6 20.7% 3 10.3% 0 0.0%
9 (1-34)
22 61.1%
14 38.9%
36 100.0% 0 0.0%
33 91.7%
3 8.3% (1.18 – 3.35)
70 (10)
7 (0-33) 12 (13)
22 (5-51) 26 (18)
2.0 (0.0–8.0) 24.5 (2.0–91.0)
525.0 (190.5 – 918.1) 2202.0 (475.8 – 4900.0)
9 69.2% 4 30.8% 0 0.0%
0 0.0% 3 27.3% 8 72.7%
2 18.2% 8 72.7% 1 9.1% 0 0.0% 0 0.0%
13 (2-30)
8 61.5%
5 38.5%
12 92.3% 1 7.7%
10 76.9%
3 23.1% (0.10 – 1.71)
Duration of treatment with chelation (months) Median(p10-p90)
Ever received ESA
No
Yes
Ever received hypomethylating No
Yes
Ever received lenalidomide
No
Yes
Overall Survival (OS)* Unadjusted Adjusted**
1.99
0.42
2.46(1.12–5.41)
0.30 (0.02–3.58)
*Hazard Ratios (HR) and 95% Confidence Intervals (CI) were estimated using receipt of chelation as a time-varying co-variate. ** Adjusted by age at eligibility, sex, comorbidity, Performance Status,number of units transfused,Revised-International Prognostic Scoring System (IPSS-R),and ringed sideroblasts present.***LOCF:last observation carried for- ward (only for cytogenetics and bone marrow blasts); SD: Standard Deviation; RBCT: red blood cell transfusion; MDSCI: Myelodysplastic Syndrome Specific Comorbidity Index; ESA: erythropoiesis stimulating agents; NA: not applicable.
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haematologica | 2020; 105(3)