|
TOP
|
|
vidaza(azacitidine)injection, powder, lyophilized, for suspe(三)
|
|
|
|
RA |
21 (21.2) |
18 (19.6) |
|
RARS |
6 (6.1) |
5 (5.4) |
|
RAEB |
38 (38.4) |
39 (42.4) |
|
RAEB-T |
16 (16.2) |
14 (15.2) |
|
CMMoL |
8 (8.1) |
7 (7.6) |
|
AML |
10 (10.1) |
9 (9.8) |
|
Transfusion product used in 3 months before study entry (n%) |
|
|
|
Any transfusion product |
70 (70.7) |
59 (64.1) |
|
Blood cells, packed human |
66 (66.7) |
55 (59.8) |
|
Platelets, human blood |
15 (15.2) |
12 (13.0) |
|
Hetastarch |
0(0.0) |
1(1.1) |
|
Plasma protein fraction |
1(1.0) |
0(0.0) |
|
Other |
2(2.0) |
2(2.2) |
Table 2. Response Criteria
|
|
RA |
RARS |
RAEB |
RAEB-T |
CMMoL |
Complete
Response
(CR), duration ≥ 4 weeks |
Marrow |
< 5% blasts |
Peripheral
Blood |
Normal CBC if abnormal at baseline
Absence of blasts in the peripheral circulation |
Partial
Response
(PR), duration ≥ 4 weeks |
Marrow |
No marrow requirements |
≥50% decrease in blasts
Improvement of marrow dyspoiesis |
Peripheral
Blood |
≥50% restoration in the deficit from normal levels of baseline white cells, hemoglobin and platelets if abnormal at baseline
No blasts in the peripheral circulation
For CMMoL, if WBC is elevated at baseline, a ≥ 75% reduction in the excess count over the upper limit of normal |
The overall response rate (CR +PR) of 15.7% in Vidaza-treated patients without AML (16.2%for all Vidaza randomized patients including AML) was statistically significantly higher than the response rate of 0% in the observation group (p<0.0001) (Table 3). The majority of patients who achieved either CR or PR had either 2 or 3 cell line abnormalities at baseline (79%; 11/14) and had elevated bone marrow blasts or were transfusion dependent at baseline. Patients responding to Vidaza had a decrease in bone marrow blasts percentage, or an increase in platelets, hemoglobin or WBC. Greater than 90% of the responders initially demonstrated these changes by the 5th treatment cycle. All patients who had been transfusion dependent became transfusion independent during PR or CR. The mean and median duration of clinical response of PR or better was estimated as 512 and 330 days, respectively; 75% of the responding patients were still in PR or better at completion of treatment. Response occurred in all MDS subtypes as well as in patients with adjudicated baseline diagnosis of AML.
Table 3. Response Rates
|
|
Vidaza
(N=89) |
Observation Before Crossover
(N=83) |
|
|
Response |
n(%) |
N(%) |
|
|
