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While Idamycin use provides consistently favorable results, the differences with three randomized studies below are
only significant when noted by bold type |
Berman et al[1] |
Wiernik et al[2] |
Vogler et al[3] |
IDA arm |
DNR arm |
IDA arm |
DNR arm |
IDA arm |
DNR arm |
Evaluable pts |
60 |
60 |
97 |
111 |
105 |
113 |
Median age |
36 |
42 |
56 |
55 |
60 |
61 |
Induction regimen |
12 mg/m≤ IV qd x 3 and Ara-C,
25 mg/m≤ IV x 1 followed by
Ara-C, 200 mg/m≤ CI qd x 5 |
50 mg/m≤ qd x 3 and Ara-C,
25 mg/m≤ IV x 1 followed by
Ara-C, 200 mg/m≤ CI qd x 5 |
13 mg/m≤ IV bol qd x 3 and
Ara-C, 100 mg/m≤ CI qd x 7 |
45 mg/m≤ IV bol qd x 3 and
Ara-C, 100 mg/m≤ CI qd x 7 |
12 mg/m≤ IV qd x 3 and
Ara-C, 100 mg/m≤ CI qd x 7 |
45 mg/m≤ IV qd x 3 and
Ara-C, 100 mg/m≤ Cl qd x 7 |
Overall CR rate |
80% (P=.005) |
58% |
70% |
59% |
71% (P=.032) |
58% |
CR rate in pts < 50 |
83% |
58% |
88% (P=.035) |
70% |
86% |
75% |
CR rate in pts 51-60 |
71% |
58% |
71% |
65% |
71% |
45% |
CR rate in pts > 60 |
NA |
NA |
50% |
44% |
63% |
53% |
CR after one course (% of total CRs) |
75% (P=.01) |
49% |
55% |
38% |
77% |
78% |
Median time to CR (days) |
33 |
41 |
35 |
36 |
42 (P=.007) |
31 |
Median duration of response |
NA |
NA |
9.4 mo (P=.021) |
8.4 mo |
14.2 mo |
10.8 mo |
Overall survival (median) |
19.7 mo (P=.025) |
13.5 mo |
12.9 mo (P=.038) |
8.7 mo |
9.7 mo |
9.1 mo |
Median survival4 initial WBC <= 41.1 x 103/mm≥* |
19.9 mo |
15.3 mo |
12.1 mo |
10.7 mo |
11.3 mo |
11.3 mo |
Median survival4 initial WBC > 41.1 x 103/mm≥* |
14.1 mo |
10.6 mo |
11.3 mo |
6.7 mo |
9.8 mo |
7.0 mo |
Patients with resistant disease |
8 |
21 |
6 |
22 |
11 (P=.05) |
21 |
Early deaths |
4
(< 14 days and during aplasia) |
4
(< 14 days and during aplasia) |
21
(on induction) |
21
(on induction) |
18
(on induction) |
25
(on induction) |
Percent incidence adverse events during induction
(nonhematologic)** |
Nausea/Vomiting 94% |
Nausea/Vomiting 94% |
Nausea/Vomiting 82%/57% |
Nausea/Vomiting 82%/66% |
Nausea/Vomiting 82% |
Nausea/Vomiting 80% |
Mucositis 57% |
Mucositis 41% |
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Mucositis 50% |
Mucositis 55% |
Diarrhea 17% |
Diarrhea 25% |
Diarrhea 78% |
Diarrhea 78% |
Diarrhea 73% |
Diarrhea 69% |
Bilirubin> 2 g/dL 38% |
Bilirubin > 2 g/dL 27% |
Bilirubin 59% |
Bilirubin 45% |
Bilirubin 45% |
Bilirubin 47% |
|
Anorexia 63% |
Anorexia 71% |
|
SGOT > 50 U 57% |
SGOT > 50 U 57% |
|
SGOT 52% |
SGOT 39% |
|
Stomatitis 63% |
Stomatitis 63% |
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Transient increase liver enzymes and mild
transient hyperbilirubinemia 59% |
Transient rise in liver enzymes and mild
transient hyperbilirubinemia 45% |
> 10% decrease in LVEF*** 17% |
> 10% decrease in LVEF*** |
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> 10% decrease in LVEF*** 25% |
> 10% decrease in LVEF*** 31% |
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Abbreviations: IDA, idarubicin; DNR, daunorubicin; Ara-C, cytosine arabinoside; CI, continuous infusion; bol, bolus
; SGOT, serum glutamic oxaloacetic transaminase; LVEF, left ventricular ejection fraction.
*WBC counts were not obtained at baseline for all randomized patients. 41.1 x 103/mm≥ value determined by upper quartile of patient values.
**Myelosuppression, sometimes severe, occurred in the majority of patients in all three studies. For more information regarding
myelosuppression, please see full prescribing information in pocket.
***Twenty-nine patients achieving CR on Idamycin/Ara-C arm had preinduction and postconsolidation MUGA scans. Five of these patients
experienced >10% decreases in LVEF.
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