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Comparative Clinical Trials

Idarubicin

Comparative Clinical Trials In Adult AML

IDAMYCIN® v DAUNORUBICIN

Clinical Studies Show The Differences...
And With Idamycin Many Differences Are "Significant"

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%


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%


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***


> 10% decrease in LVEF*** 25%

> 10% decrease in LVEF*** 31%

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.

Idarubicin

BECAUSE IN AML, TIME IS OF THE ESSENCE

Please click here for full prescribing information.

IDAMYCIN®

FOR SIGNIFICANT ADVANTAGES - IDEAL FOR TODAY'S ENVIRONMENT

  • Significantly longer survival and significantly higher complete remission rates*
  • Consistently more CRs achieved after one course of therapy* — Fewer second courses of therapy
  • Significantly fewer patients with resistant disease — Less need for additional cytotoxic therapies
  • Comparable side-effects profile to daunorubicin — An important factor considering the implications for additional in- or out-patient supportive care
  • After Idamycin there are more options for postinduction therapy — Greater opportunity for potential increased survival

References:

  1. Berman E, Heller G, Santorsa J, et al. Results of a randomized trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia. Blood. 1991;77:1666-1674.
  2. Wiernik PH, Banks PLC, Case DC Jr, et al. Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood. 1992;79:313-319.
  3. Vogler WR, Velez-Garcia E, Weiner RS, et al. A phase III trial comparing idarubicin and daunorubicin in combination with cytarabine in acute myelogenous leukemia: a Southeastern Cancer Study Group study. J Clin Oncol. 1992;10:1103-1111.
  4. Data on file, Pharmacia Inc.

Pharmacia & Upjohn

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