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Idarubicin

Higher CR Rates — Longer Overall Survival

1994 - A review of three pivotal US trials

Studies

Total Dose of
IDA and Ara-C[4]

Trial design differences[4]

Response rates
after 1-2 cycles.[4]

Berman et al[1]

N=130

IDA 36 mg/m"
Ara-C 1000 mg/m"

  • Excluded pts > 60 yrs; median age, 36yrs; range (17-60) yrs
  • Excluded pts with preexisting myelodysplastic syndrome > 3 months
  • Maintenance randomized in 1st 50 pt only

Complete remission
(IDA v DNR): 80% v 58% (P=.005)
Overall survival-significant
improvement (P=.025)

Wiernick et al[2]

N=214

IDA 39 mg/m"
Ara-C 700 mg/m"

  • No upper limit; median age, 56 yrs; range (18-85 yrs); 39% > 60 yrs)
  • No maintenance

Complete response rates
(IDA v DNR); 70% v 59% (P=.08)
Pts < 60: 83% v 68% (P=.055)
Overall survival-significant
improvement (P=.038)

Vogler et al[3]

N=230

IDA 36 mg/m"
Ara-C 700 mg/m"

  • No upper age limits; median age, 60 yrs; range (15-80 yrs); (50% > 60 yrs)
  • Maintenance

Overall remission
(IDA v DNR); 71% v 58% (P=.03)
Pts < 60: 79% v 63% (P=.06)
Overall survival-no significant
difference between the arms

Less Resistant Disease

Signicantly fewer patients with persistent blasts on the IDAMYCIN arm in every study.

Blast Study

"[Idarubicin] is equivalent, if not superior, to [daunorubicin] in the induction of remisssions and possible prolongation of survival."[3]

Improved Survival in AML Subtype: APL

Responses in acute promyelocytic leukemia (APL) with IDAMYCIN in the regimen.


No. newly diagnosed APL pts

APL response with IDA

Avvista et al[5]

28

82% achieve CR

Berman et al.[6]

81

IDA/ARA-C use - a signigicant factor
for improved survival (P=.01)

"These data suggests that IDR/Ara-C offers improved survival for APL patients."[6]

An Equivalent Safety Profile

"Intravenous idarubicin in patients with newly diagnosed AML produces the same degree of nonhematologic toxicity as does daunorubicin, including the potential for cardiotoxicity at high total doses.[4]



WITH IMPROVED CR AND SURVIVAL RATES PLUS FEWER PERSISTENT BLASTS

IDAMYCIN provides patients options for postinduction therapy

"Nonetheless, even if the compound [idarubicin] represents only an incremental improvement, it give more patients the opportunity for more intensive postinduction therapy, such as bone marrow transplantation, or innovative approaches to eradicating minimal residual disease, such as the use of recombinant interleukin-2."[4]

References

  1. Berman, E, Heller G, Santors J el al. Results of a randomized trial comparing idarubicin and cytosine arabinoside with duanorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogeneous
  2. leukemia. Blood 1992;77(8):1666-1674.
  3. 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(2):313-319.
  4. 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(7):1103-1111.
  5. Berman E. A review of idarubicin in acute leukemia. Oncology 1993;7(10):91-107.
  6. Avvisati G, Petti MC, Spadea A et al Idarubicin (IDA) treatment in acute promyelocytic leukemia (APL) Haematologica 1991;76:10. Abstract.
  7. Berman E, Little C, Kher U. Prognostic analysis of patients with acute promyelocytic leukemia (APL) Blood 1991; 78 (suppl 1):43a. Abstract.
  8. Dutcher J. reviewer Oncology. 1993;7(10):91-107. Review of Berman E. A Review of Idarubicin in Acute Leukemia.

Pharmacia & Upjohn

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