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Idarubicin: a second-generation anthracycline.

S M Fields¹, J M Koeller

¹University of Texas Health Science Center, San Antonio 78284.

DICP : the Annals of Pharmacotherapy

|May 1, 1991

Summary

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Idarubicin hydrochloride combined with cytarabine demonstrated superior complete remission rates and overall survival in acute leukemia patients compared to daunorubicin. This led to FDA approval for treating acute myelogenous leukemia in adults.

Area of Science:

Oncology
Hematology
Pharmacology

Background:

Idarubicin hydrochloride showed in vitro activity against leukemia cell lines.
Phase I studies supported further clinical investigation in acute leukemia.

Purpose of the Study:

To evaluate the efficacy and safety of idarubicin hydrochloride in Phase II and III clinical trials for acute lymphocytic leukemia and acute nonlymphocytic leukemia.
To compare the combination of idarubicin and cytarabine with daunorubicin and cytarabine.

Main Methods:

Phase II and III clinical trials were conducted.
Comparative trials assessed idarubicin/cytarabine versus daunorubicin/cytarabine combinations.

Main Results:

The idarubicin/cytarabine combination achieved significantly higher complete remission rates and longer overall survival in two of three US-based Phase III studies.

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Idarubicin hydrochloride was approved by the FDA in 1990 for adult acute myelogenous leukemia treatment in combination therapy.

Recommended dosage: 12 mg/m2/day for three days via slow intravenous injection with cytarabine.

Conclusions:

Idarubicin/cytarabine is an effective combination therapy for acute myelogenous leukemia.
Idarubicin exhibits a potentially lower cardiotoxicity profile than daunorubicin in animal models.
Oral formulation and use in pediatric patients require further investigation.