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Idamycin

HISTORICAL PERSPECTIVE

Acute myelogenous leukemia (AML) is characterized by the proliferation and accumulation of malignant myeloblasts and other immature myeloid cells. Left untreated, this type of leukemia is rapidly fatal with a median survival of less than 2 months.[1]

In 1990, approximately 8000 new cases of AML were diagnosed in the United States, and treated according to current standard treatment. But the standard therapy still leaves very few patients with long-term disease-free survival.

Although far more dramatic therapeutic advances have been made in childhood acute leukemia there has been some progress through the years in the treatment of AML. The first agent that produced some remission in AML (about 15%) was 6-mercaptopurine. Until then, single agents such as methotrexate, adrenal corticosteroids, and vincristine, were usually ineffective.[2]

In the early 1960s researchers combined large doses of these four drugs (VAMP) resulting in a 20% to 40% remission rate. Drug toxicity though, was manifested mostly as severe and often fatal infection.

I he situation improved again with the introduction of cytosine arabinoside (Ara-C) in 1965. complete remission (CR) rate of Ara-C as a single agent was 14%, with a duration of remission of 11 months. This new agent was immediately used in several different combinations, although CR rates did not go above 40%.[4]

In the late 1960s, the anthracyclines Adriamycin® (doxorubicin HCI) and daunorubicin were introduced with exciting results in the treatment of AML. Daunorubicin as a single agent induced CRs in 55% of patients[4,5] and was shown to be the most active agent in the treatment of AML. Immediately included as combination therapy in different regimens, daunorubicin improved the outcome of AML.

In the early 1980s, the "7 & 3" combination of Ara-C (7-day infusion) and daunorubicin (3 days) achieved CRs of 70%, and 20% of patients had 5-year disease-free survival.[6]

Now, from the same laboratory where daunorubicin and Adriamycin were discovered, has come IDAMYCIN® (idarubicin HCI), a new potent analogue with even higher antileukemic activity. Under investigation for over a decade, this new anthracycline has been characterized pharmacologically by: higher potency than its parent in experimental tumors,[7] a presence of a metabolite as active as the parent drug,[8] and a lower cardiotoxicity than that of doxorubicin in mice and rabbits in equipotent doses.[9].

Pharmacologic superiority has been confirmed in a series of randomized U.S. clinical trials where IDAMYCIN arms demonstrated longer survival, higher complete remission rates, and longer durations of remission than daunorubicin arms. Improved efficacy with an acceptable safety profile makes the therapeutic index of IDAMYCIN clearly superior during induction, when compared to daunorubicin. DAMYCIN represents a significant advance in the treatment of AML; and, properly combined with other new techniques or agents, such as bone marrow transplantation or biological response modifiers, IDAMYCIN will make a critical contribution to the improvement of long-term disease-free survival in AML.

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