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Drugs such as doxorubicin and daunorubicin play an important role in the treatment of leukemia and other cancers. However, these drugs, members of the anthracycline class, can cause particularly serious toxic effects, the most notable being serious damage to the heart muscle. Due to the high risk of heart failure, these drugs are not suitable for use in patients who have experienced a relapse of cancer. Similarly, these drugs may not be appropriate for patients suffering heart problems from other causes. A study was conducted to determine if the anticancer drug amsacrine might be safe and effective for use in patients for whom further anthracycline treatment is not appropriate. A total of 305 patients who had previously been treated for acute leukemia were evaluated. These patients had either relapsed after treatment or failed to respond to initial therapy. Among the 305 patients, 24 patients were found to have reduced left ventricular ejection fraction (LVEF). Reduced LVEF indicates that a smaller than normal amount of blood is being expelled from the heart with each beat; this measurement is a physiological indicator that the heart muscle is not functioning normally. These 24 patients were treated with amsacrine and high-dose cytosine arabinoside (cytarabine). Nine of the 24 patients achieved a complete remission. The treatment caused a significant reduction in LVEF in only two patients. In seven patients, the LVEF actually increased. Six additional patients were treated with the amsacrine and cytarabine protocol; these patients had not been treated previously. They suffered from heart conditions that prevented the use of the standard protocol. Four of the six patients experienced complete remissions. The results of this study indicate that amsacrine is safe and effective in the treatment of patients with acute leukemia and heart disease. (Consumer Summary produced by Reliance Medical Information, Inc.)

Thirty-six patients with relapsed acute lymphoblastic leukemia (ALL) and four with primary refractory ALL were treated with a regimen that included amsacrine, 200 mg/ m2, intravenously daily for three days with cytarabine, 3 gm/m2, by infusion over three hours daily for five days. There were 27 remissions in the 36 relapsed patients and two in the four patients with primary refractory disease. Seventeen of the 23 patients with common ALL, four of the six with T-cell ALL, one of the three with B-cell ALL, and seven of eight whose cells were not characterized responded. Toxicity of this regimen was comparable to other reinduction regimens for ALL, but the side effects characteristic of high-dose cytarabine therapy were absent. Since these results compare favorably with conventional induction regimens, its use in the primary treatment of adults and children with high-risk ALL is proposed.