A prospective randomized trial of KRN8602 and cytosine arabinoside vs. daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia. The KRN8602 Leukemia Study Group.

Abstract

A prospective randomized study was conducted to compare the efficacy and toxicity of two anthracyclines for the treatment of patients with acute myelogenous leukemia (AML). Fifty-eight patients were randomized and received induction therapy consisting of cytosine arabinoside (AraC) 100 mg/m2/day for 7 days combined with either KRN8602 (3'-deamino-3'-morpholino-13-deoxo-10-hydroxycarminomycin hydrochloride [KRN]) 15 mg/m2/day for 5 days (KRN/AraC group) or daunorubicin (DNR) 40 mg/m2/day for 3 days (DNR/AraC group). Complete remission rate was 78.6% (22/28) in the KRN/AraC group and 73.1% (19/26) in the DNR/AraC group. There was a higher incidence of nausea/vomiting and anorexia observed in the KRN/AraC group compared to the DNR/AraC group, while the incidence of other adverse effects (stomatitis, diarrhea, and infectious complications) were similar between both groups. No electrocardiogram (ECG) abnormalities were observed after treatment in the KRN/AraC group, while in the DNR/AraC group, one patient showed ECG abnormality and three patients exhibited either arrhythmia, heart failure, or tachycardia. Mental disorder was reported in two cases in the KRN/AraC group. These findings suggest that KRN/AraC is similar in effectiveness to DNA/AraC but more toxic in central nervous system and gastrointestinal symptoms and less toxic regarding cardiac function in patients with previously untreated AML.

• Authors: Y Takemoto, K Sampi, Y Kuraishi, K Okabe, K Tamura, H Mizoguchi, H Saito, T Masaoka, M Ogawa
• Journal: International journal of hematology (Int J Hematol) Vol. 70 Issue 1 Pg. 20-5 (Jul 1999) ISSN: 0925-5710 [Print] Japan
• PMID: 10446490 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibiotics, Antineoplastic
• Cytarabine
• morpholinoanthracycline MX2
• Carubicin
• Daunorubicin

Topics

• Adolescent
• Adult
• Antibiotics, Antineoplastic (administration & dosage, adverse effects, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Carubicin (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Central Nervous System Diseases (chemically induced)
• Cytarabine (administration & dosage)
• Daunorubicin (administration & dosage)
• Drug Therapy, Combination
• Female
• Gastrointestinal Diseases (chemically induced)
• Humans
• Leukemia, Myeloid, Acute (drug therapy)
• Male
• Middle Aged
• Prospective Studies
• Treatment Outcome