Early phase II study of KRN8602 (MX2), a novel anthracycline derivative for acute leukemia

• Published in: Gan to kagaku ryoho Vol. 25; no. 14; p. 2243
• Main Authors: Takemoto, Y, Sampi, K, Kuraishi, Y, Toki, H, Tamura, K, Ogawa, M
• Format: Journal Article
• Language: Japanese
• Published: Japan 01-12-1998
• Subjects: Adult; Aged; Anorexia - chemically induced; Antibiotics, Antineoplastic - adverse effects; Antibiotics, Antineoplastic - therapeutic use; Carubicin - adverse effects; Carubicin - analogs & derivatives; Carubicin - therapeutic use; Drug Administration Schedule; Female; Humans; Leukemia, Myeloid, Acute - drug therapy; Male; Middle Aged; Nausea - chemically induced; Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy; Vomiting - chemically induced
• ISSN: 0385-0684

We performed an early phase II study of KRN8602, a new anthracycline derivative for refractory or relapsed acute leukemias. KRN8602 was given at a dose of 15 mg/m2 for 3 to 5 consecutive days, repeating every 3-4 weeks. Among 53 patients entered in the study, 51 were evaluable for safety, and 46 were evaluable for efficacy. The response rate at schedules of 3 and 4 consecutive days was 9.1% (1 PR/11), while that at a schedule of 5 consecutive days was 22.9% (3 CR + 5 PR/35). With the 5 consecutive day schedule, the response rates were 21.4% (1 CR + 2 PR/14) for acute myelogenous leukemia and 29.4% (2 CR + 3 PR/17) for acute lymphocytic leukemia, but no response was observed in 4 patients with blastic crisis of chronic myelogenous leukemia. Major toxicities were nausea/vomiting and anorexia, however, all these toxicities were clinically manageable. From these results it is concluded that KRN8602 is effective against acute leukemias, and the optimal dose is 15 mg/m2 for 5 consecutive days.