Phase I and II clinical and pharmacological study of 4-demethoxydaunorubicin (idarubicin) in adult patients with acute leukemia Journal Article
| Authors: | Daghestani, A. N.; Arlin, Z. A.; Leyland-Jones, B.; Gee, T. S.; Kempin, S. J.; Mertelsmann, R.; Budman, D.; Schulman, P.; Baratz, R.; Williams, L.; Clarkson, B. D.; Young, C. W. |
| Article Title: | Phase I and II clinical and pharmacological study of 4-demethoxydaunorubicin (idarubicin) in adult patients with acute leukemia |
| Abstract: | Fifty-two adults treated previously with either acute leukemia (43 patients) or blastic-phase chronic myelogenous leukemia (nine patients) received 4-demethoxydaunorubicin (20 to 45 mg/ sq m) i.v. over 2 to 3 days. Three of the ten patients with acute lymphocytic leukemia achieved a complete remission (CR) lasting 5 to 7 weeks. Five of the 28 patients with acute nonlymphocytic leukemia achieved a CR lasting 5 to 80 weeks. All remissions were induced with one course of treatment with a median time to CR of 28 days (range, 22 to 40 days). None of the patients with blastic chronic myelogenous leukemia or secondary leukemia achieved a CR. The drug was well tolerated; mucositis (36%), nausea and vomiting (35%), and hepatic dysfunction (26%) were the most common side effects. Pharmacokinetic observations on five patients demonstrated multiphasic clearance of 4-demethoxydaunorubicin and extensive formation and prolonged retention of 4-demethoxy-13-hydroxydaunorubicin; that metabolite accumulated in plasma on repeated daily dosing. 4-Demethoxydaunorubicin has sufficient antileukemic activity in both acute lymphocytic leukemia and acute nonlymphocytic leukemia to warrant a prospective comparison, in combination regimens, against the conventional anthracyclines, daunorubicin and/or doxorubicin. © 1985, American Association for Cancer Research. All rights reserved. |
| Keywords: | adolescent; adult; cancer chemotherapy; clinical article; aged; middle aged; leukemia; antineoplastic agents; liver toxicity; phase 2 clinical trial; mucosa inflammation; nausea; vomiting; lymphatic system; gastrointestinal toxicity; liver; acute leukemia; kinetics; daunorubicin; drug clearance; liver disease; drug metabolism; drug blood level; phase 1 clinical trial; idarubicin; acute lymphocytic leukemia; lymphatic leukemia; drug therapy; adverse drug reaction; therapy; intravenous drug administration; pharmacokinetics; acute disease; drug evaluation; intoxication; acute nonlymphocytic leukemia; humans; human; male; female; priority journal; nonlymphatic leukemia; blood and hemopoietic system |
| Journal Title: | Cancer Research |
| Volume: | 45 |
| Issue: | 3 |
| ISSN: | 0008-5472 |
| Publisher: | American Association for Cancer Research |
| Date Published: | 1985-03-01 |
| Start Page: | 1408 |
| End Page: | 1412 |
| Language: | English |
| PUBMED: | 3855696 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 26 October 2021 -- Source: Scopus |
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