High-dose zidovudine (AZT) in patients with treated myelodysplastic syndromes (MDS), and relapsed or refractory AML: a preliminary report (Meeting abstract).

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High-dose zidovudine (AZT) in patients with treated myelodysplastic syndromes (MDS), and relapsed or refractory AML: a preliminary report (Meeting abstract).

Proc Annu Meet Am Assoc Cancer Res; 34:A1184 1993. Unique Identifier : AIDSLINE ICDB/93692157
Silverman LR; Roboz J; Demakos EP; Holland JF; Derald H. Ruttenberg Cancer Center, Dept. of Neoplastic Diseases,; Mount Sinai Sch. of Medicine, New York, NY 10029

Abstract: AZT, a chain terminator of DNA synthesis with myelosuppressive effects in patients (pts) with AIDS, can inhibit the growth and induce the differentiation of HL-60 leukemia cells in vitro (Proc AACR 30:53, 1989). In a feasibility study, AZT was administered po q 6 hr in divided doses rounded off to the nearest 100 mg, according to diagnosis and preset cohorts: 600 mg/m2/day (n=1); 900 (n=5); 1100 (n=3); 1300 (n=1); 1500 (n=3); 1700 (n=3). Doses were escalated in 3 pts. 8 of 9 evaluable pts diagnosed with MDS (1), transformed (tx) AML following MDS (2), tx biphenotypic leukemia following MDS (3), refractory AML (1) and relapsed biphenotypic AML (1) were studied. All pts had failed at least one prior treatment regimen (median 2). The median age was 63 yr (22-76); 5 were male and 5 had a PS 0-1. Responses occurred in 5; 1 CR (MDS); 2 PR (tx AML, biphenotypic AML); 2 improved (2 tx AML). Significant side effects included increased skin pigmentation (n=4), grade 4 leucopenia (1) or thrombocytopenia (3) and bone marrow hypoplasia (1). Marrow aplasia did not occur. Pharmacokinetic studies by HPLC demonstrated peak serum levels between 4.3-16.4 uM and GAZT peak levels between 8.6-48.8 uM. Peak levels (30-90) tended to increase within single pts as doses escalated. Absolute doses of AZT ranged from 1200 to 3600 mg/day up to 7x higher than the dose in AIDS. High-dose AZT was well tolerated and produced clinical responses, without bone marrow aplasia, in a heavily pretreated group of pts with advanced myelodysplasia.

Keywords: Adult Aged Female Human Leukemia, Myelocytic, Acute/*DRUG THERAPY/ETIOLOGY Male Middle Age Myelodysplastic Syndromes/COMPLICATIONS/*DRUG THERAPY Zidovudine/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS/ PHARMACOKINETICS ABSTRACT
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M9391190

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