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A comparative study of two different doses of cytarabine for acute myeloid
leukemia: a phase III trial of Cancer and Leukemia Group B
RO Dillman, RB Davis, MR Green, RB Weiss, AJ Gottlieb, S Caplan, S Kopel, H Preisler, OR McIntyre and C Schiffer
University of California San Diego School of Medicine.
Between 1982 and 1986, 326 evaluable patients with acute myeloid leukemia
(AML) were randomized to receive cytarabine (Ara-C) at 200 mg/m2 (A200) or
100 mg/m2 (A100) for induction and maintenance therapy. Cycle 1 of
induction therapy consisted of 7 days of continuous intravenous (IV) Ara-C
and 3 days of i.v. daunorubicin (DNR); cycle 2, if needed, consisted of 5
days of Ara-C and 2 days of DNR. Complete responders (CR) then received
monthly subcutaneous (SC) Ara-C at the respective doses (A100 or A200) with
6-thioquanine (6TG) at months 1 and 5, with vincristine (VCR) and
prednisone at months 2, 4, 6, and 8, and with DNR at months 3 and 7.
Complete response rates were 58% (A100) and 64% (A200) (P = .29). Median
survival was 46 weeks (A100) and 38 weeks (A200) (P = .64); 5-year survival
was 10% (A200) and 8% (A100). Median time to remission was 6.7 weeks (A200)
and 8.1 weeks (A100) (P = .18). Median disease-free survival was 41 weeks
(A200) and 44 weeks (A100) (P = .86). Deaths were attributed to
therapy-related toxicities in 21% (A200) and 13% (A100) (P = .05). The
5-year survival was 15% for patients with performance status (PS) 0, 8% for
PS 1 to 2, and 2% for PS 3 to 4, 18% for patients less than 40 years, 8%
for ages 40 to 59, and 3% for age 60 or greater. Stratification of data by
age and PS suggested that A200 may improve survival in patients less than
60 years with a good PS 0 (P = .05). This trial does not support the
superiority of A200 over A100 in the treatment of AML.
Volume 78,
Issue 10,
pp. 2520-2526,
11/15/1991
Copyright © 1991 by The American Society of Hematology
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