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All-trans retinoic acid for the treatment of newly diagnosed acute
promyelocytic leukemia. Japan Adult Leukemia Study Group [see comments]
A Kanamaru, Y Takemoto, M Tanimoto, H Murakami, N Asou, T Kobayashi, K Kuriyama, E Ohmoto, H Sakamaki and K Tsubaki
2nd Department of Internal Medicine, Hyogo College of Medicine, Japan.
We conducted a multicenter trial of treatment with all-trans retinoic acid
(ATRA) for newly diagnosed acute promyelocytic leukemia (APL) in the AML-92
study and compared it with our previous study with standard intensive
chemotherapy, the AML-89 study, in the view of complete remission (CR)
rate, incidence of early death, and event-free survival (EFS). Patients
were scheduled to receive oral ATRA 45 mg/m2 daily until CR. If patients
had leukocyte counts above 3 x 10(9)/L at the start of therapy, they
received daunorubicine (DNR) 40 mg/m2 for 3 days and behenoyl cytosine
arabinoside (BHAC) 200 mg/m2 for 5 days in addition to ATRA. During the
ATRA therapy, if patients showed myeloblast plus promyelocyte counts higher
than 1 x 10(9)/L in the peripheral blood, they received additional DNR and
BHAC in the same schedule, as well. A total of 110 patients were entered
into the study. Median age was 43 years (range, 16 to 74). Twenty-eight
(26%) of 109 patients (one died before the start of therapy) received ATRA
alone. Ninety-seven patients (89%) achieved CR; 48 of 49 (98%) aged less
than 40 years, 44 of 52 (84%) aged between 40 and 69, and 5 of 8 (63%) aged
above 70 achieved CR, respectively; 25 of 28 (89%) with ATRA alone, 46 of
51 (90%) with ATRA plus initial chemotherapy and 26 of 30 (87%) with ATRA
plus later chemotherapy attained CR, respectively. Nine (8%) patients died
within 28 days after the start of therapy. In contrast, 44 of 62 patients
(71%) attained CR, and 13 (21%) died within 28 days in the AML-89 study
with the combination of DNR, BHAC, 6-mercaptopurine and prednisolone. Seven
developed retinoic acid syndrome and one died of it in the present study.
Other toxicities associated with this drug included cheilitis,
desquamation, muscle pain, and hypertriglyceridemia. Predicted 23 months
EFS for all ATRA-treated patients and disease-free survival (DFS) in the CR
cases were 75% and 81%, respectively, in a median follow-up period of 21
months. Compared to the AML-89 study, there was a highly significant
difference in remission rate (P = .004), EFS (P = .0007), and also early
mortality rate (P = .02). Present results demonstrated that ATRA with or
without chemotherapy gives a statistical improvement in CR rate and early
mortality rate, as well as superior survival in newly diagnosed APL.
Volume 85,
Issue 5,
pp. 1202-1206,
03/01/1995
Copyright © 1995 by The American Society of Hematology
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