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Blood, Vol. 94 No. 7 (October 1), 1999:
pp. 2230-2235
Molecular Remissions Induced by Liposomal-Encapsulated All-Trans
Retinoic Acid in Newly Diagnosed Acute Promyelocytic Leukemia
Elihu H. Estey,
Francis J. Giles,
Hagop Kantarjian,
Susan O'Brien,
Jorge Cortes,
Emil J Freireich,
Gabriel Lopez-Berestein, and
Michael Keating
From the Departments of Leukemia and Biologic/Immunologic Therapy,
The University of Texas M.D. Anderson Cancer Center, Houston, TX.
All-trans retinoic acid administered orally (oral ATRA) may not
regularly lead to either molecular complete remissions (CRs) or
prolonged hematologic CRs (HCR) unless combined with
chemotherapy. Because serum tretinoin concentrations are higher, and
maintained longer, after use of liposomal-encapsulated ATRA (lipoATRA)
rather than oral ATRA, we investigated lipoATRA monotherapy in newly diagnosed acute promyelocytic leukemia (APL). Patients received lipoATRA 90 mg/m2 every other day for
remission induction. The same dose was given 3 times a
week until 9 months had elapsed from HCR date.
Treatment then stopped. Chemotherapy (idarubicin 12 mg/m2
daily days 1-2 for 2 courses) was to be added only if 2 polymerase chain reaction (PCR) tests, performed 2 weeks apart, were positive at
3, 6, or 9 months from HCR date. The sensitivity level of the PCR was
10 4. We treated 18 patients (median age,
54 years; median white blood cell [WBC] count 4,500/µL). The HCR
rate was 12/18 (67%, 95% confidence interval [CI], 41% to 87%).
This rate was similar to that we observed in a previous study using
oral ATRA + idarubicin. Nine of 10 patients studied at HCR date were
PCR-positive. Subsequently, however, overall (+/ idarubicin) rates
of PCR positivity were 0/12 at 3 months, 1/10 at 6 months, 1/7 at 9 and
12 months, and 0/4 at 15 to 17 months. Idarubicin has been added in 3 patients, with this addition occurring at 6 months in 2 patients and at
9 months in 1 patient. Among patients who had not received idarubicin
when the PCR was evaluated, 0 of 12 were PCR-positive at 3 months, 1 of
10 was positive at 6 months, 1 of 6 was positive at 9 months, 0 of 4 were positive at 12 months, and 0 of 3 were positive at 15 to 17 months. Morphologic APL has recurred in 1 patient, with a median
follow-up time of 13 months in the 11 patients remaining in first CR.
The median follow-up time is 91/2 months (range, 3 to 17) in the 9 patients who have received only lipoATRA and who remain PCR-negative
and in first CR. Our data suggest that lipoATRA is an effective means
of producing molecular CR in newly diagnosed APL.
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