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Blood, 1 January 2001, Vol. 97, No. 1, pp. 73-80
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Treatment of newly diagnosed and relapsed acute promyelocytic
leukemia with intravenous liposomal all-trans
retinoic acid
Dan Douer,
Elihu Estey,
Sergio Santillana,
John M. Bennett,
Gabriel Lopez-Bernstein,
Kristi Boehm, and
Tony Williams on
behalf of the ATRAGEN Study Group
From the Division of Hematology, University of Southern
California Medical School and Norris Cancer Center, Los Angeles, CA;
the University of Texas M.D. Anderson Cancer Center, Houston, TX;
Instituto de Enfermedades, Neoplásicas, Lima, Peru; the
University of Rochester School of Medicine, Rochester, NY; and Aronex
Pharmaceuticals, Inc, The Woodlands, TX.
A novel intravenous liposomal formulation of all-trans
retinoic acid (ATRA) was evaluated in 69 patients with acute
promyelocytic leukemia (APL): 32 new diagnoses, 35 relapses, and 2 oral
ATRA failures. Liposomal ATRA (90 mg/m2) was administered
every other day until complete remission (CR) or a maximum of
56 days. Treatment following CR was liposomal ATRA with or without
chemotherapy. In an intent-to-treat (ITT) analysis of all patients, CR
rates were 62%, 70%, and 20% in newly diagnosed, group 1 first
relapses (ATRA naive or off oral ATRA more than or equal to 1 year), or
group 2 relapses (second or subsequent relapse or first relapses off
oral ATRA less than 1 year), respectively. In 56 evaluable patients
(receiving 4 or more doses), CR rates for the same groups were 87% (20 of 23), 78% (14 of 18), and 23% (3 of 13). Remission failure in newly diagnosed patients was not from resistant disease. Several patients in
CR became polymerase chain reaction (PCR) negative for
promyelocytic leukemia/retinoic acid receptor-alpha
(PML/RAR ) after liposomal ATRA alone. Toxicity was generally
mild, most commonly headaches (67.5%). Eighteen patients (26%) had
ATRA syndrome develop during induction. One-year survival of ITT
patients was 62%, 56%, and 20% for newly diagnosed, group 1, and group 2, respectively. The medium duration of CR has not yet been
reached and was 18 and 5.5 months in the same groups. These results
demonstrate that liposomal ATRA is effective in inducing CR in
newly diagnosed or group 1 APL patients. It provides a reliable dosage
of ATRA for patients with APL unable to swallow or absorb
medications and can induce molecular remissions without chemotherapy.
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