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Prepublished online as a Blood First Edition Paper on April 30, 2002; DOI 10.1182/blood-2001-12-0174.
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Blood, 1 June 2002, Vol. 99, No. 11, pp. 4222-4224
BRIEF REPORT
Experience with gemtuzumab ozogamycin ("mylotarg") and
all-trans retinoic acid in untreated acute
promyelocytic leukemia
Elihu H. Estey,
Francis J. Giles,
Miloslav Beran,
Susan O'Brien,
Sherry A. Pierce,
Stefan H. Faderl,
Jorge E. Cortes, and
Hagop M. Kantarjian
From the Department of Leukemia, The University of
Texas MD Anderson Cancer Center, Houston.
We administered gemtuzumab ozogamycin ("mylotarg"; 9 mg/m2 day 1 or 5) and all-trans retinoic acid
(ATRA) to 19 patients with untreated acute promyelocytic leukemia
(APL). There were 3 patients who also received idarubicin because of a
white blood cell (WBC) count of more than 30 000/µL. In complete
remission (CR), patients were to receive 8 courses of mylotarg
(9 mg/m2 every 4 to 5 weeks) and ATRA; idarubicin was added
only for persistent or recurrent polymerase chain reaction (PCR)
positivity. The CR rate was 16/19 (84%). All 12 patients tested to
date were PCR-negative 2 to 4 months from CR date; none of the 7 patients evaluated subsequently have reverted to PCR positivity (median
follow-up in CR was 5 months, up to 14 months). Mylotarg was well
tolerated. A median of 5 post-CR courses have been given to
date with 3 patients having currently received 8 post-CR courses,
and 4 patients receiving 7 post-CR courses. Mylotarg appears
active in APL, and repeated administration is feasible.

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