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Prepublished online as a Blood First Edition Paper on April 30, 2002; DOI 10.1182/blood-2001-12-0174.

Submitted December 5, 2001
Accepted January 17, 2002
Experience with gemtuzumab oxogamycin (mylotarg) + 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
Department of Leukemia, University of Texas M. D. Anderson Cancer Center, Houston, TX, USA
* Corresponding author; email: ehestey{at}mdanderson.org.
We administered gemtuzumab ozogamycin ("mylotarg", 9 mg/m2 day 1 or 5 ) and all-transretinoic acid (ATRA) to 19 patients with untreated acute promyelocytic leukemia (APL). 3 of the patients also received idarubicin because of a WBC >30,000/µl. In CR, patients were to receive 8 courses of mylotarg (9 mg/m2 every 4-5 weeks) and ATRA; idarubicin was added only for persistent or recurrent PCR positivity. The CR rate was 16/19 (84%). All 12 patients tested to date were PCR negative 2-4 months from CR date; none of the 7 patients evaluated subsequently have reverted to PCR positivity (median follow-up in CR 5 months, up to 14). Mylotarg was well-tolerated. A median of 5 post-CR courses have been given to date. Three patients having currently received 8 and four 7 post-CR courses. Mylotarg appears active in APL, and repeated administration is feasible.
ehestey@mdanderson.org

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