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Blood, 1 October 2004, Vol. 104, No. 7, pp. 1995-1999. Prepublished online as a Blood First Edition Paper on June 8, 2004; DOI 10.1182/blood-2004-04-1550. This Article Full Text Full Text (PDF) All Versions of this Article: 2004-04-1550v1 104/7/1995    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Lo-Coco, F. Articles by Mandelli, F. Search for Related Content PubMed PubMed Citation Articles by Lo-Coco, F. Articles by Mandelli, F. Related Collections Neoplasia Oncogenes and Tumor Suppressors Gene Expression Clinical Trials and Observations Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS Gemtuzumab ozogamicin (Mylotarg) as a single agent for molecularly relapsed acute promyelocytic leukemia Francesco Lo-Coco, Giuseppe Cimino, Massimo Breccia, Nélida I. Noguera, Daniela Diverio, Erica Finolezzi, Enrico M. Pogliani, Eros Di Bona, Concetta Micalizzi, Mariagrazia Kropp, Adriano Venditti, Agostino Tafuri, and Franco Mandelli From the Dipartimento di Biopatologia e Diagnostica per Immagini, Università Tor Vergata, Rome, Italy; Dipartimento di Biotecnologie Cellulari ed Ematologia, Università "La Sapienza," Rome, Italy; Dipartimento di Medicina, Divisione di Ematologia, Università di Milano, Ospedale S. Gerardo, Milan, Italy; Dipartimento di Terapia Cellulare ed Ematologia, Divisione di Ematologia, Ospedale San Bortolo, Vicenza, Italy; Dipartimento di Ematologia ed Oncologia Pediatrica, Ospedale G. Gaslini, Genoa, Italy; and Ospedale Regionale, Catanzaro, Italy. The anti-CD33 antibody calicheamicinconjugate gemtuzumab ozogamicin (GO) was used to treat 16 patients with acute promyelocytic leukemia (APL) who had relapsed at the molecular level. Of these patients, 8 were experiencing a first, 5 a second, 2 a third, and 1 a fourth relapse. GO was administered at 6 mg/m2 for 2 doses, and patients achieving a new molecular remission (MR) (ie, negativity of the reverse transcriptase–polymerase chain reaction [RT-PCR] test for PML/RAR) received a third dose. MR was obtained in 9 (91%) of 11 patients tested after 2 doses and in 13 (100%) of 13 patients tested after the third dose. Of the 3 remaining patients, 1 achieved MR after one GO administration and received no further therapy owing to hepatic toxicity, and 2 showed disease progression during treatment. Quantitative RT-PCR studies showed that responding patients experienced a dramatic decline (at least 2 logs) of the PML/RAR transcript after the first GO dose. Of 14 responders, 7 remained in sustained MR for a median of 15 months (range, 7-31 months) while 7 experienced relapse at 3 to 15 months. GO was administered again in 2 patients with relapse, and both obtained a new MR. These data indicate that GO is highly effective as a single treatment for patients with molecularly relapsed APL including those with very advanced disease. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Related Article in Blood Online: Acute promyelocytic leukemia: a target for preemptive strike? Dan Douer Blood 2004 104: 1913-1914. 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