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Annals of Oncology Advance Access originally published online on September 28, 2007
Annals of Oncology 2008 19(1):128-134; doi:10.1093/annonc/mdm451
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© 2007 European Society for Medical Oncology. For Permissions, please email: journals.permissions@oxfordjournals.org

hematologic malignancies

Gemtuzumab ozogamicin, citosine arabinoside, G-CSF combination (G-AraMy) in the treatment of elderly patients with poor-prognosis acute myeloid leukemia

L. Fianchi1,*, L. Pagano1, F. Leoni2, S. Storti3, M. T. Voso1, C. G. Valentini1, S. Rutella1, A. Scardocci1, M. Caira1, G. Gianfaldoni2 and G. Leone1

1 Istituto di Ematologia, Università Cattolica del Sacro Cuore, Roma
2 Dipartimento di Ematologia, Università di Firenze
3 Dipartimento di Ematologia, Università Cattolica S. Cuore, Campobasso, Italy

* Correspondence to: Dr. L. Fianchi, Istituto di Ematologia, Università Cattolica del Sacro Cuore, Largo Francesco Vito 1, I-00168 Roma, Italy. Tel: +39-063-0154180; Fax: +39-063-5503777; E-mail: luana.fianchi{at}rm.unicatt.it

Background: Gemtuzumab ozogamicin (GO) is effective as single agent in the treatment of acute myeloid leukemia (AML). We evaluated efficacy and safety of a chemotherapy including growth factors, cytarabine, and GO (G-AraMy) in the treatment of poor-prognosis AML in elderly patients.

Patients and methods: In three Italian hematology departments from September 2003 to September 2006, 53 elderly patients [median age 69 years (range 65–77)] with untreated or primary refractory/relapsed AML were enrolled on the combination G-AraMy administered according to two consecutive schedules (G-AraMy1 and G-AraMy2), with intensified consolidation in the second. Twenty-three of 53 patients had a secondary acute myeloid leukemia (sAML).

Results: The overall response rate was 57%. The most common adverse event was myelosuppression. Seven patients died in induction (13%). No differences for response rate and toxicity profile were observed between untreated and primary resistant/relapsed patients, de novo AML and sAML, and in the two treatment trials. Median disease-free survival and overall survival were 8 months (range 2–23+) and 9 months (range 2–24+).

Conclusions: G-AraMy therapy may be considered an useful treatment approach for poor-risk elderly AML patients, with a complete remission rate comparable to literature data with reduced side-effects, also in a poor-prognosis population.

Key words: Acute myeloid leukemia, elderly, gemtuzumab-ozogamicin

Received for publication July 16, 2007. Revision received August 9, 2007. Accepted for publication August 13, 2007.


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