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


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.
Fianchi
L
L
Istituto di Ematologia, Università Cattolica del Sacro Cuore, Roma, Italy. luana.fianchi@rm.unicatt.it
Pagano
L
L
Leoni
F
F
Storti
S
S
Voso
M T
MT
Valentini
C G
CG
Rutella
S
S
Scardocci
A
A
Caira
M
M
Gianfaldoni
G
G
Leone
G
G
D000368:Aged; D000617:Aminoglycosides / Q000008:administration & dosage / Q000009:adverse effects; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001855:Bone Marrow Diseases / Q000139:chemically induced; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D000079982:Gemtuzumab; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007239:Infections / Q000209:etiology; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D015479:Leukemia, Myelomonocytic, Acute / Q000188:drug therapy*; D008297:Male; D016609:Neoplasms, Second Primary / Q000188:drug therapy; D011379:Prognosis; D012074:Remission Induction; D012306:Risk
D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D003561:Cytarabine; D016179:Granulocyte Colony-Stimulating Factor; D000079982:Gemtuzumab