Gemtuzumab ozogamicin in combination with attenuated doses of standard induction chemotherapy can successfully induce complete remission without increasing toxicity in patients with acute myeloid leukemia aged 55 or older.
BACKGROUND
In this study, the effectiveness and safety of combining gemtuzumab ozogamicin (GO) with an abbreviated schedule of standard induction chemotherapy were assessed in 37 patients (aged > or =55) yr with previously untreated acute myeloid leukemia (AML).


METHODS
GO was administered at a dose of 6 mg/m(2) as a single 2-h intravenous infusion on day 1. Following GO, an abbreviated schedule of induction chemotherapy consisting of idarubicin (12 mg/m(2)/d, days 2-4), and N4-behenoyl-1-beta-arabinofuranosyl cytosine (300 mg/m(2)/d, days 2-6) was given.


RESULTS
Thirty-seven patients were treated with GO in combination with chemotherapy. Complete remission (CR) and CR with incomplete platelet recovery were achieved in 28 patients (75.7%) and one patient (2.7%) respectively. Two patients (5.4%) died during induction and two patients (5.4%) with grade 4 treatment emergent adverse effects during chemotherapy did not complete induction chemotherapy. The majority of toxicities were mild and manageable. Severe myelosuppression was universal with significantly prolonged thrombocytopenic period. In total, 25 patients who received consolidation treatment, 19 patients remain alive at the time of analysis. Thirteen patients had undergone hematopoietic stem cell transplantation, three are preparing for transplantation and seven are receiving their consolidation chemotherapy course.


CONCLUSIONS
Although only a relatively small number of cases were included in this preliminary study and the follow-up duration was short, frontline GO in combination with attenuated conventional chemotherapy was found to be effective and feasible in elderly patients with AML.
Eom
Ki-Seong
KS
Catholic Hematopoietic Stem Cell Transplantation Center, St Mary's Hospital, The Catholic University of Korea, Seoul, Korea. dreom@catholic.ac.kr
Kim
Hee-Je
HJ
Min
Woo-Sung
WS
Lee
Seok
S
Min
Chang-Ki
CK
Cho
Byung-Sik
BS
Kim
Sung-Yong
SY
Kim
Yoo-Jin
YJ
Lee
Dong-Gun
DG
Choi
Su-Mi
SM
Cho
Seok-Goo
SG
Kim
Dong-Wook
DW
Lee
Jong-Wook
JW
Shin
Wan-Shik
WS
Kim
Chun-Choo
CC
D000368:Aged; D000617:Aminoglycosides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012074:Remission Induction / Q000379:methods; D016896:Treatment Outcome
D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000079982:Gemtuzumab