Gemtuzumab ozogamicin (GO) in relapsed/refractory patients with acute myeloid leukemia.
OBJECTIVE
Gemtuzumab ozogamicin (GO) is a humanized anti-CD33 antibody, linked to calicheamicin, which has been approved in Japan recently. We conducted to evaluate the efficacy and toxicity of GO in our patients with relapsed or refractory AML retrospectively.


METHODS
Data were collected between March 1, 2000, and March 1, 2006, on 10 patients with relapsed or refractory AML(excluding FAB: M3). Scheduled treatment was two doses of GO monotherapy, 14-28 days apart.


RESULTS
Of the 10 assessable patients, two patients achieved CR. CR duration of one patient lasted for 52 months with post-remission treatment. Grade 4 neutropenia occurred in 9 patients, and the incidence of grade 3 or 4 thrombocytopenia was 100%, with no severe bleeding events. Two patients developed infusion-related adverse events that included grade 3 allergic reaction with shock status. Liver damage (grade 3 or 4) were observed in 40% of patients after GO treatment. No patient developed hepatic veno-occlusive disease including 2 patients who underwent HSCT.


CONCLUSIONS
GO is a valuable new treatment option for relapsed or refractory AML patients, however, the benefit from single agent appears insufficient. On going clinical trials including combination with other antileukemic agents might better define the role of GO.
Yamaguchi
Yuko
Y
Department of Oncology and Hematology, Jikei University School of Medicine, Komae-shi, Tokyo, Japan.
Usui
Noriko
N
Dobashi
Nobuaki
N
Yano
Shingo
S
Yahagi
Yuichi
Y
Takei
Yutaka
Y
Sugiyama
Katsunori
K
Ogasawara
Yoji
Y
Saito
Takeshi
T
Minami
Jiro
J
Kobayashi
Tatsunosuke
T
Katsube
Atsushi
A
Kamiyama
Yutaro
Y
Machishima
Tomohito
T
Morikawa
Noriyuki
N
Otsubo
Hiroko
H
Kaito
Ken
K
Asai
Osamu
O
Aiba
Keisuke
K
D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D056486:Chemical and Drug Induced Liver Injury; D005260:Female; D000079982:Gemtuzumab; D006801:Humans; D006967:Hypersensitivity / Q000209:etiology; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D012189:Retrospective Studies; D013921:Thrombocytopenia / Q000139:chemically induced
D000617:Aminoglycosides; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D000079982:Gemtuzumab