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Final report of the efficacy and safety of gemtuzumab ozogamicin (Mylotarg) in patients with CD33‐positive acute myeloid leukemia in first recurrence
Author(s) -
Larson Richard A.,
Sievers Eric L.,
Stadtmauer Edward A.,
Löwenberg Bob,
Estey Elihu H.,
Dombret Hervé,
Theobald Matthias,
Voliotis Dimitris,
Bennett John M.,
Richie Maria,
Leopold Lance H.,
Berger Mark S.,
Sherman Matthew L.,
Loken Michael R.,
van Dongen Jacques J. M.,
Bernstein Irwin D.,
Appelbaum Frederick R.
Publication year - 2005
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.21326
Subject(s) - medicine , gemtuzumab ozogamicin , gastroenterology , neutropenia , surgery , hematopoietic stem cell transplantation , calicheamicin , myeloid leukemia , transplantation , chemotherapy , cd33 , stem cell , cd34 , genetics , biology
BACKGROUND In this study, the authors analyzed the efficacy and safety of gemtuzumab ozogamicin (GO) (Mylotarg®), an antibody‐targeted chemotherapy for CD33‐positive acute myeloid leukemia (AML). METHODS Patients with CD33‐positive AML in first recurrence were entered in 3 open‐label, single‐arm, Phase II studies. Patients received monotherapy with GO 9 mg/m 2 as a 2‐hour intravenous infusion in 2 doses separated by 2 weeks. Patients were evaluated for remission, survival, and treatment‐emergent adverse events. RESULTS Two hundred seventy‐seven patients (median age, 61 yrs) were treated with GO, and 71 patients (26%) achieved remission, which was defined as ≤ 5% blasts in the bone marrow without leukemic blasts in the peripheral blood, neutrophil recovery to ≥ 1500/μL, hemoglobin ≥ 9 g/dL, and independence from red blood cell and platelet transfusions. Complete remission (CR) with platelet recovery (≥ 100,000/μL) or without full platelet recovery (< 100,000/μL) (CRp) was observed in 35 patients (13%) and 36 patients (13%), respectively. The median recurrence‐free survival was 6.4 months for patients who achieved CR and 4.5 months for patients who achieved CRp. Although expected incidences of Grade 3 or 4 neutropenia (98%) and thrombocytopenia (99%) were observed, the incidence of Grade 3 or 4 sepsis (17%) and pneumonia (8%) was relatively low. Grade 3 or 4 hyperbilirubinemia and hepatic aspartate aminotransferase and alanine aminotransferase elevations were reported in 29%, 18%, and 9% of patients, respectively; 0.9% of patients who did not undergo prior or subsequent hematopoietic stem cell transplantation developed hepatic venoocclusive disease after GO treatment. CONCLUSIONS When it was administered to patients with CD33‐positive AML in first recurrence, single‐agent GO induced a 26% remission rate with a generally acceptable safety profile. Cancer 2005. © 2005 American Cancer Society.