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Journal of Clinical Oncology, Vol 19, Issue 13 (July), 2001: 3244-3254
© 2001 American Society for Clinical Oncology

Efficacy and Safety of Gemtuzumab Ozogamicin in Patients With CD33-Positive Acute Myeloid Leukemia in First Relapse

By Eric L. Sievers, Richard A. Larson, Edward A. Stadtmauer, Elihu Estey, Bob Löwenberg, Hervé Dombret, Chatchada Karanes, Matthias Theobald, John M. Bennett, Matthew L. Sherman, Mark S. Berger, Catharine B. Eten, Michael R. Loken, Jacques J.M. van Dongen, Irwin D. Bernstein, Frederick R. Appelbaum, for the Mylotarg Study Group

From the Clinical Research Division, Fred Hutchinson Cancer Research Center, Department of Pediatrics, University of Washington, and Hematologics Inc, Seattle WA; Department of Medicine, University of Chicago, Chicago, IL; Hematologic Malignancies Program, University of Pennsylvania Cancer Center, Philadelphia, PA; M.D. Anderson Cancer Center, Houston, TX; Department of Hematology, University Hospital Rotterdam, and Department of Immunology, Erasmus University Medical Center, Rotterdam, the Netherlands; Hospital Saint Louis, Paris, France; Karmanos Cancer Institute, Wayne State University, Detroit, MI; Department of Hematology, Johannes Gutenberg-University, Mainz, Germany; University of Rochester Medical Center, Rochester, NY; and Wyeth-Ayerst Research, Radnor, PA.

Address reprint requests to Eric L. Sievers, MD, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave North, D5-280, Seattle, WA 98109-1024; email: esievers{at}fhcrc.org

PURPOSE: Three open-label, multicenter trials were conducted to evaluate the efficacy and safety of single-agent Mylotarg (gemtuzumab ozogamicin; CMA-676; Wyeth Laboratories, Philadelphia, PA), an antibody-targeted chemotherapy agent, in patients with CD33-positive acute myeloid leukemia (AML) in untreated first relapse.

PATIENTS AND METHODS: The study population comprised 142 patients with AML in first relapse with no history of an antecedent hematologic disorder and a median age of 61 years. All patients received Mylotarg as a 2-hour intravenous infusion, at a dose of 9 mg/m2, at 2-week intervals for two doses. Patients were evaluated for remission, survival, and treatment-emergent adverse events.

RESULTS: Thirty percent of patients treated with Mylotarg obtained remission as characterized by 5% or less blasts in the marrow, recovery of neutrophils to at least 1,500/µL, and RBC and platelet transfusion independence. Although patients treated with Mylotarg had relatively high incidences of myelosuppression, grade 3 or 4 hyperbilirubinemia (23%), and elevated hepatic transaminase levels (17%), the incidences of grade 3 or 4 mucositis (4%) and infections (28%) were relatively low. There was a low incidence of severe nausea and vomiting (11%) and no treatment-related cardiotoxicity, cerebellar toxicity, or alopecia. Many patients received Mylotarg on an outpatient basis (38% and 41% of patients for the first and second doses, respectively). Among the 142 patients, the median total duration of hospitalization was 24 days; 16% of patients required 7 days of hospitalization or less.

CONCLUSION: Administration of the antibody-targeted chemotherapy agent Mylotarg to patients with CD33-positive AML in first relapse induces complete remissions with what appears to be a favorable safety profile.




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