Antibody-targeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg (gemtuzumab ozogamicin).

Abstract

We analyzed the safety and efficacy of Mylotarg (gemtuzumab ozogamicin, an antibody-targeted chemotherapy consisting of a humanized anti-CD33 antibody linked to calicheamicin, a potent antitumor antibiotic) in the treatment of 101 patients > or =60 years of age with acute myeloid leukemia (AML) in untreated first relapse in three open-label trials. Mylotarg is administered as a 2-h intravenous infusion at 9 mg/m(2) for two doses with 14 days between doses. The overall remission rate was 28%, with complete remission (CR) in 13% of patients and complete remission with incomplete platelet recovery (CRp) in 15%. Median survival was 5.4 months for all patients and 14.5 months and 11.8 months for patients achieving CR and CRp, respectively. CD33 antigen is present on normal hematopoietic progenitor cells; thus, an expected high incidence of grade 3 or 4 neutropenia (99%) and thrombocytopenia (99%) was observed. The incidences of grade 3 or 4 elevations of bilirubin and hepatic transaminases were 24% and 15%, respectively. There was a low incidence of grade 3 or 4 mucositis (4%) and infections (27%) and no treatment-related cardiotoxicity, cerebellar toxicity, or alopecia. Mylotarg is an effective treatment for older patients with CD33-positive AML in first relapse and has acceptable toxicity.

• Authors: R A Larson, M Boogaerts, E Estey, C Karanes, E A Stadtmauer, E L Sievers, P Mineur, J M Bennett, M S Berger, C B Eten, M Munteanu, M R Loken, J J M Van Dongen, I D Bernstein, F R Appelbaum, Mylotarg Study Group
• Journal: Leukemia (Leukemia) Vol. 16 Issue 9 Pg. 1627-36 (Sep 2002) ISSN: 0887-6924 [Print] England
• PMID: 12200674 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Aminoglycosides
• Anti-Bacterial Agents
• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antigens, CD
• Antigens, Differentiation, Myelomonocytic
• CD33 protein, human
• Immunotoxins
• Sialic Acid Binding Ig-like Lectin 3
• Gemtuzumab

Topics

• Acute Disease
• Adult
• Aged
• Aged, 80 and over
• Aminoglycosides
• Anti-Bacterial Agents (therapeutic use)
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antigens, CD (metabolism)
• Antigens, Differentiation, Myelomonocytic (metabolism)
• Disease-Free Survival
• Female
• Gemtuzumab
• Humans
• Immunotoxins (therapeutic use)
• Leukemia, Myeloid (diagnosis, drug therapy, mortality, pathology)
• Male
• Middle Aged
• Monitoring, Physiologic
• Neoplasm Recurrence, Local (drug therapy, mortality, pathology)
• Prognosis
• Sialic Acid Binding Ig-like Lectin 3
• Survival Rate