Prevention, recognition, and management of adverse events associated with gemtuzumab ozogamicin use in acute myeloid leukemia

• Published in: Journal of hematology and oncology 2020-10, Vol.13 (1), p.137-8, Article 137
• Main Authors: Cortes, Jorge E, de Lima, Marcos, Dombret, Hervé, Estey, Elihu H, Giralt, Sergio A, Montesinos, Pau, Röllig, Christoph, Venditti, Adriano, Wang, Eunice S
• Format: Article
• Language: English
• Subjects: Acute myeloid leukemia; Adverse events; Animals; Antineoplastic Agents, Immunological - adverse effects; Antineoplastic Agents, Immunological - therapeutic use; Calicheamicin; Chemotherapy; Children; Clinical trials; Cytotoxicity; Disease Management; Disease prevention; Drug dosages; FDA approval; Gemtuzumab - adverse effects; Gemtuzumab - therapeutic use; Gemtuzumab ozogamicin; Hematology; Hematopoietic stem cells; Hepatic Veno-Occlusive Disease - chemically induced; Hepatic Veno-Occlusive Disease - prevention & control; Hepatic Veno-Occlusive Disease - therapy; Hepatotoxicity; Humans; Immunotherapy; Leukemia; Leukemia, Myeloid, Acute - drug therapy; Liver diseases; Lysis; Monoclonal antibodies; Myeloid leukemia; Myelosuppression; Neutropenia - chemically induced; Neutropenia - prevention & control; Neutropenia - therapy; Oncology; Patients; Pediatrics; Review; Stem cell transplantation; Targeted cancer therapy; Thrombocytopenia; Thrombocytopenia - chemically induced; Thrombocytopenia - prevention & control; Thrombocytopenia - therapy; Treatment management; Tumor Lysis Syndrome - etiology; Tumor Lysis Syndrome - prevention & control; Tumor Lysis Syndrome - therapy; Veno-occlusive disease; VOD/SOS
• ISSN: 1756-8722; 1756-8722
• DOI: 10.1186/s13045-020-00975-2

Gemtuzumab ozogamicin (GO), a humanized anti-CD33 monoclonal antibody conjugated to the cytotoxic antibiotic agent calicheamicin, is approved for the treatment of newly-diagnosed CD33 + AML in adults and children ≥ 1 month old, and relapsed or refractory CD33 + AML in adults and children ≥ 2 years old. GO treatment has been associated with an increased risk of hepatotoxicity and hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS), especially following hematopoietic stem cell transplantation. Other non-specific serious adverse events (SAEs) associated with GO treatment are myelosuppression, bleeding/thrombocytopenia, infusion-related reaction, and tumor lysis syndrome. This report summarizes an expert panel of physicians' recommendations for the evaluation and management of SAEs following GO, emphasizing the prevention and management of VOD/SOS.