BACKGROUND: Mylotarg (Wyeth-Ayerst Laboratories, St. Davids, PA) is the brand name for a calicheamicin-conjugated humanized anti-CD33 monoclonal antibody (gemtuzumab ozogamicin, CMA-676) and has been approved recently for the treatment of a subset of elderly patients who have relapsed acute myeloid leukemia (AML). Mylotarg is associated with an incidence of approximately 20% Grade 3 or 4 hyperbilirubinemia and liver transaminitis in this patient population. Hepatic venoocclusive disease (VOD) has been reported in patients who have undergone stem cell transplantation (SCT) after Mylotarg therapy. Outside of the SCT setting, VOD has been associated very rarely with cytotoxic therapy. METHODS: The authors assessed the incidence of VOD in 119 patients who were receiving Mylotarg-containing non-SCT regimens. VOD was diagnosed through the use of standard Seattle and Baltimore criteria. RESULTS: A cohort of 119 (61 previously untreated, 58 with relapsed disease) patients with AML (92 patients), advanced myelodysplastic syndrome (25 patients), or chronic myeloid leukemia in blast phase (2 patients), received Mylotarg-based regimens. Fourteen (12%) developed VOD. The diagnosis of VOD was supported by histology in 2 patients and radiologic studies in a further 10 patients. Five (36%) of 14 patients with VOD had received no prior antileukemic cytotoxic therapy, including 2 patients who received single-agent Mylotarg therapy. CONCLUSIONS: Mylotarg was shown to be associated with the development of potentially fatal VOD in patients with leukemia who had not received SCT. VOD occurred when Mylotarg was used either as a single agent or when it was given with other cytotoxic agents. VOD occurred in Mylotarg-treated patients who had received no prior cytotoxic therapy. The current study concluded that risk factors for VOD should be assessed when considering Mylotarg therapy, and that attempts to avoid and treat VOD are warranted in patients who receive Mylotarg therapy. Copyright 2001 American Cancer Society.
BACKGROUND:Mylotarg (Wyeth-Ayerst Laboratories, St. Davids, PA) is the brand name for a calicheamicin-conjugated humanized anti-CD33 monoclonal antibody (gemtuzumab ozogamicin, CMA-676) and has been approved recently for the treatment of a subset of elderly patients who have relapsed acute myeloid leukemia (AML). Mylotarg is associated with an incidence of approximately 20% Grade 3 or 4 hyperbilirubinemia and liver transaminitis in this patient population. Hepatic venoocclusive disease (VOD) has been reported in patients who have undergone stem cell transplantation (SCT) after Mylotarg therapy. Outside of the SCT setting, VOD has been associated very rarely with cytotoxic therapy. METHODS: The authors assessed the incidence of VOD in 119 patients who were receiving Mylotarg-containing non-SCT regimens. VOD was diagnosed through the use of standard Seattle and Baltimore criteria. RESULTS: A cohort of 119 (61 previously untreated, 58 with relapsed disease) patients with AML (92 patients), advanced myelodysplastic syndrome (25 patients), or chronic myeloid leukemia in blast phase (2 patients), received Mylotarg-based regimens. Fourteen (12%) developed VOD. The diagnosis of VOD was supported by histology in 2 patients and radiologic studies in a further 10 patients. Five (36%) of 14 patients with VOD had received no prior antileukemic cytotoxic therapy, including 2 patients who received single-agent Mylotarg therapy. CONCLUSIONS:Mylotarg was shown to be associated with the development of potentially fatal VOD in patients with leukemia who had not received SCT. VOD occurred when Mylotarg was used either as a single agent or when it was given with other cytotoxic agents. VOD occurred in Mylotarg-treated patients who had received no prior cytotoxic therapy. The current study concluded that risk factors for VOD should be assessed when considering Mylotarg therapy, and that attempts to avoid and treat VOD are warranted in patients who receive Mylotarg therapy. Copyright 2001 American Cancer Society.
Authors: Carol O'Hear; Hiroto Inaba; Stanley Pounds; Lei Shi; Gary Dahl; W Paul Bowman; Jeffrey W Taub; Ching-Hon Pui; Raul C Ribeiro; Elaine Coustan-Smith; Dario Campana; Jeffrey E Rubnitz Journal: Cancer Date: 2013-09-04 Impact factor: 6.860
Authors: Mark S Berger; Lance H Leopold; James A Dowell; Joan M Korth-Bradley; Matthew L Sherman Journal: Invest New Drugs Date: 2002-11 Impact factor: 3.850
Authors: Robert K Hills; Sylvie Castaigne; Frederick R Appelbaum; Jacques Delaunay; Stephen Petersdorf; Megan Othus; Elihu H Estey; Hervé Dombret; Sylvie Chevret; Norbert Ifrah; Jean-Yves Cahn; Christian Récher; Lucy Chilton; Anthony V Moorman; Alan K Burnett Journal: Lancet Oncol Date: 2014-07-06 Impact factor: 41.316
Authors: Kevin P O'Boyle; Ashwin Murigeppa; Dharamvir Jain; Leonard Dauber; Janice P Dutcher; Peter H Wiernik Journal: Med Oncol Date: 2003 Impact factor: 3.064
Authors: Thomas Schirrmann; André Frenzel; Lars Linden; Beatrix Stelte-Ludwig; Jörg Willuda; Axel Harrenga; Stefan Dübel; Beate Müller-Tiemann; Mark Trautwein Journal: MAbs Date: 2014-01-15 Impact factor: 5.857