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Mylotarg™ (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation
Author(s) -
Giles Francis J.,
Kantarjian Hagop M.,
Kornblau Steve M.,
Thomas Deborah A.,
GarciaManero Guillermo,
Waddelow Tracey A.,
David Cynthia L.,
Phan Alexandria T.,
Colburn Dawn E.,
Rashid Asif,
Estey Elihu H.
Publication year - 2001
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(20010715)92:2<406::aid-cncr1336>3.0.co;2-u
Subject(s) - gemtuzumab ozogamicin , medicine , calicheamicin , transplantation , hepatic veno occlusive disease , myeloid leukemia , surgery , hematopoietic stem cell transplantation , population , gastroenterology , cd33 , stem cell , cd34 , genetics , environmental health , biology
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 occured when Mylotarg was used either as a single agent or when it was given with other cytotoxic agents. VOD occured 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. Cancer 2001;92:406–13. © 2001 American Cancer Society.