Analysis of Predisposing Factors for Hepatic Veno-Occlusive Disease after Treatment with Gemtuzumab Ozogamicin (Mylotargr, CMA-676).

Reviewer: William Levin, MD
The Abramson Cancer Center of the University of Pennsylvania
Last Modified: December 8, 2001

Presenter: Edward Stadtmauer
University of Pennsylvania Cancer Center


  • Hepatic veno-occlusive disease (VOD) occurs frequently after hematopoietic stem cell transplantation (HSCT) but is rarely seen with other forms of therapy.
  • Gemtuzumab Ozogamicin is a monoclonal anti-CD33 antibody that is used in the treatment of Acute Myeloid Leukemia.

Materials and Methods

  • Of 188 patients treated with gemtuzumab for relapsed AML in phase II studies, 4 developed hepatic VOD.
  • In the current study Investigators attempt to identify those factors that predispose patients to hepatic VOD.


  • A 2% incidence of hepatic VOD was seen in 188 patients treated with gemtuzumab for relapsed AML.
  • No correlation was found between the occurrence of VOD and age, gender, baseline bilirubin levels, prior chemotherapeutic regimens, or administration of concomitant medications.
  • Only prior autologous hematopoetic stem cell transplant was a risk factor for the development of hepatic VOD, but the correlation was a weak one (p=0.0384)

Author's conclusions:

  • Efforts must continue to be made in order to identify factors associated with hepatic VOD.
  • Patients with a history of liver disease, elevated liver enzymes, and history of bone marrow transplant should be evaluated closely when considering them for gemtuzumab therapy.

Clinical/Scientific Implications:

  • This abstract illustrates the importance of clinical study in the evaluation of new medications.
  • The excitement over the emergence of new cancer therapies must be tempered by the continued monitoring for both acute and long term side-effects of these treatments.