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

Background:

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.

Results:

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.