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Prepublished online as a Blood First Edition Paper on May 8, 2003; DOI 10.1182/blood-2003-01-0255.

Submitted January 29, 2003
Accepted April 6, 2003
Prior gemtuzumab ozogamicin exposure significantly increases the risk of veno-occlusive disease in patients who undergo myeloablative allogeneic stem cell transplantation
Martha Wadleigh, Paul G Richardson, David Zahrieh, Stephanie J Lee, Corey Cutler, Vincent Ho, Edwin P Alyea, Joseph H Antin, Richard M Stone, Robert J Soiffer, and Daniel J DeAngelo*
Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA
Department of Biostatistical Science, Dana-Farber Cancer Institute, Boston, MA, USA
* Corresponding author; email: ddeangelo{at}partners.org.
Gemtuzumab ozogamicin (GO; Mylotarg®), a monoclonal antibody used in the treatment of acute myelogenous leukemia (AML) has been linked to the development of veno-occlusive disease (VOD). We conducted a retrospective study of 62 patients with previously treated AML/MDS who underwent allogeneic SCT at our institution from December 2000 to October 2002 to determine whether GO exposure prior to allogeneic stem cell transplant (SCT) increases the risk of developing VOD. Fourteen patients received GO prior to SCT. Of 62 patients, 13 (21%) developed VOD. Nine of fourteen (64%) with prior GO exposure developed VOD compared to 4 of 48 (8%) without prior GO exposure (P< 0.0001). Logistic regression controlling for sex, disease status, donor type, and graft versus host disease prophylaxis identified prior treatment with GO as a significant risk factor for VOD [OR 21.6; 95% CI 4.2,112.2]. Nine of 10 patients who underwent SCT 3.5 months following GO developed VOD compared to zero of 4 patients who underwent SCT >3.5 months from GO administration. Three of 14 patients who received GO prior to SCT died of VOD. We conclude that patients undergoing SCT within a short interval of time from GO administration are at increased risk of developing VOD.

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