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Prepublished online as a Blood First Edition Paper on May 8, 2003; DOI 10.1182/blood-2003-01-0255.
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Blood, 1 September 2003, Vol. 102, No. 5, pp. 1578-1582
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC
TRIALS
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
From the Department of Medical Oncology and Department of Biostatistical
Science, Dana-Farber Cancer Institute; and the Department of Medicine, Brigham
and Women's Hospital, Boston, MA.
Gemtuzumab ozogamicin (GO), a monoclonal antibody used in the treatment of
acute myelogenous leukemia (AML) has been linked to the development of
venoocclusive disease (VOD). We conducted a retrospective study of 62 patients
with previously treated AML/MDS (myelodysplastic syndrome) who underwent
allogeneic stem cell (SC) transplantation at our institution from December
2000 to October 2002 to determine whether GO exposure prior to allogeneic SC
transplantation increases the risk of developing VOD. Fourteen patients
received GO prior to SC transplantation. Of 62 patients, 13 (21%) developed
VOD; 9 (64%) of 14 with prior GO exposure developed VOD compared with 4 (8%)
of 48 without prior GO exposure (P < .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 (odds ratio [OR], 21.6; 95% confidence interval [CI], 4.2-112.2]. Nine
of 10 patients who underwent SC transplantation 3.5 months or less following
GO developed VOD compared with none of 4 patients who underwent SC
transplantation more than 3.5 months from GO administration. Three of 14
patients who received GO prior to SC transplantation died of VOD. We conclude
that patients undergoing SC transplantation within a short interval from GO
administration are at increased risk of developing VOD.
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