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Veno-occlusive Disease Risk in Pediatric Patients with Acute Myeloid Leukemia Treated with Gemtuzumab Ozogamicin Before Allogeneic Hematopoietic Cell Transplantation

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Date 2021 Apr 19
PMID 33871892
Citations 2
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Abstract

Background: Gemtuzumab ozogamicin (GO) administered before allogeneic hematopoietic cell transplantation (alloHCT) has been linked to an increased risk of hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS).

Procedure: This retrospective analysis examined VOD/SOS risk and clinical outcomes in pediatric patients with acute myeloid leukemia who received myeloablative alloHCT in 2008-2011 with (n = 148) and without (n = 348; controls) prior GO exposure and were reported to the Center for International Blood and Marrow Transplant Research.

Results: Cumulative incidences (95% confidence interval [CI]) of VOD/SOS and severe VOD/SOS, respectively, at 100 days were 16% (11-23%) and 8% (4-13%) for GO-exposed patients and 10% (7-13%) and 3% (2-5%) for controls. With a median follow-up of approximately 7 years, the 5-year adjusted overall survival probability (95% CI) after alloHCT was 51% (43-58%) and 55% (50-60%) for GO-exposed patients and controls, respectively; three (4%) and one (<1%) deaths were attributed to VOD/SOS. In multivariate analyses, GO exposure was observed to be associated with an increased risk of VOD/SOS at 100 days, but was not associated with overall survival, disease-free survival, relapse, or nonrelapse mortality.

Conclusions: Results suggest that GO treatment prior to alloHCT in pediatric patients may increase the risk of VOD/SOS but not death.

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Inotuzumab ozogamicin in B-cell precursor acute lymphoblastic leukemia: efficacy, toxicity, and practical considerations.

Rubinstein J, OBrien M Front Immunol. 2023; 14:1237738.

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References
1.
McKoy J, Angelotta C, Bennett C, Tallman M, Wadleigh M, Evens A . Gemtuzumab ozogamicin-associated sinusoidal obstructive syndrome (SOS): an overview from the research on adverse drug events and reports (RADAR) project. Leuk Res. 2006; 31(5):599-604. DOI: 10.1016/j.leukres.2006.07.005. View

2.
Palmer J, McCune J, Perales M, Marks D, Bubalo J, Mohty M . Personalizing Busulfan-Based Conditioning: Considerations from the American Society for Blood and Marrow Transplantation Practice Guidelines Committee. Biol Blood Marrow Transplant. 2016; 22(11):1915-1925. DOI: 10.1016/j.bbmt.2016.07.013. View

3.
Coppell J, Richardson P, Soiffer R, Martin P, Kernan N, Chen A . Hepatic veno-occlusive disease following stem cell transplantation: incidence, clinical course, and outcome. Biol Blood Marrow Transplant. 2009; 16(2):157-68. PMC: 3018714. DOI: 10.1016/j.bbmt.2009.08.024. View

4.
Corbacioglu S, Carreras E, Ansari M, Balduzzi A, Cesaro S, Dalle J . Diagnosis and severity criteria for sinusoidal obstruction syndrome/veno-occlusive disease in pediatric patients: a new classification from the European society for blood and marrow transplantation. Bone Marrow Transplant. 2017; 53(2):138-145. PMC: 5803572. DOI: 10.1038/bmt.2017.161. View

5.
Aplenc R, Alonzo T, Gerbing R, Lange B, Hurwitz C, Wells R . Safety and efficacy of gemtuzumab ozogamicin in combination with chemotherapy for pediatric acute myeloid leukemia: a report from the Children's Oncology Group. J Clin Oncol. 2008; 26(14):2390-3295. PMC: 4558626. DOI: 10.1200/JCO.2007.13.0096. View