Characterization Of Veno-Occlusive Disease (Vod) In Adult Patients With Acute Myeloid Leukemia (Aml) Receiving Gemtuzumab Ozogamicin (Go) Before Allogeneic Stem Cell Transplant (Sct)

Hepatic VOD has been reported in pts with AML exposed to the CD33-directed antibody-drug conjugate GO prior to SCT. To determine VOD risk and outcomes after GO exposure and subsequent SCT, we analyzed data from a subset of pts randomly selected for research level reporting to the Center for International Blood & Marrow Transplant Research (CIBMTR). Adults with AML and GO exposure before first myeloablative allogeneic SCT were matched 1:4 by age at SCT (within 5 y) and disease status before SCT (complete remission [CR] 1, CR ≥2, and relapse/primary induction failure) to pts without GO exposure. Marginal Cox regression and marginal logistic regression modeling were used to determine overall survival and the incidence of VOD at 100-d, respectively. A stepwise model building approach was used to identify risk factors associated with VOD and death. In this analysis, 141 pts with GO exposure and 564 pts without GO exposure underwent SCT between 2008 and 2011. Median (range) age for pts with and without GO exposure before SCT was 42 (18-73) y and 38 (18-74) y, respectively. Myeloablative conditioning (MAC) with chemotherapy (with GO, 61%; without GO, 57%) was utilized more frequently than MAC with total body irradiation (with GO, 39%; without GO, 43%). Pts with and without GO exposure were matched according to disease status: 32% of pts in CR1, 31% of pts in CR ≥2, and 37% of pts with relapse/primary induction failure. Median (range) time from GO exposure to transplant was 4 (2-10) mo for pts in CR1, 6 (1-68) mo for pts in ≥CR2, and 3 (<1-76) mo for pts with relapse/primary induction failure. Incidence of VOD at 100-d between pts with and without GO exposure was similar (4% versus 3%), as was the incidence of severe VOD (3% versus 1%). Survival probabilities at 100 d (81% versus 81%), 6 mo (67% versus 69%), and 1 y (52% versus 58%) from SCT were similar in pts with and without GO exposure. Likewise, 100-d (50% versus 43%), 6-mo (33% versus 30%), and 1-y (33% versus 26%) survival probabilities from the onset of VOD were comparable in pts with and without GO exposure before SCT. Of 90 deaths in pts with GO exposure, 3% (n = 3) were attributed to VOD; of 358 deaths in pts without GO exposure, <1% (n = 3) were attributed to VOD. In multivariate analysis (MVA), GO exposure was not associated with an increased risk of VOD (odds ratio, 1.05; 95% CI, .41-2.67). Furthermore, GO exposure was not associated with an increased risk of death in MVA (hazard ratio, 1.08; 95% CI, .86-1.36). In conclusion, the incidence of VOD in pts with GO exposure prior to first myeloablative allogeneic SCT was similar to pts without GO exposure before SCT. Moreover, GO exposure was not associated with an increased risk of VOD or death in pts with AML. Funding: Pfizer. The data presented are preliminary and were obtained from the Coordinating Center of the CIBMTR.