Gemtuzumab ozogamicin (GO) therapy before allogeneic hematopoietic cell transplantation (alloHCT) has been historically associated with an increased risk of hepatic veno-occlusive disease/sinusoidal obstruction syndrome (VOD/SOS) in patients with acute myeloid leukemia (AML). The current analysis examined VOD/SOS risk and outcomes in a cohort of patients who in recent years were reported to the Center for International Blood and Marrow Transplant Research. Adults with AML who had GO exposure before myeloablative alloHCT were matched 1:4 by age and disease status at transplant to recipients without GO exposure (control subjects). One hundred thirty-seven patients with GO exposure and 548 matched control subjects who underwent alloHCT between 2008 and 2011 were included in this analysis. With a median ∼8-year follow-up of survivors, the 5-year overall survival probability was similar in the 2 cohorts: 38% and 38% in the GO-exposed versus control groups (P = .97). Incidence of VOD/SOS and severe VOD/SOS, respectively, at 100 days was 4% (95% confidence interval [CI], 1% to 7%) and 3% (95% CI, 1% to 6%) in GO-exposed patients and 3% (95% CI, 2% to 5%) and 1% (95% CI, 0% to 2%) in control subjects. Correspondingly, among patients who developed VOD/SOS, 1-year survival probability after VOD/SOS diagnosis was 33% (95% CI, 5% to 72%) and 27% (95% CI, 11% to 47%; P = .78). In multivariate analyses, GO exposure before alloHCT was not associated with an increased risk of VOD/SOS (odds ratio, 1.10; P = .85) or death (hazard ratio, 1.08; P = .57). Three deaths (3%) in the GO group and 3 deaths (<1%) in the control group were attributed to VOD/SOS. Our results suggest that GO treatment before myeloablative alloHCT in the recent era is not associated with an increased risk of post-transplant VOD/SOS or death.

中文翻译：

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成人急性髓系白血病先前暴露于 Gemtuzumab Ozogamicin 不会增加同种异体造血细胞移植后肝静脉闭塞性疾病的风险：国际血液和骨髓移植研究分析中心。

在同种异体造血细胞移植 (alloHCT) 之前，吉姆单抗奥佐米星 (GO) 治疗历来与急性髓系白血病 (AML) 患者发生肝静脉闭塞病/窦性阻塞综合征 (VOD/SOS) 的风险增加有关。目前的分析检查了近年来向国际血液和骨髓移植研究中心报告的一组患者的 VOD/SOS 风险和结果。在清髓性alloHCT 前有GO 暴露的AML 成人按移植时的年龄和疾病状态与没有GO 暴露的受者（对照受试者）按1:4 匹配。该分析包括 137 名 GO 暴露患者和 548 名匹配的对照受试者，他们在 2008 年至 2011 年期间接受了 alloHCT。对幸存者进行中位约 8 年的随访，2 个队列的 5 年总生存概率相似：GO 暴露组与对照组分别为 38% 和 38% (P = .97)。在 100 天时，VOD/SOS 和严重 VOD/SOS 的发生率分别为 4%（95% 置信区间 [CI]，1% 至 7%）和 3%（95% CI，1% 至 6%） - 暴露患者和 3%（95% CI，2% 至 5%）和 1%（95% CI，0% 至 2%）的对照受试者。相应地，在发生 VOD/SOS 的患者中，VOD/SOS 诊断后的 1 年生存概率分别为 33%（95% CI，5% 至 72%）和 27%（95% CI，11% 至 47%；P = .78）。在多变量分析中，alloHCT 前暴露于 GO 与 VOD/SOS（比值比，1.10；P = .85）或死亡（风险比，1.08；P = .57）风险增加无关。GO 组 3 例死亡 (3%) 和对照组 3 例死亡 (<1%) 归因于 VOD/SOS。