Department of Pharmaceutical Services, Vanderbilt University Medical Center, Nashville, USA.
Department of Biostatistics, Vanderbilt University Medical Center, Nashville, USA.
J Oncol Pharm Pract. 2023 Sep;29(6):1326-1333. doi: 10.1177/10781552221118635. Epub 2022 Aug 9.
Venetoclax is utilized with low-dose cytarabine or a hypomethylating agent for the treatment of acute myeloid leukemia. Clinical trials report a risk of tumor lysis syndrome and the package insert recommends a venetoclax dose ramp-up at the initiation. The purpose of this study was to evaluate the risk of tumor lysis syndrome in a large population of patients with acute myeloid leukemia outside of a clinical trial and evaluate the incidence of hospital-acquired complications during inpatient ramp-up.
We performed a retrospective study of adult patients with acute myeloid leukemia receiving venetoclax with a hypomethylating agent or low-dose cytarabine. The primary outcome was the incidence of tumor lysis syndrome. Secondary outcomes included risk factors for tumor lysis syndrome, length of admission, and incidence of hospital-acquired complications.
One hundred thirteen patients were included. Although all patients were given some form of prophylaxis, the incidence of tumor lysis syndrome was 8.8%. All were laboratory tumor lysis syndrome; one with hyperuricemia, nine with hypocalcemia, and ten with hyperphosphatemia. Six patients received sevelamer. Tumor lysis syndrome was resolved in all cases. No clinical tumor lysis syndrome occurred. Hepatic dysfunction, tumor lysis syndrome high-risk stratification, higher baseline white blood cell count, and lactate dehydrogenase levels were more common in the tumor lysis syndrome group. Hospital-acquired complications reached 13% in those directly admitted for dose ramp-up.
Tumor lysis syndrome was uncommon and manifested as minor lab abnormalities. White blood cell count continues to be an indicator of risk for tumor lysis syndrome. Those who present with an elevated white blood cell or are otherwise at high risk for tumor lysis syndrome should be admitted for ramp-up. Otherwise, initiation and monitoring of venetoclax are feasible in the outpatient setting.
维奈托克与低剂量阿糖胞苷或低甲基化剂联合用于治疗急性髓系白血病。临床试验报告有肿瘤溶解综合征的风险，说明书建议在开始时逐渐增加维奈托克的剂量。本研究的目的是评估临床试验外大量急性髓系白血病患者发生肿瘤溶解综合征的风险，并评估住院期间逐渐增加剂量过程中发生医院获得性并发症的发生率。
我们对接受维奈托克联合低甲基化剂或低剂量阿糖胞苷治疗的急性髓系白血病成年患者进行了回顾性研究。主要结局是肿瘤溶解综合征的发生率。次要结局包括肿瘤溶解综合征的危险因素、住院时间和医院获得性并发症的发生率。
共纳入 113 例患者。尽管所有患者都接受了某种形式的预防治疗，但肿瘤溶解综合征的发生率为 8.8%。所有患者均为实验室肿瘤溶解综合征，1 例高尿酸血症，9 例低钙血症，10 例高磷血症。6 例患者接受了司维拉姆治疗。所有患者的肿瘤溶解综合征均得到缓解。无一例发生临床肿瘤溶解综合征。肝功能障碍、肿瘤溶解综合征高危分层、较高的基线白细胞计数和乳酸脱氢酶水平在肿瘤溶解综合征组中更为常见。直接入院进行剂量递增的患者中，医院获得性并发症发生率为 13%。
肿瘤溶解综合征并不常见，表现为轻微的实验室异常。白细胞计数仍然是肿瘤溶解综合征风险的指标。对于白细胞计数升高或有其他肿瘤溶解综合征高危因素的患者，应入院进行递增治疗。否则，维奈托克的起始和监测可在门诊进行。
