Infectious Disease Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Department of Medicine, Weill Cornell Medical College, Cornell University, New York, New York, USA.
Med Mycol. 2020 Nov 10;58(8):1029-1036. doi: 10.1093/mmy/myaa008.
We sought to describe the clinical experience of voriconazole as primary antifungal prophylaxis (AFP) in allogeneic hematopoietic cell transplant recipients (allo-HCTr). This was a single-center retrospective study of adult allo-HCTr (1 January 2014 to 31 December 2016) who received ≥two doses of voriconazole-AFP. Voriconazole-AFP was started on day +7 post-HCT and continued at least through day +60 post-HCT, or longer as clinically indicated. We reviewed the rate, reasons, and risk factors of voriconazole-AFP discontinuation until day-100 post-HCT. A total of 327 patients were included. Voriconazole-AFP was continued for a median of 69 days (mean: 57.9; range 1, 100): for a median of 90 days (mean :84; range 2, 100) in 180/327 (55%) in the standard-of-care (SOC) group and 20 days (mean :25.6 ; range 1, 89; P-value < .001) in 147/327 (45%) patients in the early-discontinuation-group. Early-voriconazole-AFP discontinuation was due to adverse events, drug interactions, insurance coverage, and other reasons in 101/147 (68.7%), 27 (18.4%), 13 (8.8%), and 6 (4.1%) patients, respectively. Early-voriconazole-AFP discontinuation occurred in 73/327 (22.3%) patients due to hepatotoxicity. Important predictors for early-voriconazole-AFP discontinuation included: graft-versus-host disease grade ≥2 (odds ratio [OR]: 1.9, P-value: .02), alanine-aminotransferase ≥75 IU/ml on voriconazole-administration day-14 (OR: 5.6, P-value: .02) and total bilirubin ≥1.3 mg/dl on voriconazole-administration day-7 (OR: 3.0, P-value: .03). There were 13 proven/probable invasive fungal infections by day-180 post-HCT (8/147, 5.4%, and 5/180, 2.8% in the early-discontinuation and SOC-groups, respectively; log-rank:0.13). By day-180 post HCT, 23/147 (15.6%) and 14/180 (7.8%) patients in the early-discontinuation and SOC-groups had died, respectively (log-rank:0.03). Voriconazole-AFP was discontinued in up to 45% of allo-HCTr. Hepatotoxicity during the first 2 weeks post-HCT is a significant predictor of early-voriconazole-AFP discontinuation.
我们旨在描述异基因造血细胞移植受者(allo-HCTr)中伏立康唑作为原发性抗真菌预防(AFP)的临床经验。这是一项对 2014 年 1 月 1 日至 2016 年 12 月 31 日接受≥两剂伏立康唑-AFP 的成人 allo-HCTr 的单中心回顾性研究。伏立康唑-AFP 在移植后第 7 天开始使用,并持续至少至移植后第 60 天,或根据临床需要延长使用。我们回顾了直至移植后第 100 天伏立康唑-AFP 停药的比率、原因和危险因素。共纳入 327 例患者。伏立康唑-AFP 的中位持续时间为 69 天(平均值:57.9;范围 1 至 100):在标准护理(SOC)组的 180/327(55%)中,中位持续时间为 90 天(平均值:84;范围 2 至 100),在 147/327(45%)的早期停药组中,中位持续时间为 20 天(平均值:25.6;范围 1 至 89;P 值<.001)。101/147(68.7%)、27(18.4%)、13(8.8%)和 6(4.1%)患者分别因不良事件、药物相互作用、保险覆盖范围和其他原因而提前停用伏立康唑-AFP。由于肝毒性,73/327(22.3%)患者提前停用伏立康唑-AFP。提前停用伏立康唑-AFP 的重要预测因素包括:移植物抗宿主病(GVHD)分级≥2(优势比[OR]:1.9,P 值:.02)、伏立康唑给药第 14 天丙氨酸氨基转移酶(ALT)≥75IU/ml(OR:5.6,P 值:.02)和伏立康唑给药第 7 天总胆红素≥1.3mg/dl(OR:3.0,P 值:.03)。在移植后第 180 天,分别有 13 例(8/147,5.4%,和 5/180,2.8%)在早期停药和 SOC 组中确诊/可能侵袭性真菌感染(IFI)(对数秩检验:0.13)。在移植后第 180 天,早期停药组和 SOC 组分别有 23/147(15.6%)和 14/180(7.8%)患者死亡(对数秩检验:0.03)。在 allo-HCTr 中,多达 45%的患者停用了伏立康唑-AFP。移植后前 2 周的肝毒性是提前停用伏立康唑-AFP 的重要预测因素。