Melica Giovanna, Luna de Abia Alejandro, Shah Gunjan L, Devlin Sean, Corona Magdalena, Fein Joshua, Dahi Parastoo B, Giralt Sergio A, Lin Richard J, Palomba M Lia, Parascondola Allison, Park Jae, Salles Gilles, Saldia Amethyst, Scordo Michael, Shouval Roni, Perales Miguel-Angel, Seo Susan K
Department of Medicine, Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Infectious Diseases and Clinical Immunology, Henri Mondor Hospital, APHP, Creteil, France.
Department of Medicine, Adult Bone Marrow Transplant Service, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Adult Bone Marrow Transplantation, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Transplant Cell Ther. 2025 Jan;31(1):36-44. doi: 10.1016/j.jtct.2024.10.010. Epub 2024 Oct 22.
Patients undergoing CD19 chimeric antigen receptor (CAR)-T cell therapy exhibit multiple immune deficits that may increase their susceptibility to infections. Invasive fungal infections (IFIs) are life-threatening events in the setting of hematologic diseases. However, there is ongoing debate regarding the optimal role and duration of antifungal prophylaxis in this specific patient population. The objective of this study was to provide a comprehensive overview of the evolution of IFI prophylactic strategies over time and to assess IFI incidence rates in a cohort of patients with relapsed or refractory (R/R) lymphoma treated with CAR-T cell therapy. A single-center retrospective study was conducted on a cohort of patients with R/R B cell lymphoma treated with CD19 CAR-T cell therapy between April 2016 and March 2023. Group A (April 2016-August 2020) consisted of patients primarily treated with fluconazole, irrespective of their individual IFI risk profile. In Group B (September 2020-March 2023) antifungal prophylaxis was recommended only for high-risk patients. Overall, 330 patients were included. Antifungal prophylaxis was prescribed to 119/142 (84%) patients in Group A and 58/188 (31%) in Group B (P < .001). Anti-mold azoles were prescribed to 8 (5.6%) patients in Group A and 21 (11.2%) patients in Group B. In Group A, 42 (29%) patients were switched to another antifungal, 9 (21%) because of toxicity, with 6 cases of transaminitis and 3 cases of prolonged QTc. In Group B, 21 (11.2%) patients were switched to the antifungal drug, mainly from fluconazole or micafungin to a mold-active agent following revised guidelines. No difference was found in liver toxicity between the two groups at infusion, day 10, and day 30. No significant differences were observed between the groups. IFIs following CAR-T cell therapy were rare, with 1 case of cryptococcal meningoencephalitis in group A (.7%) and 1 case of invasive aspergillosis in Group B (.5%), both occurring in patients on micafungin prophylaxis. In this large single-center cohort of patients with R/R lymphoma treated with CAR-T cells, we show that individualized prophylaxis, alongside careful management of CAR-T cell-related toxicities such as CRS, was associated with a very low IFI rate, avoiding the risk of unnecessary toxicities, drug-drug interactions, and high costs.
接受CD19嵌合抗原受体(CAR)-T细胞治疗的患者存在多种免疫缺陷,这可能会增加他们感染的易感性。侵袭性真菌感染(IFI)在血液系统疾病背景下是危及生命的事件。然而,对于这一特定患者群体中抗真菌预防的最佳作用和持续时间仍存在争议。本研究的目的是全面概述IFI预防策略随时间的演变,并评估接受CAR-T细胞治疗的复发或难治性(R/R)淋巴瘤患者队列中的IFI发病率。对2016年4月至2023年3月期间接受CD19 CAR-T细胞治疗的R/R B细胞淋巴瘤患者队列进行了一项单中心回顾性研究。A组(2016年4月至2020年8月)主要由接受氟康唑治疗的患者组成,无论其个体IFI风险状况如何。B组(2020年9月至2023年3月)仅建议对高危患者进行抗真菌预防。总体而言,共纳入330例患者。A组119/142(84%)例患者接受了抗真菌预防,B组为58/188(31%)例(P <.001)。A组8(5.6%)例患者和B组21(11.2%)例患者使用了抗霉菌唑类药物。在A组中,42(29%)例患者更换了另一种抗真菌药物,9(21%)例是因为毒性,其中6例发生转氨酶升高,3例出现QTc延长。在B组中,21(11.2%)例患者更换了抗真菌药物,主要是根据修订后的指南从氟康唑或米卡芬净更换为具有抗霉菌活性的药物。两组在输注时、第10天和第30天的肝毒性方面没有差异。两组之间未观察到显著差异。CAR-T细胞治疗后的IFI很少见,A组有1例隐球菌性脑膜脑炎(.7%),B组有1例侵袭性曲霉病(.5%),均发生在接受米卡芬净预防的患者中。在这个接受CAR-T细胞治疗的R/R淋巴瘤患者的大型单中心队列中,我们表明个体化预防以及对CRS等CAR-T细胞相关毒性的精心管理与非常低的IFI发生率相关,避免了不必要的毒性、药物相互作用和高成本风险。