Pilot Trial of Homebound Hematopoietic Cell Transplantation.

Pilot Trial of Homebound Hematopoietic Cell Transplantation.
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DOI:
10.1016/j.jtct.2022.09.014
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发表时间:
2022-12
影响因子:
3.2
通讯作者:
Giralt, Sergio A.
Giralt, Sergio A.
中科院分区:
医学2区
文献类型:
--
作者:
Landau, Heather J.;Orlando, Evelyn;Rodriguez, Elizabeth S.;Applebaum, Allison;Mitchell, Hannah -Rose;Peled, Jonathan U.;Khan, Niloufer;Funnell, Tyler;Chung, David;Scordo, Michael;Shah, Gunjan L.;LeStrange, Nicole J.;Hambright, Katie A.;McElrath, Courtney M.;Cazeau, Naomi;Devlin, Sean M.;Perales, Miguel -Angel;Giralt, Sergio A.

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对于符合条件的多发性骨髓瘤(MM)和轻链(AL)淀粉样变性患者,高剂量治疗和自体造血细胞移植(HCT)是一种标准且广泛使用的巩固治疗。自体HCT需要移植中心的专门护理以及患者和护理人员的投资。我们研究了在家庭环境中提供移植护理的安全性和可行性,以减少治疗负担并增加自体HCT的可及性。接受自身HCT的MM和AL淀粉样变患者如果居住在指定的邮政编码地区,有全职护理人员,Wi-Fi连接,HCT合发指数≤3,Karnofsky性能状态评分≥80,则符合条件。在门诊给予大剂量美法兰(第2天)和造血细胞回输(第0天)。从第1天到种植期间提供特定方案的家庭护理。由高级医生每天对患者进行评估和抽血。干预措施由注册护士提供。主治医生每天通过远程医疗进行沟通。收集生活质量、患者和护理人员满意度以及粪便微生物群分析数据。15例患者在造血细胞输注后第1天开始在家中接受移植护理。患者在该项目中平均停留12天,在接受家庭护理时平均需要2次门诊。15例患者中有7例住院时间中位数为4天(范围3-10天);在第7天(n=5)、第8天(n=1)和第12天(n=1)出现中性粒细胞减少症发热(n=2)、移植物综合征发热(n=2)、腹泻(n=2)和脱水(n=1)。只有1例患者有记录感染(艰难梭菌)。一名因中性粒细胞减少热入院的患者因胃肠道出血而需要进入重症监护病房。47%的患者出现≥3级非血液学毒性。研究中没有死亡病例。患者和护理人员报告了对护理的高满意度。微生物群多样性模式与未在家中接受HCT后护理的自体HCT受者相似,尽管我们的队列中有一部分人始终保持着微生物群多样性。在城市环境中,居家HCT是安全可行的,只有不到一半的患者需要住院治疗。尽管与住院患者相比,在家的患者和护理人员的责任有所增加,但患者和护理人员的满意度很高。这些结果支持扩大家庭移植项目。
For eligible patients with multiple myeloma (MM) and light chain (AL) amyloidosis, high-dose therapy and autologous hematopoietic cell transplantation (HCT) is a standard and widely used consolidation therapy. Autologous HCT requires specialized care at a transplant center and investment from patients and caregivers. We studied the safety and feasibility of delivering transplant care in a homebound setting to decrease the burden of therapy and increase access to autologous HCT. Patients with MM and AL amyloidosis undergoing autologous HCT were eligible if they were residing in designated zip codes and had a full-time caregiver, Wi-Fi connection, HCT co-morbidity index ≤3, and Karnofsky Performance status score ≥80. High-dose melphalan (day −2) and hematopoietic cell reinfusion (day 0) were administered in the outpatient clinic. Protocol-specific home care was provided from day +1 through engraftment. Patients were assessed and blood was drawn daily by advanced-practice providers. Interventions were delivered by registered nurses. Attending physicians communicated through telemedicine daily. Quality-of-life, patient and caregiver satisfaction, and fecal microbiota profiling data were collected. Fifteen patients were enrolled and received transplant care at home starting on day + 1 following hematopoietic cell infusion. Patients remained in the program for an average of 12 days and required an average of 2 outpatient visits while receiving home care. Seven of 15 patients were admitted for a median of 4 (range 3-10) days; admission occurred on day +7 (n=5), day +8 (n=1), and day +12 (n=1) for neutropenic fever (n=2), fever attributed to engraftment syndrome (n=2), diarrhea (n=2), and dehydration (n=1). Only 1 patient had a documented infection (Clostridioides difficile). One patient admitted with neutropenic fever required intensive care unit admission for a gastrointestinal bleed. Forty-seven percent of patients experienced grade ≥3 non-hematologic toxicities. There were no deaths on study. Patients and caregivers reported high satisfaction with care. Microbiota diversity patterns were similar to those of autologous HCT recipients who did not receive post-HCT care at home, although a subset of our cohort maintained microbiota diversity throughout. Homebound HCT in an urban setting is safe and feasible, with less than half of patients requiring inpatient admission. Despite increased patient and caregiver responsibility in the homebound setting compared to an inpatient setting, patient and caregiver satisfaction was high. These results support expansion of homebound transplant programs.
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影响因子: 4.3
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