Nguyen Diana T, Shayani Sepideh, Palmer Joycelynne, Dagis Andrew, Forman Stephen J, Epstein Joel, Spielberger Ricardo
Department of Pharmacy, City of Hope National Medical Center, Duarte, CA, USA.
Department of Biostatistics, City of Hope National Medical Center, Duarte, CA, USA.
Support Care Cancer. 2015 Nov;23(11):3141-7. doi: 10.1007/s00520-015-2688-7. Epub 2015 Mar 21.
The purpose of this study is to assess the impact of palifermin on oral mucositis (OM) and its sequelae in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) who were conditioned with fractionated total body irradiation (FTBI) and etoposide.
This retrospective chart review study compared the effect of palifermin on the development of OM in patients who received this agent during an allo-HSCT (n = 99) to those who did not (n = 30). The primary end points were severity and duration of OM. Secondary end points included requirements for opioids, total parenteral nutrition (TPN), and intensive oral care; incidence of infection; length of hospital stay; and overall survival.
There was no significant difference in the incidence of all grades of OM, but incidence of severe OM was decreased in palifermin-exposed patients (34 vs 80 %, p < 0.0001). In patients who developed OM (all grades), the median duration of OM was shorter in palifermin-exposed patients (13 vs 18 days, p = 0.0001); there was no difference in the median duration of severe OM. Patients who received palifermin used less opioids and required a shorter duration of intensive oral care. There was no difference in duration of TPN, incidence of infection, length of hospital stay, and overall survival.
Our findings demonstrated a significant benefit with the use of palifermin for allo-HSCT recipients who were conditioned with FTBI and etoposide. Palifermin can potentially improve quality of life for this patient population and reduce complications and resources used during the transplant process. A randomized clinical trial is required to confirm these results.
本研究旨在评估帕利夫明对接受分次全身照射（FTBI）和依托泊苷预处理的异基因造血干细胞移植（allo-HSCT）患者口腔黏膜炎（OM）及其后遗症的影响。
这项回顾性图表审查研究比较了帕利夫明对接受该药物的allo-HSCT患者（n = 99）与未接受该药物的患者（n = 30）发生OM的影响。主要终点是OM的严重程度和持续时间。次要终点包括阿片类药物、全胃肠外营养（TPN）和强化口腔护理的需求；感染发生率；住院时间；以及总生存期。
所有级别OM的发生率没有显著差异，但接受帕利夫明治疗的患者严重OM的发生率降低（34%对80%，p < 0.0001）。在发生OM（所有级别）的患者中，接受帕利夫明治疗的患者OM的中位持续时间较短（13天对18天，p = 0.0001）；严重OM的中位持续时间没有差异。接受帕利夫明治疗的患者使用的阿片类药物较少，强化口腔护理的持续时间较短。TPN持续时间、感染发生率、住院时间和总生存期没有差异。
我们的研究结果表明，对于接受FTBI和依托泊苷预处理的allo-HSCT受者，使用帕利夫明有显著益处。帕利夫明有可能改善该患者群体的生活质量，并减少移植过程中的并发症和资源使用。需要进行一项随机临床试验来证实这些结果。
