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培洛昔福联合粒细胞集落刺激因子治疗非霍奇金淋巴瘤和多发性骨髓瘤患者:长期随访报告。

Plerixafor Plus Granulocyte Colony-Stimulating Factor for Patients with Non-Hodgkin Lymphoma and Multiple Myeloma: Long-Term Follow-Up Report.

机构信息

Division of Hematology, Mayo Clinic, Rochester, Minnesota.

Division of Hematology/Oncology, Loyola University, Chicago, Illinois.

出版信息

Biol Blood Marrow Transplant. 2018 Jun;24(6):1187-1195. doi: 10.1016/j.bbmt.2018.01.039. Epub 2018 Feb 2.

Abstract

The purpose of this report is to analyze long-term clinical outcomes of patients exposed to plerixafor plus granulocyte colony-stimulating factor (G-CSF) for stem cell mobilization. This was a study of patients with non-Hodgkin lymphoma (NHL; n = 167) and multiple myeloma (MM; n = 163) who were enrolled in the long-term follow-up of 2 pivotal phase III studies (NCT00741325 and NCT00741780) of 240 µg/kg plerixafor plus 10 µg/kg G-CSF, or placebo plus 10 µg/kg G-CSF to mobilize and collect CD34 cells for autologous hematopoietic stem cell transplantation. Overall survival (OS) and progression-free survival (PFS) were evaluated over a 5-year period following the first dose of plerixafor or placebo. The probability of OS was not significantly different in patients with NHL or MM treated with plerixafor or placebo (NHL: 64%; 95% confidence interval [CI], 56% to 71% versus 56%; 95% CI, 44% to 67%, respectively; MM: 64%; 95% CI, 54% to 72% versus 64%; 95% CI, 53% to 73%, respectively). In addition, there was no statistically significant difference in the probability of PFS over 5 years between treatment groups in patients with NHL (50%; 95% CI, 44% to 67% for plerixafor versus 43%; 95% CI, 31% to 54% for placebo) or those with MM (17%; 95% CI, 10% to 24% for plerixafor versus 30%; 95% CI, 21% to 40% for placebo). In this long-term follow-up study, the addition of plerixafor to G-CSF for stem cell mobilization did not affect 5-year survival in patients with NHL or patients with MM.

摘要

本报告的目的是分析接受培洛昔芳联合粒细胞集落刺激因子(G-CSF)进行干细胞动员的患者的长期临床结局。这是一项针对非霍奇金淋巴瘤(NHL;n=167)和多发性骨髓瘤(MM;n=163)患者的研究,这些患者参加了两项关键性 III 期研究(NCT00741325 和 NCT00741780)的长期随访,这些研究中患者接受了 240µg/kg 培洛昔芳联合 10µg/kg G-CSF,或安慰剂联合 10µg/kg G-CSF 进行干细胞动员和采集 CD34 细胞用于自体造血干细胞移植。在接受培洛昔芳或安慰剂治疗的患者中,在首次接受培洛昔芳或安慰剂后 5 年内评估总生存期(OS)和无进展生存期(PFS)。接受培洛昔芳或安慰剂治疗的 NHL 或 MM 患者的 OS 概率无显著差异(NHL:64%;95%置信区间[CI],56%至 71%比 56%;95%CI,44%至 67%;MM:64%;95%CI,54%至 72%比 64%;95%CI,53%至 73%)。此外,在 NHL 患者中(培洛昔芳组 5 年 PFS 概率为 50%;95%CI,44%至 67%,安慰剂组为 43%;95%CI,31%至 54%)和 MM 患者中(培洛昔芳组 5 年 PFS 概率为 17%;95%CI,10%至 24%,安慰剂组为 30%;95%CI,21%至 40%),5 年内 PFS 概率在接受培洛昔芳和 G-CSF 联合治疗与接受安慰剂和 G-CSF 联合治疗的患者之间也无统计学显著差异。在这项长期随访研究中,培洛昔芳联合 G-CSF 进行干细胞动员并未影响 NHL 或 MM 患者 5 年生存率。

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