Phase II trial of a transplantation regimen of yttrium-90 ibritumomab tiuxetan and high-dose chemotherapy in patients with non-Hodgkin's lymphoma
Phase II trial of a transplantation regimen of yttrium-90 ibritumomab tiuxetan and high-dose chemotherapy in patients with non-Hodgkin's lymphoma
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DOI：
10.1200/jco.2007.11.9248
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发表时间：
2008-01-01
影响因子：
45.3
通讯作者：
Forman, Stephen J.
中科院分区：
文献类型：
--
作者：
Krishnan, Amrita;Nademanee, Auayporn;Forman, Stephen J.
目的 本 II 期试验评估了钇 90 (90Y) ibritumomab tiuxetan 与高剂量卡莫司汀、阿糖胞苷、依托泊苷和美法仑 (BEAM) 联合治疗以及自体干细胞移植治疗因年龄较大或既往放疗而被认为不适合全身照射的非霍奇金淋巴瘤患者的安全性和有效性。 2002 年 5 月期间的患者和方法2006 年 1 月，自体干细胞移植前 14 天，41 名非霍奇金淋巴瘤患者接受标准剂量 90Y ibritumomab tiuxetan (14.8 MBq/kg [0.4 mCi/kg])，随后接受高剂量 BEAM。 结果 中位年龄为 60 岁（范围，19 至 78 岁），既往治疗次数中位为 2 次（范围，一到六）。疾病组织学为弥漫性大 B 细胞 (n = 20)、套细胞 (n = 13)、滤泡性 (n = 4) 和转化性淋巴瘤 (n = 4)。中位随访时间为 18.4 个月（范围为 5.5 至 53.3 个月），预计 2 年总体生存率和无进展生存率分别为 88.9%（95% CI，75.3% 至 95.2%）和 69.8%（95% CI，56.4% 至 79.7%）。白细胞植入的中位时间为 11 天（范围为 9 至 26 天），血小板植入的时间为 12 天（范围为 3 至 107 天）。不良事件与历史上单独使用高剂量 BEAM 所见的不良事件相似，包括 10 名患者出现 3 级或 4 级肺毒性。 结论 在自体干细胞移植的高剂量 BEAM 中添加 90Y ibritumomab tiuxetan 是可行的，并且具有与单独使用 BEAM 观察到的相似的毒性和耐受性特征。这些患者的无进展生存率是有希望的，值得进一步研究。
Purpose This phase II trial evaluated the safety and efficacy of combining yttrium-90 (90Y) ibritumomab tiuxetan with high-dose carmustine, cytarabine, etoposide, and melphalan (BEAM) and autologous stem-cell transplantation in patients with non-Hodgkin's lymphoma who were considered ineligible for total-body irradiation because of older age or prior radiotherapy.Patients and Methods Between May 2002 and January 2006, 14 days before autologous stem-cell transplantation, 41 patients with non-Hodgkin's lymphoma received standard-dose 90Y ibritumomab tiuxetan (14.8 MBq/kg [0.4 mCi/kg]) followed by high-dose BEAM.Results The median age was 60 years (range, 19 to 78 years), and the median number of previous therapies was two ( range, one to six). Disease histologies were diffuse large B-cell (n = 20), mantle cell (n = 13), follicular (n = 4), and transformed lymphoma (n = 4). With a median follow-up of 18.4 months (range, 5.5 to 53.3 months) the estimated 2-year overall and progression-free survival were 88.9% (95% CI, 75.3% to 95.2%) and 69.8% ( 95% CI, 56.4% to 79.7%). The median time to WBC engraftment was 11 days (range, 9 to 26 days) and time to platelet engraftment was 12 days (range, 3 to 107 days). Adverse events were similar to those seen historically with high-dose BEAM alone, and included grade 3 or 4 pulmonary toxicity in 10 patients.Conclusion Adding 90Y ibritumomab tiuxetan to high-dose BEAM with autologous stem-cell transplantation is feasible and has a toxicity and tolerability profile similar to that observed with BEAM alone. Rates of progression-free survival seen in these patients are promising and warrant additional study.