评价改良beam(苯达莫司汀、依托泊苷、阿糖胞苷、美法兰)方案对复发或难治性淋巴瘤自体干细胞移植的疗效:来自发展中国家两个中心的经验。

Mani Ramzi, Elaheh Vafaie, Hourvash Haghighinejad, Hashim Imran
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引用次数: 0

摘要

背景:大剂量化疗后自体干细胞移植(SCT)是复发和难治性淋巴瘤的治疗选择。由于成本、毒性和卡莫司汀的短缺,我们决定进行一项2期临床试验,以评估苯达莫司汀代替卡莫司汀在先前使用的beam样方案中的安全性和有效性。材料和方法:招募102例霍奇金淋巴瘤(n=54)和非霍奇金淋巴瘤(n=48)患者,中位年龄37岁,在两个中心进行移植。干细胞收集后,对所有患者进行改良的beam方案。计算2年总生存期和无病生存期(DFS)作为研究的主要终点。结果:中位时间为12、13天后,观察到中性粒细胞和血小板恢复,所有患者均移植成功。25例(24.5%)出现发热,仅有2例有记录的感染。唯一的III级毒性是粘膜炎(20%)和恶心(15.6%)。100天后未观察到移植相关死亡率(TRM)。中位随访37个月(25-48个月)后,68例(66.6%)患者完全缓解,21例患者部分缓解,16例(15.6%)患者病情进展,其中13例(12.7%)患者死亡。2年OS (89 / 102, 87.3%), DFS(68 / 102, 66.7%)。结论:我们的研究表明,改良的BEAM是一种安全、有效、可行的治疗方案,可以替代BEAM方案治疗淋巴瘤ASCT。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Evaluating the Efficacy of Modified BeEAM(Bendamustine, Etoposide, Cytarabine, Melphalan) Regimen as Conditioning for Autologous Stem Cell Transplantation in Relapsed or Refractory Lymphoma: An Experience from Two Centers of a Developing Country.

Background: High-dose chemotherapy followed by Autologous SCT (stem cell transplantation) is a treatment of choice for relapsed and refractory lymphoma. Due to cost, toxicity, and shortage of Carmustine, we decided to conduct a phase 2 clinical trial to evaluate the safety and efficacy of Bendamustine instead of Carmustine in a previously used BEAM-like protocol. Materials and Methods:102 patients (median age,37) with Hodgkin(n=54) and non-Hodgkin lymphoma(n=48) were recruited and transplanted in two centers. After stem cell harvesting, a modified BeEAM regimen was administered to all the patients. Overall survival and disease-free survival (DFS) at two years were calculated as the study's primary endpoints. Results: Neutrophil and platelet recovery were observed after a median of 12 and 13 days, and all the patients were engrafted. Fever was observed in 25(24.5%) with only two documented infections. The only grade III toxicities were mucositis (20%) and nausea (15.6%). No transplant-related mortality (TRM) was observed after 100 days. After a median follow-up of 37(range 25-48) months, 68(66.6%) patients were in complete remission while 21 patients were in partial response, and 16 patients (15.6%) developed progressive disease, among which 13 (12.7%) had died. The OS at two years was (89 of 102, 87.3%), and the DFS rate was 68 of 102(66.7%). Conclusion: Our study showed that modified BeEAM is a safe, effective, and feasible conditioning regimen for ASCT in lymphoma instead of the BEAM regimen.

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来源期刊
CiteScore
1.30
自引率
0.00%
发文量
32
审稿时长
12 weeks
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