Ramzi Mani, Vafaie Elaheh, Haghighinejad Hourvash, Imran Hashim
Hematology Research Center and Department of Bone Marrow Transplantation, Shiraz University of Medical Sciences, Shiraz, Iran.
Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.
Int J Hematol Oncol Stem Cell Res. 2023 Apr 1;17(2):106-113. doi: 10.18502/ijhoscr.v17i2.12647.
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. :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. 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%). Our study showed that modified BeEAM is a safe, effective, and feasible conditioning regimen for ASCT in lymphoma instead of the BEAM regimen.
大剂量化疗后进行自体干细胞移植(SCT)是复发难治性淋巴瘤的首选治疗方法。由于卡莫司汀的成本、毒性以及供应短缺,我们决定开展一项2期临床试验,以评估在先前使用的类似BEAM方案中用苯达莫司汀替代卡莫司汀的安全性和有效性。102例患者(中位年龄37岁),其中霍奇金淋巴瘤患者54例,非霍奇金淋巴瘤患者48例,在两个中心招募并接受移植。在采集干细胞后,对所有患者采用改良的BeEAM方案。计算两年时的总生存率和无病生存率(DFS)作为研究的主要终点。中性粒细胞和血小板恢复的中位时间分别为12天和13天,所有患者均实现造血重建。25例(24.5%)患者出现发热,仅有2例有记录的感染。仅有的3级毒性反应为粘膜炎(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(范围25 - 48)个月后,68例(66.6%)患者完全缓解,21例部分缓解,16例(15.6%)疾病进展,其中13例(12.7%)死亡。两年时的总生存率为102例中的89例(87.3%),DFS率为102例中的68例(66.7%)。我们的研究表明,改良的BeEAM方案对于淋巴瘤自体干细胞移植而言,是一种安全、有效且可行的预处理方案,可替代BEAM方案。