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BeEAM(苯达莫司汀、依托泊苷、阿糖胞苷、美法仑)与 CEM(卡铂、依托泊苷、美法仑)作为淋巴瘤患者自体造血细胞移植前的预处理方案的临床和安全性结果。

Clinical and safety outcomes of BeEAM (Bendamustine, Etoposide, Cytarabine, Melphalan) versus CEM (Carboplatin, Etoposide, Melphalan) in lymphoma patients as a conditioning regimen before autologous hematopoietic cell transplantation.

机构信息

Senior Clinical Pharmacist in Hematology, Oncology, and Stem Cell Transplantation at International Medical Center (IMC) Hospital, Clinical pharmacy & pharmacy practice master candidate at Faculty of pharmacy, Damanhour University, Cairo, Egypt.

Clinical Pharmacy & Pharmacy Practice Department, Faculty of Pharmacy, Damanhour University, Damanhour, 22514, Egypt.

出版信息

BMC Cancer. 2024 Aug 13;24(1):1002. doi: 10.1186/s12885-024-12694-9.

Abstract

BACKGROUND

Autologous stem cell transplantation (ASCT) is a pivotal treatment for lymphoma patients. The BeEAM regimen (Bendamustine, Etoposide, Cytarabine, Melphalan) traditionally relies on cryopreservation, whereas the CEM regimen (Carboplatin, Etoposide, Melphalan) has been optimized for short-duration administration without the need for cryopreservation. This study rigorously compares the clinical and safety profiles of the BeEAM and CEM regimens.

METHODS

A controlled, randomized clinical trial was conducted with 58 lymphoma patients undergoing ASCT at the International Medical Center (IMC) in Cairo, Egypt. Patients were randomly assigned to either the BeEAM (n = 29) or CEM (n = 29) regimen, with an 18-month follow-up period. Clinical and safety outcomes were meticulously compared, focusing on time to engraftment for neutrophils and platelets, side effects, length of hospitalization, transplant-related mortality (TRM), and survival rates.

RESULTS

The findings demonstrate a significant advantage for the CEM regimen. Neutrophil recovery was markedly faster in the CEM group, averaging 8.5 days compared to 14.5 days in the BeEAM group (p < 0.0001). Platelet recovery was similarly expedited, with 11 days in the CEM group versus 23 days in the BeEAM group (p < 0.0001). Hospitalization duration was substantially shorter for CEM patients, averaging 18.5 days compared to 30 days for those on BeEAM (p < 0.0001). Furthermore, overall survival (OS) was significantly higher in the CEM group at 96.55% (95% CI: 84.91-99.44%) compared to 79.31% (95% CI: 63.11-89.75%) in the BeEAM group (p = 0.049). Progression-free survival (PFS) was also notably superior in the CEM group, at 86.21% (95% CI: 86.14-86.28%) versus 62.07% (95% CI: 61.94-62.20%) in the BeEAM group (p = 0.036).

CONCLUSION

The CEM regimen might demonstrate superiority over the BeEAM regimen, with faster neutrophil and platelet recovery, reduced hospitalization time, and significantly improved overall and progression-free survival rates. Future studies with longer duration and larger sample sizes are warranted.

TRIAL REGISTRATION

This study is registered on ClinicalTrials.gov under the registration number NCT05813132 ( https://clinicaltrials.gov/ct2/show/NCT05813132 ). (The first submitted registration date: is March 16, 2023).

摘要

背景

自体干细胞移植(ASCT)是淋巴瘤患者的重要治疗方法。BeEAM 方案(苯达莫司汀、依托泊苷、阿糖胞苷、马法兰)传统上依赖于冷冻保存,而 CEM 方案(卡铂、依托泊苷、马法兰)经过优化,可在无需冷冻保存的情况下短时间给药。本研究严格比较了 BeEAM 和 CEM 方案的临床和安全性特征。

方法

在埃及开罗的国际医疗中心(IMC)对 58 例接受 ASCT 的淋巴瘤患者进行了一项对照、随机临床试验。患者被随机分配到 BeEAM(n=29)或 CEM(n=29)方案组,随访期为 18 个月。精心比较了临床和安全性结局,重点关注中性粒细胞和血小板的植入时间、副作用、住院时间、移植相关死亡率(TRM)和生存率。

结果

研究结果表明 CEM 方案具有显著优势。CEM 组中性粒细胞恢复明显更快,平均为 8.5 天,而 BeEAM 组为 14.5 天(p<0.0001)。血小板恢复也同样加快,CEM 组为 11 天,BeEAM 组为 23 天(p<0.0001)。CEM 组患者的住院时间明显缩短,平均为 18.5 天,而 BeEAM 组为 30 天(p<0.0001)。此外,CEM 组的总生存率(OS)显著更高,为 96.55%(95%CI:84.91-99.44%),而 BeEAM 组为 79.31%(95%CI:63.11-89.75%)(p=0.049)。CEM 组的无进展生存率(PFS)也明显更高,为 86.21%(95%CI:86.14-86.28%),而 BeEAM 组为 62.07%(95%CI:61.94-62.20%)(p=0.036)。

结论

CEM 方案可能优于 BeEAM 方案,具有更快的中性粒细胞和血小板恢复、缩短住院时间以及显著提高总生存率和无进展生存率。需要进行更长时间和更大样本量的后续研究。

试验注册

本研究在 ClinicalTrials.gov 上注册,注册号为 NCT05813132(https://clinicaltrials.gov/ct2/show/NCT05813132)。(首次提交注册日期:2023 年 3 月 16 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3bbf/11320894/7182e141d772/12885_2024_12694_Fig1_HTML.jpg

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