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