背景:自体干细胞移植(ASCT)是淋巴瘤患者的关键治疗方法。BeEAM方案(苯达莫司汀,依托泊苷,阿糖胞苷,美法伦)传统上依赖于冷冻保存,而CEM方案(卡铂,依托泊苷,美法仑)已针对短期给药进行了优化,而无需冷冻保存。这项研究严格比较了BeEAM和CEM方案的临床和安全性。
方法:A控制,在开罗的国际医学中心(IMC)对58名接受ASCT的淋巴瘤患者进行了随机临床试验,埃及。患者被随机分配到BeEAM(n=29)或CEM(n=29)方案,随访18个月。仔细比较了临床和安全性结果,专注于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),和存活率。
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,与BeEAM组的14.5天相比,平均8.5天(p<0.0001)。血小板恢复同样加快,CEM组11天对BeEAM组23天(p<0.0001)。CEM患者的住院时间大大缩短,与服用BeEAM的30天相比,平均18.5天(p<0.0001)。此外,CEM组的总生存率(OS)为96.55%(95%CI:84.91~99.44%),高于BeEAM组的79.31%(95%CI:63.11~89.75%)(p=0.049).CEM组的无进展生存期(PFS)也明显优于CEM组,在86.21%(95%CI:86.14-86.28%)和62.07%(95%CI:61.94-62.20%)的BeEAM组(p=0.036)。
结论:CEM方案可能显示优于BeEAM方案,中性粒细胞和血小板恢复更快,缩短住院时间,并显著提高总体生存率和无进展生存率。未来的研究需要更长的持续时间和更大的样本量。
背景: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)。
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).
CONCLUSIONS: 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.
BACKGROUND: 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).