肿瘤细胞治疗研究
英文原题:Toxicity of a Modified PEG-Asparaginase-Based SMILE Regimen Is Comparable to L-Asparaginase-Based SMILE in a Non-Asian Population.
Toxicity of a Modified PEG-Asparaginase-Based SMILE Regimen Is Comparable to L-Asparaginase-Based SMILE in a Non-Asian Population.
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在非亚洲人群中,含 PEG-天冬酰胺酶的 mSMILE 方案是含 L-天冬酰胺酶的 SMILE 方案的安全替代选择。
回顾性筛查 Moffitt 癌症中心(MCC)数据库中 2009 年 12 月 1 日至 2021 年 7 月 30 日接受 mSMILE 化疗方案的所有成人患者。无论基础诊断如何,凡接受 mSMILE 者均纳入。使用不良事件通用术语标准(CTCAE)5.0 版评估毒性,并将 mSMILE 组毒性率与 SMILE 方案毒性荟萃分析数据(Pokrovsky 等,2019)进行数值比较。
在 12 年分析期间,MCC 共 21 例患者接受 mSMILE。与接受基于 L-天冬酰胺酶 SMILE 的患者相比,mSMILE 患者 3–4 级白细胞减少较少,毒性率为 62%(SMILE 中位数 85%;95% CI:74%–95%);但血小板减少更常见,毒性率为 57%(SMILE 中位数 48%;95% CI:40%–55%)。还报告了其他血液学、肝脏及凝血相关毒性。
在非亚洲人群中,采用 PEG-asparaginase 的 mSMILE 是基于 L-天冬酰胺酶 SMILE 方案的安全替代方案。血液学毒性风险相当,且本研究人群中未观察到治疗相关死亡。
We retrospectively identified all adult patients treated with the mSMILE chemotherapy regimen in our database at Moffitt Cancer Center (MCC) between December 1, 2009, and July 30, 2021. Patients were included if they were treated with mSMILE irrespective of their underlying diagnosis. Toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5. The rate of toxicity in our mSMILE treatment group was numerically compared to data published in a metanalysis of the SMILE regimen's toxicity (Pokrovsky et al., 2019).
A total of 21 patients were treated with mSMILE at MCC during the 12-year analysis window. Compared to patients receiving the L-asparaginase-based SMILE, patients receiving mSMILE experienced grade 3 or 4 leukopenia less often, with a toxicity rate of 62% (median with SMILE, 85% [95% CI, 74%-95%]); thrombocytopenia, however, was more common, with a toxicity rate of 57% (median with SMILE, 48% [95% CI, 40%-55%]). Other hematological, hepatic and coagulation related toxicities were also reported.
In a non-Asian population, the mSMILE regimen with PEG-asparaginase is a safe alternative to the L-asparaginase-based SMILE regimen. There is a comparable risk of hematological toxicity, and no treatment-related mortality was seen in our population.
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