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首页> 外文期刊>EBioMedicine >A Phase II Study of Methotrexate, Etoposide, Dexamethasone and Pegaspargase Sandwiched with Radiotherapy in the Treatment of Newly Diagnosed, Stage IE to IIE Extranodal Natural-Killer/T-Cell Lymphoma, Nasal-Type
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A Phase II Study of Methotrexate, Etoposide, Dexamethasone and Pegaspargase Sandwiched with Radiotherapy in the Treatment of Newly Diagnosed, Stage IE to IIE Extranodal Natural-Killer/T-Cell Lymphoma, Nasal-Type

机译：甲氨蝶呤，依托泊苷，地塞米松和Pegaspargase夹心放疗的II期研究，用于治疗新诊断的IE到IIE结外型自然杀手/ T细胞淋巴瘤（鼻型）

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Background A phase II study of methotrexate, etoposide, dexamethasone, and pegaspargase (MESA) sandwiched with radiotherapy for newly diagnosed, stage IE-IIE extranodal natural-killer/T-cell lymphoma, nasal-type (ENKTL) was conducted to explore its clinical efficacy and safety, as well as novel serum biomarkers upon anti-metabolic treatment. Methods Four cycles of MESA sandwiched with radiotherapy were administered. The primary end point was the overall response rate (ORR). Serum metabolomic profiles were assessed by liquid chromatography-mass spectrometry, with specific metabolites quantified by targeted metabolic analysis. Findings Forty patients were enrolled and the ORR was 92.1% (95%CI, 83.1%–100.0%). The 2-year progression-free survival (PFS) rate was 89.1% and overall survival (OS) rate was 92.0%. Grade 3/4 non-hematologic and hematologic toxicities were observed in 17 (42.5%) and 26 patients (65·0%) during chemotherapy, and in 9 (22.5%) and 0 (0.0%) patients during radiotherapy, respectively. Fifty-six significantly decreased and 59 increased metabolites were identified in ENKTL, as compared to healthy volunteers. A predictive principal components analysis model of asparaginase-associated metabolites, asparaginase-associated metabolic score (AspM), was established, including alanine, aspartate, glutamate, and succinic acid. Patients with high AspM score displayed superior survival and prognostic significance of AspM was validated in a historical cohort of early and advanced-stage ENKTL treated with asparaginase-based regimens. Multivariate analysis confirmed AspM as a prognostic score independent of PINK and PINK combined with Epstein-Barr virus DNA. Interpretation MESA sandwiched with radiotherapy is an effective and safe regimen for early-stage ENKTL. AspM score may be a promising prognostic index of serum metabolites in addition to clinical prognostic index in ENKTL.
机译：背景甲氨蝶呤，依托泊苷，地塞米松和培加斯加酶（MESA）联合放疗用于新诊断的IE-IIE期结外自然杀伤/ T细胞鼻腔淋巴瘤（ENKTL）的II期研究进行了临床研究功效和安全性，以及抗代谢治疗后的新型血清生物标志物。方法进行四轮MESA放疗治疗。主要终点是总体缓解率（ORR）。通过液相色谱-质谱法评估血清代谢组学特征，并通过靶向代谢分析对特定代谢产物进行定量。结果纳入40例患者，ORR为92.1％（95％CI，83.1％–100.0％）。 2年无进展生存（PFS）率为89.1％，总生存（OS）率为92.0％。在化疗期间分别观察到3/4级非血液学和血液学毒性，分别为17例（42.5％）和26例患者（65·0％），以及9例（22.5％）和0例（0.0％）患者。与健康志愿者相比，ENKTL中有56项显着减少，代谢物增加了59种。建立了与天冬酰胺酶相关代谢产物，天冬酰胺酶相关代谢评分（AspM）的预测性主成分分析模型，包括丙氨酸，天冬氨酸，谷氨酸和琥珀酸。 AspM评分高的患者显示出优越的生存率，AspM的预后意义在以天冬酰胺酶为基础的方案治疗的早期和晚期ENKTL的历史队列中得到了验证。多变量分析证实AspM是独立于PINK和PINK结合爱泼斯坦-巴尔病毒DNA的预后评分。解释MESA与放疗夹心是早期ENKTL的有效和安全方案。除ENKTL的临床预后指标外，AspM评分可能是血清代谢产物的有希望的预后指标。

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