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首页> 外文期刊>British journal of clinical pharmacology >High melphalan exposure is associated with improved overall survival in myeloma patients receiving high dose melphalan and autologous transplantation
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High melphalan exposure is associated with improved overall survival in myeloma patients receiving high dose melphalan and autologous transplantation

机译：高剂量美法仑暴露与接受高剂量美法仑和自体移植的骨髓瘤患者的整体生存率提高相关

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Aim High dose melphalan (HDM) and autologous stem cell transplantation (ASCT) retains a central role in the treatment of myeloma. The aim of this study was to determine whether HDM exposure (area under the concentration vs . time curve, AUC), is significantly associated with transplant outcomes. Methods Melphalan concentrations were measured in six to 11 plasma samples collected after HDM (median 192?mg?m–2) to determine melphalan AUC for a total of 114 patients. Binary logistic regression was used to assess whether melphalan AUC was associated with severe (≥ grade 3) oral mucositis. Multivariate Cox regression was used to assess whether melphalan AUC was significantly associated with time to progression, progression-free survival and overall survival (OS). Results Melphalan AUC ranged from 4.9 to 24.6?mg?l–1?h, median 12.84?mg?l–1 h. Melphalan AUC above the median was a risk factor for severe mucositis (HR 1.21, 95% CI 1.06, 1.38, P =?0.004) but was also associated with significantly improved overall survival (OS) (HR 0.40, 95% CI 0.20, 0.81, P =?0.001), with an estimated median survival of 8.50?years vs . 5.38?years for high vs . low AUC groups. Multivariate analysis did not identify melphalan AUC as being significantly associated with time to progression or progression-free survival. Conclusions This large scale pharmacodynamic analysis of HDM demonstrates that high melphalan exposure is associated with improved survival, with an acceptable increase in transplant toxicity. These results suggest studies targeting a higher AUC are warranted in patients undergoing HDM and ASCT for myeloma.
机译：目的高剂量美法仑（HDM）和自体干细胞移植（ASCT）在骨髓瘤的治疗中保持着核心作用。这项研究的目的是确定HDM暴露（浓度与时间曲线下的面积，AUC）是否与移植结果显着相关。方法对HDM采集的6至11份血浆样本（中位数192？mg？m – 2 ）中的美法仑浓度进行测定，以测定总共114例患者的美法兰AUC。二元逻辑回归用于评估美法仑AUC是否与严重（≥3级）口腔粘膜炎相关。多因素Cox回归用于评估美法仑AUC是否与进展时间，无进展生存期和总生存期（OS）显着相关。结果Melphalan AUC范围为4.9至24.6？mg？l –1 ？h，中位数为12.84？mg？l –1 h。 Melphalan AUC高于中位数是重度粘膜炎的危险因素（HR 1.21，95％CI 1.06，1.38，P =？0.004），但也与总体存活率（OS）显着改善有关（HR 0.40，95％CI 0.20，0.81 ，P =？0.001），估计中位生存期为8.50？年。高vs. 5.38年低AUC组。多变量分析未发现美法仑AUC与进展时间或无进展生存时间显着相关。结论这项对HDM的大规模药效学分析表明，高马法兰的暴露与改善的存活率相关，并且移植毒性增加可接受。这些结果表明，针对患有骨髓瘤的HDM和ASCT的患者，有必要针对更高的AUC进行研究。

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