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首页> 外文期刊>Clinical lymphoma & myeloma >A pharmacokinetic study evaluating the relationship between treatment efficacy and incidence of adverse events with thalidomide plasma concentrations in patients with refractory multiple myeloma
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A pharmacokinetic study evaluating the relationship between treatment efficacy and incidence of adverse events with thalidomide plasma concentrations in patients with refractory multiple myeloma

机译：药物动力学研究评估难治性多发性骨髓瘤患者治疗功效与沙利度胺血浆浓度不良事件发生率之间的关系

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Background: Multiple myeloma (MM) is a clonal disorder of plasma cells, accounting for 10% of hematologic malignancies. Relapsed or refractory MM has a poor prsognosis. Thalidomide has been reported to be effective for these patients; however, high-dose thalidomide has induced many adverse events, including in the nervous, gastrointestinal, and hematopoietic systems in approximately 20%-50% of patients. Recently, low-dose thalidomide therapy has been used in many countries in order to reduce these adverse events. The objective of this study was to determine whether plasma concentration of thalidomide is related to the efficacy and the development of adverse events in patients with refractory MM treated with low-dose thalidomide plus low-dose dexamethasone. Patients and Methods: A total of 66 patients (age range, 40-74 years) presenting with progressive disease after previous treatments were treated with low-dose thalidomide and low-dose dexamethasone. Thalidomide was administered orally at 100 mg/day for the first week. When severe adverse events did not develop, the dose was increased to 200 mg/day in the second week and was continued until progression. Dexamethasone was administered at a dose of 4 mg/day for the first 4 weeks, then decreased by 1 mg every week, and finally maintained at 1 mg/day. Plasma trough concentration of thalidomide 3 days after thalidomide treatment was analyzed by high-performance liquid chromatography in 45 patients (age range, 42-74 years) who agreed to participate in this study of thalidomide concentration analysis. Results: The mean concentrations at 100 mg/day and 200 mg/day were 0.343 μg/mL (range, 0.05-1.45 μg/mL) and 0.875 μg/mL (range, 0.19-2.09 μg/mL), respectively. The overall response rate (near-complete response + partial response + minimal response) of this treatment was 73%. Five had stable disease, and 3 patients experienced progressive disease. There was no relationship between the concentration of thalidomide in the plasma and the efficacy (P > .8). Severe adverse events, including grade > 2 nonhematologic and grade > 3 hematologic adverse events, were observed in 21 patients (46.6%). There was no significant difference in the concentration of thalidomide between the patients with and without severe adverse events (P > .843). Conclusion: The thalidomide concentration in the plasma does not predict treatment efficacy and the development of adverse events.
机译：背景：多发性骨髓瘤（MM）是浆细胞的克隆性疾病，占血液系统恶性肿瘤的10％。复发或难治性MM的预后较差。据报道沙利度胺对这些患者有效。但是，大剂量沙利度胺已引起许多不良事件，包括约20％-50％的患者的神经，胃肠道和造血系统不良事件。最近，在许多国家已经使用了低剂量的沙利度胺疗法，以减少这些不良事件。这项研究的目的是确定沙利度胺的血浆浓度是否与低剂量沙利度胺加低剂量地塞米松治疗的难治性MM患者的疗效和不良事件的发展有关。患者和方法：总共66例（年龄范围为40-74岁）在先前治疗后出现进行性疾病的患者接受低剂量沙利度胺和低剂量地塞米松治疗。第一周以100毫克/天的剂量口服他利度胺。当没有发生严重的不良事件时，在第二周将剂量增加至200 mg / day，并一直持续到病情进展。在最初的4周中，地塞米松的剂量为4 mg /天，然后每周减少1 mg，最后维持在1 mg /天。应用高效液相色谱分析了沙利度胺治疗3天后沙利度胺的血浆谷浓度，该患者同意参加该沙利度胺浓度分析研究的45例患者（年龄范围42-74岁）。结果：100 mg / day和200 mg / day的平均浓度分别为0.343μg/ mL（范围0.05-1.45μg/ mL）和0.875μg/ mL（范围0.19-2.09μg/ mL）。该治疗的总缓解率（接近完全缓解+部分缓解+最小缓解）为73％。 5例疾病稳定，3例患者进行性疾病。血浆中沙利度胺的浓度与疗效之间没有关系（P> .8）。在21例患者中观察到了严重不良事件，包括> 2级非血液学不良事件和> 3级血液学不良事件（46.6％）。在有和没有严重不良事件的患者之间，沙利度胺的浓度没有显着差异（P> .843）。结论：血浆中沙利度胺的浓度不能预测治疗效果和不良事件的发生。

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