背景:含沙利度胺的治疗方案会引起不良事件(AEs),这可能需要降低多发性骨髓瘤患者的治疗强度或甚至停止治疗。由于沙利度胺的毒性是剂量依赖性的,确定每位患者的最合适剂量至关重要。
目的:本研究旨在研究沙利度胺剂量递增策略对治疗反应和无进展生存期(PFS)的影响。
结果:这项前瞻性观察研究包括93例接受硼替佐米治疗的新诊断多发性骨髓瘤(NDMM)患者,沙利度胺,和地塞米松(VTD)。本研究评估了沙利度胺剂量减少和停药的发生率,总剂量强度,以及它们对治疗效果的影响。此外,本研究使用Cox比例风险模型分析了导致沙利度胺不能耐受的因素.结果显示,所有患者和可评价患者的总有效率分别为78.5%和98.7%,分别。未达到研究队列中的中位PFS。最常见的沙利度胺相关不良事件为便秘(32.3%)和皮疹(23.7%),导致剂量减少和停药率为22.6%和21.5%,分别。响应者的平均沙利度胺剂量强度明显高于无响应者(88.6%vs.42.9%,p<.001)。
结论:沙利度胺剂量递增方法对于接受VTD诱导治疗的NDMM患者是一种可行的选择,具有满意的疗效和耐受性。然而,沙利度胺不耐受可能导致剂量减少或因不可预测的不良事件而停药。导致较低的剂量强度和潜在较差的治疗结果。除了剂量增加策略,最佳支持治疗对于接受VTD诱导治疗的多发性骨髓瘤患者至关重要.
BACKGROUND: Thalidomide-containing regimens cause adverse events (AEs) that may require a reduction in treatment intensity or even treatment discontinuation in patients with multiple myeloma. As thalidomide toxicity is dose-dependent, identifying the most appropriate dose for each patient is essential.
OBJECTIVE: This
study aimed to investigate the effects of a
thalidomide dose step-up strategy on treatment response and progression-free survival (PFS).
RESULTS: This prospective observational
study included 93 patients with newly diagnosed multiple myeloma (NDMM) who received bortezomib, thalidomide, and dexamethasone (VTD). The present
study assessed the incidence of
thalidomide dose reduction and discontinuation, the overall dose intensity, and their effects on therapeutic efficacy. Furthermore, this
study used Cox proportional hazard models to analyze the factors contributing to
thalidomide intolerability. The results showed the overall response rates in all patients and the evaluable patients were 78.5% and 98.7%, respectively. The median PFS in the
study cohort was not reached. The most common thalidomide-related AEs were constipation (32.3%) and skin rash (23.7%), resulting in dose reduction and discontinuation rates of 22.6% and 21.5%, respectively. The responders had a significantly higher average thalidomide dose intensity than the nonresponders (88.6% vs. 42.9%, p < .001).
CONCLUSIONS: The thalidomide dose step-up approach is a viable option for patients with NDMM receiving VTD induction therapy with satisfactory efficacy and tolerability. However, thalidomide intolerance may lead to dose reduction or discontinuation due to unpredictable AEs, leading to lower dose intensity and potentially inferior treatment outcomes. In addition to a dose step-up strategy, optimal supportive care is critical for patients with multiple myeloma receiving VTD induction therapy.