University Hospital Hôtel-Dieu, Nantes, France.
National and Kapodistrian University of Athens, Athens, Greece.
Eur J Haematol. 2017 Sep;99(3):199-206. doi: 10.1111/ejh.12903. Epub 2017 Jun 14.
Heavily pretreated patients with relapsed and refractory multiple myeloma are susceptible to treatment-related adverse events (AEs). Managing AEs are important to ensure patients continue therapy long enough to receive the best clinical benefit. Data from the MM-002, MM-003, and MM-010 trials were pooled to further characterize the safety profile of pomalidomide plus low-dose dexamethasone and AE management.
This analysis included 1088 patients who received ≥ 2 prior therapies, including lenalidomide and bortezomib, and progressed ≤ 60 days of last therapy. Patients received 28-day cycles of pomalidomide 4 mg/day on days 1-21 and low-dose dexamethasone 40 mg (20 mg if aged > 75 years) weekly until disease progression or unacceptable toxicity. Thromboprophylaxis was required.
The most common grade 3/4 AEs were neutropenia (56.2%), anemia (32.3%), and thrombocytopenia (25.8%), which occurred within the first few cycles of treatment. Grade 3/4 infections occurred in 33.7% patients, of whom 13.9% had pneumonia, and 40.3% had neutropenia. Pomalidomide dose reductions or interruptions were reported in 24.2% and 66.0% of patients, respectively. AEs were managed by dose modifications and/or supportive care.
Pomalidomide plus low-dose dexamethasone showed an acceptable safety profile, and AEs were well managed according to study protocols and established guidelines.
复发和难治性多发性骨髓瘤的大量预处理患者易发生与治疗相关的不良事件（AE）。管理 AE 对于确保患者继续治疗足够长的时间以获得最佳临床获益非常重要。来自 MM-002、MM-003 和 MM-010 试验的数据进行了汇总，以进一步描述泊马度胺联合低剂量地塞米松的安全性概况和 AE 管理。
这项分析包括 1088 名患者，他们接受了≥2 种先前的治疗，包括来那度胺和硼替佐米，并且在最后一次治疗后≤60 天进展。患者接受 28 天周期的泊马度胺 4mg/天，第 1-21 天和低剂量地塞米松 40mg（年龄>75 岁时为 20mg），每周一次，直到疾病进展或无法耐受毒性。需要进行血栓预防。
最常见的 3/4 级 AE 是中性粒细胞减少症（56.2%）、贫血（32.3%）和血小板减少症（25.8%），这些情况发生在治疗的前几个周期内。3/4 级感染发生在 33.7%的患者中，其中 13.9%有肺炎，40.3%有中性粒细胞减少症。分别有 24.2%和 66.0%的患者报告了泊马度胺剂量减少或中断。AE 通过剂量调整和/或支持性治疗进行管理。
泊马度胺联合低剂量地塞米松的安全性特征可接受，AE 根据研究方案和既定指南得到了很好的管理。
